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Morpho-anatomy of leaf, stem and root of Alternanthera sessilis (L.) R. Br. ex DC and Alternanthera pungens Kunth (Amaranthaceae) and its
significance in drug identification
H C Gupta et al
ORIGINAL ARTICLE
Morpho-anatomy of leaf, stem and root of Alternanthera sessilis (L.) R. Br. ex DC
and Alternanthera pungens Kunth (Amaranthaceae) and its significance in drug
identification
H.C. Gupta1, J. Raj2, A. Rathi3*, E. N. Sundaram3, S. Kumar3 and R.K. Manchanda1
1 Central
Council for Research in Homoeopathy, New Delhi
H-58, South Extn, New Delhi
3 Central Research Institute (H), Noida
2
The present communication deals with morpho-anatomical characters of leaf, stem and root of
Alternanthera sesilis and Alternanthera pungens and its signifinace in identification and differentiation
of raw drug originated from these species. The plant characters of diagnostic importance are for
example colour of stem is green in Alternanthera sesilis and brown in Alternanthera pungens; flower
of Alternanthera sesilis possess three stamens while Alternanthera pungens possess five stamens.
The study will be useful in confirming the authenticity of raw drug and also serve as a reference for
advanced studies of these two such closely related species.
Keywords: Alternanthera sessilis; Alternanthera pungens; pharmacognosy.
Roxb.), commonly known as ‘matsyakshi’ in Hindi, is a
small prostrate herb with several spreading branches
bearing short petiolate, simple leaves and small white
flowers. It grows throughout the warmer parts of India
and is frequently found in wet places especially around
tanks and ponds.2-7 In indigenous systems of medicine,
it is used as a galactagogue, cholagogue, febrifuge
and “cure” for snake bite.2,6,8,9 The plant is reported to
have hydrocarbons, enecycloartanol, cycloecucalenol,
stigmasterol, campesterol, β-sistosterol, α-spinasterol,
oleanolic acid rhamnoside, 24-methylene cycloartenol,
cycloeucarlenol, lupeol, 5-α-stigmasta-7-enol, and
its palmitate, nonacosane, 16-hentriacontane, and
handianol.2
Introduction
The genus Alternanthera (family Amaranthaceae)
includes approximately 80 species, native to tropical
and sub-tropical regions of Australia and South
America1. In India, five species have been recorded,
out of which Alternanthera sessilis (L.) R. Br. ex DC and
Alternanthera pungens Kunth are utilized extensively
as raw drug sources worldwide in many traditional
systems of medicine.1,2 As drugs are collected by
traditional practitioners who have inherited herbal
practices by tradition, the identification is mostly
based on morphological features or other artificial and
traditionally known characteristics. However, in such
cases, there is a chance of misidentification resulting
in spurious quality of medicine. Therefore, it is essential
that anatomical details of authentic drug material should
be prepared as diagnostic characters in identification
and differentiation between closely related species to
avoid any ambiguity.3
Alternanthera pungens (Syn. Alternanthera repens
L.), commonly called as ‘Chaff-flower’ or ‘khaki-weed’
is a creeping herb, with small paired leaves, bearing
flowers with whitish bracts in small cylindrical or almost
round heads. It is native to South Carolina to Florida
and California, widely spreading on road sides and in
waste places.11 In India, it was introduced during in
1918 and the first report of its occurrence was from
southern India.12 The plant is reported to contain
azulene, borneol, camphene, eudesmol, geraniol,
limonene, linalool, pinene, terpineol and thujone. 13 It
is said to possess diuretic properties and its decoction
is taken in gonorrhoea.14,15 In Homoeopathic system
of medicine the drug was proved by Dr. Manuel M. De
Alternanthera sessilis (Syn. Alternanthera triandra
Lam., Alternanthera prostrata Don., Achyranthus triandra
*Address for correspondence:
Dr. Anshu Rathi, Senior Research Fellow (H)
Central Research Institute (H),
A1/1 sector 24, Noida-201 301, Uttar Pradesh,
Email: [email protected]
Received : 30th August 2012
Accepted : 29th January 2013
1
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
Morpho-anatomy of leaf, stem and root of Alternanthera sessilis (L.) R. Br. ex DC and Alternanthera pungens Kunth (Amaranthaceae) and its
significance in drug identification
H C Gupta et al
Legarreta of Mexico, in 1911 and found mention in the
Homoeopathic Pharmacopoeia of United States under
official name Paronichia illeceberum.16,17
In view of the medicinal uses of Alternanthera
sessilis and Alternanthera pungens, an attempt is made
to study morpho-anatomical data of the leaf, stem and
root which would provide data for differentiation and
identification of these two closely related species.
Materials and Methods
The plant materials, obtained from Survey of
Medicinal Plants & Collection Unit, Nilgiris District,
Tamil Nadu, India, were preserved in F.A.A. and used
for anatomical studies following the method of Wallis.18
Epidermal peels were taken by scraping with razor
blade. Free hand sections were cut, stained in safraninfast green combination, mounted and subjected for
microscopical studies by following the method of
Johansen.19
Fig. 1B: Adaxial surface view of leaf
seen on both surfaces (Fig. 1C), the later type is
predominant on the abaxial surface. Trichomes are of
two types: (a) multicellular, non-glandular, uniseriate
with characteristic interlocking cells and (b) capitate
trichomes having 3-4 celled stalk and unicellular,
Observations
External morphology: Leaf: green, simple,
sessile, 1.3-7.5 cm long, 0.3-2.0 cm broad, linear,
oblong or elliptic, obtuse or subacute, tapering towards
the base. Stem: yellowish-brown to light-brown,
cylindrical, occasionally sub-quadrangular, fracture
short. Root: creamish to grey, cylindrical, 1-6 mm in
diameter, numerous roots arising from the main tap
root as lateral rootlets; fracture short.
Fig. 1C: Anomocytic & Diacytic Stomata
spherical ellipsoid head. Both types of trichomes are
covered with a conspicuous papillose cuticle (Fig. 1D,
E). On the epidermis, the trichome detachment areas
are distinguishable. Transverse section of leaf through
midrib shows single layer of upper epidermis and double
Fig. 1A: Alternanthera sessilis : Whole plant
Anatomy
Leaf: The adaxial surface shows polygonal
epidermal cells and abaxial cells are sinuous (Fig.
1B) with rosette aggregates of calcium oxalate
crystals. Anomocytic and diacytic stomata are
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
Fig. 1D: Trichomes
2
Morpho-anatomy of leaf, stem and root of Alternanthera sessilis (L.) R. Br. ex DC and Alternanthera pungens Kunth (Amaranthaceae) and its
significance in drug identification
H C Gupta et al
Vascular bundles are conjoint, collateral arranged in a
ring. Each vascular bundle is encapped by a patch of
pericyclic fibres. Pith is wide and consists of thin-walled
large parenchymatous cells. Idioblast containing druses
are found in the cortex and in the pith (Fig.1G).
Fig. 1E: Trichomes
layer of lower epidermis covered with a smooth and
thin cuticle. Mesophyll is dorsiventral and consists of
a single layer of palisade parenchyma and about four
layers of spongy parenchyma, the latter occupy 50-60%
of the mesophyll. Idioblasts with druses are prominent
in the palisade parenchyma. Both upper and lower
epidermis is underlain by 4-5 layers of chlorenchyma.
The midrib, in transverse section, shows a biconvex
shape, prominent on the abaxial face followed by 3-4
layers of angular collenchyma on the adaxial side and
4-7 on the opposite side. Collateral vascular bundles,
accompanied by thick-walled parenchymatous cells
adjoining the phloem, are embedded in the ground
parenchyma. These vascular bundles vary in number
and arrangement, from the crescent-shaped central
vascular bundle (Fig 1F).
Fig. 1G: TS of stem
ep-Epidermis, col-Collenchyma, ph-Ploem,
xy-xylem, pi-Pith
Root: The root in a transverse section shows
circular outline. The cork is composed of 4-5 layers
of tangentially elongated suberised rectangular
cells followed by 4-5 layers of loosely arranged
parenchymatous cortex. Pericycle and endodermis are
indistinct. Phloem is narrow and consists of phloem
fibres, sieve tubes, companion cells and phloem
parenchyma. Xylem is composed of radially arranged
tracheary elements. Xylem is exarch, and consists
of vessels, tracheids, fibres and xylem parenchyma
(Fig.1H, Table.1).
Fig. 1F: TS of leaf
Cu-Cuticle, Col-Collenchyma, up-Upper epidermis,
pal-Palisade, xy-Xylem, ph-Phloem
Stem: The stem in transverse section shows
circular outline. The epidermis is single-layered and
consists of polygonal cells. The trichomes present on
the stem are non-glandular. The cortex is composed of
6-7 layers of loosely arranged parenchymatous cells
with alternate strands of chlorenchyma and angular
collenchyma. In the vascular cylinder the first cambium
forms phloem centrifugally and xylem centripetally.
Fig. 1H: TS of root
ck-Cork, ct-Cortex, pxy-Primary xylem, v-Vessel
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Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
Morpho-anatomy of leaf, stem and root of Alternanthera sessilis (L.) R. Br. ex DC and Alternanthera pungens Kunth (Amaranthaceae) and its
significance in drug identification
H C Gupta et al
Table 1: Diagnostic features of two Alternanthera species: Alternanthera sessilis and Alternanthera pungens
Parts
Stem
Leaves
Flowers
Perianth
Androecium
Alternanthera sessilis
Alternanthera pungens
Macroscopic characters
Prostrate, cylindrical but slightly ridged, Similar but, stem clothed with
branched, solid, green.
shaggy hair and brown.
Opposite, linear – lanceolate, oblong or ovate, Opposite pairs unequal, obtuse,
sessile, exstipulate, margin entire, measuring entire, tapering at the base, orbicular
up to 20mm long and 8 mm broad.
or ovately orbicular, measuring up
to 35mm long 28 mm broad.
Bracteoles scarious.
Bracteoles with spinscent awns.
Lobes 5, 2.5-3 mm long, segments not spine- Tepals very dissimilar, glochidiate
tipped.
hair present, outer 2 tepals similar
to spinscent bract, 2 innermost
deeply keeled concave, hairy on
the back becoming spiny
Stamens 3.
Stamens 5.
F r u i t s a n d Utricle with winged margins.
seeds
Seed, suborbicular.
Utricle.
Seeds round and brownish.
Microscopic characters
Leaf:
Stomata
Trichomes
Epidermis
Midrib
Anomocytic and diacytic on both surfaces,
although the later type is predominant on the
abaxial face.
Non glandular uniseriate with characteristic
interlocking cells; multicellular with 3-4 celled;
glandular, capitate, 3-4 celled stalk and
unicellular, spherical ellipsoid head all coated
with a conspicuous papillose cuticle
Only anomocytic stomata are seen
on both surfaces
Non glandular uniseriate to
multicellular trichomes with
characteristic interlocking cells;
all coated with a conspicuous
papillose cuticle, glandular type of
trichomes absent.
Uniseriate layer of upper epidermis while Uniseriate layer of on both the
biseriate layer of lower epidermis
surface
Palisade parenchyma single layer and 4 Palisade parenchyma and about 3
layers of spongy parenchyma.
layers of spongy parenchyma.
Stem:
Cortex
Root:
Cortex
Vascular
bundle
6-7 layer of loosely arranged, oval to circular 2 - 6 l a y e r s o f t h i c k - w a l l e d
parenchymatous cells.
parenchymatous cells.
4-5 layers, of compactly arranged parenchyma 8-10 layers of compactly arranged
in cortex region.
thin-walled parenchyma in cortex.
Phloem narrows, parenchymatous followed
by xylem. Xylem is composed of radially
arranged vascular bundle. Xylem exarch,
metaxylem vessels meet in the centre.
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
4
Primary xylem triarch cambium
forms a complete ring of xylem
surrounded phloem at the centre
which results in anomalous
secondary growth.
Morpho-anatomy of leaf, stem and root of Alternanthera sessilis (L.) R. Br. ex DC and Alternanthera pungens Kunth (Amaranthaceae) and its
significance in drug identification
H C Gupta et al
of leaf passing through midrib shows a single layer
of epidermis, covered with thin cuticle on both lower
and upper surfaces. The mesophyll is dorsiventral,
comprising one layer of palisade parenchyma and about
three layers of spongy parenchyma. Idioblast containing
druses are present in the ground spongy parenchyma.
The midrib, in vertical section, shows a prominent ridge
on both abaxial and adaxial surfaces followed by 3
layers of chlorenchyma which lie below the upper and
above the lower epidermises. The meristele consists
of crescent-shaped vascular bundle embedded in
parenchymatous ground tissue (Fig.2 D).
Fig. 2A: Alternanthera pungens whole plant
External morphology: Leaf: green, simple,
3.5x2.8 cm, orbicular or ovately orbicular, opposite pairs
unequal, obtuse, entire, tapering at the base. Stem:
yellowish-brown to light-brown, cylindrical, occasionally
sub-quadrangular, clothed with shaggy hairs, fracture
short. Root: cream to grey, cylindrical, 1-6 mm in
diameter, numerous roots arising from the main tap
root as lateral rootlets; fracture short.
Fig. 2D: TS of leaf
cu-Cuticle, up-Upper Epidemis,
pal-Palisade, xy-xylem, ph-Phloem
Anatomy
Leaf: The surface view of leaf has adaxial
epidermal cells with sinuous anticlinal abaxial cells.
Anomocytic stomata are present on both surfaces (Fig.2
B). Uniseriate, multicellular trichomes with characteristic
Stem: In a transverse section the stem is circular
in outline. The epidermis is single-layered and covered
with a thin layer of cuticle and interrupted by stomata
and uniseriate or multiseriate types of trichomes.
Hypodermis is 3-4 layered and is composed of
collenchymatous cells. The cortex comprises 2-6 rows
of thick-walled parenchymatous cells. Endodermis is
indistinct. The vascular bundles are conjoint, collateral
and are arranged in a ring. Each vascular bundle is
encapped by a patch of pericyclic fiber. Pith is wide
and consists of thin-walled large parenchyma cells.
Idioblast containing druses are found both in the cortex
and pith (Fig.2 E).
Fig. 2B: Surface of leaf
S-Stomata
interlocking cells, all covered with a conspicuous
papillose cuticle are seen (Fig.2 C). Vertical section
Fig. 2E: TS of stem
col-Collenchyma, ph-Ploem, pl-Pith ep-Epidermis,
xy-Xylem
Root: In a transverse section, root is circular in
outline. The cork comprising of 4-5 layers of tangentially
elongated suberised rectangular cells followed
by 8-10 layers of compactly arranged thin-walled
parenchymatous cortex. Primary xylem is triarch, and
Fig. 2C: Trichome
5
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
Morpho-anatomy of leaf, stem and root of Alternanthera sessilis (L.) R. Br. ex DC and Alternanthera pungens Kunth (Amaranthaceae) and its
significance in drug identification
H C Gupta et al
cambium forms a complete ring of xylem surrounded of
phloem at the centre. Unusual secondary growth occurs
by formation of cambium arising successively outward
from the centre of root, each producing xylem towards
the inside and phloem towards outside, thus exhibiting
collateral vascular strands arranged in concentric circles
and embedded in parenchymatous conjunctive tissue)
(Fig.2 F, Table.1).
identification and differentiation in two closely related
species of Alternanthera.
Acknowledgement
The authors are thankful to Mr. A.K.Tiwari, Lab.
Technician for his technical assistance in preparation
of this manuscript.
References
1. Government of India. Wealth of India, Raw Materials.
New Delhi: Publication and Information Directorate
(CSIR); 1985, 1: 206.
2. Chopra R N, Nayar S L and Chopra I C. Glossary of
Indian Medicinal Plants. New Delhi: Publication and
Information Directorate (CSIR); 1956.
3. Vaibhav S and Kamlesh D. Pharmacognosy: The
Changing Scenario, Pharmacog Rev 2007; 1(1):
1- 6.
Fig. 2F: TS of root
ck - cork, ct-cortex, pxy-Primary xylen
4. Chunekar K C. Bhaprakasa Nighantu [Commentar].
Varanasi: The Chowkhamba Vidya Bhawan, 1969.
5. Duthie J F. (Repr.). Flora of the Upper Gangetic Plain
and of the Adjacent Siwalik and Sub-himalayan Tracts.
11 vol. Bishen Singh Mahendra Pal Singh, New
Connaught Place, Dehradun & Periodical experts,
Delhi: 1973.
Discussion
Earlier study showed that the leaf morphology
of Alternanthera sessilis and Alternanthera pungens
are similar, 2 but the present investigation shows
that leaves can be distinguished on the basis of
size and stomata type. We found two types of
stomata viz., anomocytic and diacytic in Alternanthera
sessilis whereas only anomocytic type of stomata
for Alternanthera sessilis was previously reported.20
In case of Alternanthera pungens only anomocytic
type of stomata are predominant. The trichomes in
the family Amaranthaceae have been reported to be
of taxonomic value.22, 21 We noted glandular capitate
trichomes, 3-4 celled stalk with unicellular, spherical,
ellipsoidal head in Alternanthera sessilis whereas
Alternanthera pungens possess unicellular nonglandular trichomes along the veins of the epidermal
surface of leaf. Concerning the stem organization in
secondary growth, the Amaranthaceae family has an
unusual development characterized by a sequence of
concentrical extra cambium, formed outside the original
cambium.21 In the present study, secondary growth
pattern of Alternanthera sessilis was noted as first
cambium formed a complete cylinder and differentiated
bidirectionally, as described earlier.23 However, unusual
secondary growth of cambium was also evident in case
of Alternanthera pungens. We observed anomalous
thickenings in stem and roots of similar kind, the first
accessory cambium arising in the pericambial region
and the subsequent one in the secondary ground tissue.
These data may be considered as standard for correct
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
6. Kirtikar K R and Basu D D. Indian Medicinal Plants.
2nd ed., Allahabad: L. M. Basu; 1933.
7. Trimen Henry. A Hand Book to the Flora of Ceylon.
Part III. Bishen Singh, Mahendra Pal Singh, Delhi,
New Connaught Place, Dehradun and Periodical
Experts, 1974:405.
8. Nadkarni A K and Nadkarni K M. Indian Materia
Medica. Bombay: Popular Prakashan Private ltd;
1976.
9. Watt G. (Repr) A Dictionary of the Economic Products
of India Delhi: Cosmo Publication; 1972.
10. Rickett H W. Wild flowers of the United States Vol.4,
The New York Botanical Garden: New York: Mc Graw
Hill Book Company; 1966.
11. Rastogi R P & Mehrotra B N. Compendium of
Medicinal Plants.1993,3:36
12. Rao R R and Razi B A. A systematic flora of Mysore
District. New Delhi: Today and Tomorrow Printers;
1981: 401- 2.
13. Rastogi R P & Mehrotra B N. Compendium of
Medicinal Plants.1995, 4:41.
14. Government of India. The useful plants of India. New
6
Morpho-anatomy of leaf, stem and root of Alternanthera sessilis (L.) R. Br. ex DC and Alternanthera pungens Kunth (Amaranthaceae) and its
significance in drug identification
H C Gupta et al
Delhi: Publication and Information Directorate (CSIR);
1986.
20. Johansen D A. Plant Microtechnique. New York:
McGraw Hill Book Co. Inc; 1940:182-203.
15. Parrotta J A. Healing Plants of Peninsular India.
New York: CABI publication; 2001.
21. Anitha R and Kanimozhi S. Pharmacognostic
Evaluation of Alternanthera sessilis (L.) R Br. Ex.
DC. Pharmacognosy Journal vol. 4, 28, 20:31-4.
16. Gupta HC. Pharmacognostic standardisation of
Achyranthes pungens H.B and K. Indian Journal of
Research In Homeopathy 2008; 2(2): 16-19.
22. Rajput K S and Rao K S. Secondary growth in
the stem of some species of Alternanthera and
Achyranthes aspera (Amaranthaceae). IAWA J.
2002;21(4):417-24.
17. Government of United States of America. The
Homoeopathic Pharmacopoeia of United States
(Repr. Ed.).
23. Esau K. Anatomy of seed plants. 2nd ed. New York:
John Wiley; 1977.
18. Virginia (USA), American Institute of Homoeopathy,
1979: 439-40.
24. Metcalfe C R. Chalk L. Anatomy of the
dicotyledons: leaves, stem, and wood in relation
to taxonomy with notes on economic uses. Oxford:
Clarendon;1950.
19. Wallis TE. Textbook of Pharmacognosy, 5th ed.,
New Delhi:CBS Publishers and Distributors 2005.
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7
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
A multicentric, double-blind randomized, homoeopathic pathogenetic
trial of Caesalpinia bonducella
ORIGINAL ARTICLE
A multicentric, double-blind randomized, homoeopathic pathogenetic trial of Caesalpinia
bonducella
Rajpal*1, Vinay Kr. Singh1, V.A. Siddiqui1, C. Nayak1, A.K. Majumdar2, P.K. Chandra2, J.P. Singh3, S. D. Pathak3,
G. Rakshit4
1Central
Council for Research in Homoeopathy, New Delhi
Proving Research Unit of Homoeopathy, KolKata
3 Homoeopathic Drug Research Institute, Lucknow
4Drug Proving Unit (Homoeopathy), Bhubaneswar
2 Drug
Objective: To elicit the pathogenetic response of Caesalpinia bonducella in homoeopathic potencies
on healthy human volunteers.
Methodology: The drug Caesalpinia bonducella was proved by the Central Council for Research in
Homoeopathy (CCRH) through randomized, double-blind, placebo-controlled design. The proving was
conducted at three centres. The drug was proved in 6 & 30 centesimal potencies on 50 apparently
healthy volunteers, declared eligible after their pre-trial medical examinations by the medical specialists
and routine laboratory investigations. In first phase of proving, provers were given 56 doses of placebo
divided in 04 doses per day for 14 days. In next two phases, 56 doses of pre-selected potencies or
placebo as per the randomization were administered in divided doses same as in first phase. The
symptoms manifested during the trial period were noted down by the provers and elaborated by the
Proving Masters. The generated data of the drug from all three centres were compiled at provingcum-data processing cell of CCRH headquarters after de-coding.
Observations: Out of 34 provers who were on actual drug trial, only 12 manifested symptoms. Drug
was able to manifest symptoms in both the potencies, in more or less every part of the body.
Conclusion: The pathogenetic response elicited during the proving trial, expands the scope of use of
the drug Caesalpinia bonducella and will benefit the research scholars and clinicians. The generated
symptoms of this drug will carry more value when verified clinically.
Keywords: homoeopathy; pathogenetic effect; homoeopathic pathogenetic trial; drug proving;
Caesalpinia bonducella
Introduction
dispersing swellings, arresting haemorrhage, febrifuge,
anti-periodic and warding off infectious diseases.1
Caesalpinia bonducella (Nata) is a well known wild
shrub of India containing excellent medicinal properties.
The medicinal properties of the plant have been known
from the ancient times. The root, bark, leaves and
seeds of the shrub are used in medicine. The seeds
are considered to be “very hot and dry” and useful in
Botanical Name : Caesalpinia bonducella (Linn.) Roxb.
Synonym : Caesalpinia crista Linn.,
Guilandina bonducella Linn.
Caesalpinia bonducella (Linn) Flem.
Family2 : Caesalpiniaceae
Common names :
Hindi
: Karanju
Sanskrit
: Kuberakshi
Bengali
: Nata karanja
Tamil
: Kazharshikkay
Persian
: Khyahe-i- iblis
*Address for correspondence:
Dr. Rajpal,
Scientist-4
Central Council for Research in Homoeopathy
61-65, Institutional Area, Janakpuri,
New Delhi- 110 058
Email: [email protected]
Received: 30th November 2012
Accepted: 22nd February 2013
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
8
A multicentric, double-blind randomized, homoeopathic pathogenetic
trial of Caesalpinia bonducella
(Devil’s testicle)
English
: Bonduc nut, Fever nut, Physic nut
“Bonducella” the name of the species is derived
from the Arabic word “Bonduce” meaning a “little ball”
which indicated the globular shape of the seed.3
flavonoids, fatty oil 20-24%, starch, sucrose, two
phytosterols; bitter amorphous glycoside bonducin can
be isolated from the oil.5,6,7
The crude extract of Caesalpinia bonducella and its
fractions have been found to be antibacterial, antifungal,
antispasmodic and possess Ca++ antagonistic
properties.8
Description
A climbing prickly shrub, extending up to 15 m
in height, with branchlets glossy, black, armed with
hooked and straight, hard yellow prickles at the base
of pinnae and elsewhere. Leaves: pinnate, 30 to 60 cm
long; petioles prickly; stipules in the form of a pair of
reduced pinnae at the base of the leaf, each furnished
with a long mucronate point; pinnae 6-11 pairs 5 to
7.5 cm long, stalked, coriaceous, elliptic-oblong, base
rounded to acute, apex mucronate, with upper surface
glabrous, shining, lower surface puberulous, dull.
Inflorescence: 30-60 cm long, axillary and terminal
raceme. Flowers: yellow, fragrant, dense at the top of
raceme, lax downwards, pedicles 5 to 8 mm, brown
downy; bracts squarrose, linear, acute, 1 cm long,
fulvous-hairy, calyx 5, corolla 5, stamens 10. Fruit: a
pod, dark brown to black, shortly stalked, oblong, 5 to
7.5 cm long and 4.5 cm wide, densely armed on the
faces with wiry prickles. Seed: 1 or 2, black, orbicular
or ovoid to reniform, beaked and hard.4
The ethanolic extract of Caesalpinia bonducella
seed kernel possesses potent antipyretic9 and antifilarial activity10. The aqueous extract of Caesalpinia
bonducella produced significant anti-ulcer and antisecretory effects.11
The methyl extract of Caesalpinia bonducella
exhibited significant antitumor and antioxidant activity
in Ehrlich ascites carcinoma bearing mice.12 In an
investigation it was revealed that the Petroleum
Ether extract of Caesalpinia bonducella possessed
anticonvulsant activity.13
OBJECTIVE
To elicit the pathogenetic response of Caesalpinia
bonducella on apparently healthy human volunteers in
homoeopathic potencies.
MATERIALS AND METHODS
Distribution
Study Design
This shrub is found throughout India up to 2000 m
from sea level; most common along the sea-coast of
West Bengal, southern India and up to 850 m on the
hills.4
The study was a randomized, double-blind, placebo
controlled trial.
Participants & settings
Part used in Homoeopathy: Seed.4
The proving of this drug was conducted in 200708 at Drug Proving Research Unit of Homoeopathy
(DPRU), Kolkata (West Bengal) and Homoeopathic
Drug Research Institute (HDRI), Lucknow (Uttar
Pradesh) and in 2008-09 at Drug Proving Unit (DPU),
Bhubaneswar (Orissa). The study was conducted
according to the Drug Proving Protocol of CCRH
approved by the Ethical Committee of the Council.
Dr. Kali Kumar Bhattacharyya of Gouripore, Assam
proved this drug and he published an account of proving
in Bengali Monthly Homoeopathic Journal, Hahnemann,
in the month of Baisakh, 1331. The extended provings of
the drug have not been made.1 Therefore, a systematic
Homoeopathic Pathogenetic Trial (HPT) of the drug
in homoeopathic potencies was necessary to elicit its
pathogenetic power which was carried out by Central
Council for Research in Homoeopathy (CCRH) as per
its approved protocol.
Selection of Provers: Applications from 15-20
volunteers from each Drug Proving Centre were
invited from apparently healthy, males & females
between the age group of 18-50 years through notices
on notice boards of the Institute/Unit/College. The Incharge of the Institute/Unit, Proving Master/Proving
Associate, teachers motivated the students & staff of
the Homoeopathic Medical College to participate in the
Proving Programme.
The seeds are tonic; useful in asthma and in snakebite. Oil from seeds is an emollient which is used as
embrocation to remove freckles from the face and for
stopping discharges from the ear.2,5,6
Seeds contain bitter substance furanoditerpenes ,
phytosterinin, bonducellin, bonducin, saponin, aspartic
acid, arginine, citrulline and β-carotene, β-sitosterol,
Volunteers of 18 to 50 years of age, both males
and females and apparently healthy, intelligent enough
9
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
A multicentric, double-blind randomized, homoeopathic pathogenetic
trial of Caesalpinia bonducella
to record the subjective symptoms generated during
proving were included in the trial. The assessment
of health status of the volunteers was done through
Pre-trial Medical Examination (PME), carried out by
General Physicians, Psychiatrists, Ophthalmologists,
ENT Specialists, Dermatologists, Gynaecologists and
Radiologists. The routine laboratory investigations
of the volunteers were done at the study centres to
ascertain their health status. After recommendation of
experts, 50 healthy volunteers (24 males & 26 females)
were enrolled in the Homoeopathic Drug Proving
Programme.
Volunteers showing any psychical or physical
symptoms requiring any kind of medical treatment were
excluded from the study.
‘Written informed consent’ from each volunteer
was obtained before starting the proving. Volunteers
were well informed about the aim & objective of the
programme and risk & benefits of participation in
Prover’s Information Sheet.
Sample size
According to the Drug Proving Protocol of the
Council, there should be at least 15 volunteers at one
centre, 30% of whom will act as control. As the study
was conducted at three centres and consisted of 50
volunteers, 15 volunteers were enrolled at DPRU,
Kolkata, 15 volunteers at HDRI, Lucknow and 20
volunteers at DPU (H), Bhubaneswar. Therefore, out
of 50 volunteers, 34 were on verum and 16 were on
placebo. All the volunteers completed the Proving
Programme successfully.
Intervention
Provers and Proving Master blind about what Prover
was consuming (drug or placebo). The codes were
allotted to each volunteer and randomization was done
at CCRH headquarters.
The drug was sent to the proving centres in coded
phials (verum) along with placebo (control).
Methodology of Proving
The study consisted of three phases. In each
phase, 56 doses of drug or placebo were administered,
divided into 4 doses/day for fourteen days, if no
symptom arises.
Phase-I : Placebo phase. It is useful in generating
prover’s response to placebo and therefore symptoms
generated by the prover in this stage act as control for
subsequent phases.
Phase-II : In 2nd phase, the proving was conducted
with 6C potency of the drug.
Phase-III : In 3rd phase, the proving was conducted
with 30C potency of the drug.
Dose schedule: The volunteers were asked to take
4-6 globules of a particular potency of the coded drug,
four times a day, dry on tongue.
The volunteers were instructed to note down the
details of their feelings/changes in mind and body, after
taking the coded drug/placebo in ‘Prover’s Day Book
Proforma’ daily.
If sign(s)/ symptoms(s) appeared
•
The volunteers were asked to stop taking the drug/
placebo as soon as they felt any change or any
sign(s) and/or symptoms(s) developed during the
trial.
•
Placebo was made up of unmedicated
globules (number 30) moistened with unmedicated
dispensing alcohol (unsuccussed) and was therefore
indistinguishable from verum.
The volunteer noted down the sequence of the
appearance of new sign(s) and/or symptoms(s),
their progress and the number of doses after which
such sign(s) and/or symptoms(s) appeared, with
date, time of onset and duration for which they
persisted.
•
Intake of drug remained suspended till the sign(s)
and/or symptoms(s) totally disappeared.
Randomization and Blinding
•
Any change in normal routine of the prover in
respect of daily habits pertaining to diet, living
conditions etc./any treatment taken was also noted
in the Prover’s Day Book Proforma.
Drug
Caesalpinia bonducella was procured from a GMP
certified Homoeopathic Drug manufacturer in India, in
6C and 30C potencies, in 100 ml. sealed bottles of each
dilution. Globules of number 30 were medicated with
these attenuations at the CCRH headquarters office.
Placebo
All the volunteers were assigned code numbers
and the coded drugs of different potencies/ placebo
were supplied in separate glass phials bearing code
numbers of the respective volunteer; keeping both
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
After disappearance of sign(s) and/or symptom(s)
10
A multicentric, double-blind randomized, homoeopathic pathogenetic
trial of Caesalpinia bonducella
produced by the drug, the volunteer had to wait for a
further period of 07 days before taking the remaining
doses of that potency following the same dose schedule
as stated above. In case of further appearance of new
sign(s) and/or symptom(s), the same procedure as
stated above was followed till the consumption of 56
doses of that potency by the volunteer.
If the prover was experiencing the same symptom(s)
what he/she had already shown, he/she was asked to
stop the current quota and to switch over to the next
quota after a washout period of 14 days.
Each volunteer was interrogated by the Proving
Master to verify the sign(s) and/or symptom(s) recorded
by the volunteer. The symptoms recorded in ‘Prover's
Day Book Proforma’ were verified by the Proving Master
and completed through further interrogation with the
provers in respect to their location(s), sensation(s),
modalities and concomitants, extension of symptoms,
causation, clinico-pathological findings and other
treatment taken, if any, in 'Symptoms Elaboration
Proforma'.
During the course of proving, the volunteers
were referred for specific laboratory investigation(s)
to rule out any pathological cause of appearance of
symptom(s). Since laboratory tests were performed
to identify any correlation between the subjective
and objective changes during the course of proving,
the expert opinion of the honorary consultant(s) was
obtained, wherever needed.
If no sign(s)/ symptoms(s) appeared
If no symptom was observed, the volunteers noted
down as ‘No Symptom’ with date and time of intake of
the respective dose of the drug/placebo.
Before commencing the administration of
subsequent potencies (subsequent Phase) of the drug,
the volunteers remained on a washout/rest period (it
should be a symptom free period between two phases
of drug proving in which a volunteer does not take drug)
for 14 days and started taking next potency following
the same procedure as mentioned above, till completion
of 56 doses.
The same procedure was followed for the 3rd
phase.
After completion of trial of all potencies, the
volunteers underwent Terminal Medical Examination
(TME).
On completion of all the phases of the drug proving,
the compilation of data recorded in ‘Prover's Day
Book Proforma’, ‘Symptoms Elaboration Proforma’,
‘Pathological Report Sheets’ and ‘TME sheets', was
done at the Council’s headquarters by the Drug
Proving-cum-Data Processing Cell. After decoding, the
sign(s) and/or symptom(s) generated by the volunteers
kept on the drug were separated from those generated
by the volunteers kept on placebo.
Management of adverse effects:
A vial of Camphora was sent with each quota to
each centre as antidote as it is believed that Camphora
can antidote nearly every vegetable medicine. 14
Proving Master used to give antidote to the volunteer
if symptoms continue for a long time or intensity was
more to cause discomfort. Proving Master was also
directed to take advice of honorary consultants and to
get laboratory investigations done, if required.
Pathogenetic effects
Pathogenetic effects (Proving symptoms)
are defined as all changes in clinical events and
laboratory findings reported by the volunteers during
a Homoeopathic Pathogenetic Trial and recorded in
the final report. The incidence of pathogenetic effects
per volunteer is defined as the total number of findings
observed in the trial divided by the total number of
provers.15
Pathogenetic effects were deduced from:
(i) comparison of symptoms developed in placebo
phase with symptoms during intervention phases
(Intraprover comparison)
(ii) comparison of symptoms developed by provers
on control (for all phases) with provers on actual
drug trial (Interprover comparison)
Results
At Drug Proving Unit (H), Bhubaneswar, out of
14 volunteers on trial drug, 06 volunteers reported
symptoms (42.86%). At Drug Proving Research Unit of
Homoeopathy (DPRU), Kolkata, out of 10 volunteers on
trial drug, 03 volunteers reported symptoms (30.00%)
and also, at Homoeopathic Drug Research Institute for
Homoeopathy (HDRI), Lucknow, out of 10 volunteers
on trial drug, only 03 volunteers reported symptoms
(30.00%). During the pathogenetic trial, out of 34
volunteers who were in verum group, only 35.29%
(n=12) volunteers reported symptoms consequent upon
the administration of the drug. Incidence in this proving
was 2.08 findings per volunteer. The drug Caesalpinia
bonducella was able to produce symptoms in both
the potencies i.e. 6C and 30C. Twenty five symptoms
11
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
A multicentric, double-blind randomized, homoeopathic pathogenetic
trial of Caesalpinia bonducella
were produced by the Provers in verum group in 2nd &
3rd phases. Twelve symptoms were produced in 30C
potency and thirteen symptoms were produced in 6C
potency. (Fig. 1) No adverse effect was observed during
the trial, hence, antidote (Camphora) was not used.
Throat
The following symptoms were manifested during the
drug proving:
External throat
 Pain in throat with difficulty in deglutition, agg.
morning; amel. drinking tea. (1,6C) (24,5)
 Sore throat. (1,30C) (22,3)
 Red, herpetic eruptions with burning sensation
in right side of external throat extending upto
the mandible, agg. touch, followed by pus
formation and later blackening of eruptions.
(1,30C) (5,12)
Head
 Headache with vertigo, agg. after watching T.V.
at night. (1,6C)* (22,1)Ť
 Heaviness of head. (1,6C) (9,1)
 Severe throbbing pain in whole head with
chilliness; amel. pressure, tight bandage.
(1,6C) (45,1)
Stomach
 Nausea with loss of appetite. (1,6C) (48,6)
 Nausea with vomiting in early morning, agg.,
sitting; amel. open air. (1,30C) (32,1)
Eyes
 Redness and swelling with pain in right upper
eyelid and lachrymation followed by pain in left
eyelid with headache. (1,6C) (16,13)
 Painful red eruptions on upper eyebrow;
throbbing pain, agg. bending head forward;
amel. bending head backward. (1,30C) (32,7)
Rectum
 Diarrhoea: yellowish 1‡, watery, gushing
stool with pain in abdomen from morning to
afternoon. (1,30C) (32,1)
Cough
Nose
 Acrid nasal discharge with redness and burning
sensation at tip of nose, agg. morning, touch.
(1,30C) (43,5)
 Running nose. (1,30C) (16,3)
 Spasmodic dry cough, agg. at night, during
sleep. (1,30C) (22,4)
 Cough with expectoration. (1,30C) (16,8)
Back
 Red, hard nodular painful swelling on left
scapula. (1,6C) (38,14)
 Coryza with severe sneezing, agg. morning.
(1,30C) (29,5)
 Red, itching eruptions on back mainly on
scapular region, agg. from contact of clothes.
(1,6C) (8,2)
Face
 Swelling of right parotid gland with severe pain.
(1,6C) (45,8)
Extremities
Mouth
 Mild loss of sensation with numbness of left
index finger. (1,6C) (36,7)
 Bad taste in mouth. (1,6C) (48,6)
 Itching and burning sensation in calf muscles
with redness, agg. bathing in cold water.
(1,30C) (53,8)
 Swelling of gums. (1,6C) (4,2)
 Ulcer on lower lip with burning sensation, agg.
eating. (1,30C) (29,5)
•In the first parenthesis, the 1st number given after every symptom denotes number of volunteers who produced that particular symptom and 2nd number denotes potency used.
Ť In second parenthesis, the 1st number denotes number of doses of the drug after which that particular symptom was
produced and the 2nd number denotes the duration (in days) for which the symptom lasted.
‡Symptoms produced during the pathogenetic trial of the drug were compared with the homoeopathic literature cited in
the reference and those symptoms which were found in the literature, are shown in bold, superscribed with a numerical
that refers to the respective literature.
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
12
A multicentric, double-blind randomized, homoeopathic pathogenetic
trial of Caesalpinia bonducella
potency
produced in 6C
potency
No. of symptoms
produced in 30C
No. of symptoms
Figure-1:Number of symptoms produced by 6C and 30C potencies of Caesalpinia bonducella and their duration in
6
5
4
3
2
1
1
2
3
4
5
6
7
8
9
10 11 12
OCCURRENCE OF SYMPTOMS (in days)
13
14
15
1
2
3
4
5
6
7
8
9
10 11 12
OCCURRENCE OF SYMPTOMS (in days)
13
14
15
6
5
4
3
2
1
Fever
Chest
 Fever with chill1, amel. noon. (1,6C) (45,6)
Extremities
Itching of both legs and feet without eruptions. (1) (8,1)
Sleep
Drowsiness. (1) (8,3 & 24,1)
Fever
Fever with coryza and cough after drenching in rain. (1)(32,21)
Skin
Itching of whole body with red
macular eruptions, agg. heat; amel.
cold air. (1) (1,6 & 3,32)
Generalities
Internal heat feeling everywhere. (1) (1,6 & 3,41)
Symptoms produced by provers in Control
(Placebo) group
Head
Hammering pain in both temporal regions
of head, agg. reading; amel. lying down,
closing eyes. (1)Φ(36,3)Φ Headache.(2
(40,2) (16,1)ΦΦ
Eye
Bruised pain in left eye extending to left
side of forehead. (1)(32,5 & 36,3)Ψ
Throat
Throat pain with coryza; nose block after
eating ice-cream. (1) (13,7)
Stomach
Hunger with weakness. (1) (8,2)
Nausea and mild eructation after food. (1) (14,3)
Abdomen Cutting pain in whole upper abdomen. (1) (24,1)
Rectum
Watery diarrhea, agg. morning. (1)
(24,2)
Chest pain. (1)(12,2)
Discussion
All the symptoms of the drug were new except
two viz. “yellowish stool” and “fever with chill” which
were produced during previous proving as compiled
by Dr. S.C. Ghose1. Some symptoms like of eyes,
external throat, cough, back etc. lasted for many
days; this shows the drug has affinity towards these
regions. Some symptoms appeared on administration
after few doses, like swelling of gums appeared after
ϕ
The number given in first parenthesis denotes number of volunteers who produced that particular symptom.
In second parenthesis, the 1st number denotes number of doses after which that particular symptom was produced and
the 2nd number denotes the duration (in days) for which the symptom lasted.
ΦΦ In third parenthesis, symptom produced in second prover is shown.
Ψ Symptom produced two times in same prover shown in single parenthesis with no. of doses and duration.
Φ
13
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
A multicentric, double-blind randomized, homoeopathic pathogenetic
trial of Caesalpinia bonducella
administration of 4th dose and symptom of external
throat appeared after administration of 5th dose which
lasted for 12 days. The symptoms developed in Control
(placebo) group were different from those developed
by verum group.
7. Lilaram R, Ahamed Nazeer. Effect of Caesalpinia
bonducella seed extract on histoarchitecture of some
vital organs and clinical chemistry in female albino
rats. Journal of King Saud University - Science 2013;
25(1):1-6.
Conclusion
8. Khan HU, Ali I, Khan AU, Naz R, Gilani AH. Antibacterial,
antifungal, antispasmodic and Ca++ antagonist effects
of Caesalpinia bonducella. Natural Product Research
2011; 25(4): 444-49.
The symptoms appeared during the trial will add
to the available literature on this medicine and benefit
the research scholars and clinicians. These proved
symptoms need further verification through application
in different clinical settings.
Conflict of interest: There is no conflict of
interest.
acknowledgement
The authors are greateful to ex-Director General
Incharge, CCRH for his persistent encouragement and
enthusiastic support for the preparation of the article.
References
1. Ghose SC. Drugs of Hindoosthan. 9th ed. Kolkata:
Hahnemann Publishing Co. Pvt. Ltd.; 1984.
2. Council of Scientific & Industrial Research. The Useful
Plants of India. New Delhi: Publication & Information
Directorate; 1986.
3. Moon Komal, Khadabadi S S, Deokate U A, Deore S
L editors. Caesalpinia bonducella F - An Overview.
Govt. College of pharmacy, Kathora naka, AmravatiINDIA. 2010;(2)3. Available from : http://www.
sciencepub.net/report/report0203 /13_2487_komal_
report0203_83_90.pdf
4. Govt. of India, Ministry of Health and Family Welfare.
Homoeopathic Pharmacopoeia of India, Vol.8. New
Delhi: The Controller of Publication; 2000.
5. Chopra RN. Indigenous Drugs of India. 2 nd ed.
Kolkata: Academic Publishers; 2006.
9. Archana P, Tandan SK, Chandra S, Lal J. Antipyretic
and analgesic activities of Caesalpinia bonducella
seed kernel extract. Phytother Res 2005;19(5):
376-81.
10. Gaur RL, Sahoo MK, Dixit S, Fatma N, Rastogi
S, Kulshreshtha DK, et. al. Antifilarial activity of
Caesalpinia bonducella against experimental filarial
infections. Indian J Med Res 2008;128: 65-70.
11. Ansari JA, Ahmad S, Jameel Md. Effect of Caesalpinia
bonducella L. on ulcer and gastric secretions in
pylorus ligated rat model. Journal of Drug Delivery &
Therapeutics 2012; 2(5): 102-4.
12. Gupta M, Mazumder UK, Kumar RS, Sivakumar
T, Vamsi ML. Antitumor activity and antioxidant
status of Caesalpinia bonducella against Ehrlich
ascites carcinoma in Swiss albino mice. Journal of
Pharmacological Sciences 2004; 94(2):177-84.
13. Ali A, Rao NV, Shalam Md., Gouda TS, Shantakumar
SM. Anticonvulsive Effects of Seed Extract of
Caesalpinia bonducella (Roxb.). Iranian Journal of
Pharmacology & Therapeutics 2009; 8: 51-5.
14. Allen HC. Allen’s Key Notes and Characteristics with
comparisons of the leading remedies of the Materia
Medica with Nosodes. 8th ed. New Delhi: B. Jain
Publishing (P) Ltd.; 1997.
15. Dantas F, Fisher P, Walach H, Wieland F, Rastogi DP,
Teixeira H et. al. A systematic review of the quality of
homeopathic pathogenetic trials published from 1945
to 1995. Homeopathy 2007; 96 (1): 4-16.
6. Chopra RN, Nayar SN, Chopra IC. Glossary of Indian
Medicinal Plants. New Delhi: Publication & Information
Directorate;1980.
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
14
A multicentric, double-blind randomized, homoeopathic pathogenetic
trial of Caesalpinia bonducella
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15
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
Homeopathic individualized LM-potencies versus Centesimal potencies for pain management of cervical spondylosis:
A multicenter prospective randomized exploratory clinical study
C.Nayak et al
ORIGINAL ARTICLE
Homoeopathic individualized LM-potencies versus Centesimal potencies for pain
management of cervical spondylosis: A multicenter prospective randomized exploratory
clinical study
C. Nayak1, Vikram Singh1, Jaya Gupta1, Mohd. Shahid Ali2, Ramendar Pal3, M.D. Arya4, P. Hima Bindu2, Debdatta
Nayak1, Paromita Goswami1
1 Central Council for Research in Homoeopathy, New Delhi, India
2 Extension Clinical Research Unit of DSU, Hyderabad, Andhra Pradesh, India
3 Regional Research Institute for Homoeopathy, Jaipur, Rajasthan, India
4 Central Research Institute for Homoeopathy, Noida, Uttar Pradesh, India
Objective: Primary objective was to assess the feasibility for a further definite study to compare the
effectiveness of LM–vs-CM homoeopathic potencies in reducing pain due to cervical spondylosis.
Method: A multi center prospective randomized clinical pilot study was conducted by Central Council
for Research in Homoeopathy at its three centers during June 2009 - June 2010. Out of 148 patients
screened, 56 patients were enrolled and randomized as per the pre-set inclusion criteria. However
54 patients, LM group (n=28) and CM group (n=26) were analyzed. Pain was assessed using visual
analog scale. The primary end point for pain from 1 to 60 days was calculated using Area under the
curve method. Secondary outcome was to assess the quality of life using WHO QoL Bref questionnaire.
Medicines were prescribed to the enrolled patients on the basis of their totality of symptoms and
according to principles of homeopathy.
Results: AUC for pain was significantly less in the LM group [Median (IQR): 112 (86 to 299); p=
0.007] after the prescription of homeopathic medicines. Overall quality of life of the patients after
homeopathic medication showed significant improvement in the WHO-BREF domains: Physical,
psychological, and Environmental only.
Conclusion: Homeopathic medicines in LM potencies are better than CM potencies for pain
management of cervical spondylosis. Further blinded RCT can be conducted for validation of the
results.
Keywords: pain; cervical spondylosis; homeopathy; randomized clinical study.
Introduction
Cervical spondylosis (CS), a degenerative disease
of cervical intervertibral disc and their associated
intervertebral joints. 1 It is defined as “vertebral
osteophytosis secondary to degenerative disc disease”
due to the osteophytic formations that occur with
progressive spinal segment degeneration.2 Spondylosis
is a natural process of aging; it is seen in 10% of
individuals by age of 25 years and in 95% by the age
Address for Correspondence:
Prof. (Dr.) C. Nayak
Former Director General,
Central Council for Research in Homeoopathy
61-65, Institutional area, Opp. D-Block, Janakpuri,
New Delhi, India
Email: [email protected]
Received : 3rd September 2012
Accepted : 16th October 2012
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
of 65 years.3 Though it is a natural consequence of a
bipadel existence and is not a disease state. However,
this degenerative process may cause symptoms in up
to 10% to 15% of population and therefore is among
the most common causes of patient visits to health
care providers.4 Neck pain is the second largest cause
of time off work, after low back pain (LBP).5,6 Some
prognostic studies have suggested that chronic neck
pain is related to repetitive working conditions.7,8
Neck pain experienced with CS is often accompanied
by stiffness, with radiation into the shoulders or occiput
that may be chronic or episodic with long periods of
remission.2 One third of patients with cervicalgia due
to CS present with headache, and greater than two
thirds present with unilateral or bilateral shoulder pain.
A significant amount of these patients also present
with arm, forearm, and/or hand pain. CS may cause
16
Homeopathic individualized LM-potencies versus Centesimal potencies for pain management of cervical spondylosis:
A multicenter prospective randomized exploratory clinical study
C.Nayak et al
one of three syndromes: radiculopathy, myelopathy
or mechanical neck pain.3 Cervicalgia, is the most
common syndrome seen in clinical practice.9
Available non-operative managements for neck
pain are analgesics, nonsteroidal anti-inflammatory
agents, corticosteroids, muscle relaxants, and
antidepressants. In a meta-analysis it has been found
that physical modalities such as heat, cold, therapeutic
ultrasound, massage, use of transcutaneous electrical
nerve stimulator (TENS), and cervical traction were not
found to have any reproducible benefit in the treatment
of acute or chronic neck pain10.
Homeopathic therapy has shown positive role in
alleviating symptoms due to CS.11 Another study
using bowel nosode group of medicines and prescribed
them on the basis of the corresponding micro-organism
found in the stool culture also reflected its usefulness
in relieving symptoms due to CS12 but these studies
had some methodological flaws. In the former study
the authors used homeopathic medicines in centesimal
potency while LM potencies were used in later study
Hahnemann in his 6 th edition of Organon of
Medicine 13 clearly mentioned the new method of
preparation of medicines i.e. renewed dynamization
or fifty millesimal (LM) potencies which caused less
aggravation in comparison to centesimal (CM)
potencies, where the patient had to wait as long as
they were improving even in the slightest manner
after single dose of medicine. Adler et al’s14 review
of Hahnemann’s Paris case records showed the
superiority of the LM potencies in comparison with
the CM potencies and it was based on a significant
number of experiments with the two potencies.
The studies conducted by Mohan et al 11 and
Nayak12 also had different groups but these studies
had methodological flaws viz. randomization, a different
group size, which has been considered in this present
study. There was many drop outs too. Taking the above
findings into consideration a comparative study of
individualized homeopathic medicines in LM vis-a-vis
CM potencies was designed to explore its effectiveness
in persons suffering from pain due to CS and to further
assess the feasibility for a further definite study. The
secondary objective of this study was to assess the
changes in quality of life.
METHODS
Design
A multi center prospective randomized exploratory
study was designed to compare the effectiveness of
homoeopathic medicines in LM vis-a-vis CM potencies
from June 2009-June 2010. The investigators were
trained before the trial was carried out. The ethics
committee of the Council approved the study protocol.
Written informed consent of the study participants was
obtained before enrolling them in the study and the
study followed the declaration of Helsinki and Good
Clinical Practices of India. This sample was assembled
to be representative of the type of patients seen in
general practice. Patients’ case history was recorded
in prescribed case recording format, devised by the
Council.
Patient selection and Setting
Patients meeting all of the following criteria were
enrolled for study participation: either sex, age group
30-60 years, at least15 one symptom out of (i) cervical
pain aggravated by movement or (ii) pain in occiput,
between the shoulder blades, upper limbs; And with
any one of the following symptoms: (i) retro-orbital
or temporal pain, (ii) cervical stiffness—reversible or
irreversible, (iii) numbness of upper limb, (iv) tingling,
or weakness in upper limbs; (v) Dizziness or vertigo
and any one signs of the following; (i) poorly localized
tenderness in neck, (ii) limited range of movement
in neck (forward flexion, backward extension, lateral
flexion, and rotation to both sides).
Patients were excluded for any of the following
conditions: evidence of a specific pathologic condition,
such as malignancy, fracture, primary neurological
disease or systemic rheumatic disease, previous
surgery of the neck, neurological changes complicated
by myelopathy or radiculopathy, Inflammatory
disease(rheumatoid arthritis, ankylosing spondylitis,
or polymyalgia rheumatic), other non-specific neck
pain lesions (acute neck strain, postural neck ache, or
whiplash), inability to comply with the study protocol
(including psychiatric diseases), lactating mother
and pregnant lady were excluded. Erythrocyte
Sedimentation Rate(ESR), C-reactive protein(CRP)
& RA factor, Magnetic Resonance imaging (MRI) was
carried out to screen the eligibility of the patient.
Four investigators from three study centers:
Central Research Institute(H), Noida (Uttar Pradesh),
Regional Research Institute(H), Jaipur (Rajasthan),
Princess Durru Shehvar General Hospital, Purani
Haveli, Extension Centre of Drug Standardization Unit,
Hyderabad (Andhra Pradesh) under Central Council for
Research in Homoeopathy participated in the trial for
collecting data.
Intervention
Homoeopathic medicines either in LM or CM potencies
were given randomly as per the randomization chart. The
selection of medicines was arrived at by repertorising
17
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
Homeopathic individualized LM-potencies versus Centesimal potencies for pain management of cervical spondylosis:
A multicenter prospective randomized exploratory clinical study
C.Nayak et al
the symptoms of the disease and the patient as a whole.
The repertorisation was done using the Complete
Repertory in Hompath classic software16. But the final
selection of the medicine was done in consultation with
the Materia Medica. Homoeopathic treatment was given
as per instructions given in Hahnemann’s Organon of
Medicine.13 Its characteristics are: Selection of one drug
at a time, using the ‘Similia Principle’ and the drug picture
and disease picture should be as similar as possible.
If the first prescription didn’t work, Investigators were
allowed to change the prescription after reviewing the
case. All medicines were procured from GMP certified
pharmaceutical companies approved by the Scientific
Advisory Committee of the Council.
CM Potency
The indicated homoeopathic medicine in 30c
potency was administered initially with frequent
repetition (6 hourly, 4 hourly, 2 hourly) as per the
intensity of pain. Each dose consisted of 4 pills, size
no. 20. The medicine was stopped when improvement
began. After a particular prescription, if the improvement
remained stand still after repetition, a next higher
potency 200c was given and later as per requirement.
Placebo pills were given as soon as the improvement
was observed.
LM Potency
The indicated homoeopathic medicine in 0/1 potency
was administered initially with frequent repetition as per
the intensity of the pain. One globule (poppy-seed size)
of the medicine in the desired LM potency was dissolved
in 120 ml of distilled water; containing 2.4 ml(2% v/v)
of dispensing alcohol, premixed in it; followed by ten
uniformly-forceful downward strokes given against
the bottom of the phial. This solution was given to the
respective patient with the instructions regarding the
dosage as follows:
•
Before each dose, ten uniformly-forceful downward
strokes to be given to the bottle held in the hand,
on a firm surface.
•
To mix three tea-spoonfuls (15 ml) of this solution
with eight tea-spoonfuls (40ml) of water in a
separate clean glass and stir the solution well.
•
One tea spoonful (5 ml) of this solution would
constitute one dose and this is to be taken as
advised by the investigator.
•
The liquid remaining in the glass after taking this
dose is to be discarded.
After a particular prescription, if the improvement
commenced and the medicine was exhausted then the
next higher potency was prescribed in serial order. If
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
improvement was consistent then the same medicine
was continued.
Sample size
As this was a exploratory study, to assess the
feasibility, a small sample size of 60 (LM:CM: 30:30)
was taken.
Randomization
A permuted block containing unique 20 sets
of random numbers, two per set, numbers ranging
from 1 to 2 was generated to ensure even treatment
allocation, using www.randomizer.org. Only patients
were blinded to study medication. Due to nature of
therapy investigator was not blinded to treatment. The
patient’s enrolment numbers were used for the purpose
of randomization.
Outcomes
The primary outcome was to compare the
effectiveness of homoeopathic treatment (LM vis-àvis CM potencies) in CS pain at the end of 60 days of
treatment. The secondary outcome was to assess the
quality of life of patients treated with homoeopathic
medication using WHOQoL (Bref) health status
questionnaires for quality of life.
The patients were assessed at 1st, 7th, 14th, 30th ,
th
45 and 60th day for pain, tingling, stiffness, weakness
and vertigo on a visual analogue scale (VAS) of 0 to
10 where ‘0’ indicates no symptoms and ‘10’ indicates
worst possible symptoms. World Health Organization
–quality of life–Bref (WHOQoL Bref) questionnaire
has been designed to be applicable to people living
in different conditions or cultures. This questionnaire
has been validated in Indian population and was used
to evaluate quality of life17 of patients suffering from
pain due to CS. It contains 26 items divided into four
domains: physical, psychological, social relationships
and environmental. Each item uses a 5-point response
scale, with higher scores indicating a better QOL. All
the patients were assessed for their quality of life at
baseline and at study end.
Statistical analysis
Reporting adhered to the Consolidated Standards
of Reporting Trials statement for reports of parallelgroup randomized designs and RedHOT. The primary
outcome measure was Area under the Curve(AUC) pain
using the VAS corresponding to person’s total pain at 6
time points (Day1, 7, 14, 28, 30, 45 and 60) in both the
groups and was compared. Similarly other symptoms
18
Homeopathic individualized LM-potencies versus Centesimal potencies for pain management of cervical spondylosis:
A multicenter prospective randomized exploratory clinical study
C.Nayak et al
like stiffness, tingling, numbness, weakness, vertigo
were also analyzed for AUC.
considered as clinically unsuccessful. P-value < 0.05
was considered as significant.
SPSS ver.20, for Windows and Med Calc ver.12 for
windows were used for all the data analysis. Minitab
ver.16 for Windows was used for calculating confidence
intervals of non-parametric inferences. Independent
and paired t test were used for inferring WHOQoL Bref.
The analysis was done as per the protocol. Percentage
change was calculated for pain and total symptom score
Scoreatat end
(TSS) using the formula = Baseline score - Score
x100
Results
Enrolment took place from June 2009 to April 2010.
Three centres actively screened the patients. Of the
148 patients, 54 patients (36%; 28 males; 26 females)
were eligible for the study and were randomly assigned
for treatment; the 94 ineligible patients were excluded
as per the protocol, for the reasons of not meeting
inclusion criteria or refusing to give consent (Figure1).
The baseline demographics for the patients enrolled in
the study are given in Table 1. There were no statistical
differences between the two groups at baseline.
Baseline score
A change of 75% and above improvement in TSS was
considered as Clinical success and less than 75% was
Table 1: Baseline characteristics of two potency arms
Characteristics
LM (n=28)
CM (n=26)
p-value
Age in years
45 (8.6)
44.8 (8.2)
0.90
Sex
- Male
- Female
12 (43)
16 (57)
14 (53.8)
12 (46.2)
0.58
Duration of disease (in yrs)
1.3(2.1)
2.3(3.2)
0.17
Occupation
- Astrologer
- Bank employee
- Business
- Cobbler
- Computer professional
- Electrician
- Housewife
- Police
- Physician
- sales person
- Tailor
- Teacher
- Others
0
2(7.1%)
4(14.3%)
1(3.6%)
0
0
12(42.9%)
1(3.6%)
0
1(3.6%)
4(14.3%)
1(3.6%)
2(7.2%)
2(7.7%)
2(7.7%)
3(11.5%)
1(3.8%)
1(3.8%)
1(3.8%)
9(34.6%)
0
2(7.7%)
0
2(7.7%)
2(7.7%)
1(3.8%)
- Pain VAS(0-10)
28(100%),7.8(2)
26(100%), 7.9(1.8)
0.85
- Stiffness VAS (0-10)
21(75%), 3.8(3)
18(69%), 4(3.2)
0.83
- Tingling VAS (0-10)
11(39%),1.7(2.4)
10(38.5%),1.6(2.3)
0.88
- Numbness VAS (0-10)
19(68%), 3.7(2.9)
20(77%), 4.2(2.8)
0.48
0.65
Symptoms
- Weakness VAS (0-10)
10(36%), 2(3)
11(42%), 2.4(3)
0.61
19(68%),3.9 (3.5)
16(61%), 3.8 (3.5)
0.91
28(100%), 23(10.5)
26(100%), 24.1(11.5)
0.71
- Physical health
12.5 (1.8)
12.5 (2.1)
0.99
- Psychological
11.8 (2.3)
12.5 (1.7)
0.24
- Social relationships
15.4(2.8)
15.04 (2.7)
0.67
- Environment
13.5(2.9)
13.8(2.4)
0.67
- Vertigo VAS (0-10)
- Total Symptom Score
(TSS)
WHO-Qol Bref
Data are presented in mean(sd), n(%); VAS: Visual Analog Scale; WHO-Qol Bref: World Health Organization quality of life
brief questionnaire
19
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
Homeopathic individualized LM-potencies versus Centesimal potencies for pain management of cervical spondylosis:
A multicenter prospective randomized exploratory clinical study
C.Nayak et al
Figure 1 : Flow of study patients
Table 2: Comparative variables between groups
Characteristic
LM (n=28)
CM (n=26)
Difference (95% CI)
p-value
Symptoms
-
AUC pain
112 (86 to 299)
225.5(135 to 378)
-80.8 (-150.5, -21)
0.007
-
AUC stiffness
86 ( 0.9 to 168)
132 (0 to 236)
-36.5 (-112.5,10.5)
0.3
-
AUC tingling
0
132.3
-102.5 (-139, 0)
0.005
-
AUC numbness
76(0 to 173)
179(21 to 247)
-59 (-142.5, 0)
0.06
-
AUC weakness
0(0 to 168)
0 (0 to 237)
0 (-10.5, 0)
0.54
-
AUC vertigo
60(0 to 158)
75 (0 to 233)
0 (-90.5, 32)
0.66
272.5(167 to 1159)
642(332 to 1455)
-270.7(-492.9,21.5)
0.08
AUC TSS
WHO-Qol Bref
-
Physical health
13.5(2)
14(2.1)
-0.5(-0.6, 1.6)
0.41
-
Psychological
12.9(1.6)
13.4(2.1)
-0.5(-0.5, 1.5)
0.31
-
Social relationships
15.6(2.9)
14.8(2.9)
-0.8(-2.4, 0.8)
0.34
-
Environment
13.7(2.8)
14(2.3)
-0.3(-1.1, 1.7)
0.68
Data are presented in Mean (SD), Median (Q1 to Q3). AUC scores were compared using Mann Whitney U test. WHOQol Bref domains were compared with paired t test.
The primary outcome measure for AUC pain (day
1–day 60) corresponding to person’s total pain was
compared. A significant difference in median pain AUC
[Median difference, -80.8, 95%CI:-150.5 to -21, p=0.007)
was found towards LM group [Median(IQR),112 (86 to
299)], in comparison to CM group [225.5(135 to 378)].
There was sharp reduction in pain as early as 7th day(1st
follow up) which was maintained till the end in LM group
in comparison to CM group as depicted in figure 2.
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
Significant difference was also found in AUC tingling
(p=0.005), whereas no difference (p >0.05) was found
in AUC stiffness, AUC numbness, AUC vertigo and
AUC weakness. There was no significant difference (p
>0.05) observed in various domains of WHOQoL Bref
between the groups (Table 2).
All the patients were given homoeopathic therapy
either in LM or CM potencies. So an overall comparison
20
Homeopathic individualized LM-potencies versus Centesimal potencies for pain management of cervical spondylosis:
A multicenter prospective randomized exploratory clinical study
C.Nayak et al
Table 3: Comparison of overall treatment
Characteristic
Mean(sd)
Diff.(95%CI)
p-value
Day1 (n=54)
Day 60(n=54)
7.8(1.9)
1.5(1.9)
6.4(5.8 to 6.9)
0.0001
Stiffness
4(3.2)
0.8(1.3)
3.1(2.3 to 3.9)
0.0001
Tingling
1.7(2.3)
0.4(0.8)
1.3(0.8 to 1.9)
0.0001
Numbness
3.3(2.5)
1.1(1.7)
2.4(2.1 to 3.6)
0.0001
Weakness
2.2(3)
0.7(1.3)
1.5(0.9 to 2.1)
0.0001
3.9 (3.5)
0.8(1.3)
3.6(2.7 to 4.5)
0.0001
Physical health
12.5
13.7
-1.3(-1.7 to -0.8)
0.0001
Psychological
12.1
13.1
-1.0(-1.5 to -0.6)
0.0001
Social relationships
15.2
15.2
0 (-0.4 to 0.4)
1
Environment
13.7
13.8
-0.1(-0.3 to 0)
0.05
Pain
Vertigo
WHO-QOL BREF
Data are presented in mean(sd). Negative findings in WHOQol Bref domains indicate improvement.
Figure 2: Comparison of pain reduction in LM –vs-CM group at different time points
(pre-post) with mean scores was also carried out
(Table 3). Paired t test showed significant difference (P =
0.0001) after homoeopathic therapy in both the primary
and secondary outcome variables except for social
relationship component of WHOQoL Bref (p=1).
Patients who had more than 75% improvement
were considered as clinically successful. There was a
statistically significant clinical success (χ=6.26,df=1, p=
0.01) in LM (82%, n=23) compared to CM group(50%,
n=13) for pain. Similarly statistically significant clinical
success (χ=7.65,df=1, p= 0.006) was found in LM (82%,
n=23) compared to CM group (46%, n=12) in TSS.
Over the course of the trial most frequently used
homeopathic medicines in both the groups are: Lyc.
(n=11, 20%), Sulp. (n=8,15%), Bry. (n=7, 13%), Phos.
(n=7, 13%), Calc. (n=5,9%), Nux- v (n=5, 9%), Rhus- t
(n=4, 8%), Nat-m (n=2, 4%). The other less frequently
used medicines in this trial are Caust (n=1), Chel. (n=1),
Con. (n=1), Sep.(n=1) and Sil. (n=1).
21
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
Homeopathic individualized LM-potencies versus Centesimal potencies for pain management of cervical spondylosis:
A multicenter prospective randomized exploratory clinical study
C.Nayak et al
Discussion
Acknowledgements
Cervical region problems can have varying
symptoms as they are caused by many different
conditions such as excessive workload, postural
disorders, psychological state, structural disorders,
degenerative conditions, and trauma. In this study
patient who received individualized homeopathic
medicines in LM potencies had significantly less
pain after 60 days of treatment than did patients who
received individualized homeopathic medicines in CM
potencies. The findings of this exploratory study with
small sample size, supports Hahnemann’s concept of
renewed dynamization13.
We are thankful to Consultant Orthopaedicians Dr. Adil
Ahmed, DSU(ext) ,Hyderabad, Dr. Manoj Chowdhary,
RRI, Jaipur, Dr. Rahul Gupta, CRI, Noida, for their
continuous guidance throughout the study. We are
thankful to Dr. Chetna Deep Lamba, Research Officer,
CCRH HQ, for helping in monitoring the study. The
authors would like to thank Dr. D. Sahu , Scientist D,
National Institute of Medical Statistics , ICMR, New
Delhi, Mrs.Maya Nambiar, and Sh. Arvind Kumar,
Statistical Assistants , CCRH, New Delhi for their help
in analyzing the data statistically. We are thankful to
Dr. Rachna Bhargava, Associate Professor, Deptt.
of Psychiatry, Govt. Medical College and Hospital,
Chandigarh, for helping in analyzing the WHO QoL
questionnaire data statistically. We are thankful to
Programme Officers of the study at different Institutes
and unit for their administrative help. A special thanks
goes to Dr. Anil Khurana, Assistant Director (H) for his
critical comments, which helped us to further improve
the manuscript.
The majority of patients were found to be above 40
yrs of age. This observation was found to be similar to
a previous study.18 A contradiction to previous studies,
the sex incidence was found to be insignificant with very
slight increase in female.19
Individualized homeopathic medicines have better
results in relieving neck pain in cervical spondylosis
patients. This finding is supported by Mohan et al11.
Even though the improvement commenced from 7th day
onwards in both the groups but it was steeper in LM
group. It shows that LM potency was capable of pain
alleviation more rapidly than the CM potency. Clinical
success in relieving pain for LM group was 82%.
All the patients irrespective to which group they
were randomized improved in their physical health and
psychological domains of WHO QoL Bref whereas in
another study with surgical intervention for cervical
spondylotic myelopathy, there was improvement in
environment domain also.18
The strength of this study is that it represents a
pragmatic setting of homeopathic practice reflecting
the day-to-day clinical setting.
As the study did not have any control group and
blinding, it can’t conclude the efficacy of the homeopathic
therapy in the pain management of patients with CS.
To validate the rapid effect of homeopathic care in the
pain management of CS further research effort may
include blinding and inclusion of control group.
Conclusion
Homoeopathic intervention in LM potencies are
better than CM potencies for pain management of CS.
Further blinded RCT can be conducted for validation
of the results.
Conflict of interest
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A multicenter prospective randomized exploratory clinical study
C.Nayak et al
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djrs gq, dh xbZA f}rh; ifj.kkeksa dks fo'o LokLF; laxBu D;w-vks-,y- czsQ Á'ukoyh dk Á;ksx djrs
gq, thou xq.koÙkk dk ewY;kadu fd;k x;kA v/;;u esa ukekafdr ejht+ksa dk mipkj y{k.kksa dh laiw.
kZrk vkSj gksE;kiSFkh ds fl)krksa ds vk/kkj ij fd;k x;kA
ifj.kke % gksE;ksiSFkh vkS’kf/k;ksa ds lsou ds mijkUr ,y-,e-lewg esa ¼ekf./kdk½ ¼vkbZ-D;w-vkj-½%¼86 ls
299½( ih-¾0-007½ nnZ dh ,-;w-lh- esa deh ik;h xbZA gksE;ksiSFkh fpfdRlk ls mipkj ds mijkar ejht+ksa
dh lesfdr thou xq.koÙkk esa fo'o LokLF; laxBu&czsQ ekudksa % 'kkfjfjd] ekufld vkSj i;kZoj.kh;
vk/kkj ij lq/kkj vk;kA
fu"d"kZ % xzhok d'ks:dk laf/kxzg ihM+k ds mipkj esa lh-,e-iksVsalh dh rqyuk esa ,y-,e-iksVsalh esa
gksE;ksiSFkh vkS"kf/k ÁHkkodkjh gksrh gSA ifj.kkeksa dh oS/krk gsrq CykbaM ;kn`fPNd fu;af=r ijh{k.k fd;k
tk ldrk gSA
[kkst'kCn % ihM+h] xzhok d'ks:dk laf/k xzg] gksE;ksiSFkh] ;kn`fPNd uSnkfud v/;;uA
23
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
Clinical Verification of Ichthyolum - A multicentric observational study
ORIGINAL ARTICLE
Clinical Verification of Ichthyolum - A multicentric observational study
P.S. Chakraborty1*, Subhash Kaushik2, S.S. Nain2,, Pramodji Singh3,, Ojit Singh4, K.C. Das5, Darshan Singh6,
V.K. Singh7, M.K. Rai 8, P.K. Pradhan,9
1 Central
Council for Research in Homoeopathy, New Delhi
Research Institute, Noida
3 Homoeopathic Drug Research Institute, Lucknow
4 Regional Research Institute, Imphal
5Regional Research Institute, Kolkata
6 Regional Research Institute, Shimla
7 Clinical Verification Unit, Patna
8 Clinical Verification Unit, Vrindaban
9 Clinical Research Unit, Portblair
2 Central
Introduction: Ichthyolum is reported to have pronounced action on various systemic affections in
various literatures. On the basis of this literature, Council conducted a thorough proving on this drug
earlier and subsequently clinical verification, to ascertain its clinical importance in Homoeopathy.
Objectives: The primary objective was to clinically verify the symptomatology of Ichthyolum as
observed during its proving conducted by Council on this drug and the secondary objective was to
ascertain the clinical symptoms.
Method: In the multicentre study, a total of 131 patients from all age groups & both sexes were enrolled
from the O.P.D.s of the respective institutes & units of the Council. If Ichthyolum was found to be
the similimum or covering maximum number of symptoms of the patient, the case was enrolled. The
medicine was prescribed in different potencies as per the need of the case and in accordance with
the homoeopathic principles. The progress was noted in a predefined follow up sheet to determine
the effects of the medicine.
Result: It was found that 35 symptoms including 22 symptoms elicited during drug proving
were verified, along with a good number of clinical symptoms, which were relieved completely or
partially, exploring the wider area of the medicine for its therapeutic use.
Conclusion: Ichthyolum can be considered as an important medicine for Acne, Conjunctivitis,
Constipation, Coryza, Cracked Lips, Dysentery, Eczema, Flatulence, Headache, Insomnia, Nausea,
Psoriasis, Restlessness, Tonsillitis & Vertigo. The noted clinical symptoms are acne and scaly
eruptions on whole body specially on joints, burning after itching, warts and polydypsia. All these
verified symptoms confirm the scope of its therapeutic action.
Keywords: Clinical verification; Homoeopathy; Ichthyolum.
Introduction
The clinical verification of symptoms, obtained
during proving, is the keystone of the homeopathic
Address for correspondence
*Dr. P.S. Chakraborty,
Scientist -3
Central Council for Research in Homoeopathy,
61-65, Institutional Area, Janakpuri, New Delhi -110058.
Email: [email protected]
Received: 12th October 2012
Accepted: 5th January 2013
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
system of medicine. It is a link between pathogenetic
symptoms and curing of patients presenting these
symptoms. Before Hahnemann, the clinical application
of the medicines were guided by the speculative
indications, mainly on the basis of authority and
without conducting a proper and thorough experiment
of drug substances to claim their clinical usefulness. It
was Hahnemann who introduced the logical concept
of drug proving by conducting a safe and thorough
experimentation of a drug, directly on human beings,
in order to find out its clinical usefulness, in a scientific
24
Clinical Verification of Ichthyolum - A multicentric observational study
and easily acceptable way, otherwise known as clinical
verification.1
Ichthyolum or Ichthyol is a natural product, having
thick reddish brown colour with bituminous odor & taste.
Its chemical name is Ammonium Ichthyol Sulphonate
C28H36 S3 O6 (NH4)2. One of its important constituent
Ichthyosulphonic acid, is soluble in water but insoluble
in strong alcohol or concentrated ether and is obtained
by dry distillation from a bituminous mineral found in
the Tyrol which is rich in fossilized remains of fish. It
has been in use by the other systems of medicine
as an external application in burns, in enlarged
glands, diseases of skin like erysipelas, eczema,
acne, rheumatic gout, urticaria etc. and internally for
tuberculosis, measles, pertusis and rheumatism. Both
internally & externally it has been used for catarrhal &
ulcerative conditions of the eyes, nose & throat.2,3,4
It is an anti-inflammatory, anodyne, antipruritic,
antiseptic and astringent due to presence of sulphur
in it. In larger doses it increases peristalsis and has
a laxative action on the bowels. When applied locally,
it acts as a reducing agent and exerts a peculiar
contractile effect upon the vascular tissues and thus
reduces heat, swelling & pain.5 Merck has reported
that it is readily oxidisable and moreover is a powerful
vasomotor constrictor & having the ability to penetrate
the unbroken skin.2 Clinically it is reported to be used by
modern system of medicine in various skin affections
like acne, erysipelas, eczema, rheumatism, neuralgia,
peritonitis, catarrh, phthisis, acute bronchitis, chronic
metritis, inflammatory conditions of the tubes and
ovaries, erosion of cervix, leucorrhoea, pruritus vulva,
cystitis, urethritis, burns, frost-bite and injuries.5
Icthyolum was introduced to Homoeopathy by
Dr. Wm. H. Dieffenbach of New York and has not
been proved thoroughly, except for some fragmentary
proving. 2 The mother tincture (Q), having drug
strength of 1/10 of Ichthyolum is prepared by adding
purified water in sufficient quantity. The subsequent
higher potencies like 6X and higher are prepared
with dispensing alcohol.6 Its homoeopathic uses as
mentioned in literature, indicates its usefulness in winter
cough of old people, polyarthritis, chronic rheumatism,
in uric acid diathesis, gout, tuberculosis and also in
aiding nutrition.3,4,7
The Council therefore conducted a thorough
proving of this drug during the period of 2000-2001 at its
two Drug Proving centres at Midnapur and Ghaziabad.
The symptoms observed during the proving, along with
the symptoms found in other available Materia Medica
were subjected to Clinical Verification.
Objectives
Primary objective: To clinically verify the
symptomatology of Ichthyolum as observed during
the proving conducted by the Council on this drug.
Secondary objective: To ascertain the clinical
symptoms (which were not observed during the
proving of the drug but disappeared in the sick during
the application of the medicine, either partially or
completely).
Methodology
Patients for the study were enrolled from the OPDs
of eleven Institutes/ Units of the Council, viz. Central
Research Institute, Noida (U.P.), Homoeopathic Drug
Research Institute, Lucknow (U.P.), Dr. Anjali Chatterji
Regional Research Institute of Homoeopathy, Kolkata
(W.B.), Regional Research Institute, Puri (Odisha),
Regional Research Institute, Shimla (H.P.), Regional
Research Institute, Gudivada (A.P.), Regional
Research Institute, Imphal (Manipur), Clinical Research
Unit, Port Blair (Andaman and Nicobar Islands), Clinical
Verification Unit, Ghaziabad (U.P.), Clinical Verification
Unit, Patna (Bihar), Clinical Verification Unit, Vrindaban
(U.P.)
131 patients comprising of 62 males and 69 females
were prescribed Ichthyolum according to the similarity
of symptoms, during the period from October 2005
to March 2010. The medicine was procured from the
licensed pharmacy in various potencies, viz.30C, 200C
and 1M. The patients were from all age groups and
both sexes. Patients who were on any medication for
one week prior to being enrolled in the study were put
on a wash-out period of 7 days. The patients, who were
suffering from any systemic disease and were under
regular medication for that, were excluded from the
study and treated in the general OPD of the institute.
An informed written consent was obtained from the
eligible subjects before initiating the study.
The presenting symptoms and signs of the patients
were recorded in a predefined case recording proforma.
After doing the anamnesis of each enrolled case, special
attention was given to the peculiarity of complaints, their
peculiar sensations, modalities and any associated
or concomitant symptom with the main symptom and
also the causation, the physical and mental generals.,
thermal reactions, cravings, aversions, perspiration,
sleep, dreams, appetite, thirst, stool, urine etc.
Taking into consideration the totality of the case, the
symptoms were repertorised using a repertory prepared
for this purpose by the Council and finally the Materia
Medica was consulted to see if the characteristics of
the patient matched with those of Ichthyolum.
25
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
Clinical Verification of Ichthyolum - A multicentric observational study
on the basis of symptoms available or proving records
(drug proving profile generated by CCRH) and also the
number of patients who got relief after administration
of Ichthyolum. The numerical superscripted along
with the symptoms in the Table-1 denote the literature
cited. Part of the main symptom (character, modalities,
concomitants, etc.) which was not observed during the
proving but disappeared in the patients during the study
either partially or completely and are not mentioned in
the referred literature, has been kept along with the
main symptom in italics. In the column ‘Improvement
status’, the first figure denotes the number of patients
who had the symptom and to whom the medicine was
prescribed and the second figure denotes the number
of patients who got relief of the same symptom. The
table -2 contains those symptoms which were not
found in the proving literature of the medicine, but found
to have disappeared clinically after the application of
Ichthyolum, otherwise known as clinical symptoms. The
details of participants have been given in figure 1.
Thus, if Ichthyolum was found suitable for the
patient on the basis of similarity, it was prescribed in
30C potency. The changes in presenting symptoms
and signs were recorded during the follow-up visits.
Any kind of improvement was followed by placebo. If
there was no change in the symptoms and signs for a
considerable period, next higher potencies like 200C
& 1M potencies were prescribed. If no change was
observed, even after change of potencies, the case
was closed and considered as a clinical failure. If the
patient presented with new symptoms of mild intensity,
placebo was prescribed; while appearance of severe
symptoms, sufficient to cause considerable discomfort
to the patient, called for change of medicine.
Results
The data of all the cases was collected, compiled
and analysed. The clinically verified symptoms are given
in Table-1 along with the number of patients prescribed
Table 1: Clinically verified symptoms observed during the study
Location
Symptom
MIND
Great mental irritability7,8 with pain in chest8
3,2
Forgetful, lack of concentration2,3,7
6,1
Restlessness8
7,7
VERTIGO
Vertigo agg. while
Improvement
Status
sitting8
4,4
with dizziness8
HEAD
Frontal
water2,8
headache2,3,7,8
1,1
agg. in
evening8
amel. by washing head & face with cold
7,6
Pain and heaviness on vertex agg. from heat of sun amel. cold-open air & hard
pressure8
8,6
EYE
Pain & heaviness in eyes, agg. from reading, amel. from rest8
NOSE
Bland discharge from nose with constant sneezing agg. from change of
temperature2
FACE
Burning in acne on face after scratching and itching in acne8
1,1
MOUTH
Tongue white coated in the centre,2 both edges and tip is normal in colour
11,7
15,13
Bitter taste in mouth8
14,12
Lower lip dry, cracked in centre with sore pain2
THROAT
1,1
Burning pain in throat amel. from cold water2
Pain in right tonsil agg. from
swallowing,2,8
amel. from gargling with hot
1,1
saline8
Dryness of pharynx with desire for cold drinks which ameliorates the troubles2
STOMACH &
ABDOMEN
Appetite
increased2,3,7,9
10,10
1,1
5,5
Nausea3,7,8,9 with loose stool agg. in morning8
4,4
Nausea with bitter taste in mouth2
3,2
Flatulence8
4,3
Flatulence with pain in abdomen agg. before stool, amel. after stool8
Griping (pain) in umbilical region2,3,7 with urging for stool, amel. by bending
forwards2
RECTUM &
STOOL
1,1
Constipation-hard, offensive stool8
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
16,14
5,4
15,13
26
Clinical Verification of Ichthyolum - A multicentric observational study
Location
Symptom
Improvement
Status
Stool – loose watery, yellow2,8 and frequent8
U R I N A RY
SYSTEM
COUGH
Burning pain in urethra2,8 and meatus2,3,7 while in urination8
11,7
Urine increased in quantity and in frequency3,7,9
6,4
Cough dry, irritating worse at
night2
Cough dry worse from change of
and in morning
weather2
2,1
1,1
followed by vomiting
Cough hacking2
BACK &
EXTREMITIES
1,1
Pain in right shoulder joint extending to
SLEEP
SKIN
deltoid2
1,1
Weakness of right arm, as if paralyzed2
1,1
Dull aching pain in calf2, right side , inability to sit still
1,1
Lameness in right shoulder and right lower extremity2,3,7 on beginning to move,
amel. from continued motion2
1,1
Sleep disturbed8, due to itching
6,4
Eczema – itching, heat and
irritation3,7,9
3,1
Psoriasis,3,7 eruptions on legs, thighs, back and abdomen with mild itching
sensation
4,1
Mild itching, heat and irritation in eruptions3,7,9
5,2
Table 2 : Clinical Symptoms
Location
Symptom
Improvement
Status
NOSE
Chronic coryza with whitish thick discharge and stuffed up feeling
1,1
FACE
Dryness of face with itching
1,1
Small pimples with burning sensation agg. on scratching
18,10
Itching amel. by washing with cold water
2,2
Multiple small eruptions on forehead without itching
7,5
MOUTH
Taste bad
2,2
THROAT
Enlarged both tonsils, painful worse on swallowing and better by hot saline water
2,2
Inflammation of right tonsil
2,2
Profuse thirst for large quantities
7,5
Appetite decreased
1,1
Soft stool
1,1
Pain in knee joint better from continued motion
1,1
Numbness of arms and fingers amel. by pressure
1,1
Eczema on both palms and soles
1,1
Acneform eruptions on both the thighs with itching
1,1
Itching eruption on fingers of both hands
3,2
Warts on wrist
7,5
Scaly eruption with itching worse from heat, night
4,2
Scaly eruption on elbow joints, ankle joints and lobes of ears (Psoriasis)
2,1
Eruptions in small spots, reddish in color
1,1
Hypersensitive to cold
1,1
STOMACH &
ABDOMEN
RECTUM
STOOL
&
EXTREMITIES
SKIN
GENERALITIES
27
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
Clinical Verification of Ichthyolum - A multicentric observational study
Figure 1: Flow chart showing the participants in this study.
REPERTORY
washing head and face with cold water amel.
A concise repertory of the verified symptoms
according to the structure of the Kent’s Repertory of
the Homoeopathic Materia Medica has been compiled
for quick reference. Rubrics and sub-rubrics in italics
are new rubrics i.e. not mentioned in Kent’s repertory
while rubrics and sub rubrics in roman letters are
existing rubrics of the said repertory which were
reconfirmed through verification in this study
Vertex, heaviness with
MIND
CONCENTRATION
difficult
FORGETFUL
IRRITABILITY
chest pain, with
RESTLESSNESS
VERTIGO
SITTING, while
dizziness, with
HEAD
PAIN, Forehead
evening
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
air, cold, amel.
air, open, amel
heat of sun, from
pressure, amel.
EYE
PAIN heaviness, with
reading
rest, amel.
EAR
ERUPTIONS, scaly
lobes, on
NOSE
CORYZA
chronic, long-continued
stuffed up, feeling, with
28
DISCHARGE
Clinical Verification of Ichthyolum - A multicentric observational study
bland
change of temperature, from
ENLARGEMENT of tonsils
constant sneezing, with
INFLAMMATION, Tonsils, right
thick
PAIN
white
OBSTRUCTION, sensation if
desire for cold drinks, with
burning
cold, drinks amel.
Tonsils, right
FACE
CRACKED lips
lower lip, centre in
sore pain, with
gurgling with hot saline, amel.
DRYNESS
swallowing, on
STOMACH
APPETITE
itching, with
diminished
lips, lower ,in
increased
centre
NAUSEA
ERUPTIONS
morning
acne
bitter taste in mouth, with
burning and itching ,with
loose stool, with
scratching, after
pimples, forehead
burning, with
scratched, after
ITCHING
washing with cold water, amel.
MOUTH
DISCOLORATION
Tongue, white, centre
THIRST
extreme large quantities, for
ABDOMEN
ERUPTIONS
psoriasis, itching with
FLATULENCE
PAIN
stool, before
after, amel.
TASTE
cramping, griping,
bad
Umbilicus
bitter
bending, forward amel.
urging for stool, with
THROAT
DRYNESS
pharynx
RECTUM
29
CONSTIPATION
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
Clinical Verification of Ichthyolum - A multicentric observational study
STOOL
BACK
FREQUENT
HARD
itching, with
ODOR
offensive
EXTREMITIES
SOFT
THIN, liquid
WATERY
ERUPTIONS, psoriasis
ERUPTION, Elbow
psoriasis
Hand, palm
YELLOW
eczema
Hand, Fingers
BLADDER
URINATION
frequent
itching
Thigh, pimples, itching
psoriasis
itching, with
URETHRA
PAIN, burning
urination, during
meatus
psoriasis
itching, with
Ankle, psoriasis
sole of
URINE
COPIOUS (increased)
Leg
eczema
EXCRESCENCES (Warts)
on wrists
COUGH
LAMENESS
DRY
Shoulder, right
morning
beginning to move, on
night
continued motion, amel.
temperature, from change of
vomiting, follows
right
beginning to move, on
continued motion, amel.
HACKING
IRRITATING
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
30
Lower Limbs
Clinical Verification of Ichthyolum - A multicentric observational study
NUMBNESS
Upper Arm
Fingers
pressure, amel.
PAIN
Shoulder
right
extending to deltoid
Knee
motion, continued, amel.
aching
calf, right
inability to sit still
WEAKNESS, Upper Arm, right
paralyzed, as if
SLEEP
DISTURBED
itching, from
SKIN
ERUPTIONS
eczema
heat, irritation & itching, with
itching
heat & irritation, with
scaly
night
GENERALITIES
HEAT, vital, lack of
Discussion
During the study, 35 (thirty five) symptoms including
22 (twenty two) symptoms of drug proving conducted
by the Council were verified, along with a good number
of clinical symptoms, which were relieved completely
or partially. Ichthyolum has been used in old school
therapeutics as an external application and internally
in skin affections, rheumatism, scrofula, nephritis and
gonorrhea. But as revealed from this study, it has
prompt action on gastrointestinal system, eyes, tonsils,
mouth, head and urinary system.
Dryness and burning pain are the two characteristic
symptom of this medicine. While dryness is marked in
lips, pharynx and rectum (producing dry, hard stool),
the burning pain is marked in skin (acne), throat and
urethra.
Its usefulness in gastrointestinal system is marked
with flatulence with pain in abdomen, worse before
stool and relieved after stool. Its action is also proved
in cramping pain in umbilical region with urging for stool
and relieved by bending forwards. Apart from this, it is
also beneficial to the patients complaining of nausea
with bitter taste in mouth and loose stool.
Its action on head is centered in frontal region worse
in evening and better from cold application, and this may
be associated with heaviness feeling in vertex which
gets worse from sun heat. Its usefulness in vertigo is
marked with aggravation while sitting.
In upper respiratory tract, its action is more
marked in catarrhal condition of nose with bland
discharge and constant sneezing worse from change
of temperature.
Its action on glandular system is manifested in
tonsillitis, which is more marked on right side and pain
is better from hot saline gurgles.
It is found in the study that most of the symptoms
of Ichthyolum were relieved from cold applications
including frontal headache, pain and heaviness in
vertex, burning pain in throat, dryness of pharynx and
itching of face. Hence it becomes a general modality
of the drug.
The study shows that Ichthyolum can be considered
as an important medicine for certain clinical conditions
like headache, vertigo, eye pain, acne, tonsillitis,
dyspepsia, abdominal colic, constipation, diarrhea,
urinary tract infections, dry cough, disturbed sleep,
warts and itching eruptions on skin. It may also be
used in mental restlessness, forgetfulness and in
insomnia.
31
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
Clinical Verification of Ichthyolum - A multicentric observational study
Besides these, the medicine was also found
to relieve acne and scaly eruptions on whole body
specially on joints, burning after itching, eczematous
eruptions, enlarged tonsils, warts on wrist joint and
polydypsia. All these symptoms have emerged as
clinical symptoms of Ichthyolum.
Conclusion
The study confirms many symptoms of the drug
proving conducted by the Council and at the same time
many existing symptoms of other Materia Medica were
re-confirmed, signifying its more effective clinical use.
All these verified symptoms provide more information
about this medicine and confirm the scope of its
wider therapeutic action. This medicine is reported to
have wider use in modern system of medicine in the
treatment of all forms of rheumatism, arthritis, sciatica
and gout either externally or internally in inflammatory
conditions of female reproductive organs, as reported
in literature but not observed during the trial of this
drug under our study. Hence, enough scope is still
remaining to explore the therapeutic usefulness of
this medicine in homoeopathy. Therefore, further
studies may be conducted to re-verify the symptoms
repeatedly & to deduce its more clinical importance so
that more reliable characteristics of Ichthyolum can be
ascertained.
ACKNOWLEDGEMENT
The authors are thankful to Dr. R.K. Manchanda,
Director General, Central Council for Research in
Homoeopathy, for giving valuable suggestions in
the construction of this article. Valuable guidelines
provided by Dr. Alok Kumar & Prof. Dr. C. Nayak, former
Director General, CCRH, in supervising the study and
reviewing the article, are sincerely acknowledged.
The authors are deeply indebted to Drs. Vikram
Singh, Deputy Director (H), Dr. Anil Khurana, Asstt.
Director (H), CCRH and Dr. Krishna Singh, former
Assistant Director (H), for rendering guidance & expert
advice in the study.
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
Technical assistance provided by research
personnel of the Council in the study are deeply
acknowledged.
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32
Clinical Verification of Ichthyolum - A multicentric observational study
ifjp; % fofHkUu lkfgR; esa 'kjhj dh vkarfjd O;oLFkkvksa ij bdFkk;ksye ds ÁHkko ns[ks x;s gSaA bl
lkfgR; ds vk/kkj ij ifj"kn~ us gksE;ksiSFkh esa bldh uSnkfud egÙo dk irk yxkus ds mÌs'; ls igys
iw.kZ lR;kiu vkSj rnqijkar uSnkfud :i ls lR;kiu fd;kA
mÌs'; % bl v/;;u dk ÁkjafHkd mÌs'; ifj"kn~ }kjk bdFkk;ksye ds Áek.ku ds nkSjku voyksfdr
fd;s x;s y{k.kksa ,oa bdFkk;ksye ds y{k.kksa dks uSnkfud :i ls lR;kfir djuk Fkk vkSj f}rh; blds
uSnkfud y{k.kksa dk lR;kiu FkkA
i)fr % bl cgqdsafæd v/;;u ds nkSjku] ifj"kn~ ds fofHkUu laLFkkuksa@bdkbZ;ksa ds ckg~; jksxh foHkkxksa ls
lHkh vk;q lewgksa ds efgyk ,oa iq:"kksa ds dqy 131 ejht+ksa dks ukekafdr fd;k x;kA ;fn bdFkk;ksye
flfefyee ik;k x;k ;k ejht+ksa ds vf/kdkf/kd y{k.k blesa ik;s x;s] rHkh jksxh dks v/;;u esa ukekafdr
fd;k x;kA jksx ,oa gksE;ksiSFkh fl)krksa ds vk/kkj ij fofHkUu iksVsafl;ksa esa vkS"kf/k nh x;hA vkS"kf/k ds
ÁHkkoksa dks lqfuf'pr djus gsrq Áxfr dks ,d iwoZ&fu/kkZfjr vuqorZu i= esa ntZ fd;k x;kA
ifj.kke % ;g ik;k x;k fd vkS"k/k Áek.k ds nkSjku mYysf[kr 22 y{.kksa lfgr 35 y{.kksa dk lR;kiu
gqvk] tks fd iw.kZr;k ;k v/kZ:i ls ik;s x;s] ftlls fd bl vkS"kf/k dk foLr`r fpfdRlh; {ks=
ifjyf{kr gksrk gSA
fu"d"kZ % bdFkk;ksye dks eq¡gkls] us=”ys’eyk'kksFk] dCt+] Áfr”;ki] QVs gksaB] isfp'k] Ropk 'kksFk]
vQkjk] fljnnZ] vfuæk] feryh] lksfj;kfll] cspSuh] xykxaM vkSj 'osr dq"B ds mipkj gsrq ,d
egÙoiw.kZ vkS"kf/k Lohdkjk tk ldrk gSA
mYysf[kr uSnkfud y{k.k eq¡gkls vkSj iwjs 'kjhj ij fo'ks"k :i ls tksM+ksa ij gqYdh Q¡qfl;k¡] [kqtyh ds
mijkar tyus] eLls vkSj vfr fiiklk ik, x;sA ;s lHkh lR;kfir y{k.k bl vkS"kf/k ds fpfdRlh;
ÁHkko dks lR;kfir djrs gSaA
[kkst'kCn % uSnkfud lR;kiu] gksE;ksiSFkh] bdFkk;ksyeA
33
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
CCRH Quarterly Bulletin
S.R. Sharma et al
REMINISCENCES
CCRH Quarterly Bulletin (1982)
S.R. Sharma
AUTHOR’S NOTE
If I reminisce how the Council’s research bulletins
looked like 30 years ago and compare them with the
recent ones, certainly a noticeable metamorphosis is
seen. Not only its name, design and presentation but the
way contents are presented be a case study, success
story or research data have undergone a leap mutation.
The material contained therein in older issues, one still
finds interesting and intriguing. Long ago, when I was
a new incumbent to CCRH, I happened to read this
issue of Quarterly Bulletin. To-day when I have been
extended an opportunity by the Editor-in-Chief of IJRH
for writing a review article on this issue, I read it with
same zest and enthusiasm and find it as refreshing as
when I read it for the first time. I am writing article-wise
review here-under:
Homoeopathic Provings – With Crude or Dynamised
Drugs:
Since the time of Hahnemann the question whether
homoeopathic drugs be proved in tincture or potentised
dilution has remained unanswered. This subject is
dealt with, in Dr. V. P. Singh’s editorial quite lucidly.
The author does not impose his own point of view over
the readers knowing that unsupported suggestions
would be unethical. He, however, highlights the lack
of consensus among the fraternity on this issue.
Dr. Singh goes down the history lane and reminiscences
the ‘Peruvian Bark Trial’ when Hahnemann for the
first time experimented with powdered Peruvian bark.
Subsequent experimentation with some other drug
substances on his own person led to the genesis of drug
proving on healthy human beings. Initially, Hahnemann
proved drugs with tinctures, but after the evolution
of the doctrine of dynamisation he started proving
drugs with dynamised dilutions. The author quotes
references of Bradford and Hartmann, contemporary
of Hahnemann, available in support of this. Dr. Cook
in his latest book, at the time when editorial was
written, also confirmed this. The author further quotes
Address for correspondence:
Dr. S.R. Sharma
Former Scientist, CCRH
RZ 101/10B, Mohan Nagar, Pankha Road, Opposite D- Block,
Janakpuri, New Delhi – 110046
Email: [email protected]
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
Hahnemann who himself has written in preamble to the
Materia Medica Pura (3rd Edition) that for the proving
of medicines on healthy human beings dilutions and
dynamisations are to be employed as high as used for
the treatment of disease. In Organon of Medicine (6th
Edition), Hahnemann opined that virtues of drugs are
exhibited to the full amount only when they are taken
in high dilutions potentised through trituration and
succussion. Dudgeon, Hering, Griesselich and Trinks
supported this idea of proving drugs in dilutions. But
Schron strongly opposed Hahnemann’s idea to prove
all medicines in dilutions.
The author in the later part of his editorial discusses
methodology of drug proving which has undergone
sea change and talks about double blind placebo
controlled and cross-over designs. He also talks about
classification of drug proving into descending and
ascending series for thorough proving with inherent
advantages and disadvantages. However, in the end
the author is seemingly inclined in favour of employment
of drugs in dynamised form during proving.
Now the time is ripe for international agreement
on standardisation of Homoeopathic Drug Proving
Methodology.
Homoeopathic Repertorial Index for Diabetes
Mellitus:
The authors, V. P. Singh and Gulraj Kaur, in
their literary work define Diabetes Mellitus, describe
incidence, prevalence and history of the disease.
Under aetiology hereditary trait, co-factors responsible
for DM and iatrogenic effect of certain diabetogenic
drugs are given. The authors elucidate the phenotype
observable manifestations of ‘Maturity Onset Diabetes’
and ‘Juvenile Diabetes’. In the management of DM,
in addition to conventional therapeutic management,
dietary management of the disease is described.
Beneficial effects of physical and yogic exercises
on metabolism in general and DM in particular are
also highlighted. Authors feel that conventional
therapeutic approach is to control blood sugar whereas
homoeopathy being a specialized treatment is aimed at
curing the sick person as a whole. Unlike other systems
of medicine homoeopathy requires methodical case
taking, interpretation and evaluation of symptoms in
34
CCRH Quarterly Bulletin
S.R. Sharma et al
order to arrive at a similimum. Thus, the whole process
is laborious, time consuming and requires skill of high
order.
The objective of this literary research work is
to evolve ‘A Homoeopathic Repertorial Index for
Diabetes Mellitus’ to facilitate a physician to make a
correct prescription and the cumbersome process of
arriving at the similimum becomes simpler and less
time consuming. The source of compilation of this work
consists of mainly 2 fundamental books namely Kent’s
Repertory of Homoeopathic Materia Medica and William
Boericke’s Manual of Homoeopathic Materia Medica
with Repertory. A set of 25 pathognomonic (common),
non pathognomonic (uncommon) and pathological
signs and symptoms of DM found in various stages of
the disease are selected for repertorization. For these
25 signs and symptoms 115 medicines are tabulated
along with their grading found in the repertories. They
conclude their literary work with characteristic features
of all the 115 medicines arranged in alphabetical order
starting from Acetic acid and ending with Zincum
metallicum.
Once considered useful tool now hardly finds any
place on a physician’s desk.
Role of Arsenicum Iodatum during Acute Attack
of Asthma:
Authors: Bhatia,Anil. R., Bhatia Amar K., Kothari, S. R.
In this short research communiqué the outcome and
observations on Ars. Iod in acute stage of asthma are
presented. The authors taking a lead from pathogenetic
symptoms of the drug used it impirically in atopic and
non-atopic asthma during acute attack. The study is
conducted at Clinical Research Unit in Homoeopathy,
Bombay. A population of 115 patients suffering from
asthma was studied. For inclusion of patients in the
study no cap was kept for gender and age. Population
of male and female was more or less equal in proportion
(M 57, F 58). Maximum number of patients 35 fell in
the age group of 11 to 20 years, followed by 29 in the
age group of 21 to 30 years and 27 in the age group
of 31 to 40 years. Above 51 years of age there were 4
patients while 15 were below 10 years.
Character of cough and expectoration, cold and
coryza associated with breathlessness, characteristic
modalities and concomitants like sneezing, hay fever etc.
formed the basis of inclusion in the study. The medicine
was prescribed in 30 C potency to start with. Depending
on the improvement in intensity and frequency of the
attacks the medicine was repeated in 30 C and / or 200
C potency. During symptom-free period Tuberculinum
1000 C was also administered to 74 patients as a
single dose regimen. At the conclusion of the study in
about 91% of enrolled patients improvement of various
degrees was observed. In 82.60% patients +++ and in
8.70% ++ improvement was observed, ( +++ ….75%
and above and ++….50 – 75%), while 8.70% patients
worsened.
The authors conclude their paper with the
observation that Ars. Iodatum is equally useful in atopic
as well as non atopic asthma and found it suitable
especially in acute asthmatic stage. They found the
complementary relationship of Tuberculinum with
Ars. Iodatum as it was found to have enhanced the
therapeutic effect of Ars. Iod. when administered as an
inter-current medicine during the trial.
Addition of Drugs and Rubrics for Asthma to
Kent’s Repertory of the Homoeopathic Materia
Medica : By Dr. Sanjeev Bhatia, Research Assistant
RRI (H), New Delhi, and Dr. Alok Kumar, Research
Assistant DPRU, Ghaziabad
In this paper the authors present literary research
work on Review and Revision of Chapter RESPIRATION
in Kent’s Repertory done at Regional Research Institute
(Homoeopathy), New Delhi. The objective of this literary
work was addition of certain rubrics and drugs which for
various reasons were not included in Kent’s Repertory.
The authors propose addition of some new rubrics,
sub-rubrics along with drugs at appropriate place in the
chapter ‘RESPIRATION’.
The methodology adopted in this literary work was
comparison of a rubric in Boericke’s Repertory with that
in the corresponding chapter in Kent’s. Those rubrics
and drugs which were not in Kent’s repertory but found
in Boericke’s were recommended for inclusion as a
rubric or sub- rubric at an appropriate place. Before
proposing such additions the same were verified from
the authentic reference books namely:
Encyclopaedia of Pure Materia Medica by T. F.
Allen
The Guiding Symptoms of our Materia Medica by
C. Hering
A Dictionary of Practical Materia Medica by J. H.
Clarke
In total 11 drugs were recommended for inclusion
under same number of new rubrics/sub-rubrics in
Kent’s Repertory. For example one of such additions
recommended is:
Solidago appears in Boericke’s repertory for
‘Periodical asthma with nightly dysuria’, but this is
missing in Kent’s repertory. After verifying this symptom
35
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
CCRH Quarterly Bulletin
S.R. Sharma et al
from ‘A Dictionary of Practical Materia Medica’ by J. H.
Clarke, vol. 3 pg 1221, the authors propose addition
in Kent’s Repertory as a new sub rubric in the chapter
RESPIRATION: ASTHMATIC: periodic with nightly
dysuria.
Looking Downwards
either way, right or left
moving objects, at
To cite another example from the chapter ‘HEAD’:
SULPHUR (references of, in Kent’s Repertory)
This paper is a part of serial publication of
compilation work done by Vishal Chawla and V. P.
Singh. In this literary work the authors have compiled
and arranged the rubrics/sub-rubrics from the chapters
‘Vertigo’ and ‘Head’ in Kent’s Repertory to construct
a symptomatological picture of the drug ‘Sulphur’.
They have gathered all the rubrics/sub-rubrics vis-àvis symptoms where ever Sulphur appeared. In their
endeavour the compilers paradoxically have attempted
to construct an exhaustive drug picture of SULPHUR
from Kent’s Repertory. From this compilation it is
evident that in the drug Sulphur there are 71 variables
of VERTIGO and 730 symptoms pertaining to HEAD.
The differential grading of the drug for each symptom
is reflected through the font style of the symptoms i.e.
bold, italics and regular respectively. One such example
is from the chapter ‘VERTIGO’:
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
Congestion, Hyperaemia
night
air, in open
bed, while in
coughing , on
eating, after
menses, during
Each symptom is graded through font style
according to the corresponding grading of the medicine
for a given symptom. Such compilation of database from
the repertory would help construct a compendium on the
drug SULPHUR and serve the purpose of an authentic
reference book that could be a useful tool for academic
and research purpose.
36
Book Review
book review
Pharmacological Actions of Homoeopathic Drugs
Price: ¿` 260.00
Pages: 212
Published by: Central Council for Research in Homoeopathy
New Delhi
The recent publication of the Central Council for
Research in Homoeopathy (CCRH) on Pharmacological
actions of the homoeopathic drugs is an effort to
bridge the gap that exists in the system between
materialistic science and dynamic principles. The
CCRH is mandated to validate the scientificity of
homoeopathy and is also responsible to take steps
to remove misconceptions of the system. Ever since
the codification of its principles by Dr. S. Hahnemann
in 1810, through publication of the first edition of his
Master work, The Organon of the Healing Art (Organon
der rationellen Heilkunde), Homoeopathy has become
a distinct medical system. Its gentle approach in
therapeutics made way for envious challenges from
the people of crude practices prevailing at that time.
Thus homoeopathy started its development with large
number of detractors on one side and supporters on
the other side. Over a period of time, both allopathy as
well as homoeopathy accepted scientific advances
based on contemporary information and now these
are the two principle methods of treatment of the sick
widely accepted across the world. Though both these
systems have diverse approach in the treatment, but
with the introduction of scientific and modern teaching,
there is emergence of interest to understand both
these systems by the investigators from both the
side. In the teaching and training programmes, there
are common subjects in both the systems except
in the pharmacology. Due to this in many countries,
Homoeopathy is a specialization after Allopathic
training and in few Asian countries the teachings are
independent. The Central Council of Homoeopathy had
taken a step to teach the pharmacological action of 30
drugs in the BHMS syllabus and the Central Council
for Research in Homoeopathy has made efforts to
codify these in the form of a book. Both these apex
organizations need appreciation for this initiative.
Homoeopathy is a dynamic system of medicine
with unique principles on theory and its practice.
The properties of the Homoeopathic medicines are
elicited through Human Pathogentic trial. The elicited
properties form the pure Materia medica. Anybody
can at any time can elicit the characteristic property
of a dynamic homoeopathic medicine anywhere
on a defined protocol. Inspite of the fact that there
are no demonstrable evidence of drug substance in
Homoeopathic high dilutions, its effect on the sick
as well as healthy are demonstrable. This is the
greatest scientific evidence of Homoeopathy. This is
the main reason why Homoeopathy survives today
in spite of severe onslaught by its opponents. Most
of the information documented in the book are
loosely available in different Materia medica such as
Encyclopaedia of Pure Materia Medica, (12 volumes)
by Timothy Allen, MD, A Manual of Pharmacodynamics
by Richard Hughes, Homoeopathic Materia Medica by
Willam Boreicke M.D, Homoeoapathic Pharamacopeia
of India etc. However the credit goes to CCRH in
systematizing that and presenting it in a text book form.
The referencing given under each drug will help people
to go into the details. The presentation would have been
better if the transparencies were printed in color.
The objective of the book seems to be only to
give information on the pharmacological action of low
dilutions/ mother tinctures with demonstrable original
drug substance, but the title gives an impression that
it includes the dynamic medicines which could have
been avoided. Otherwise it is a ready reference to the
scientists and students. For the benefit of the system,
it is advised that the council documents information
on more drugs.
*Reviewed by:
Dr. Eswara Das
Consultant Adviser (Homoeopathy)
Department of AYUSH, Ministry of Health & Family Welfare
Residence: A2/23, Hahnemann Enclave, Plot No 40,
Sector 6, Dwarka, New Delhi.110075
Email: [email protected]
37
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
Guidelines for Authors
The indian journal of research in homoeopathy
Guidelines for Authors
SCOPE
The Indian Journal of Research in Homoeopathy
(IJRH) is a homoeopathic research journal with
international circulation. It publishes articles pertaining to
homoeopathic research that reflects the advancements
made in the field of Homoeopathy which will enlighten
medical science as well as homoeopathic fraternity.
Conflict of interest: A conflict of interest exists if
authors or their institutions have financial or personal
relationships with other people or organizations that
could inappropriately influence (bias) their actions. A
conflict can be actual or potential, and full disclosure
to the Editor is absolute requirement. All submissions
must include disclosure of all relationships that could be
viewed as presenting a potential conflict of interest.
IJRH invites papers for publication. dealing with Drug
standardization, Drug proving, Clinical verification,
Clinical research and Fundamental research in
Homoeopathy provided they contain results of original
investigations. Research papers reporting original
research, review articles (both narrative and
evidence based), research correspondence, letter
to editor will also be considered. Papers related to
records of interesting cases treated on homoeopathic
principles and having sufficient documentary evidence
will be encouraged. All contributions are subject to peer
review by independent experts and the Editor’s decision
concerning publication is final. It is issued quarterly, in
four issues per year.
All authors must disclose any financial and personal
relationships with other people or organizations that
could inappropriately influence (bias) their work. If there
is no conflict of interest, authors should state so.
IJRH is entitled to make alterations in submissions to
adequate them to the journal’s standards, while keeping
their style and contents.
SUBMISSION CATEGORIES
The IJRH strongly discourages duplication/reduplication
of data already published in other journals (even
when certain cosmetic changes/additions are made).
Manuscripts may be subjected to a plagiarism software.
If and when duplication is detected after publishing
in IJRH, the journal will be forced to ‘retract’ such
articles.
Authorship: All authors should have made substantial
contributions to all of the following: (i) the conception
and design of the study, or acquisition of data, or
analysis and interpretation of data, (ii) drafting the article
or revising it critically for important intellectual content,
(iii) final approval of the version to be submitted (www.
icmje.org).
Acknowledgements: All contributors who do not meet
the criteria for authorship as defined above should be
listed in an acknowledgements section. Examples of
those who might be acknowledged include a person
who provided purely technical help, writing assistance,
or a department Chair who provided only general
support. Authors should disclose whether they had any
writing assistance and identify the entity that paid for
this assistance.
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
Role of the funding source: All sources of funding
should be declared as an acknowledgement at the end
of the text. Authors should declare the role of study
sponsors, if any, in the study design, in the collection,
analysis and interpretation of data; in the writing of the
manuscript; and in the decision to submit the manuscript
for publication. If the study sponsors had no such
involvement, the authors should so state.
Manuscripts submitted for publication to the IJRH shall
include the following categories:
1. ORIGINAL ARTICLES: this category includes
original research including both clinical and basic
science submissions. These are selected at the
discretion of the editor(s) based upon novelty, relevance
and the quality of the research.
2. REVIEW ARTICLES (Including Systematic and
Meta-analysis): Critical analysis and updated literature
on some topics related to field of Homoeopathic
research. Both types of articles must adhere to the
guidelines outlined in the PRISMA statement. The
articles under this section will be critical appraisal of
different studies on important topics of clinical/public
health significance to obtain an unbiased quantitative
estimate of the overall effect of an intervention or
variable for a defined outcome. Systematic reviews
could be about 2500-3000 words with minimum number
of Tables/Figures. For the most up-to-date information
about these guidelines and access to future visions,
visit http://www.prisma-statement.org. Methods should
provide a detailed literature search strategy and
a description of the way in which the studies were
reviewed and analyzed.
38
Guidelines for Authors
3. CLINICAL CASE HISTORIES. Cases should be well
presented and concise (maximum of 1500 words per
case). Cases should address a specified therapeutic
and/or management issue. Discussion should be
critical and reflective rather than doctrinaire. Case
analysis (symptom selection, prescribing strategy, etc)
should be transparent and well justified. Case histories
should discuss the materia medica involved, and the
rationale of any differential diagnosis. Case analysis
and materia medica should be illustrated with tables
and figures where appropriate. Case histories should
include adequate follow-up to demonstrate sustained
improvement. Documentation and independent
evidence strengthen case reports, and as much of such
evidence as possible should be presented. This includes
results of pathology and other investigations, images
(including photographs), physical examination, ability
to work and fulfill social roles, educational performance,
and assessments by other health professions and
agencies etc.
4. SHORT COMMUNICATIONS: Preliminary report of
research under progress
5. STUDENT IJRH (Dissertation abstracts/full article)
With an aim to encourage and promote the participation
of postgraduate students in homoeopathic medical
research, the articles based on the dissertation work
done by them are invited in IJRH for publication. This
new section is started exclusively for homoeopathic
postgraduate students.
6. BOOK REVIEWS: non –advertising texts presenting
a critical analysis of books related to Homoeopathy
7. LETTERS TO EDITOR: Summarily discussing IJRH
published materials
8. EDITORIAL: Editorials are exclusively solicited by
the editor. Editorials should express opinions and /or
provide comments on papers published elsewhere in
the same issue and should be approximately 1,000
words in length with upto 10 references. A single author
is preferred. Editorial submissions are subject to review/
request for revision, and editors retain the right to modify
text as per our house style.
MANUSCRIPT SUBMISSION
Authors do not need to pay for submission, processing
or publication of articles. Manuscripts can also be
submitted by e-mail at [email protected]
or [email protected].
The manuscript should contain all the documents listed
below before submission:
1. COVERING LETTER
A covering letter explaining why the paper should be
published in the IJRH. One of the authors could be
identified as the corresponding author of the paper,
who would be responsible for the contents of the paper
as also answer.
2. MANUSCRIPT
General instructions:
Manuscripts must be typewritten, double-spaced with
one inch margins, in Times New Roman font and font
size 12 on A-4 size, good quality bond paper. Authors
are urged for clarity, brevity and accuracy of information
and language. Authors whose first language is not
English should have their articles checked for linguistic
accuracy by a professional editor who is well acquainted
with English language. Each of these segments of
the manuscripts should begin on a new page: Title;
structured abstract; introduction; material and methods;
discussion; acknowledgement; references; legends;
figures and tables. Size of a write up in a letter form
should not exceed 500 words where as original writing
should not exceed more than 5000 words. References
are limited to no more than 40, with the exception of
review articles.
The names of homoeopathic medicines, books and
journals appear in italics. The binomial system and
abbreviations are used for homeopathic medicines e.g.
Nat-m, Kali-ar. Homoeopathy potencies are indicated as
6x, 30c, 1M 10M (or dH, cH, MK etc where the method of
dilution is specified).Names of homoeopathic remedies
should be written in italics (Aconitum napellus).
Only standard abbreviations are to be used. The title of
article should not contain abbreviations. The full term
for which the abbreviation stands should be given after
its first use in the text.
Pages should be numbered consecutively.
Manuscript format and sequence:
Papers should be structured as follows: (a) Title page,
(b) Abstract, (c) Keywords, (d) Text, (e) References,
(f) Figure and Table Legends, (g) Figures and (h)
Tables.
TITLE PAGE
1. The title of the article — Title of the article
should be short (not more than 6-7 words), continuous
(broken or hyphenated titles are not acceptable) and
yet sufficiently descriptive and informative so as to be
useful in indexing and information retrieval.
39
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
Guidelines for Authors
2. First name, middle initial, last name, highest
academic degree, and institution /department of each
author;
3. The corresponding author’s name, full postal address with pin, telephone, fax and e-mail;
4. Three to six keywords alphabetically arranged;
5. State the word count for text;
6. State the word count for abstract;
7. Substantial contributions to all of the following: (1)
the conception and design of the study, or acquisition of
data, or analysis and interpretation of data, (2) drafting
the article or revising it critically for important intellectual
content, (3) final approval of the version.
At the end of the title page; the title, the name of Author/
Authors (excluding designations viz..Dr, Mr, Mrs..etc)
may be placed with superscript digits 1, 2, 3… etc,
(eg: Suman1 Y.Ram2* Smith3…) which should explain
the designation and qualifications of the author in the
subsequent line. The name of author who will entertain
correspondence related to the article also have an
asterix (*) sign as superscript (eg:-Y.Ram2*) the details
of which (the correspondence address and e-mail of
the author) should appear as footer in the introductory
page of the article.
STRUCTURED ABSTRACT
The structured abstract should not be more than 300
words. No abbreviations are allowed in the abstract.
Do not provide any manufacturer information in the
abstract. Randomized control trials must include in the
Abstract the unique registration number as evidence
of registration. Organize structured abstracts for the
articles shown below:
Original Contribution: Background, Objective, Design,
Settings, Patients, Interventions(s) if any, Main Outcome
Measures, Results, Limitations, Conclusions. BE
SURE TO USE THESE SPECIFIC HEADERS WHEN
FORMATTING AND SUBMITTING THE ABSTRACT
WITH YOUR PAPER. If not done, the paper will be
returned for compliance prior to any review process.
Systematic Reviews, including Meta-analyses:
Background, Objective, Data Sources, Study Selection,
Intervention(s), Main Outcome Measures, Results,
Limitations, Conclusions. BE SURE TO USE THESE
SPECIFIC HEADERS WHEN FORMATTING AND
SUBMITTING THE ABSTRACT WITH YOUR PAPER.
If not done, the paper will be returned for compliance
prior to any review process.
(Cummings P, Rivara FR, Koepsell TD. Writing
informative abstracts for journal articles. Arch Pediatr
Adolesc Med. 2004;158:1086-1088.
Available from http://pediatrics.medschool.ucsf.edu/
brochure/pedsplus/resident_only/docs/2007_09/APAMwriting_informative_abstracts.pdf )
TEXT
Arrange in the following order:
1. Introduction: Clearly state the purpose of the
article. Summarize the rationale for the study or
observation. Give only strictly pertinent references, and
do not review the subject extensively;
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Guidelines for Authors
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41
Indian Journal of Research in Homoeopathy
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Guidelines for Authors
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Malinowski JM, Bolesta S. Rosiglitazone in the
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Clin Ther. 2000;22(10):1151-68; discussion 1149-50.
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Breedlove GK, Schorfheide AM. Adolescent pregnancy.
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Method for measuring the size distribution of airborne
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Pratt B, Flick P, Vynne C, cartographers. Biodiversity
hotspots [map]. Washington: Conservation International;
2000.
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Harnden P, Joffe JK, Jones WG, editors. Germ cell
tumours V. Proceedings of the 5th Germ Cell Tumour
Conference; 2001 Sep 13-15; Leeds, UK. New York:
Springer; 2002.
16. Conference paper
Christensen S, Oppacher F. An analysis of Koza’s
computational effort statistic for genetic programming.
In: Foster JA, Lutton E, Miller J, Ryan C, Tettamanzi
AG, editors. Genetic programming. EuroGP 2002:
Proceedings of the 5th European Conference on
Genetic Programming; 2002 Apr 3-5; Kinsdale, Ireland.
Berlin: Springer; 2002. p. 182-91.
21. Dictionary and similar references
Dorland’s illustrated medical dictionary. 29th ed.
Philadelphia: W.B. Saunders; 2000. Filamin; p. 675.
Unpublished Material
22. In press
Tian D, Araki H, Stahl E, Bergelson J, Kreitman M.
Signature of balancing selection in Arabidopsis. Proc
Natl Acad Sci U S A. In press 2012.
Electronic Material
23. CD-ROM
Anderson SC, Poulsen KB. Anderson’s electronic atlas
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of hematology [CD-ROM]. Philadelphia: Lippincott
Williams & Wilkins; 2002. Witko, David. CARA
Professional © 1997, London, Miccant Ltd. Revised
programme by John Stevenson. 1999
24. Journal article on the Internet [date of access is
mandatory]
[Abood S. Quality improvement initiative in nursing
homes: the ANA acts in an advisory role. Am J
Nurs[serial on the Internet]. 2002 Jun. Available from:
http://www.nursingworld.org/AJN/2002/june/Wawatch.
htm , accessed on August 12, 2002.
25. Monograph on the Internet
Foley KM, Gelband H, editors. Improving palliative care
for cancer [monograph on the Internet]. Washington:
National Academy Press; 2001 [cited 2002 Jul 9].
Available from: http://www.nap.edu/books/0309074029/
html/.
26. Homepage/Web site
Cancer-Pain.org [homepage on the Internet]. New York:
Association of Cancer Online Resources, Inc.; c200001 [updated 2002 May 16; cited 2002 Jul 9]. Available
from: http://www.cancer-pain.org/.
27. Part of a homepage/Web site
American Medical Association [homepage on the
Internet]. Chicago: The Association; c1995-2002
[updated 2001 Aug 23; cited 2002 Aug 12]. AMA Office
of Group Practice Liaison; [about 2 screens].
Available from: http://www.ama-assn.org/ama/pub/
category/1736.html
28. Database on the Internet
Open database: Who’s Certified [database on the
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Specialists. c2000 - [cited 2001 Mar 8]. Available from:
http://www.abms.org/newsearch.asp
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Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
48
A Case of Paraphimosis with Balanitis
Ch. Raveendar et al
ORIGINAL ARTICLE
A Case of Paraphimosis with Balanitis
Ch. Raveendar*, Kishan Banoth
Paraphimosis occurs when the foreskin of the uncircumcised or partially circumcised male is retracted
behind the glans penis, develops venous and lymphatic congestion and cannot be returned to its
normal position. This urologic emergency impedes blood flow to the glans penis with potential for
permanent damage and gangrene.
In infants and young children, paraphimosis usually results from self manipulation by the child or
inappropriate retraction of the foreskin by the caretaker in misguided attempts at cleaning. In the
sexually active adolescent or adult male, intercourse is a potential precipitant. Iatrogenic paraphimosis
follows cystoscopy or bladder catheterization if the foreskin is not reduced back over the glans penis
by the medical provider. This surgical intervention can be avoided through homoeopathic treatment.
A case of paraphimosis with balanitis of an adolescent treated with homoeopathy is reported here.
This case shows the usefulness of homoeopathic medicine, Merc. sol and Cinnabaris or Mercurius
sulphuratus ruber (MSR) in giving not only symptomatic relief to the patient, but also restoring the
foreskin completely to its normal position.
Keywords: homoeopathy; paraphimosis; inflammation; penis; prepuce; balanitis; glans penis
INTRODUCTION
Paraphimosis is an uncommon clinical condition
where the foreskin becomes trapped behind the glans
penis, and cannot be reduced (that is, pulled back to its
normal flaccid position covering the glans penis).1 If this
condition persists for several hours or there is any sign
of a lack of blood flow, paraphimosis should be treated
as a medical emergency, as it can result in gangrene
or other serious complications.1,2 Paraphimosis is
usually caused by medical professionals or parents
who handle the foreskin improperly.1,2 The foreskin
may be retracted during penile examination, penile
cleaning, urethral catheterization, or cystoscopy. If the
foreskin is left retracted for a long period of time, some
of the foreskin tissue may become edematous, which
makes subsequent reduction of the foreskin difficult.
Paraphimosis can be avoided by bringing the
Address for Correspondence:
* Dr. Ch. Raveendar, Asst. Director (H), Scientist – 4, Officer
Incharge, RRI (H), Gudivada – 521301, Krishna Dist., Andhra
Pradesh,
e – mail: [email protected]
Received on 6.7.12
Approved on 17.10.12
foreskin back to its reduced position after retraction is
no longer necessary (for instance, after cleaning the
glans penis or placing a Foley’s catheter). Paraphimosis
can often be treated by manual manipulation of the
swollen foreskin tissue. This involves compressing
the glans and moving the foreskin back to its normal
position, with an aid of a lubricant, cold compression,
and local anesthesia as necessary. If this fails, the
tight edematous band of tissue can be relieved
surgically with a dorsal slit 1,2 or circumcision.3-7 An
alternative method, the Dundee technique, entails
placing multiple punctures in the swollen foreskin with
a fine needle, and then expressing the edema fluid by
manual pressure.4 According to Ghory and Sharma,
treatment by circumcision may be elected as "a last
resort, to be performed by a urologist".8
CASE PRESENTATION
A boy of 15 years age, high school student
came to the OPD of Regional Research Institute
for Homoeopathy, Gudivada on 18.03.2011 with
complaints of swelling of prepuce and glans penis (Fig.
1) and fever for the past 7 days. The fever was more
prominent in the forenoon. The boy was subjected
to the investigations of ESR, TLC, DLC, HB%, Retro
49
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
A Case of Paraphimosis with Balanitis
Ch. Raveendar et al
Hompath Software.10 The outcome of repertorization
with weightage of different drugs is given in the Table
1. The medicines have been prescribed on the basis
of presenting symptoms of the patient and medicines
were changed depending upon the response to
the earlier medicine prescribed. During the course
of treatment, the medicines were also prescribed
alternately i.e., Mercurius sulphuratus ruber (MSR) 30
& Merc. sol 30 for 4 days. Such type of prescriptions
giving medicines alternately is also suggested by
certain homoeopathic stalwarts11 in acute conditions.
Details of the follow up, response and prescription of
medicines are given in Table 2.
Viral screening & Urine analysis which were found to
be within normal limits. Previously the boy was treated
with a course of antibiotics (Amoxicillin) and anti –
inflammatory preparations of paracetamol, ibuprofen,
but he did not respond.
On local examination: Oedematous swelling of
glans penis and prepuce +, tenderness +
Past Medical History:
Not significant
Family History: Not Significant
All the presenting symptoms of paraphimosis
were repertorised with complete repertory9 in
Cinnb
Mer
Calc
Gels
Lach
Nat-c
Sulph
Thuj
Canth
9/4
7/3
7/3
6/4
6/4
6/4
6/4
6/4
6/4
6/3
C: Male Genitalia,
Inflammation; penis,
prepuce, balanitis
2
2
2
3
3
2
2
1
2
2
2
2
C: Male Genitalia
Inflammation; penis, glans,
balanitis
1
1
2
3
2
2
2
1
2
2
2
1
C: Male Genitalia
Inflammation
3
2
3
1
2
1
1
1
1
1
1
3
C: Male Genitalia
Inflammation; penis,
prepuce; erysipelatous
3
3
2
C: Fever, Heat, Forenoon
1
2
1
1
1
Acon
Apis
10/5
Lyc
Rhus-t
10/5
Totality of Paraphimosis
symptoms & Rubrics
Nat-m
Ars
Table 1: Reportorial outcome with weightage of medicines
6/3
5/4
5/3
1
2
2
2
2
1
1
1
3
1
3
1
1
First prescription with justifications
Oedematous, inflammatory swelling of prepuce and glans penis. (Fig. 1) Stinging & burning pain with
fever.
Rx Apis mel. 30/ BD for 3 days
Fig.1 BEFORE TREATMENT (Dt. 18.03.2011)
Indian Journal of Research in Homoeopathy
Vol. 6, No. 4, October - December 2012
Fig.2 AFTER TREATMENT (Dt. 05.04.2011)
50
A Case of Paraphimosis with Balanitis
Ch. Raveendar et al
Table 2: Follow up Visits
Sl.
No.
Date of
follow up
visits
Symptoms
Medicine & Doses
Criteria for
prescription
21-03-11
Fever relieved.
Oedematous, inflammatory swelling of
prepuce and glans penis status quo.
Rhus tox. 30 – TID for 3
days
25-03-11
Oedematous, inflammatory swelling of
prepuce and glans penis status quo, no
improvement.
MSR 30 - 1 dose in
morning
Merc. sol. 30 - 1dose at
night for 4days
Change of medicines
MSR 30 & Merc. sol.
30 based on coverage
of symptoms
01-04-11
Oedematous, inflammatory swelling of
prepuce and glans penis significantly reduced
but persisting.
MSR200 - 1 dose in
morning
Merc.sol.200 - 1dose at
night for 4days
Same medicines in
higher potency
05- 04-11
Oedematous, inflammatory swelling of
prepuce and glans penis completely reduced.
(Fig.-2)
Merc. sol 200 - 1dose/
day for 5 days followed
by Placebo BD for 15
days.
Repetition of Merc.
sol 200 as concluding
prescription & to
prevent recurrence.
DISCUSSION
Paraphimosis condition is usually considered
as a surgical, in its pathological form and is usually
treated by the surgical method preputioplasty to loosen
the preputial orifice or circumcision by amputating
the foreskin tissue partially or completely. In certain
occasions, the paraphimosis is treated by manual
manipulation of the swollen foreskin tissue and if this
fails, the tight edematous band of tissue is relieved
surgically with a dorsal slit. The patient visited OPD
of Regional Research Institute (H), Gudivada the
after taking a course of antibiotic & anti-inflammatory
drugs for which he did not respond. The case was
repertorised with all local symptoms of paraphimosis.
During the first 6 days, Apis mellifica and Rhus
toxicodendron in 30 potency were prescribed based
on repertorization of presenting symptoms; no inimical
relationship was observed between Apis mellifica and
Rhus toxicodendron. Though the fever was reduced
with Apis mellifica 30, there was no improvement in
paraphimosis. Later on, Cinnabaris or Mercurius
sulphuratus ruber (MSR) and Merc. sol. in 30 potency
were prescribed 1 dose in morning and 1dose at night
respectively for 4 days. Within 7 days of administration
of Cinnabaris and Merc. sol in 30 potency alternately,
the signs & symptoms relating to paraphimosis were
significantly improved but the normal condition was
not restored. Therefore, the same medicines were
continued in 200 potency for another 4 days and the
patient was cured completely within 4 days. Usually in
acute conditions like Arthritis, Acute coryza, Dyspepsia,
Acute headaches of different origin, etc., if the patient’s
totality of symptoms do not cover a single medicine,
rather two medicines, then both those medicines can
be prescribed alternately. With this concept both Merc.
Sol. & MSR were prescribed in this case, which yielded
positive result. Though Merc. sol. has night aggravation
as mentioned in homoeopathic literature, no adverse
event has happened in this case when Merc. sol was
prescribed at night.
CONCLUSION
Paraphimosis, usually considered as an
emergency urologic condition in modern medicine
and treated by minimally invasive surgery, was
successfully treated by homoeopathic intervention.
The administration of two medicines, alternately in
this case may invite criticism from some quarters. But
the reality is, the patient has been benefited out of
such prescription. However, further research can be
undertaken for finding the usefulness of different types
of prescriptions in various acute clinical conditions like
acute abdomen, acute disc prolapse, renal colic, acute
inflammatory conditions, etc.
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