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Omeprazole Triple Therapy As First-Line Treatment For Helicobacter Pylori In Patients With Active Duodenal Ulcers

Helicobacter pylori infection in patients with active duodenal ulcers can be effectively eradicated by either omeprazole triple therapy or omeprazole quadruple therapy.

Greek researchers suggest, however, that omeprazole, amoxicillin and clarithromycin (OAC) is better tolerated than are omeprazole, colloidal bismuth subcitrate, metronidazole and tetracycline hydrochloride (OBMT).

OAC should therefore be used as a first-line treatment, say investigators at the Departments of Gastroenterology and Histopathology, Evangelismos Hospital, Athens, Greece.

In this prospective, investigator-blind study, 149 consecutive patients with active duodenal ulcer were randomised into two groups.

Seventy-eight in the OAC group received 20 mg omeprazole, 1g amoxicillin and 0.5 g clarithromycin twice daily for ten days. The OBMT group of 71 subjects received twice daily 20 mg omeprazole, four times a day 120 mg colloidal bismuth subcitrate, three times a day 0.5 g metronidazole and four times a day 0.5 g tetracycline hydrochloride.

Endoscopy was carried out before treatment and was again at 10/12 weeks and 12 months

Histology, immunohistochemistry and campylobacter-like organisms (CLO) tests on multiple biopsies taken from the gastric antrum, corpus and fundus were used to check for H.Pylori infection and its eradication.

At 21-24 months all subjects were re-evaluated clinically and given a C-urea breath test (UBT). Re-endoscopy was received by patients with dyspepsia and/or recrudescence of H. Pylori.

Both groups were comparable for current or past bleeding episodes, age, gender, smoking and occasional use of nonsteroidal anti-inflammatory drugs (NSAID).

Six subjects in the OAC group and seven OBMT subjects were lost to follow-up. Non-compliance was seen in eight patients and three ulcers failed to heal.

In OAC group ulcer healing rates for intention-to-treat (ITT) and per-protocol (PP) analyses were 86 percent (67/78) and 97 percent (67/69), respectively. In the OBMT group the rates were 82 per cent (58/71) by ITT and 98 percent (58/59) PP analyses.

At 10-12 weeks after treatment H.Pylori eradication in OAC patients was 78 percent (61/78) by ITT and 88 percent (61/69) PP analyses. In the OBMT group eradication was 65 percent (46/71) and 78 percent (46/59) by ITT and PP analyses, respectively (P > 0.1).

Side effect were found to be more common in the OBMT group

In the first and second years, H.Pylori relapse rates were 3 percent and 2 percent.

While reflux symptoms developed in four H. Pylori-negative patients, erosive oesophagitis was seen to develop in only two between 12 and 24 months.
Eur J Gastroenterol Hepatol 2002:Nov;14(11):1237-43. "Omeprazole triple therapy versus omeprazole quadruple therapy for healing duodenal ulcer and eradication of Helicobacter pylori infection: a 24-month follow-up study."

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