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Sucralfate in the Treatment and Prevention of Gastric Ulcer: Multicentre Double Blind Placebo Controlled Study

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Sucralfate in the Treatment and Prevention of Gastric Ulcer: Multicentre Double Blind Placebo Controlled Study Gut, 1990,31,825-830 825 CLINICAL TRIAL Gut: first published as 10.1136/gut.31.7.825 on 1 July 1990. Downloaded from Sucralfate in the treatment and prevention of gastric ulcer: multicentre double blind placebo controlled study A L Blum, H Bethge, J Ch Bode, W Domschke, G Feurle, K Hackenberg, B Hammer, W Huttemann, M Jung, G Kachel, H Kaess, B C Manegold, P Peter, T Pfleiderer, H G Rohner, U Rasenack, R Sanwald, G A Stalder, J-J Vallotton Abstract following reasons: a small number of patients A randomised controlled multicentre trial was admitted to the trial,33 a short duratiqh of only performed in 160 patients with gastric ulcer, six months,432 ' failure to standardise initial proved by endoscopy and biopsy, to compare ulcer treatment,203335 administration of different ulcer healing with sucralfate and ranitidine doses of sucralfate during maintenance treat- (double blind double dummy design) and to ment,42032-35 problems with randomisation and assess the effect of maintenance treatment blinding,4 and inclusion of patients with pyloric with sucralfate on ulcer recurrence (double ulcers in the gastric ulcer group.20 Some groups blind placebo controlied design). The healing of patients appear in more than one publica- rates were similar with 4 g sucralfate suspen- tion3336 but are often quoted as belonging to sion per day and 300 mg ranitidine per day (82% different studies. Information on 497 patients and 88% after 12 weeks, respectively). Of the with gastric ulcer is available from these 109 patients with healed ulcers, 92 were trials.42032-35 The four placebo controlled trials entered into the maintenance trial and treated lasting for six months gave widely differing http://gut.bmj.com/ with sucralfate tablets (2 g per day) or placebo results; the overall recurrence rate was lower tablets. Maintenance treatment with sucral- with sucralfate (26/101, 26%) than with placebo fate delayed symptoms of gastric ulcer recur- (50/91, 55%). No information on the one year rence. Lifetable analysis showed significant recurrence rate is available. Thus, the value of differences between sucralfate and placebo, sucralfate in the longterm maintenance treat- both after six months (p=0-018) and after 12 ment of gastric ulcer patients remains to be months (p=0044). The rates of symptom established. on September 23, 2021 by guest. Protected copyright. recurrences were 13% and 34% after six We therefore planned an adequately sized, months and 34% and 55% after 12 months for double blind one year trial where only patients sucralfate and placebo, respectively. The rate with an endoscopically proved healed gastric of asymptomatic recurrences after 12 months ulcer were included and both initial ulcer treat- was similar in the two groups (9% and 10%, ment and maintenance treatment were pre- Division de Gastro- respectively). The recurrence rate was higher defined by randomisation before admission to enterologie, Centre in patients who had never taken non-steroidal the initial treatment phase. Hospitalier, Universitaire Vaudois, CH-1011 anti-inflammatory drugs than in those who had Lausanne, Switzerland but had stopped on admission to the study. It A L Blum was also higher in patients with recurrent ulcer Patients and methods H Bethge and in those with scarring deformation and The patients entered into this study fulfilled the J Ch Bode W Domschke narrowing of the pylorus. Maintenance treat- following criteria. They were ambulatory, had a G Feurle ment with sucralfate slowed the appearance of benign gastric ulcer proved by endoscopy and K Hackenberg symptom recurrences ofgastric ulcer. biopsy, were over 18 years of age, gave informed B Hammer W Huttemann consent, were likely to cooperate, and were M Jung willing to fill in a diary card. G Kachel The prevention of gastric ulcer recurrences is At the onset ofthe study the gastric ulcer had a H Kaess B C Manegold still a major problem. While it is possible to delay diameter of 5 to 30 mm (ulcer size was estimated P Peter the recurrence of a duodenal ulcer by initial with open biopsy forceps; for calculation ofulcer T Pfleiderer treatment with agents such as bismuth com- area see Blum et a137)) was located entirely in the H G Rohner U Rasenack pounds,' this is not the case for gastric ulcer.2'8 stomach without involving the pyloric area or the R Sanwald Maintenance treatment in patients with healed duodenal bulb, showed no endoscopical signs of G A Stalder gastric ulcers has been attempted with varying acute ulceration (large, flat, irregular, multiple J-J Vallotton success using cimetidine,"2' ranitidine,'2 22-28 mucosal defects), and had not bled within the Correspondence to: Professor A L Blum, Division pirenzepine,29 carbenoxolone,303 Caved-S,3 previous 24 hours. At least two biopsy specimens de Gastro-enterologie, CHUV, antacids,'93' and also sucralfate.4 20 32-35 from the ulcer area, four from the ulcer wall, and CH-101 1 Lausanne, Switzerland. The results of randomised maintenance trials two from the surrounding mucosa showed no Accepted for publication comparing sucralfate with either placebo32-35 malignant tissue or severe dysplasia. The 11 September 1989 or cimetidine20133 are not conclusive for the presence of a deep ulcer with edges markedly 826 Blum, Bethge, Bode, et al raised above the general mucosal surface was with their meals and were advised not to take recorded. An antrum with standing folds, not hard liquor on an empty stomach. flattened by forceful insufflation of air, was Maintenance treatment was started immedi- considered to show scarring deformation. ately after endoscopy. Outpatient visits were Gut: first published as 10.1136/gut.31.7.825 on 1 July 1990. Downloaded from Pyloric deformation was diagnosed when the scheduled at two monthly intervals. During open pylorus was neither round nor oval. 'Stress- these visits weight and blood pressure were ful life events' were recorded when the patients measured and the patients were interviewed responded affirmatively to the question: Do you concerning symptoms suggestive of a recur- think that your present ulcer attack is the rence. When a recurrence was suspected endo- consequence of stressful life events? Daily use scopy was performed. When no recurrence was of coffee, cigarettes, non-steroidal anti- suspected the patient received drugs for the next inflammatory drugs, and alcohol was recorded. two months and a new outpatient appointment Patients with reflux oesophagitis or a pyloric was made. In the event of epigastric distress or duodenal ulcer were excluded from this study. occurring between scheduled visits, the patients Other exclusion criteria were age below 18 years, were asked to contact their physician; an pretreatment with antiulcer drugs, surgery in interim, off-schedule endoscopy was performed the upper gastrointestinal tract (except for even if only mild or atypical symptoms were appendectomy and surgery for inguinal hernia), present. At the end of the one year maintenance continuing treatment with non-steroidal anti- period an endoscopy was performed on all inflammatory drugs or other potentially ulcero- patients who were still in the trial. genic drugs, alcoholism (daily pure ethanol consumption of more than 100 ml (women) or more than 120 ml (men), or behaviour compat- MEDICATION ible with alcoholism), and concurrent diseases The patients were randomly assigned to one of which might have influenced longterm outcome the following four treatment arms: (i) initial such as malignancy, liver cirrhosis, or renal ulcer treatment with sucralfate followed by main- insufficiency. Pregnant and lactating women tenance treatment with sucralfate; (ii) sucralfate were also excluded. followed by placebo; (iii) ranitidine followed by The study was accepted by the Ethics sucralfate; (iv) ranitidine followed by placebo. Committee ofthe Triemli Hospital. For each patient a complete set ofmedication for both phases of the study was available on admission. INITIAL ULCER TREATMENT Sucralfate was given for initial ulcer treatment Initial ulcer treatment has been described in as a suspension contained in plastic bags (5 ml of http://gut.bmj.com/ detail elsewhere.37 Briefly, endoscopy was per- the suspension corresponded to 1 g of sucralfate) formed before the patient was entered into the and as tablets (1 g each) in the maintenance trial. Initial curative treatment was started phase. For initial ulcer treatment patients took within 24 hours after endoscopy. The first con- 5 ml ofthe sucralfate suspension four times daily trol endoscopy was performed six weeks after plus a ranitidine placebo, one tablet twice daily; treatment was started. When the ulcer was those allocated to ranitidine treatment took one healed four biopsy specimens from the ulcer scar tablet (150 mg) twice daily plus a placebo on September 23, 2021 by guest. Protected copyright. and two specimens from the surrounding sucralfate suspension (5 ml) four times daily. In mucosa were taken. Healing was defined as an this double dummy system sucralfate suspension endoscopical appearance compatible with com- and placebo suspension were identical in appear- plete re-epithelialisation and the absence of ance, colour, and taste. The same was true for mucosal defects in the biopsy specimens. Patients ranitidine tablets and placebo tablets. The with malignancy or severe dysplasia in any of the suspension was taken a half hour before break- biopsy specimens were excluded from the main- fast, lunch, and dinner and before going to bed. tenance trial. Patients whose ulcer had not The tablets were taken together with the suspen- healed after six weeks were treated for another sion before breakfast and before going to bed. six weeks and endoscopy was repeated after a The patients had free access to chewable tablets total treatment of 12 weeks. containing an antacid with a very low buffer capacity (3 mmol/tablet). In the double blind maintenance treatment MAINTENANCE TREATMENT trial the patients who were randomised to treat- All patients whose ulcer had healed within 12 ment with sucralfate took a tablet containing 1 g weeks were eligible for the maintenance part of the study.
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