A single drug for Helicobacter pylori infection: first results with a new bismuth triple monocapsule.
OBJECTIVE
In this pilot study we investigated the efficacy and tolerability of a new monocapsule that contains a bismuth compound, tetracycline, and metronidazole. If proven to be effective, this monotherapy would turn the well-accepted multidrug regimen of standard bismuth-based triple therapy into an easy and more patient-friendly regimen. It can be used in patients allergic to penicillin.


METHODS
A total of 53 consecutive H. pylori-infected patients (30 with proven ulcer disease, 23 with gastritis only) from a single center were prescribed two monocapsules q.i.d. after the three meals and after an evening snack during 10 days. Each capsule contained 60 mg colloidal bismuth subcitrate (as Bi2O3 equivalent), 125 mg tetracycline, and 125 mg metronidazole. Repeat endoscopy with biopsies for urease test, Giemsa stain, and culture was carried out > or =5 wk later. Side effect data were collected.


RESULTS
One patient was lost to follow-up, two failed to respond, and 50 were cured. The intention-to-treat cure rate was 50 of 53 (94.4%, 95% CI 88.1-100%). Antibiotic sensitivity was available from 51 isolates. The cure rate in the metronidazole sensitive strains was 44 of 45 (97.8%, 95% CI: 93.5-100%), whereas it was four of five in the resistant strains. The regimen was well tolerated, with only two drop-outs (4%) because of side effects.


CONCLUSIONS
The new monocapsule is an inexpensive, well tolerated, and patient-friendly formulation of a bismuth based triple therapy. A 10-day course with this multidrug capsule reached a very high cure rate in metronidazole-sensitive strains. The number of cases with resistant strains was insufficient to allow firm conclusions about its efficacy in case of resistance. The results are in agreement with previous data with bismuth triple therapy using separate drugs. From the high cure rate, we can conclude that the new capsule dissolves adequately, with proper delivery of its ingredients at the site of action.
de Boer
W A
WA
Department of Internal Medicine and Medical Microbiology, Sint Anna Hospital Oss, The Netherlands.
van Etten
R J
RJ
Schneeberger
P M
PM
Tytgat
G N
GN
D000328:Adult; D000368:Aged; D000897:Anti-Ulcer Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002214:Capsules; D005260:Female; D005756:Gastritis / Q000188:drug therapy*; D005773:Gastroscopy; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D009942:Organometallic Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D010437:Peptic Ulcer / Q000188:drug therapy*; D010865:Pilot Projects; D013752:Tetracycline / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D000897:Anti-Ulcer Agents; D002214:Capsules; D009942:Organometallic Compounds; D008795:Metronidazole; D013752:Tetracycline; C002791:bismuth tripotassium dicitrate