Download Evaluation of efficacy and safety of Gasex Syrup in functional

Clinical
Trial
Evaluation of efficacy and safety of
Gasex Syrup in functional dyspepsia
MAHTO A.K., PRASAD S.R., MITRA S.K.
ABSTRACT
The present study was planned to evaluate the clinical efficacy and safety of Gasex syrup in
functional dyspepsia. Dyspepsia is a symptom complex of upper abdominal pain or discomfort
believed to originate in the upper gastrointestinal (GI) tract. The pathogenesis of functional
dyspepsia remains uncertain. However, regardless of the cause, the treatment effects have generally
not been impressive.
The present study was an open clinical trial, conducted as per the ethical guidelines of Declaration
of Helsinki. All patients suffering from pain or discomfort centered in the upper abdomen with
associated bloating, belching, nausea, and heartburn were included in the study, patients having
severe vomiting and diarrhea, and those suffering with gastric or duodenal ulcer, cancer or
varices disease were excluded from the study. A thorough history, symptomatic evaluation and
clinical examination was done for all patients before treatment and during follow-up visits every
week till the end of treatment on Day 28 along with recording the occurrence of any adverse
event/s. The predefined primary endpoints were rapid symptomatic relief from upper abdominal
pain, heart burn and bloating. The predefined secondary endpoints were short- and long-term
safety, and overall compliance to the drug treatment.
A total of 50 patients were enrolled into the trial and all the patients completed the study. A
significant reduction (p<0.0001) in the mean symptom score of upper abdominal pain, heartburn,
abdominal bloating, belching, fullness of stomach after meals, and nausea were observed after 28
days of treatment with Gasex syrup. There were no clinically significant adverse events, either
reported or observed, during the entire study period. Therefore, it may be concluded that Gasex
syrup is clinically safe and effective in the management of functional dyspepsia.
INTRODUCTION
Dyspepsia is defined as episodic
or persistent symptoms of abdominal
pain or discomfort referable to the
upper gastrointestinal tract.1 However,
actual mucosal lesions, such as
erosions or ulcers, are found in as
few as 20% of dyspeptic patients.2
In patients without mucosal
changes, the dyspepsia is thought to
be secondary to a disorder of
function, rather than structure, hence
the name “functional dyspepsia”
(FD). Typical symptoms of FD include
postprandial epigastric pain, early
satiety, belching, bloating, and
Dr. A.K. Mahto, M.D. (Med.)
Professor and Head,
Department of Medicine,
Rajendra Institute of Medical Sciences,
Bariatu, Ranchi, Jharkhand, India.
Dr. S.R. Prasad,
Medical Advisor,
Dr. S.K. Mitra,
Executive Director,
R&D Center,
The Himalaya Drug Company,
Bangalore - 562 123, India.
Specially Contributed to "The Antiseptic"
Vol. 105 No. 1 & P : 35 - 40
January 2008
nausea. The current Rome II criteria
for FD are symptoms for at least a 12week duration, which need not be
consecutive, within the preceding
year of (a) persistent or recurrent
dyspepsia, (b) no evidence of organic
disease
(including
at
upper
gastrointestinal endoscopy) that is
likely to explain the symptoms, and
(c) no evidence that dyspepsia is
exclusively relieved by defecation or
associated with the onset of a change
in stool frequency or stool form (i.e.,
not irritable bowel syndrome).3
Several
pathophysiological
mechanisms underlying FD such as
delayed gastric emptying,4,5 abnormal
antroduodenal motility,6,7 altered
sensitivity to duodenal lipid or acid
exposure, 8-10
visceral
hypersensitivity11, 12 and impaired fundic
accommodation, 13, 14 have been
identified. The current knowledge of
these pathophysiological mechanisms
has not led to a complete
understanding of FD. Furthermore,
attempts to develop therapeutic
THE ANTISEPTIC
strategies based on this knowledge
have thus far not banned dyspepsia
from our midst.
However, regardless of the cause
of FD the present treatment effects
have generally not been impressive.
Gasex syrup is a polyherbal
formulation containing extracts of
Cuminum cyminum, Mentha arvensis,
Foeniculum
vulgare,
Elettaria
cardamomum, Apium graveolens,
Coriandrum sativum, Curcuma
longa, and Trikatu, all of which are
recommended for the management of
dyspepsia. This study was planned
to evaluate the clinical efficacy and
safety of Gasex syrup in the
management of functional dyspepsia.
PATIENTS AND METHODS
Inclusion criteria
All patients aged between 18 to
70 years, suffering from pain centered
in the upper abdomen with associated
bloating, belching and nausea, were
included in the study.
35
Exclusion criteria
Patients having severe vomiting
and diarrhea, and those suffering with
gastric or duodenal ulcer, cancer or
varices disease were excluded from
the study.
Study procedure
The study was an open, nonrandomized and non-comparative,
prospective, phase III clinical trial,
conducted at Rajendra Institute of
Medical Sciences, Ranchi, Jharkhand,
India, from November 2006 to January
2007 as per the ethical guidelines of
Declaration of Helsinki. The study
protocol, case report forms (CRFs),
regulatory clearance documents,
product-related information and
informed consent forms (in English,
Hindi and Tamil) were submitted to
the institutional ethics committee and
were approved by the same.
The patients who attended the
Department of Medicine, Rajendra
Institute of Medical Sciences, Ranchi,
Jharkhand, India, were informed about
the study drug, its effects, duration
of the trial, and overall plan of the
study. The patients were included in
the clinical study only after written
informed consent was obtained from
them, and a witness, independent of
the clinical trial, signed the informed
consent form.
The history was noted by
interviewing the patient. Thorough
clinical examination and symptomatic
evaluation was carried out and the
details were noted down in the CRF.
Patients were advised to take the
drug at a dose of 2 teaspoonfuls
twice a day after meals for 28 days.
All patients were received every
week till the end of treatment on Day
28 and symptomatic evaluation and
clinical examination was done, along
with recording the occurrence of any
adverse event/s (either reported or
observed).
Primary
endpoints
and
secondary
The predefined primary endpoints
were rapid symptomatic relief from
upper abdominal pain, heartburn,
bloating, and fullness after meals. The
predefined secondary endpoints were
short- and long-term safety, and
36
overall compliance to the drug
treatment.
Adverse events
All adverse events, either reported
or observed, were recorded in the
CRF with information about severity,
onset, duration, and action taken
regarding the study drug. Relation of
adverse events to the study
medication was predefined as
“unrelated” (a reaction that does not
follow a reasonable temporal
sequence from the time of
administration of the drug), “possible”
(follows a known response pattern to
the suspected drug, but could have
been produced by the patient’s
clinical state or other modes of
therapy administered to the patient),
and “probable” (follows a known
response pattern to the suspected
drug that could not be reasonably
explained
by
the
known
characteristics of the patient’s clinical
state).
Patients
were
allowed
to
voluntarily withdraw from the study,
if they experienced serious discomfort
during the study or sustained serious
clinical events requiring specific
treatment. For patients withdrawing
from the study, efforts were made to
ascertain the reason for dropout. Noncompliance (defined as failure to take
less than 80% of the medication) was
not regarded as treatment failure, and
reasons for non-compliance were
noted.
Statistical analysis
Statistical analysis was done
according
to
intention-to-treat
principles. The changes in various
parameters from pre-treatment values
to post-treatment values were
analyzed by “Friedman’s test”
followed by “Dunn’s Multiple
Comparison test analysis”. The
minimum level of significance was
fixed at 95% confidence limit and a 2sided p value of <0.05 was considered
significant.
RESULTS
A total of 50 patients suffering
from functional dyspepsia were
included in the clinical trial and all
patients completed the study. The
study group had 30 male and 20
female patients. The mean age of the
THE ANTISEPTIC
patients was 36.8 years. Out of 50
patients, all of them were suffering
from upper abdominal pain and
heartburn, 42 patients had abdominal
bloating, 39 patients had belching, 36
patients had fullness after meals, and
14 patients had nausea.
A significant reduction (p<0.0001)
in mean symptom score of upper
abdominal pain from 1.82 ± 0.133 to
0.24 ± 0.067, heartburn from 1.74 ±
0.164 to 0.38 ± 0.085, abdominal
bloating from 1.86 ± 0.149 to 0.44 ±
0.095, belching from 1.76 ± 0.155 to
0.32 ± 0.088, fullness of stomach after
meals from 1.280 ± 0.137 to 0.240 ±
0.073, and nausea from 1.140 ± 0.134
to 0.180 ± 0.062 were observed after
28 days of treatment with Gasex syrup.
The reduction in these symptoms
score started appearing from the Day
7 of treatment itself (Table 1;
Figures 1 to 6).
Patient’s
global
assessment
revealed that 22% of them became
totally symptom-free, 20% showed
marked improvement, 40% had
moderate improvement, and 18% had
slight improvement after 28 days of
therapy with Gasex syrup (Figure 7).
Investigator’s global assessment
revealed that 48% patients became
totally symptom free, 38% of patients
had marked improvement, and 14% of
them had moderate improvement at
the end of treatment with Gasex syrup
(Figure 8).
There were no clinically significant
adverse events, either reported or
observed, during the entire study
period.
DISCUSSION
Although the precise definition
of dyspepsia remains debatable, the
most widely quoted definition is a
chronic, recurrent pain or discomfort
centred in the upper abdomen.15
Once an evaluation has been
performed and organic etiologies for
the dyspeptic symptoms have been
excluded, an affected patient is said
to be suffering from functional
dyspepsia (FD; previously termed
non-ulcer dyspepsia).16
Epidemiological studies suggest
that approximately 15% of the general
population in western countries
suffers with FD.17,18
January 2008
Table 1: Reduction in mean symptom score of upper abdominal pain, heartburn, bloating, belching,
fullness after meals, and nausea with Gasex syrup treatment
Parameter
Day 0
Day 7
Day 14
Day 21
Day 28
Upper
abdominal
pain
Heartburn
1.820 ± 0.133 0.820± 0.127*
0.500± 0.112*
0.340± 0.084*
0.240± 0.067*
1.740± 0.164
1.220± 0.147
0.800± 0.137*
0.500± 0.104*
0.380± 0.085*
Bloating
1.860± 0.149 1.140± 0.149#
0.900± 0.149*
0.600± 0.121*
0.440± 0.095*
Belching
1.760± 0.155
1.100± 0.146
0.740± 0.137*
0.500± 0.100*
0.320± 0.088*
Fullness after 1.280± 0.137 0.680± 0.119#
meals
Nausea
1.140± 0.134 0.540± 0.108#
0.460± 0.104*
0.280± 0.081*
0.240± 0.073*
0.280± 0.081*
0.220± 0.072*
0.180± 0.062*
#
Friedman
Statistic (FS) &
Significance
FS: 138.3; p<0.0001,
Significant
FS: 116.6; p<0.0001,
Significant
FS: 115.9; p<0.0001,
Significant
FS: 102.5; p<0.0001,
Significant
FS: 99.27; p<0.0001,
Significant
FS: 98.47; p<0.0001,
Significant
p<0.01 and *p<0.001 as compared with Day 0 value
Figure 1: Reduction in mean symptom score of
upper abdominal pain with Gasex syrup
treatment (Mean ± SEM)
Figure 2: Reduction in mean symptom score of
heartburn with Gasex syrup treatment
(Mean ± SEM)
Figure 3: Reduction in mean symptom score of
bloating with Gasex syrup treatment
(Mean ± SEM)
Figure 4: Reduction in mean symptom score of
belching with Gasex syrup treatment
(Mean ± SEM)
January 2008
THE ANTISEPTIC
37
Figure 5: Reduction in mean symptom score
of fullness after meals with Gasex syrup
treatment (Mean ± SEM)
Figure 6: Reduction in mean symptom score
of nausea with Gasex syrup treatment
(Mean ± SEM)
Figure 7: Percentage of improvement from
patient’s global assessment
Figure 8: Percentage of improvement from
investigator’s global assessment
Nearly two-thirds of dyspeptic
patients will eventually end up with
a diagnosis of FD following an
evaluation.19 FD tends to be a chronic
condition with long-term studies
demonstrating persistent symptoms
in >80% of affected patients after 67 years of follow-up.20,21 Other studies
have consistently found that FD
negatively affects quality of life.22-24
A wide variety of pathophysiological mechanisms have been
postulated to contribute to the
development of symptoms in patients
with FD. Of the abnormalities
proposed,
alterations
in
gastroduodenal motor and reflex
function have been most extensively
studied. Delayed gastric emptying has
been reported in 30-40% of FD
patients. 25-30
38
At present, it remains unclear if
any one or more likely some
combination of these abnormalities is
responsible for symptoms in FD
patients.
A wide variety of treatments have
been used to manage FD including
dietary and lifestyle modifications,
Helicobacer pylori eradication,
antacids,
mucosal
protectants,
antisecretory agents, prokinetics,
antidepressants, and behavioural
therapies as well as complementary
and alternative medical (CAM)
therapies. But the fact is that no
single available therapy consistently
provides relief to the majority of FD
patients .
The present clinical study
observed a significant relief in the
THE ANTISEPTIC
symptoms of dyspepsia like upper
abdominal pain, heartburn, abdominal
bloating, abdominal belching, fullness
of stomach after meals, and nausea
and vomiting after 28 days of
treatment with Gasex syrup. The
reduction in these symptoms started
appearing from the Day 7 of treatment
itself and complete relief by 28 days.
There were no clinically significant
adverse events, either reported or
observed, during the entire study
period.
Earlier research works on the
extracts of individual ingredients of
Cuminum cyminum, Mentha arvensis,
Foeniculum
vulgare,
Elettaria
cardamomum, Apium graveolens,
Coriandrum sativum, Curcuma
longa, and Trikatu have proven their
carminative, antispasmodic, analgesic,
January 2008
anti-inflammatory, and antioxidant
activities.
Cuminum cyminum, belonging to
the family Apiaceae, is widely used
in Ayurvedic medicine for the
treatment of dyspepsia, diarrhea and
jaundice.31
All the herbs tested increased acid
secretion in the following declining
order: fennel, omum, cardamom,
cumin, and coriander; these herbs
increased gastric acid secretion, in
some by a cholinergic mechanism but
by other mechanism(s) as well. 32
Cumin may protect the colon by
decreasing the activity of betaglucuronidase and mucinase.33
“Trikatu” is an Ayurvedic
preparation containing black pepper,
long pepper and ginger, which is
prescribed routinely for a variety of
diseases as part of multidrug
prescriptions. These herbs along with
piperine (alkaloid of peppers) have
been shown to possess diverse
biological activities in mammalian
systems. 34
Peppers and ginger have been
commonly used in conjunction in
folklore medicines. Modern research,
mostly European, has documented
the ability of ginger to stimulate
gastric motility (efficiency of moving
food through the digestive tract) to
relieve indigestion and to promote
digestion. The main reason that this
herbal trio is part of so many
Ayurvedic formulations is its proven
ability to enhance gastrointestinal
absorption of nutrients. Many groups
of scientific investigators attribute
this bioenhancing property of pepper
to its main alkaloid, piperine.35
Mentha arvensis plant has
antispasmodic,
carminative,
cholagogic,
and
antimicrobial
properties. The oil contains 95% of
menthol and offers cytotoxic
properties.
The fruit of Foeniculum vulgare
has anti-inflammatory, analgesic and
antioxidant activities.36
Elettaria cardamomum has shown
gastroprotective property in rats.37
Extract of Apium graveolens contains
apiin as the major constituent and
exerted significant anti-inflammatory
property in in vivo model. 38 The
January 2008
antioxidant activity of the aqueous
extracts of 3 umbelliferous fruits coriander (Coriandrum sativum),
cumin (Cuminum cyminum) and
fennel (Foeniculum vulgare) has been
demonstrated. 39
Curcuma
longa
has
been
commonly used as a traditional
remedy for a variety of symptoms
such as inflammation, gastritis and
gastric ulcer. When Curcuma longa
extract was administered per os to
pylori-ligated rat stomachs, it reduced
gastric acid secretion and protected
against the formation of gastric
mucosal lesions. Therefore, it was
tested whether Curcuma longa
extract inhibits gastric ulcers by
blocking the H2 histamine receptor.
These findings suggest that the
extract from Curcuma longa
specifically inhibits gastric acid
secretion by blocking H2 histamine
receptors in a competitive manner.40
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This study observed a significant
symptomatic relief from upper
abdominal pain, heartburn, abdominal
bloating, belching, fullness of
stomach after meals, and nausea.
Symptomatic relief was evident in 7
days of treatment in majority of the
patients, while almost all were
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concluded that Gasex syrup is
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management of functional dyspepsia.
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A 31 year old woman who had taken oxytetracycline for three
months to treat rosacea attended clinic because of painful
finger nails, which had partially lifted off the nail bed and turned
yellow. She had noticed this while on holiday in Turkey three
weeks earlier. On examination she had onycholysis of all
fingernails and toenails, and a yellow discoloration of all nails.
Photo-onycholysis is a well documented side effect of
tetracyclines within the photosensitivity spectrum. Treatment
was stopped and her nails are now returning to normal .
(BMJ June 2007)
Light's criteria for pleural exudate transudate
1. Ratio of pleural fluid protein to total serum protein is 0.5 or more.
2. Ratio of pleural fluid LDH to total serum LDH is 0.6 or more.
3. Pleural fluid LDH is two-thirds or more of the upper limit for serum
LDH.
(JMAJ Sep. - Oct. 2006)
THE ANTISEPTIC
January 2008