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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 18 19