BACKGROUND: The etiology of functional dyspepsia (FD) is multi-factorial. Its prevalence is high and it considerably impairs the patients' quality of life. The treatment options are limited. Padma Digestin, a multi-herbal formula from Tibetan Medicine, is traditionally used in malabsorption and dyspeptic symptoms as they do occur in FD, but as yet no clinical data exist on the formula. The aim of this study was to evaluate the safety, tolerability, and efficacy of Padma Digestin in patients with FD in a prospective, open, clinical phase III trial. PATIENTS AND METHODS: Patients were recruited by general practitioners, internists, and gastroenterologists and treated with 2 × 3 capsules of Padma Digestin daily for 6 weeks. Dyspeptic symptoms were analyzed using the Domestic/International Gastroenterology Surveillance Study (DIGEST) questionnaire extended by the 2 symptoms stomach cramps and lack of appetite. The quality of life was assessed using the Psychological General Well-Being Index (PGWBI-S) questionnaire (short version). RESULTS: 37 patients were admitted and efficacy could be assessed in 31. In the overall efficacy assessment, the Padma Digestin treatment led to a statistically highly significant reduction of the respective most bothersome symptom scores regarding frequency, severity, and impairment of daily activities (p < 0.01). The treatment also led to significant improvements of the individual symptoms of postprandial fullness, nausea, localized and diffuse epigastric pain, stomach cramps, and lack of appetite. The onset of improvement was after a median of 7 days; time until disappearance of the symptoms was after a median of 22 days. The global efficacy and tolerability were rated as good or very good by the doctors and the patients in 84% and 78%, respectively. The PGWBI-S increased from 55 ± 19.5% to 70.5 ± 15.5%, which is nearly the normal value (73.5 ± 15.4%). As for safety, 11 patients reported a total of 17 adverse events (AE), 1 of which was serious but unrelated to the study medication. The AE were mild or moderate. The safety laboratory data showed no statistically significant or otherwise relevant changes. CONCLUSIONS: The results show that the formula Padma Digestin has a high tolerability and efficacy in FD symptoms and positively influences psychological well-being and thus quality of life. It therefore represents a much needed extension of the therapeutic repertoire in FD.
BACKGROUND: The etiology of functional dyspepsia (FD) is multi-factorial. Its prevalence is high and it considerably impairs the patients' quality of life. The treatment options are limited. Padma Digestin, a multi-herbal formula from Tibetan Medicine, is traditionally used in malabsorption and dyspeptic symptoms as they do occur in FD, but as yet no clinical data exist on the formula. The aim of this study was to evaluate the safety, tolerability, and efficacy of Padma Digestin in patients with FD in a prospective, open, clinical phase III trial. PATIENTS AND METHODS: Patients were recruited by general practitioners, internists, and gastroenterologists and treated with 2 × 3 capsules of Padma Digestin daily for 6 weeks. Dyspeptic symptoms were analyzed using the Domestic/International Gastroenterology Surveillance Study (DIGEST) questionnaire extended by the 2 symptoms stomach cramps and lack of appetite. The quality of life was assessed using the Psychological General Well-Being Index (PGWBI-S) questionnaire (short version). RESULTS: 37 patients were admitted and efficacy could be assessed in 31. In the overall efficacy assessment, the Padma Digestin treatment led to a statistically highly significant reduction of the respective most bothersome symptom scores regarding frequency, severity, and impairment of daily activities (p < 0.01). The treatment also led to significant improvements of the individual symptoms of postprandial fullness, nausea, localized and diffuse epigastric pain, stomach cramps, and lack of appetite. The onset of improvement was after a median of 7 days; time until disappearance of the symptoms was after a median of 22 days. The global efficacy and tolerability were rated as good or very good by the doctors and the patients in 84% and 78%, respectively. The PGWBI-S increased from 55 ± 19.5% to 70.5 ± 15.5%, which is nearly the normal value (73.5 ± 15.4%). As for safety, 11 patients reported a total of 17 adverse events (AE), 1 of which was serious but unrelated to the study medication. The AE were mild or moderate. The safety laboratory data showed no statistically significant or otherwise relevant changes. CONCLUSIONS: The results show that the formula Padma Digestin has a high tolerability and efficacy in FD symptoms and positively influences psychological well-being and thus quality of life. It therefore represents a much needed extension of the therapeutic repertoire in FD.