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Bismuth-Based Triple Therapy with Bismuth Subcitrate, Metronidazole and Tetracycline in the Eradication of Helicobacter Pylori

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Bismuth-Based Triple Therapy with Bismuth Subcitrate, Metronidazole and Tetracycline in the Eradication of Helicobacter Pylori Color profile: Disabled Composite Default screen ORIGINAL ARTICLE 100 100 View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by Crossref 95 95 75 75 Bismuth-based triple therapy 25 25 5 with bismuth subcitrate, 5 0 metronidazole and tetracycline 0 in the eradication of Helicobacter pylori: A randomized, placebo controlled, double-blind study 1 2 3 4 Sander Veldhuyzen van Zanten MD , Alain Farley MD , Norman Marcon MD , Raymond Lahaie MD , 5 6 7 8 9,10 André Archambault MD , Richard Hunt MD , Robert Bailey MD , David Owen MD , Jean Spénard PhD , 11 12 5 Alan Stiglick PhD , Nick Aimola MSc , Patrick Colin PhD S Veldhuyzen van Zanten, A Farley, N Marcon, et al. Bismuth- RESULTS: Fifty-three of 59 (90%) patients on bismuth-based based triple therapy with bismuth subcitrate, metronidazole and treatment and only one of 35 (3%) on placebo achieved eradica- tetracycline in the eradication of Helicobacter pylori: A random- tion by per protocol analysis. Fifty-three of 65 (82%) patients on ized, placebo controlled, double-blind study. Can J Gastroen- bismuth-based treatment achieved eradication, while only two of terol 2000;14(7):599-602. 34 (5%) achieved eradication on placebo by intention to treat analysis. Eradication rates for bismuth-based treatment across sites OBJECTIVE: To determine the rate of Helicobacter pylori eradi- ranged from 83% to 100%. Only two patients in the bismuth- cation following bismuth-based triple therapy with colloidal bis- based treatment group (4%) and one in the placebo group (3%) muth subcitrate, tetracycline hydrochloride and metronidazole. discontinued treatment because of adverse events. PATIENTS AND METHODS: One hundred and eleven CONCLUSIONS: Colloidal bismuth subcitrate plus metronida- patients were randomly assigned, in a two to one ratio, to colloidal zole plus tetracycline, given in the doses studied for 14 days, is safe bismuth subcitrate 120 mg qid plus metronidazole 250 mg qid plus and highly effective against H pylori infection and would be appro- tetracycline 500 mg qid (Gastrostat), or matching placebo tablets priate as a first-line therapy for eradication. and capsules for 14 days. Presence or absence of H pylori was docu- mented by histology at entry and at least 28 days after treatment. Patients had dyspeptic symptoms with or without a history of pep- Key Words: Bismuth; Helicobacter pylori; Metronidazole; Tetracy- tic ulcer. Patients with any previous attempt(s) at eradication of cline; Triple-therapy H pylori, who used bismuth, antibiotics, H receptor antagonists or 2 proton pump inhibitors in the previous four weeks were excluded. Pour le résumé, voir page suivante 100 100 95 1Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia; 2Centre de Gastro-Entérologie et d’Endoscopie de Montréal, Montréal, Quebec; 95 3The Wellesley Hospital, Toronto, Ontario; 4Centre Hospitalier de l’Université de Montréal, Pavillon St-Luc, Montreal, Quebec; 5Hôpital 75 Maisonneuve-Rosemont, Montréal, Quebec; 6McMaster University, Hamilton, Ontario; 7Hys Centre, Edmonton, Alberta; 8Vancouver 75 General Hospital, Vancouver, British Columbia; 9Axcan Pharma Inc, Mont-Saint-Hilaire, Quebec; 10Faculty of Medicine, Department of Pharmacology, University of Montreal, Montreal, Quebec;11SkiyLick & Associates; 12Aimola & Associates Inc, Mississauga, Ontario Correspondence: Dr Sander Veldhuyzen van Zanten, Division Of Gastroenterology, Dalhousie University, Centennial Building, Room 928, Queen 25 Elizabeth II Health Sciences Centre, 4th Floor, Halifax, Nova Scotia B3H 2Y9. 25 Telephone 902-473-2397, fax 902-473-4406, e-mail [email protected] 5 5 Received for publication March 3, 1999. Accepted January 26, 2000 0 0 Can J Gastroenterol Vol 14 No 7 July/August 2000 599 1 G:...van_zanten.vp Tue Aug 08 20:04:44 2000 Color profile: Disabled Composite Default screen Veldhuyzen van Zanten et al 100 100 95 Thérapie triple à base de bismuth avec du l’objet d’une ou plusieurs tentatives d’éradication de Helicobacter pylori 95 antérieurement, qui avaient utilisé du bismuth, des antibiotiques, des anta- 75 sous-citrate de bismuth, du métronidazole et 75 gonistes des récepteurs H2 ou des inhibiteurs de la pompe à protons dans les de la tétracycline pour l'éradication de quatre semaines précédentes ont été exclus de l’étude. Helicobacter pylori : une étude à double insu, RÉSULTATS : Cinquante-trois des 59 (90 %) patients du groupe de trai- 25 tement à base de bismuth, et seulement un des 34 (3 %) sont parvenus à 25 comparative avec placebo et randomisée une éradication par placebo selon une analyse par protocole. Cinquante- 5 OBJECTIF : Déterminer le taux d’éradication de Helicobacter pylori après trois des 65 (82 %) patients du groupe de traitement à base de bismuth sont 5 une triple thérapie à base de bismuth avec du sous-citrate de bismuth, du parvenus à une éradication, alors que deux patients seulement sur 34 (5 %) 0 chlorhydrate de tétracycline et du métronidazole. sont parvenus à une éradication par placebo selon une analyse avec inten- 0 PATIENTS ET MÉTHODES : Cent onze patients ont été assignés au tion de traiter. Les taux d’éradication pour le traitement à base de bismuth hasard dans une proportion de 2 contre1àungroupe de traitement avec à travers les sites allait de 83 % à 100 %. Seulement deux patients du groupe 120 mg de sous-citrate de bismuth colloïdal quatre fois par jour plus 250 mg de traitement à base de bismuth (4 %) et un du groupe placebo (3 %) ont de métronidazole quatre fois par jour plus 500 mg de tétracycline (Gas- cessé le traitement à cause d’effets indésirables. trostat) ou dans un groupe de traitement placebo par comprimés et capsules CONCLUSIONS : Une thérapie triple avec du sous-citrate de bismuth appariés pendant 14 jours. La présence ou l’absence de Helicobacter pylori a colloïdal, du métronidazole et de la tétracycline, administrés aux doses étu- été documentée par un examen histologique à l’inclusion des patients dans diées pendant 14 jours, est sûre et très efficace contre Helicobacter pylori et l’étude et au moins 28 jours après le traitement. Les patients souffraient de serait appropriée comme traitement de première ligne pour son éradica- dyspepsie avec ou sans ulcère gastro-duodénal. Les patients qui avaient fait tion. here is conclusive evidence that Helicobacter pylori is as- (NSAIDs); use of antibiotics in the 30 days before enroll- Tsociated with duodenal ulcer, gastric ulcer and gastric ment; regular use of bismuth compounds in the past 30 days; cancer (1-3). a previous attempt to eradicate H pylori infection; and use of H pylori A meta-analysis of eradication studies indicated antiulcer drugs (including H2 receptor antagonists or proton that bismuth-based triple therapy regimens comprising bis- pump inhibitors) during the seven days preceding enrollment. muth, a nitroimidazole and a second antibiotic achieved During endoscopy, two biopsies were taken from the an- eradication rates of up to 80%, and that the most effective trum and two from the body. They were placed in 10% for- combination in this class is colloidal bismuth subcitrate, malin in individual containers and sent to the central study metronidazole and tetracycline (4). However, many of the pathologist, who was blinded to the treatment received by studies included in that meta-analysis suffered from meth- the patients. All sections were stained using a special silver odological weaknesses (5). stain for Helicobacter organisms as well as the routine hema- The primary objective of the present study was to deter- toxylin and eosin stain (6). mine the rate of H pylori eradication following therapy with If H pylori was detected on site by rapid urease test, the pa- colloidal bismuth subcitrate 120 mg (as bismuth oxide) qid, tient was randomly assigned to active or matching placebo metronidazole 250 mg qid and tetracycline hydrochloride treatment by using a two to one ratio of active drugs or pla- 500 mg qid for 14 days in H pylori-positive dyspeptic patients cebo. This result had to be confirmed by the presence of with or without a history of peptic ulcer. H pylori on at least one of the four histology slides to confirm the patient’s validity. Active treatment comprised colloidal PATIENTS AND METHODS bismuth subcitrate 120 mg qid, metronidazole 250 mg qid This randomized, double-blind, placebo controlled, parallel and tetracycline hydrochloride 500 mg (Gastrostat, Axcan group, multicentre study comprised H pylori-positive patients Pharma, Canada) qid for 14 days. Subjects self-administered with dyspepsia. The local Ethics Committee of each of the the study drugs, provided in a blister pack, four times daily on participating centres approved the study. an empty stomach, 1 h before meals and at bedtime for Subjects were selected from patients scheduled to un- 14 days. Subjects were instructed not to take milk or other dergo gastroscopy. Males or females, aged 18 to 75 years, dairy products, or antacids within 2 h of taking the study positive for H pylori by histology at entry and presenting with medications. 100 symptoms of dyspepsia were eligible after giving informed Within four days of completion of therapy, physical ex- 100 written consent. amination and clinical laboratory tests were repeated and 95 Exclusion criteria were macroscopic esophagitis; active adverse events recorded. Not less than 28 days after the end 95 duodenal or gastric ulcer within three months of enrollment; of treatment, patients returned for a repeat endoscopy and 75 previous gastric surgery; dysphagia; vomiting; hematemesis; four biopsies were taken to verify the presence or absence of 75 melena; recent documented gastrointestinal bleeding; iron- H pylori. Eradication was defined as the absence of H pylori deficiency anemia; pregnancy; inability to abstain from alco- on all histology slides taken at least four weeks after the end 25 hol; significantly impaired renal or hepatic function; con- of treatment. 25 traindication to the use of bismuth, metronidazole or tetracy- All medications for dyspepsia were prohibited throughout 5 cline; chronic use of nonsteroidal anti-inflammatory drugs the study, as were NSAIDs and acetylsalicylic acid.
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