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April 1995, Volume 45, Issue 4

Original Article

Healing and Relapse Rates of Duodenal Ulcer with Omeprazole Vs Ranitidine

Waquaruddin Ahmed  ( PMRC Research Centre, Jinnah Postgraduate Medical Centre, Karachi. )
Huma Qureshi  ( PMRC Research Centre, Jinnah Postgraduate Medical Centre, Karachi. )
S. Ejaz Alam  ( PMRC Research Centre, Jinnah Postgraduate Medical Centre, Karachi. )
S. J. Zuberi  ( PMRC Research Centre, Jinnah Postgraduate Medical Centre, Karachi. )

Abstract

The efficacy of omeprazole 20mg a day was assessed against ranitidine 150mg twice a day in the healing and relapse of duodenal ulcer. Forty three endoscopically verified cases were allocated to 2 weeks of treatment, which was extended to 4 weeks, if the ulcer persisted on day 15. Two cases were excluded due to deviation from the protocol. Of 41 evaluable cases, 21 received omeprazole and 20 ranitidine. Healing rates with omeprazole and ranitidine at 2 weeks were 71% and 70% respectively which rose to 100% and 90% at 4 weeks (N.S). There was no significant difference in pain relief in two groups. Follow-up endoscopies, in 33 healed cases revealed 100% relapse at 3 months in omeprazole and 79% in ranitidine treated cases (P<0.05) (JPMA 45: 89, 1995).

Introduction

Of all anti-ulcerdrugs introduced so far; omeprazole has been reported to be the most potent. It works through its antisecretory proprerty by inhibiting H+, K+ ATPase en­zyme1,2. Efficacy of this drug is established on the basis of high healing and low relapse rate but scarce data is available on the frequency of ulcer relapse after cessation of the therapy3-6. The present study was done to see the healing and relapse rate of duodenal ulcer with omeprazole or ranitidine.

Patients and Methods

Adult patients with endoscopically verified duodenal ulcer seen at the PMRC Research Centre, Jinnah Postgraduate Medical Centre, were included in this study. Pregnant and lactating mothers, patients taking anti-ulcer drugs for more than 3 days during the previous 2 weeks, or on non-steroidal anti-inflammatory drugs, those with pyloric stenosis, concur­rent gastric, prepyloric or bleeding ulcers, renal and hepatic disease and those who had gastric surgery except for simple closure were excluded. Patients were assigned to two weeks treatment with eitherranitidine 150mg twice daily oromeprazole 20 mgonce in the morning. All patients were given diary cards to record the pain score (mild, moderate and severe) during day and night and were clinically assessed and endoscoped at 2 weeks to see ulcer healing. Therapy was continued for further two weeks if ulcer did not heal and reassessment was done at four weeks (± 2 days). Patients whose ulcer persisted at 4 weeks were crossed over to the other drug to see the healing at two and four weeks. The number of tablets or capsules returned was recorded and those skipping medicine for three or more days were regarded as dropouts; antacid intake was allowed but not encouraged. Laboratory tests done before enrollment and at the completion of trial, included hemoglobin, hematocrit, total and differential leukocyte and platelet counts. Urinalysis included specific gravity, pH, albumin, sugar; bile, RBC and pus cells. After completion of the trial no maintenance therapy was given and patients with healed ulcer were endoscoped at 1,3,6 and 9 months interval, or at the recurrence of symptoms to see ulcer relapse. The statistical methods used were X2 and student ‘t’ test.

Results

Initially 43 cases (35 males and 8 females) entered the study, of these two were excluded (one due to deviation from the protocol and other lost to follow-up). Of 41 patients who completed the study, 21 were on omeprazole and 20 on ranitidine.

Table I shows the demographic characteristics of patients in two treatment groups. Of 21 cases treated with omeprazolë 15 (71%) healed at 2 weeks and all (100%) at 4 weeks; similarly of 20 cases treated with ranitidine 14 (70%) healed at 2 weeks and 18 (90%) at 4 weeks. Two cases who failed to heal after 4 weeks of ranitidine therapy were cmssed overto omeprazole, ofthese one healed at 2 weeks and the A total of 18 patients healed with ranitidine and 23 with omeprazole (including two crossed over patients). Four cases in each gmup were lost to follow-up. Pain relief was earlier with omeprazole (6±4 days) as compared to ranitidine (8±5 days) (N.S). In the former group 16 (76%) patients became painfree during the first week, vs 11(55%) patients in the later group (N.S) Figure 1 and 2).


No adverse effects were noted clinically or haematologically in two treatment groups. During follow-up, of 19 patients treated with omepra­zole, 15 (79%) relapsed in one month and all (100%) within three months, where as of 14 cases treated with ranitidine 10(71%) relapsed withinone monthand 11(79%) within three months (Table II).

Remaining 3 cases treated with ranitidine had healed ulcer till 9 months of follow-up.

Discussion

The present study showed no significant difference in the efficacy of omeprazole over ranitidine in the healing of duodenal ulcer, at 2 and 4 weeks. Similar fmding has been reported earlier7-9. Although most of the patients (76%) treated with omeprazole were pain free after the first week as compared to those with ranitidine (55%), the overall difference in pain relief was not statistically significant. Very few studies are in agreement with this finding9 and most show a better response to omeprazole10-13. Two patients (one each on omeprazole and ranitidine) relapsed within first week of stopping the drug while other three ranitidine treated cases relapsed within two weeks. All these cases had recurrence of pain and were therefore endoscoped before 4 weeks. Most other relapses were seen on scheduled endoscopies done at one and three months. It is possible that actual early relapse rate might be higherbecause we might be missing asymptomatic relapses; even if this error is ignored the rapid relapse with both of these potent anti-secretaiy drugs is higher than has been reported ear­lier4,7,14,15. The relapse rate at three months in omeprazole treated group is significantly (P<0.05) higher (100%) than that in ranitidine (79%). The possible explanation for this observa­tion is not known but one reason might be a higher number of smokers in this group as compared to ranitidine treated cases. Such an association has been reported earlier16. Other causes for differences observed in pain relief, healing and relapse in the present study and those reported earlier could be the racial differences6, variable duration of disease and previous treat­ment withH2 receptor antagonists17 in these groups.

Acknowledgement

Financial support by Welicome Pakistan is gratefully acknowledged.

References

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13. Van Deventer, G. M., Cagliola, A., Whipple, J. et a!. Duodenal ulcer healing with omeprazole: a multicentre, double blind, ranitidine control­led study. Gastroenterology (abstract), 1988;94: A 476.
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15. Farup, P. G., Rosseland, A. R., Halrorsen, L. et al. Duodenal ulcer treated with omeprazole: healing and relapse rates: does treatment duration influence subsequent remission? Scand. J. Gastroenterol., 1989;24; 1107­12.
16. Eavens, E. R., Korman, M. G., Hansky, J. et al. H2 receptor antagonists, cigarette smoking and the healing of duodenal ulcer. Aust. NZ. J. Med., 1983;13:112.
17. Eleman, L., Hansson, D., Havu, N. et al. Toxicological studies on omeprazole. Scand. J. Gastroenterol., 1985 (Suppl) 108:53-69.

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