Managing upper gastrointestinal disease associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs) continues to present major problems for clinicians. Do the recent studies by Hawkey et al and Yeomans et al provide definitive recommendations?

The first, in 935 patients, compared omeprazole 20 or 40 mg daily with misoprostol 200 mcg four times daily for 8 weeks in healing gastric or duodenal ulcers or erosions detected endoscopically in NSAID takers, with re-randomisation of 732 successes after healing to omeprazole 20 mg, or misoprostol 200 mcg daily, or placebo for 6 months. On an intent-to-treat basis overall healing rates were: omeprazole 20 mg 75%, 40 mg 75%, and misoprostol 71% (confidence intervals (CI) not given, differences not significant). In the maintenance phase omeprazole recipients fared significantly better than misoprostol or placebo recipients (61%, 48%, and 27% respectively). Adverse effects were more common in the healing phase on misoprostol, mainly because of diarrhoea, abdominal pain and flatulence, with 16.9% dropping out compared with 9.9% and 10.6% dropping out on the two omeprazole regimens.

In the second study, 541 similar patients also received omeprazole 20 or 40 mg daily, or ranitidine 150 mg twice daily, for the same time and the 432 treatment successes were reassigned randomly to omeprazole 20 mg daily, or ranitidine 150 mg daily for 6 months. Healing rates were: omeprazole 20 mg 80%, 40 mg 79%, and ranitidine 63% (p<0.001 for both comparisons with ranitidine, CI not given). All treatments were generally well tolerated. Several issues must be examined before deciding whether the studies give clear guidance to clinicians: (a) Were the study designs robust? (b) Are differences detected likely to be real? (c) Can the conclusions be generalised?  Both studies were double blind and randomised. The authors do not describe the methods in detail, and we have to …