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Transcript
Health Forum in Silk-Road Regions: Sino_Pak Workshop on
Traditional Medicine” from September 16-18, 2015 in Urmqi, Xinjiang, China
QUADRUPLE THERAPY FOR THE MANAGEMENT OF
TREATING HELICOBACTER PYLORI INFECTION WITH
HERBAL AND CONVENTIONAL MEDICINES
Khan Usmanghani, M.Asif, Faisal H Zaidi
R&D, Herbion Pakistan (Pvt) Limited , Karachi, Pakistan
College of Medicine, King Saud bin Abdulaziz University. Jeddah, Saudi Arabia
1
KNOWLEDGE
“KNOWLEDGE is EXPERIENCE
EVRYTHING ELSE IS INFORMATION”
阳光灿烂, Yǎng guāng càn làn
Sunshine around you
身体健康, Shēntǐ jiànkāng
Enjoy good health
2
SILK ROAD REQUIRED BOTH FOR COMMUNIUCATION AND RESEARCH
3
Bactericidal Activity of Herbs in Unani Medicine
Bactericidal Activity of Spices against H. pylori strains
4
Bactericidal Activity of Medicinal plants against
H. pylori strains
5
MBC (mg/ml) most Active Herbs Against Pakistani and Japanese
H. pylori Strains
Plant Name
Pakistani strains
PP-001
PP-002
PP-003
159A
Japanese strains
198C
696C
CAR
62.5
31.2
31.2
31.2
15.6
15.6
MPM
15.6
15.6
15.6
31.2
15.6
15.6
MFHA
31.2
31.2
62.5
31.2
31.2
31.2
PSCL
31.2
31.2
31.2
31.2
15.6
31.2
Curcumin
50.0
50.0
25.0
25.0
25.0
25.0
Amoxicillin
25.0
12.5
12.5
25.0
12.5
25.0
CAR: Curcuma amada Roxb; MPM: Mallaotus phillippinensis Muell;
MFHA: Myristica franrans Houtt (Aril); PSCL: Psoralea corylifolia Linn
6
Screening of Pakistani community by RAPIRUN kit
reveals the high prevalence of H. pylori infection as 56%
alongwith the virulent factor CagA (75%) in average young
population of 36 years.
Among the 50 daily dietary components and commonly
used medicinal plants, more than half of them completely
killed H.pylori at 500 mg/ml. Of these, Mallotus
philippinensis Muell (MPM) exhibited the most strong
bactericidal activity (MBC:
15.6–31.2 mg/ml) which was
comparable with amoxicillin (MBC; 12.5–25.0 mg/ml).
Rottlerin, isolated from MPM, showed potent anti-H. pylori
activity at MBC value of 3.12– 6.25
mg/ml
even
in
antibiotic resistant strains.
7
A comparative randomized trial of phytomedicine-based and
quadruple therapies in Helicobacter pylori infection
Helicobacter pylori, now a challenge
Warren and Marshall in 1980s isolated Helicobacter pylori
(H. pylori) from gastric biopsies and an association was
established between bacterium and gastritis and peptic
ulceration.
After this discovery, many diagnostic tests and antibiotic
treatment strategies for H. pylori infection have been
developed.
However, emerging antibiotic resistance has consequences a
major problem for the efficacy of treatment. Therefore,
research in H. pylori epidemiology and its associated diseases
is important for the development of novel treatment strategies
and prevention.
8
Selection of Medicinal Plants
It is documented earlier that Curcuma longa L. and its major polyphenolic
chemical constituent, curcumin has potent Anti-H. pylori activity.
Curcumin has been reported to suppress IL-8 expression and NF-kB
activation in gastric epithelial cells. (Mahady et al, 2002; Faisal et al, 2009)
Anti H. pylori activity of Mallotus phillipenensis (L.) Desr has been
evaluated in many studies. It showed very potent bactericidal activity
arresting the growth of H. pylori at the concentration of 15.6–31.2g/ml in
a recent report . (Faisal et al, 2009)
Glycyrrhiza glabra L. containing glycyrrhizin has also an anti-inflammatory
action, it inhibits the production of PGE2 and increases the production of
stomach mucus, the lifetimes of the epithelial cells of the stomach and
inhibits the secretion of pepsinogen. (Toshio et al, 2002)
Extract of Ginger rhizomes inhibited the growth of 19 strains of H. pylori in
vitro with a minimal inhibitory concentration range 0.78 to 12.5µg/mL,
with significant activity against the cagA+ strains. (Mahady et al, 2003)
9
Quantitative and Comparative Study of
Helicobacter pylori infection
TEST AND CONTROLLED DRUGS
Diseases
Helicobacter
pylori
infection
Test Drugs
Composition
of Pylorex
plus
Test Drugs
Formulation
Control Drugs
Curcuma longa
150 mg
Omeprazole (20mg) bid
Malotus philipinensis
150 mg
Amoxicillin (1g) bid
Glycyrrhiza glabra
100 mg
Metronidazole (500mg) bid
Zingiber officinale
100 mg
Bismuth (425mg) tid
Aims and Methods
A randomized controlled multicenter clinical trial was
conducted in high risk areas of Pakistan such as Karachi,
Bahawalpur, Islamabad and Rawalpindi at Shifa-Ul-Mulk
Memorial Hospital, Hamdrad University Karachi, Bahawalpur
Victoria Hospital and Nawaz Salik Hospital respectively from
March 2011 to September 2013
>>>In order to evaluate the effectiveness of Herbal drug
Pylorex plus tablets and Quadruple allopathic therapy
(Bismuth, Omeprazole (PPI), Amoxicillin, Metronidazole) for
the eradication of Helicobacter pylori infection
>>>To compare the variable efficacy between two groups
(Test and Control)
11
Work Plan_Helicobacter pylori infection
ACTIVITY
Herbal
Allopathic
No. of drug compared
Pylorex plus
Bismuth,
Omeprazole(PPI),
Amoxicillin,
Metronidazole
No. of patients (Both Sex)
n= 86
n= 90
Diagnosis (test)
Urea breath, Stool
antigen
Urea breath, Stool
antigen
Time period
15 days
7 days
Total duration
2 years: 2011-2013
2 year: 2011- 2013
After every 15 days (3)
After every 15 days
(3)
Present action of report
Randomized, open intervention, clinical trial
12
H. pylori Eradication Rate of Both Therapies
Comparative data between Pylorex plus tablet and Quadruple
therapy for Helicobacter pylori infection
N
Eradicated
Failure
Pylorex plus (Test therapy)
86
48
(55.8%)*
38
(44.2%)
Quadruple therapy (Control
therapy)
90
56
(62.2%)*
34
(37.8%)
Total
176
104
72
*p value 0.477
13
Clinical Assessment
Most common symptoms of H. pylori infection are abdominal
pain, heart burning, regurgitation, feeling of abdominal
fullness, nausea/vomiting abdominal bloating and belching etc
We recorded the intensity of symptoms as
Absent:
0
Mild:
1
Moderate: 2
Sever:
3
at baseline (T0), 2nd week of treatment (T2) and after 4 weeks
(T4) of treatment.
Median values (M), interquartile ranges (IQR) were determined
and p values were calculated by using Wilcoxon signed-rank
test in order to assess the level of improvement by Herbal and
Allopathic therapies.
14
Overall severity of symptoms
H. pylori Eradicated Patients
Horizontal bar: median; box: 25–75th interquartile range;
vertical lines: range of values. **p<0.001, *** p<0.0001
H. pylori non-Eradicated Patients
Horizontal bar: median; box: 25–75th interquartile range; vertical lines
range of values. * p<0.01, ** p<0.001, *** p<0.0001 p<0.0001
15
Adverse effects profile control (Quadruple) / test
(Pylorex plus)
Control (patients)
Test (patients)
Allergic reaction
3
Allergic reaction
1
Diarrhoea
3
Diarrhoea
-
Headache
6
Headache
2
Anorexia
9
Anorexia
-
Irritability
4
Irritability
2
No life threatening and serious side effects recorded in test
group. It is because of the fact that plant drug selected for the
treatment of H. pylori infection does not contain any chemical
agent that may trigger the adverse drug reaction response.
16
CONCLUSION
From statistical comparison, it is concluded that;
Pylorex plus is equally significant for the eradication of
Helicobacter pylori infection as Quadruple allopathic
therapy.
Marked reduction in symptoms was observed both in
H. pylori-eradicated and non-eradicated patients by
Pylorex plus, pointing its potential, valid and promising
phytomedicine particularly for patients with functional
dyspepsia, seeking for a safe and effective
phytomedicine-based therapy.
17
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