Seven‐day triple therapy with ranitidine bismuth citrate or omeprazole and two antibiotics for eradication of <i>Helicobacter pylori</i> in duodenal ulcer: a multicentre, randomized, single‐blind study

Spinzi, G.; Boni, Francesca; Bortoli, A.; Colombo, E.; Ballardini, G.; Venturelli, R; Minoli, Giorgio

doi:10.1046/j.1365-2036.2000.00708.x

Cited by 21 publications

(24 citation statements)

References 21 publications

(20 reference statements)

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“…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…”

Section: Trial Characteristicsmentioning

confidence: 99%

“…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] . Seven studies collected information concerning adverse events using a diary or diary cards [21,27,32,[34][35][36]48] , two via face-toface interview [43,45] , and one via telephone interview [46] . The remainder of trials did not state how they collected adverse events data.…”

Section: Trial Qualitymentioning

confidence: 99%

“…Thirteen of the trials were double-blind randomised studies [ [21,24,45,46,48] . 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] .…”

Section: Trial Qualitymentioning

confidence: 99%

“…Diarrhoea: Twenty-two trials reported the total number of individuals experiencing diarrhoea with bismuth or bismuth-containing regimens versus comparison regimen [7,17,18,20,[24][25][26][27][28][30][31][32]34,36,[39][40][41][42][45][46][47][48] . Six of these studies utilized more than one regimen [7,20,31,34,41,47] , allowing 28 comparisons to be made.…”

Section: Dark Stoolsmentioning

confidence: 99%

“…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,...…”

Section: Trial Characteristicsmentioning

confidence: 99%

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

Ford

Malfertheiner²,

Giguere³

et al. 2008

WJG

106

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INTRODUCTIONBismuth salts have been used for centuries in medicine. From a gastroenterology perspective these drugs have been used to treat peptic ulcer disease, dyspepsia, parasitic infections, microscopic colitis, and infectious diarrhoea [1] . The discovery of Helicobacter pylori (H pylori) in 1983 by Warren and Marshall revolutionised the management of peptic ulcer disease [2] , and led to a renewed interest in bismuth compounds, largely because bismuth was found to inhibit the growth of H pylori and was effective in eradicating the organism (when combined with antibiotics or in combination with antibiotics and acid suppression therapy [3,4] ). The first randomised controlled trial (RCT) of bismuth in H pylori-positive individuals suggested that bismuth was superior to erythromycin monotherapy in eradicating the infection [5] . A further RCT of 6 wk of colloidal bismuth subcitrate versus cimetidine, in H pylori-positive duodenal ulcer patients, demonstrated that bismuth successfully eradicated the bacterium in up to 50% of patients [6] . Subsequently, an RCT of both colloidal bismuth subcitrate and cimetidine, alone or in combination with tinidazole, confirmed that colloidal bismuth subcitrate and tinidazole cleared the infection in almost 75% of patients [7] . With the addition of a second antibiotic, tetracycline or amoxicillin, eradication rates in later RCTs exceeded 80% [8][9][10] . However, there were some problems associated with bismuth-based triple therapy, which included the number of tablets patients were required to take, the duration of therapy, and side effects such as altered taste, nausea, and diarrhoea. Abstract AIM: To assess the safety of bismuth used in Helicobacter pylori (H pylori ) eradication therapy regimens. METHODS:We conducted a systematic review and meta-analysis. MEDLINE and EMBASE were searched (up to October 2007) to identify randomised controlled trials comparing bismuth with placebo or no treatment, or bismuth salts in combination with antibiotics as part of eradication therapy with the same dose and duration of antibiotics alone or, in combination, with acid suppression. Total numbers of adverse events were recorded. Data were pooled and expressed as relative risks with 95% confidence intervals (CI). RESULTS: We identified 35 randomised controlled trials containing 4763 patients. There were no serious adverse events occurring with bismuth therapy. There was no statistically significant difference detected in total adverse events with bismuth [relative risk (RR) = 1.01; 95% CI: 0.87-1.16], specific individual adverse events, with the exception of dark stools (RR = 5.06; 95% CI: 1.59-16.12), or adverse events leading to withdrawal of therapy (RR = 0.86; 95% CI: 0.54-1.37).CONCLUSION: Bismuth for the treatment of H pylori is safe and well-tolerated. The only adverse event occurring significantly more commonly was dark stools.

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