Misoprostol was found to be three times more effective as compared to placebo in healing small bowel bleeding in patients who require aspirin therapy, commonly used for cardiothrombotic diseases, according to the results of MABLE randomized controlled trial published in the journal Gastroenterology. The complete healing rate of Misoprostol was found to be 28.6 % vs 9.5 % with placebo.
Currently, the only recommendation for patients with small bowel bleeding is to discontinue aspirin, with increasing risk of serious cardiothrombotic events.
Moe H. Kyaw et al. conducted a double-blind, randomized, placebo-controlled trial to determine whether misoprostol can heal small bowel ulcers in patients with small bowel bleeding who require continuous aspirin therapy(AT).
The researchers performed a prospective study of 84 aspirin users with small bowel bleeding who required continued AT. Patients with small bowel ulcers or multiple erosions, detected by capsule endoscopy, were randomly assigned to groups that received either misoprostol (200 ug, 4 times daily; n=42) or placebo (n=42) for 8 weeks. All patients continued taking aspirin (100 mg, once daily). About 20% in both groups had multiple cardiovascular risk factors and a majority in both groups were on concomitant antithrombotics such as clopidogrel or warfarin. Almost all in both groups had used the drug for more than 3 months before enrollment.
The primary outcome was complete ulcer healing at follow-up capsule endoscopy. Secondary endpoints included changes in hemoglobin level and the number of ulcer/erosions from baseline.
The study found that:
- Misoprostol group had higher rates of complete healing of small bowel ulcers or erosions than the placebo group 28.6% vs 9.5% respectively, a difference in the proportion of 19%.
- Misoprostol group had a higher mean increase in Hb levels from baseline to posttreatment (mean difference for misoprostol vs placebo, 0.70 mg/dL).
- Misoprostol group had a greater reduction in the median number of ulcers or erosions (from 6.5 at baseline to 2 at 8 weeks vs 7 to 4 in the placebo group.
Daily aspirin linked to higher Melanoma risk in menThe study concluded that misoprostol proved to be superior to placebo in promoting healing of small bowel ulcers among aspirin users complicated by small bowel ulcer bleeding who require continuous aspirin therapy. However, the study suggests that the use of misoprostol alone would provide only limited protection against aspirin on the small bowel and complete ulcer healing effect of misoprostol may be more pronounced under a longer observation period.
For reference log on to https://doi.org/10.1053/j.gastro.2018.06.056