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Ranitidine and Sucralfate As Maintenance Therapy for Gastric Ulcer Disease: Endoscopic Control and Assessment of Scarring

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Ranitidine and Sucralfate As Maintenance Therapy for Gastric Ulcer Disease: Endoscopic Control and Assessment of Scarring Gut: first published as 10.1136/gut.30.12.1692 on 1 December 1989. Downloaded from Gut, 1989, 30, 1692-1697 Ranitidine and sucralfate as maintenance therapy for gastric ulcer disease: endoscopic control and assessment of scarring T TAKEMOTO, M NAMIKI, M ISHIKAWA, K TSUNEOKA, S OSHIBA, K KAWAI, AND N OGAWA From the Yamaguchi University School ofMedicine, Asahikawa Medical College, Yamagata University School of Medicine, Nippon Medical School, Osaka Medical College, Kyoto Prefectural University of Medicine, Ehime University School of Medicine, Japan SUMMARY The efficacy of ranitidine (150 mg nocte), and sulcralfate (1 g tds) as maintenance therapy to prevent gastric ulcer relapse was evaluated in a 12 month trial in 363 patients. The relapse rates were 8.8% at three months, 14.7% at six months, 18/1% at nine months, and 21V0% at 12 months for the ranitidine group and 1477%, 21/3%, 29.9%, and 30.2% respectively for the sucralfate group. At nine and 12 months the cumulative relapse rates for the ranitidine group were significantly lower than those for the sucralfate group (p<005). In both groups ulcers recurred mainly from red scars observed at the endoscopic scarring stage. This indicated the necessity of drug treatment up to the white scar stage. The results suggest that ranitidine is effective in preventing gastric ulcer relapse. Gastric acid is generally considered to be a key factor Methods http://gut.bmj.com/ in peptic ulcer development and the histamine H receptor blockers which inhibit its formation have PATIENTS become standard therapy for treatment of both Patients whose gastric ulcers had healed after any duodenal and gastric ulcer. active treatment were recruited if endoscopy had On average duodenal ulcer patients secrete more confirmed the ulcer and its healing and if they were gastric acid than healthy control subjects. Many suitable for outpatient management. clinical trials have therefore been conducted with H, on September 27, 2021 by guest. Protected copyright. blockers to evaluate their use as to prevent duodenal DOSAGE AND ADMINISTRAIION ulcer relapse.` The effects of ranitidine (Glaxo, UK), 150 mg/day at In contrast gastric ulcer patients as a group secrete bedtime, and sucralfate (Chugai Pharmaceutical Co, less acid than normal and are usually considered to Japan), 1 g tds, on the rate of gastric ulcer relapse have an imbalance between agressive and defensive were compared in a one year maintenlance trial factors resulting from impaired gastric defence. conducted by investigators in 72 centres. This imbalance may, in theory, be rectified by Each patient received either four 250 mg tablets of therapeutic intervention which acts to increase sucralfate three times a day (before breakfast and mucosal defence or to inhibit gastric acid and pepsin. lunch and at bedtime) or four placebo tablets before As there is no definitive information on the relative breakfast and lunch and one 150 mg ranitidine tablet merits of these two approaches to treatment we have with three placebo tablets at bedtime. In order to conducted a large clinical trial to compare the effects maintain blindness, all the drugs and placebo tablets of ranitidine, an agent which inhibits gastric acid were prepared in packages which were indistinguish- secretion and sucralfate, a mucosal protective agent able in their appearance. in the prevention of gastric ulcer relapse. I RIAI DE SIGN Address for correspondence: Professor T Tikernoto. lirst )ep.rtmnenit of Medicine. Yarnagunchi Unisersity School of Medlicinl. 114 (Ocushi. Ufe-shi Endoscopic examination of the stomach was per- Y.iniiguchi-ken. Japai. formed on five occasions, - that is, when healing was Accepted for public.itio n April l1989. confirmed and at three, six, nine, and 12 months 1692 Gut: first published as 10.1136/gut.30.12.1692 on 1 December 1989. Downloaded from Gastric ulcer maintenance therapy 1693 Table 1 Esxcliusion criteria ing to the criteria, a red scar or white scar was judged as non-relapse and the A 1, A2, H 1, or H2 stages were Reason Druig Ratnitielit Sucraljate judged as a relapse. Protocol v iolation The patients were enrolled irrespective of their Scar of DU I previous ulcer treatment, but patients with con- Scar of linear ulcer I current duodenal ulceration or those with a linear Combined use of anti-ulcer drug - Concurrent DU 1 ulcer were excluded. Also excluded were patients Gastric cancer ' who were or might be pregnant or lactating. Pyloric tumour embolus by HCC+hepatic - I Use of all other anti-ulcer drugs was prohibited as cirrhosis were known ulcerogenic agents such as oral steroids Patients w ho failed to visit hospital after start 4 5 of trial and non-steroidal anti-inflammatory drugs. Total 9 8 To evaluate drug safety the patients were questioned concerning adverse effects. In addition clinical laboratory tests including hepatic and renal function tests and urinalysis, were performed on Table 2 Background ofpatients three occasions: at the time of confirmation of healing, and at six and 12 months after the start of Ranuluud'n Sui('rall'att y' test maintenance therapy. Patients (n) 171 175 ns 1211 116 ns Male STAIISTICAI ANAI YSIS Femalle > I 59 Age Mean age (SEM) 532 (119) 52:8 (()n9)is Ulcer relapse rates were calculated by Cutler-Ederer Sniioking Yes 98 1(14 ns life-table analysis. The X' test by the Mantel Haenzel No 73 71 method was used for comparison of cumulative (offee Yes 57 61 [is The rate of transition of the endoscopic No 113 11(0 relapse rates. Alcohol No 911( (X) ns scarring stage was also calculated by the Cutier- Occasionalls 41 3 Ederer life table analysis. Eversvdav 4)0 41 The background factors of the patients were History of First occurrence 78 76 ns compared by the x)' test. g.astric Recurrence 81 86 ulcer For all of these statistical methods, p<0.005 was D)escription Location Angulus 53 47 ns regarded as indicative of a significant difference. http://gut.bmj.com/ of sentriculi atid pres ious lesser curse Results gastric Others 1 22 134 ulcer Number Single 49 1 5I ns Multiple 22 24 C OMPARISON OF SUBJICTS Shape Circle 1(02 105 ns Three hundred and sixty three patients with a healed Oval 63 *X gastric ulcer were randomised into two groups; 180 Irregular 7 14 ranitidine and 183 patients sucralfate. Size Sniall ('9 nim) 47 4n ns received on September 27, 2021 by guest. Protected copyright. Mediuinm ( 11) 19 9" 96 Seventeen subjects were excluded for the reasons mm) presented in Table 1. Table 2 shows the demographic Large (20ninm ) 23 25 346 received Depth Shallos ( 5 mm) 69 %6 ns data for the remaining subjects (171 Medium (6 mimi- 7(0 79 ranitidine and 175 sucralfate) who were eligible for 1(0 mm) Deep (ll mnl) 11 7 Fndloscopic scarring Red scar 141 145 ns Table 3 Prt'iou{ioCsulcer terapl)Y stage White scar 3(1 30( Paletits randloiisnxed1(: X (SE). ns: No signilficant differeice. Previous ulcer tiherapy Rtailuidliut S rul/jl l2 blocker alone (FERA) t1 44 Sucralfate alone (S) () thereafter. Administration of the drugs was started H2RA+sucralfate 9 soon after confirmation of ulcer healing by endo- ILRA+S+others* 32 30( scopy. Furthermore, whenever recurrence was VERA+others 56 7(0 S+others 7 1() suspected from the patient's symptoms, an additional Others 16 14 endoscopic examination was performed to confirm or Unknowsn () deny ulcer relapse using the endoscopic scarring stages classification reported by Sakita et al.' Accord- Others (eftarnate. Cetraxate, etc. Gut: first published as 10.1136/gut.30.12.1692 on 1 December 1989. Downloaded from 1694 Takemoto, Namiki, Ishikawa, Tsuineoka, Oshiba, Kawai, and Ogaw,a analysis, and no significant differences were noted for 50- any of those factors. Previous ulcer treatment for the L Ranitidine group (150 mg/day) healing phase is shown in Table 3. In both drug E Sucralfate group (3g/day) groups many subjects had been treated with HW- * p<0-05 receptor blockers but there was no difference in the distribution of any of the treatments. Also, in most X test by Mantel-Haenzel r*i cases in both groups, a red scar stage was detected at analysis method 29.9 30.2 4-1 the initial endoscopic examination (Table 2). X 25- CD 21.3 21*O CL0. CUMUIATIVE RELAPSE RAFES 10 18.1 Table 4 shows the relapse status for the two treatment 14.7 1 groups for each three month period of the study. The number of patients who had relapsed was 29 for O- ranitidine and 44 for sucralfate. In both treatment groups, ulcer relapse occurred most frequently during the first three cases month period: 14 for (171)(175) (134)(127) (106) (97) (89) (76) ranitidine and 24 cases for sucralfate. Figure 1 shows No of patients the cumulative relapse rates with both drugs calcu- 3 6 9 12 lated by Cutler-Ederer life table analysis. The Months cumulative relapse rates for ranitidine at three, six, nine, and 12 months were 8.8%, 14-7%, 18X 1%, and Fig. 1 Ulcer recurrence rate ini each1 treatment group at 21-0%, while those for the sucralfate group were thiree, six, nine, and 12 montilis calculated by tile Cutler- 14-7%, 21-3%, 29-9%, and 30(2% respectively. The Ederer life-table analysisimethiod. cumulative relapse rates at nine and 12 months in the ranitidine group were significantly lower than those ranitidine groups and 71-4% of the non-relapse cases in the sucralfate group (p<005). The symptomatic in the sucralfate group were in the white scar stage. relapse rates at three and six months were 6.9% and 10.9% for the ranitidine group and 9-2% and 10-7% ADVERSE EFFECIS AND LABORA IORY for sucralfate group.
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