| Objective: To assess the safety and efficacy of Ding-gui-you capsule in the treatment of irritable bowel syndrome (IBS) (stagnation of the cold and Qi) and the effect of it on the plasma 5-HT concentration of IBS.Methods: A prospective, randomized, placebo-controlled, double-blind clinical trial was undertaken. Fouty two patients with IBS (stagnation of the cold and qi) were randomly divided into the Ding-gui-you group with high dose (DGY-H, 1.2g, 3 times daily; n=14), the Ding-gui-you group with low dose (DGY-L, 0.8g, 3times daily; n=14), and the placebo group (placebo, , 3 times daily; n=14). And the treatment was applied for 2 weeks. The symptom score of traditional Chinese medicine (TCM), IBS-related pain condition and the plasma 5-HT concentration were determined.Results:1. Baseline levels: There are no significant difference within three group in gender, age, course of disease, severity, symptom and physical sign scores, symptom scores of TCM, abdominal pain and the concentration of 5-HT (all P<0.05). 2. Efficacy in TCM: The total effective rates in symptoms described in TCM were61.54%, 46.16 % and 15.40% in the DGY-H group, DGY-L group and the placebo group, respectively, and there was statistically significant among the groups (P<0.05).3. Abdominal pain: the cure and improvement rates in IBS-related abdominal pain were 69.23%, and 46.16%, and 15.40% in the DGY-H group, DGY-L group and the placebo group, respectively. There are statistical significance between DGY-H group and the placebo group in improving the abdominal pain.4. Effective time of the IBS-related abdominal pain: the effective time of the IBS-related abdominal pain was 3.5±1.6d, 6.8±2.3d, and 11.2±3.1d in the DGY-H group, DGY-L group and the placebo group, respectively. There are statistical difference in effective time of the IBS-related pain among three groups5. The IBS-related pain alleviation time: the IBS-related abdominal pain alleviation time was 9.9±1.6d, 11.3+3.1d, and 11.2±3.1d in the DGY-H group, DGY-L group and the placebo group, respectively. There are no statistical differences in the IBS-related pain alleviation time among three groups.6. 5-HT: the concentration of 5-HT was 76.72±57.39ng/ml, 98.15±101.70ng/ml and 67.42±71.99ng/ml in the DGY-H group, DGY-L group and the placebo group, respectively. There are no statistical differences in the 5-HT level in plasma among three groups.7. Efficacy in IBS: The total significant effective rates were 61.54%, 53.85%, and 23.08% in the DGY-H group, the DGY-L group, and the placebo group, respectively. And there was statistical difference among three groups(P<0.05).8. Safety: no adverse reaction was found in this study.Conclusions: Ding-gui-you capsule could improve the IBS-related pain, effective time of the IBS-related pain and symptoms of TCM with no adverse reaction in IBS with stagnation of cold and Qi.. |
