Madam, The efficacy of Proton pump inhibitors (PPI's) in the healing of peptic ulcer disease and eradication of H.Pylori is around 97-99%.1 The cost of PPI (omeprazole) as a single agent in ulcer healing is very high, and this enhances manifolds when it is used with antibiotics for H.Pylori eradication. Locally manufactured PPI's were introduced with an aim to reduce the cost of therapy without compromising on the efficacy. Local producers claim these PPI's are equally effective when compared to those of the multinational companies.2
To assess the efficacy of PPI marketed by the local companies a trial was done on twenty six patients (M:F 15:5, median age 37 years and age range of 17-80 years). Upper GI endoscopy was done in all prior to the initiation of therapy. Endoscopic diagnosis included 24 duodenal ulcer and 2 gastric ulcer patients. Endoscopic antral biopsies were taken simultaneously to check the H.Pylori by CLO test. Those who were positive for H.Pylori were treated by triple therapy of Amoxil 1 gram, Clarithomycin 500 mg and PPI (Meprazole/Zaprole 20 mg) twice a day for 7 days followed by once a day dose of either Zaprole or Meprazole 20 mg for a month. Those who were H.Pylori negative were treated with one of only above mentioned PPI on once a day dose and ulcer healing was reassessed at 2, 4 and 8 weeks of treatment.
Six patients were lost to follow-up, in the remaining 20 cases Zaprole = 14, (group I), Meprazole = 6 (group II); CLO was positive in 11 and negative in nine cases. Overall ulcer healing rates in group I at 2, 4 and 8 weeks were 50%, 71% and 78% respectively, while in group II they were 33%, 83% and 99% respectively. No healing was seen in 3 cases even at 8 weeks of therapy.
Similar healing rates (85%) were observed with another locally marketed PPI (Sanamidol) in a previous study of single drug therapy for ulcer healing3 versus 100% healing rates at 4 weeks with a PPI marketed by a multinational (Losec 20 mg).4 The healing rates should have been better in the present study as H.Pylori was also eradicated, which shows a poor response as compared to the standard proton pump therapy. Somewhat comparable results are being achieved with locally marketed PPI's after prolonging the duration of therapy to twice the standard time.
The results co-relate poorly with the claims of the locally manufactured omeprazoles in the healing of peptic ulcer. Effective results may be achieved by using these medicines for more than twice the recommended duration of therapy but this will prolong the misery of the patients and out weigh the monetary benefits of these relatively cheaper medicines. As the present study contains very small number of patients these findings have to be confirmed by larger studies. Waquaruddin Ahmed, Ambreen Arif,
Syed Ejaz Alam
PMRC Research Centre, Jinnah Postgraduate Medical Centre, Karachi.
1. Chaudhuri S, Chaudhuri A, Datta S, Mukhopadhyay AK, Chattopadhya S, Saha DR, et al. Anti-helicobacter pylori therapy in India:difference in eradication efficency associated with particular alleles of vacuolating cytotoxin (vacA) gene. J Gastroenterol Hepatol 2003;18:190-5.
2. PDR, 57th edition, 2003, p. 629.
3. Ahmed W, Qureshi H, Zuberi SJ. Sanamidol (Omeprazole) in the healing of duodenal ulcer. JAMA 1996;46:41.
4. Ahmed W, Qureshi H, Zuberi SJ, Alam SE. Does the rapid healing of duodenal ulcer mean longer remissions ? Eastern Mediter Health J 1998;4:554-9.