Post-marketing Re-evaluation of Tongxiening Granules (痛泻宁颗粒) in Treatment of Diarrhea-Predominant Irritable Bowel Syndrome:A Multi-center,Randomized,Double-Blind,Double-Dummy and Positive Control Trial

Objective: To evaluate the efficacy and safety of Tongxiening Granules(痛泻宁颗粒, TXNG) in the treatment of irritable bowel syndrome with predominant diarrhea(IBS-D). Methods: A randomized, double-blind, double-dummy, and positive paral el control ed clinical trial was conducted from October 2014 to March 2016. Total y 342 patients from 13 clinical centers were enrolled and randomly assigned(at the ratio of 1:1) to a treatment group(171 cases) and a control group(171 cases) by a random coding table. The patients in the treatment group were administered oral y with TXNG(5 g per time) combined with pinaverium bromide Tablet simulator(50 mg per time), 3 times per day. The patients in the control group were given TXNG simulator(5 g per time) combined with pinaverium bromide Tablets(50 mg per time), 3 times per day. The treatment course lasted for 6 weeks. The improvement of Irritable Bowel Syndrome Symptom Severity Score(IBS-SSS) was used to evaluate the primary outcome. Secondary outcomes included adequate relief(AR) rate, Irritable Bowel Syndrome-Quality of Life Questionnaire(IBS-QOL), Hamilton Anxiety Scale(HAMA), Hamilton Depression Scale(HAMD), and the recurrence rate at fol ow-ups. Safety indices including the adverse events(AEs) and related laboratory tests were evaluated. Results: Primary outcome: IBS-SSS at baseline, weeks 2, 4, 6 showed no statistical significance in both full analysis set(FAS) and per protocol set(PPS, P>0.05). After 6 weeks of treatment, the total effective rate of IBS-SSS scores in the treatment group(147/171, 86.0%) was higher than the control group(143/171, 83.6%) by FAS(P>0.05). In regard to secondary outcomes, after 6-week treatment, there was no significant difference in AR rate, total score of IBS-QOL, improvement of HAMD and HAMA total scores between the two groups(P>0.05). The recurrence rate at 8-week fol ow-up was 12.35%(10/18) in treatment group and 15.79%(12/76) in control group, respectivery(P>0.05). A total of 21 AEs occurred in 15 cases, of which 11 occurred in 8 cases in the treatment group and 10 AEs in 7 cases in the control group. The incidence of AEs had no statistical significance between the two goups(P>0.05). Conclusion: Tongxiening Granules could relieve the symptoms of patients with IBS-D and the treatment effect was comparable to pinaverium bromide.(No. ChiCTR-IPR-15006415)

Effect of Combined Acupuncture and Shen Zao An Shen Tang on Sleep Quality of Insomnia Patients Due to Deficiency of the Heart and Spleen

Objective： To observe the clinical efficacy of acupuncture combined with Shen Zao An Shen Tang for insomnia due to deficiency of the heart and spleen, investigate the law of treating insomnia based on syndrome differentiation, and thus provide evidence for treatment based on differentiation of insomnia in traditional Chinese medicine. Methods： A total of 62 cases with insomnia due to deficiency of the heart and spleen were randomized into a combined acupuncture and Chinese herbal formula group and a Western medication group, 31 cases in each group. Acupuncture and self-made Shen Zao An Shen Tang were employed in the former, while Estazolam was used in the latter. After a 28-day treatment, the clinical efficacy, sleep efficiency, sleep dysfunction rating scale （SDRS） and adverse reactions in the two groups were observed and compared. Results： The total effective rate in the combined acupuncture and Chinese herb formula group was 96.8%, versus 74.2% in the Western medication group, showing a statistically significant difference （P〈0.05）. After treatment, the sleep efficiency ratios in both groups were significantly increased （P〈O.01, P〈0.05）, and there was a between-group statistically significant difference （P〈0.05）. Also, the SDRS scores in both groups were decreased （P〈0.01, P〈0.01） and there was a between-group statistically significant difference （P〈0.01）. In addition, the adverse reaction rate in the combined acupuncture and Chinese herb formula group was significantly lower than that in the Western medication group （P〈0.05）. Conclusion： Combining acupuncture and Chinese herb formula can obtain a substantial clinical efficacy for insomnia due to deficiency of the heart and spleen and improve the patients＇ sleep quality. Compared with Estazolam, it is better in effect and less in adverse reactions.