OBJECTIVE: To observe the curative effect of a recipe for warming the kidney and fortifying the spleen on diarrhea-predominant irritable bowel syndrome (IBS-D). METHODS: This multi-center, double-blind, randomized, and controlled trial included 240 patients that met the inclusion criterion and were then divided into two groups of 120. Patients in the treatment group (group A) took modified Sishen Wan orally for warming the kidney and fortifying the spleen and patients in the control group (group B) took a placebo, Chao Maiya, for 4 weeks. 28 days after withdrawal, there was a 6-month follow-up to observe patient recurrence condition. The total effective rate, curative effect, and recurrence rate were evaluated after treatment. RESULTS: There was statistical difference (P < 0.01) between the two groups in total effective rate (92.24% in the treatment group and 49.07% in the control group), in curative effect of TCM syndrome (90.52% and 47.22%, respectively), and in the recurrence rate (15.79% and 56.86%, respectively) within 6 months after treatment. CONCLUSION: Modified Sishen Wan, for warming the kidney and fortifying the spleen, can effectively treat IBS-D and better control its recurrence.
RCT Entities:
OBJECTIVE: To observe the curative effect of a recipe for warming the kidney and fortifying the spleen on diarrhea-predominant irritable bowel syndrome (IBS-D). METHODS: This multi-center, double-blind, randomized, and controlled trial included 240 patients that met the inclusion criterion and were then divided into two groups of 120. Patients in the treatment group (group A) took modified Sishen Wan orally for warming the kidney and fortifying the spleen and patients in the control group (group B) took a placebo, Chao Maiya, for 4 weeks. 28 days after withdrawal, there was a 6-month follow-up to observe patient recurrence condition. The total effective rate, curative effect, and recurrence rate were evaluated after treatment. RESULTS: There was statistical difference (P < 0.01) between the two groups in total effective rate (92.24% in the treatment group and 49.07% in the control group), in curative effect of TCM syndrome (90.52% and 47.22%, respectively), and in the recurrence rate (15.79% and 56.86%, respectively) within 6 months after treatment. CONCLUSION: Modified Sishen Wan, for warming the kidney and fortifying the spleen, can effectively treat IBS-D and better control its recurrence.
Authors: Rolf Teschke; Albrecht Wolff; Christian Frenzel; Axel Eickhoff; Johannes Schulze Journal: World J Gastroenterol Date: 2015-04-21 Impact factor: 5.742