Comparison of ranitidine bismuth citrate plus clarithromycin with omeprazole plus clarithromycin for the eradication of Helicobacter pylori

Abstract

Background : Many dual and triple therapy treatment regimens have been proposed for the eradication of Helicobacter pylori. However, assessing the relative efficacy of these regimens is complicated by differences in study design, and few well‐controlled comparative studies have been reported. Methods : This multicentre, randomized, double‐blind study involved 530 duodenal ulcer patients, of whom 520 had confirmed H. pylori infection. Patients received 14 days b.d. dual therapy of either ranitidine bismuth citrate (RBC) 400 mg or omeprazole 20 mg, both with clarithromycin 500 mg to eradicate H. pylori, followed by a further 14 days of treatment with RBC 400 mg b.d. or omeprazole 20 mg o.d. to facilitate ulcer healing. H. pylori eradication and ulcer healing were assessed at least 26 days after the end of treatment. Adverse events were recorded throughout the study. Results : H. pylori was eradicated in 90% of patients who received RBC with clarithromycin and in 66% of patients who received omeprazole with clarithromycin (per protocol; P < 0.001). intention‐to‐treat eradication rates were 77% and 60%, respectively (P < 0.001). Ulcer healing rates were 97% in the RBC treatment group and 95% in the omeprazole treatment group. Only 3% and 1% of patients in the RBC and omeprazole treatment groups, respectively, were withdrawn due to adverse events. Conclusions : RBC with clarithromycin is a simple and highly effective dual therapy regimen for the eradication of H. pylori, and is significantly more effective than omeprazole with clarithromycin. Both treatment regimens are well tolerated and effectively heal duodenal ulcers.

Adverse events with bismuth salts for Helicobacter pylori eradication: Systematic review and meta-analysis

“…Eleven of the studies were multicentre RCTs [15,21,25,29,31,32,34,39,41,44,45] . Duration of bismuth therapy ranged from 7 to 56 d, with a total daily dose of between 400 mg and 2100 mg. Nineteen studies used ranitidine bismuth citrate [15,17,20,22,24,[28][29][30][31][32]34,36,[39][40][41]43,45,46,48] , ten studies colloidal bismuth subcitrate [7,16,18,21,26,27,37,38,42,44] , two studies tripotassium dictrato bismuthate [23,35] , two studies bismuth subsalicylate [25,33] , one study bismuth subnitrate [19] , and one study both bismuth subnitrate and www.wjgnet.com…”

“…Ten of the studies reported the method of generation of the randomization schedule [15,18,20,26,30,32,37,39,47,48] , but only four the method of concealment of allocation [27,32,47,48] . Four of the studies recorded adverse events using a questionnaire [20,24,28,40] , but only two of these stated that the questionnaire was validated [24,28] .…”

“…The duration of bismuth therapy was one month or more in eleven of the included studies [7,18,25,31,34,[37][38][39]41,42,47] . There were sufficient trials to pool data to examine the effect of duration of therapy on total number of adverse events, some of the specific individual adverse events (including diarrhoea, headache, and nausea and/ or vomiting), and withdrawal of therapy due to adverse events.…”

“…Headache: Fourteen trials reported the total number of individuals experiencing headache with bismuth or bismuth-containing regimens versus comparison regimen [17,18,20,[24][25][26]30,31,34,[39][40][41]46,47] . Five of these studies utilized more than one regimen [20,31,34,41,47] , allowing 19 comparisons to be made.…”

“…Nineteen of the trials were conducted in Europe [15][16][17][18]20,[23][24][25][27][28][29][30]37,40,[42][43][44][45]47] , eight in the Far East [21,22,32,35,36,38,46,48] , four in the USA [31,33,34,41] , one in the Middle East [26] , one in South America [19] , one in Australia [7] , and one was a multi-national study [39] . Eleven of the studies were multicentre RCTs [15,21,25,29,31,32,34,39,41,44,45] . Duration of bismuth therapy ranged from 7 to 56 d, with a total daily dose of between 400 mg and 2100 mg. Nineteen studies used ranitidine bismuth citrate [15,17,...…”