Low dose of clarithromycin in triple therapy for the eradication of Helicobacter pylori: One or two weeks?

Abstract

The aims of this pilot study were: (i) to compare the efficacy of low-dose clarithromycin (250 mg twice daily) for 1 or 2 weeks; and (ii) to evaluate possible therapeutic advantages in associating the low-dose clarithromycin with an anti-secretory agent or tripotassium dicitrate bismuthate (De Nol; Yamanouchi Pharm, Corugate Milano, Italy). A prospective, randomized, open trial was carried out on consecutive outpatients with dyspeptic symptoms and Helicobacter pylori infection. We enrolled 129 patients in one of the following schedules: (A) De Nol 120 mg q.i.d., clarithromycin 250 mg b.i.d. and metronidazole 250 mg q.i.d. for 2 weeks; (B) omeprazole 20 mg b.i.d., clarithromycin 250 mg b.i.d. and metronidazole 250 mg q.i.d. for 2 weeks; or (C) omeprazole 20 mg b.i.d., clarithromycin 250 mg b.i.d. and metronidazole 250 mg q.i.d. for 1 week. Results were evaluated by Per Protocol (PP) and Intention-To-Treat analysis (ITT). Eradication rate was 100% after treatment A, 92.6% after treatment B and 86.5% after treatment C by PP and 83.3, 75.7, and 68.1%, respectively by ITT. Side effects were reported by 16 subjects: 26.6% in group A; 9.1% in group B; and 7.5% in group C; in two cases side effects led to the withdrawal of the treatment. In conclusion, 500 mg clarithromycin per day in association with omeprazole and metronidazole, for 1 week gave comparable results to the same schedule for a 2 week period. The use of clarithromycin with bismuth and metronidazole produced a therapeutic gain compared with both of the anti-secretory schedules, although this was not statistically significant.

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

“…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] .…”

“…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…”

“…Twenty-five trials reported the total number of individuals experiencing any adverse event with bismuth or bismuth-containing regimens versus comparison regimen [15][16][17][18][19][20][23][24][25][26][27]30,32,33,[35][36][37][38][39][40]42,44,45,47,48] . Three of these studies utilized more than one regimen [20,35,47] , allowing 28 comparisons to be made.…”

“…Withdrawal of therapy due to adverse events with bismuth or bismuth-containing regimen versus comparison regimen Twenty-eight trials reported the total number of individuals who terminated therapy due to experiencing adverse events with bismuth or bismuth-containing regimens versus comparison regimen [16][17][18]20,[22][23][24][25][26][27][28][29][30][31][32][34][35][36][37][39][40][41][42][43][45][46][47][48] . Six of these studies utilized more than one regimen [20,31,34,35,41,47] , allowing 34 comparisons to be made.…”

How Can the Current Strategies forHelicobacter pyloriEradication Therapy be Improved?

“…There was a statistically nonsignificant trend for a reduction in H pylori cure for seven-day compared with 10-day therapy (RRR 4%; 95% CI -2% to 10%) ( Figure 6). Twelve trials (43,51,52,(54)(55)(56)(57)(58)(59)(60) evaluating 1592 patients that compared seven-with 14-day PPI triple therapy were also identified. Seven days of therapy was significantly less likely to cure H pylori infection (RRR 12%, 95% CI 7% to 17%; NNT 12, 95% CI 9 to 21) (Figure 7).…”