Gastrointestinal side effects of orlistat may be prevented by concomitant prescription of natural fibers (psyllium mucilloid)

OBJECTIVES: This placebo-controlled open study was designed to test the hyp othesis that most of the gastrointestinal (GI) side events induced by treat ment of obese patients with orlistat (a gastrointestinal lipase inhibitor) could be prevented or ameliorated by concomitant use of natural fibers (psy llium mucilloid). DESIGN: Two groups of obese women (BMI > 27 kg/m(2)) were treated with orli stat 120 mg three times a day. One group (A, n = 30) was randomized to rece ive orlistat and, approximately 6.0 g of orange-flavored psyllium mucilloid dissolved in water and the other group (B, n = 30) received orlistat and o range-flavored placebo. At the end of 30 days and 2 weeks of washout, group A switched to placebo and group B received psyllium while continuing orlis tat three times a day. SUBJECTS: Sixty professional women, more than 21-y-old with a body mass ind ex (BMI) between 27.3 and 48.0 kg/m2, who were not receiving any other medi cation. MEASUREMENTS: Assessments included weekly visits to attending physician, fi lling a form in which GI events were recorded, monthly measurements of body weight, blood pressure and serum lipids. The frequency and severity of GI events were evaluated by a score system, based on information provided by t he patients. RESULTS: Both groups A and B significantly lost (P < 0.01) wei ght after 60 days of orlistat (A = 96.8 to 94.9 kg and B = 98.7 to 96.5 kg) . Similarly, BMI values declined significantly in both groups. While in the psyllium plus orlistat group (group A) the mean +/- s.e.m. of the scores r eflecting GI events was 13.0 +/- 1.8, the placebo pi us orlistat group (B) had a value of 35.9 +/- 2.7 (P < 0.01). When the reverse situation was inst ituted the placebo and orlistat group presented a mean score of 36.1 +/- 3. 6 and the psyllium plus orlistat a mean score of 8.9 +/- 1.5 (P < 0.01). CONCLUSIONS: Psyllium hydrophilic mucilloid concomitantly prescribed to obe se patients receiving 120 mg of orlistat three times a day is an effective and safe adjunct therapy that is helpful in controlling the GI side effects of this pancreatic lipase inhibitor.