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.
Methods: 26 consecutive EPP for epithelioid MPM which were performed from June 2006 to December 2015 in our hospital were reviewed. We have instituted a trimodality therapy protocol consisting of EPP, adjuvant 45-50.4 Gy hemithoracic radiation therapy, and adjuvant CDDP plus PEM chemotherapy. 21 patients have been treated with this protocol. However, 5 patients were given induction CDDP plus PEM chemotherapy, and referred to us. They were scheduled to undergo EPP and adjuvant hemithoracic radiation therapy. Overall survival was calculated using Kaplan-Meier method. This was one institutional retrospective study.Results: Median age at EPP was 61 years old. Female was 7, and male was 19. Right side was 15, and left side was 11. Median EPP time was 7 hours 22 minutes. No blood transfusion during EPP was 12 cases (46%). 30 day mortality was zero. Atrial fibrillation was the most common morbidity, and developed in 9 patients (35%). IMIG pathological stage was stage IV in 1, stage III in 18, stage II in 3, and stage Ib in 4. Adjuvant 45-50.4 Gy radiation therapy was completed for 21 patients (81%). 5 patients (19%) could not undergo chemotherapy. 18 patients (69%) underwent trimodality therapy. Postoperative median follow-up period was 5 years and 2 months. Five year survival, two year survival, and median survival of all 26 patients were 40%, 55%, and 30.4 months. Conclusion:The five year survival and median survival of trimodality therapy with EPP, 45-50.4 Gy hemithoracic radiation therapy, and CDDP plus PEM chemotherapy for epithelioid MPM is 40% and 30.4 months. This treatment strategy is feasible, and the prognosis has been very improved.
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