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Bismuth Subsalicylate Inthe Treatment of H2 Blocker Resistant Duodenal Ulcers: Role of Helicobacter Pylori

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Bismuth Subsalicylate Inthe Treatment of H2 Blocker Resistant Duodenal Ulcers: Role of Helicobacter Pylori Gut, 1992, 33, 179-183 179 Bismuth subsalicylate in the treatment of H2 blocker resistant duodenal ulcers: role ofHelicobacterpylori Gut: first published as 10.1136/gut.33.2.179 on 1 February 1992. Downloaded from S Wagner, M Gebel, K Haruma, W Bar, P Lange, J Freise, U Gladziwa, F W Schmidt Abstract patients with endoscopically proved H2 blocker Fifty nine patients with Helicobacter pylon resistant duodenal ulcers were recruited to the positive duodenal ulcers that failed to heal study. A resistant duodenal ulcer was defined as after a six week course of treatment with H2 one that failed to heal after at least six weeks' blockers were randomly assigned to one of the continuous treatment with cimetidine 800 mg following three regimens: (i) bismuth subsali- daily or ranitidine 300 mg daily. The largest cylate, 600 mg three times daily (n=19), (ii) ulcer diameter was not less than 5 mm. The ranitidine, 300 mg at night (n=20), (iii) bismuth patients did not have complications of peptic subsalicylate plus ranitidine (n=20). Cumula- ulcer disease, previous gastric surgery, concomi- tive ulcer healing rates after four and eight tant treatment with ulcerogenic drugs, anti- weeks respectively were as follows: bismuth coagulants, or antibiotics, or any serious chronic subsalicylate 74% (14/19) and 95% (18/19), disease. Only patients who had not had antibiotic ranitidine 40% (8/20) and 65% (13/20), bismuth treatment in the previous six months were subsalicylate plus ranitidine 80% (16/20) and included. 95% (19/20). Bismuth subsalicylate treatment At initial endoscopy the ulcer size was assessed was better than ranitidine at both four and at and antral biopsy specimens were taken for eight weeks (p<0*05). The clearance rates for histological examination and H pylori screening. H pylon after four weeks were: bismuth sub- All patients were H pylori positive. Detailed subsalicylate 58%, ranitidine 0%, bismuth sub- information on duration and age of onset of salicylate plus ranitidine 55%. After stopping dyspeptic symptoms, previous drug therapy, bismuth therapy bacterial recrudescence fre- previous ulcer complications, and social habits quently occurred. After bismuth treatment were recorded. 86% (19/22) ofulcers had healed ifHpylori had After giving informed verbal consent, patients been cleared, whereas only 65% (11/17) had were randomised by a nurse (to guarantee blind- healed if H pylon persisted (NS). This study ness of the investigators) using given regimens shows that bismuth subsalicylate is more effec- stratified for 63 subjects. Randomisation pro- tive in the treatment of resistant duodenal cedure was accomplished by a computer pro- http://gut.bmj.com/ ulcers than standard dose ranitidine. It may be gram. Patients were allocated to receive one of that suppression of H pylori by bismuth sub- the following three treatment regimens: (i) salicylate promotes ulcer healing. bismuth subsalicylate (Jatrox) 600 mg three times daily (two chewable tablets half an hour before the three meals); (ii) ranitidine (Zantac) Approximately 85-95% of duodenal ulcers heal 300 mg at night; (iii) bismuth subsalicylate 600 on September 26, 2021 by guest. Protected copyright. within six to eight weeks of treatment with mg three times daily plus ranitidine 300 mg at Departments of standard doses of H2 blockers. '2 The reasons for night. Treatment began within three days of the Gastroenterology and treatment failure remain unclear but inadequate initial endoscopy and was continued for four Hepatology and Clinical control of acid secretion may be a weeks. If healing had occurred after four weeks Microbiology, crucial Medizinische factor.'3 Recently, the identification of Helico- the treatment was stopped; if not the patient Hochschule Hannover, bacter pyloni and its association with duodenal continued on the same regimen for another four Germany ulcer disease led to the hypothesis that H pylon weeks. If at the end of eight weeks the ulcer had S Wagner M Gebel might be involved in H2 blocker resistant ulcera- not healed the patient was withdrawn from the W Bar tion.2 The successful treatment of H2 blocker trial and ranitidine 900 mg/day was given. No P Lange refractory ulcers by colloidal bismuth subcitrate, other medications were allowed during the study J Freise F W Schmidt which is able to eliminate H pylon, supports this period. theory.4 5 Unfortunately, the role of H pylon was Compliance was ascertained by counting the Department of Medicine, not investigated in these therapeutic trials. number of remaining tablets at the end of each Rheinisch-Westfalische treatment Technische Hochschule Bismuth salts exert bactericidal effects on period. Clinical symptoms were asses- Aachen, Germany H pylon and have cytoprotective properties as sed by recording the number and severity ofpain U Gladziwa well, thus it is not clear whether the beneficial episodes on a diary card. Endoscopy and Hpylon tests were First Department of effect of colloidal bismuth in refractory ulcers is screening repeated every four weeks Internal Medicine, directly related to the elimination ofH pylon. during the course of treatment and four weeks Hiroshima University This study aimed to investigate the efficacy of after the end of the trial. School of Medicine, bismuth in the treatment of refrac- Hiroshima, Japan subsalicylate K Haruma tory duodenal ulcers and to elucidate the role of Correspondence to: H pylon. ENDOSCOPY Dr S Wagner, Department of Endoscopies were performed by PL, SW and JF Gastroenterology and Hepatology, Medizinische who were not aware of the clinical data, the bac- Hochschule Hannover, Methods teriological findings, or the treatment regimen. D-3000 Hannover 61, Germany. At each endoscopy five biopsy specimens were Accepted for publication PATIENTS AND STUDY DESIGN taken with sterilised biopsy forceps from antral 7 May 1991 Between September 1987 and May 1990 out- mucosa 2 cm proximal to the pylorus. Two 180 Wagner, Gebel, Haruma, Bar, Lange, Freise, Gladziwa, Schmidt specimens were placed in 2 ml phosphate STATISTICS buffered saline at 4°C for bacteriological exami- Statistical analysis was carried out by the X2 test nation, two were fixed in 10% formalin for for the evaluation of the healing rates and by the histopathology, and one specimen was used for a matched pairs Wilcoxon signed rank test for Gut: first published as 10.1136/gut.33.2.179 on 1 February 1992. Downloaded from rapid urease detecting test (CLO-test, Delta analysis of H pylon and gastritis scores. Differ- West Ltd, Australia). In addition, smears of ences with p values less than 0 05 were con- biopsy specimens were made for cytological sidered significant. examination using Giemsa staining. Results H PYLORI SCREENING Four ofthe 63 patients who entered the trial were H pylon status was assessed by bacterial culture, lost during follow up (bismuth subsalicylate, n= a modified Giemsa stain, and the CLO-test as 2, ranitidine, n= 1, bismuth subsalicylate plus described previously.6 Two biopsy specimens ranitidine, n= 1). Fifty nine patients completed were cultured under microaerobic conditions in the study and their characteristics are shown in blood agar base containing 5% horse blood and Table I. There were no major differences Skirrow selective supplement for seven days. between the three treatment groups. Median Cultures were considered positive for H pylori if age, sex ratio, mean duration of ulcer history, Gram negative, oxidase positive, catalase smoking habits, and previous H2 blocker positive, and urease positive spiral rods were therapy were comparable (Table I). All patients present. The degree ofcolonisation with Hpylori were H pylon positive. No relevant side effects was estimated by examination of sections and were observed in any treatment group. smears stained with Giemsa and was graded Figure 1 summarises the outcome of the semiquantitatively as follows: 0=no organism; patients under the different regimens. After four 1= occasional; 2 = moderate; 3= large numbers. weeks, ulcer healing had occurred in 74% (14/19) Hpylon status was regarded as positive ifculture of patients receiving bismuth subsalicylate, in was positive or ifthe urease test and Giemsa stain 40% (8/20) of those receiving ranitidine, and in were positive. 80% (16/20) of those treated with a combination The term 'clearance' was used ifHpylon status of both regimens (Table II). In patients with was negative immediately after stopping treat- incomplete ulcer healing the same therapeutic ment. 'Eradication' was used if H pylon was regimen was continued for another four weeks. absent four weeks after the end of treatment. After eight weeks' treatment the cumulative healing percentages were 95% on bismuth sub- HISTOPATHOLOGY salicylate, 65% on ranitidine, and 95% on bis- For histological examinations, formalin fixed muth ranitidine. The healing subsalicylate plus http://gut.bmj.com/ biopsy samples were embedded in paraffin and rate on bismuth subsalicylate alone or in combi- sections (4 ,tm) were stained with haematoxylin nation with ranitidine was significantly higher and eosin and Giemsa. Each biopsy specimen compared with that on ranitidine, both at four was assessed for the presence, type, density and and at eight weeks (p<005). There was, how- localisation of the inflammatory infiltrate. The ever, no significant difference between bismuth degree ofactivity ofgastritis was graded (0-3) by subsalicylate as a single agent and in combination estimating the density of polymorphonuclear with ranitidine. After eight weeks there was no leukocyte infiltrates as described previously.6 ulcer relapse in patients whose ulcers had healed on September 26, 2021 by guest. Protected copyright. during a four week course of bismuth subsali- cylate while two ulcers relapsed in the ranitidine group. TABLE I Patient characteristics and treatment schedules After four weeks H pylori was cleared in 58% of patients receiving bismuth subsalicylate and BSS Ranitidine BSS (3x600 mg) plus in 55% of those treated with bismuth subsalicy- (3 x 600 mg) (300 mg) ranitidine (300 mg) late plus ranitidine, while none of the patients in Patients (n) 19 20 20 the ranitidine group was Hpylon negative (Table Sex (male) 15 13 16 Median age (yrs) 46 47 43 II).
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