BACKGROUND: Beano, an over-the-counter oral solution of alpha-galactosidase, is used to prevent flatus and other gastrointestinal symptoms resulting from a high-fiber diet. The efficacy of this product, however, has not yet been adequately evaluated. METHODS:Nineteen subjects were randomized into two groups and fed test meals of meatless chili. At the first test meal, group 1 received eight drops of alpha-galactosidase solution and group 2 received eight drops of placebo. After the meal, subjects were asked to keep a careful record of gastrointestinal symptoms, including occurrences of intestinal gas passage, for the next 6 hours. One week later, an identical test meal was served to each study subject and the solutions were reversed. Again subjects recorded their symptoms for the next 6 hours. Data were analyzed by means of paired t tests. RESULTS: The number of flatulence events per hour was significantly less in the group treated with alpha-galactosidase than placebo over the 6-hour follow-up period (F = 2.87, P = .016). When the two groups were compared at each follow-up interval, this difference was statistically significant only for the 5th hour after ingesting the test meal (t = 2.19, P = .04). No differences between the two groups were found in the extent of bloating or pain following the meal. CONCLUSIONS:Oral alpha-galactosidase solution is efficacious, at least in some patients, for the prophylaxis of gastrointestinal intolerance of oligosaccharides.
RCT Entities:
BACKGROUND: Beano, an over-the-counter oral solution of alpha-galactosidase, is used to prevent flatus and other gastrointestinal symptoms resulting from a high-fiber diet. The efficacy of this product, however, has not yet been adequately evaluated. METHODS: Nineteen subjects were randomized into two groups and fed test meals of meatless chili. At the first test meal, group 1 received eight drops of alpha-galactosidase solution and group 2 received eight drops of placebo. After the meal, subjects were asked to keep a careful record of gastrointestinal symptoms, including occurrences of intestinal gas passage, for the next 6 hours. One week later, an identical test meal was served to each study subject and the solutions were reversed. Again subjects recorded their symptoms for the next 6 hours. Data were analyzed by means of paired t tests. RESULTS: The number of flatulence events per hour was significantly less in the group treated with alpha-galactosidase than placebo over the 6-hour follow-up period (F = 2.87, P = .016). When the two groups were compared at each follow-up interval, this difference was statistically significant only for the 5th hour after ingesting the test meal (t = 2.19, P = .04). No differences between the two groups were found in the extent of bloating or pain following the meal. CONCLUSIONS: Oral alpha-galactosidase solution is efficacious, at least in some patients, for the prophylaxis of gastrointestinal intolerance of oligosaccharides.