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OBJECTIVE@#To evaluate the efficacy and safety of Tongxiening Granules (, TXNG) in the treatment of irritable bowel syndrome with predominant diarrhea (IBS-D).@*METHODS@#A randomized, double-blind, double-dummy, and positive parallel controlled clinical trial was conducted from October 2014 to March 2016. Totally 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 orally 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 follow-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 follow-up was 12.35% (10/18) in treatment group and 15.79% (12/76) in control group, respectively (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).
RESUMO
Objective To investigate the effect and the mechanism of Qingbaikuijietang enema on colonic mucosa heal-ing and serum inflammatory factors in patients with ulcerative colitis(UC)and large intestine damp-heat syndrome. Methods A total of 120 patients with mild and moderate UC were selected from January 2014 to December 2015 in the Second Affilia-ted Hospital of Shaanxi University of Traditional Chinese Medicine. The patients were randomly divided into control group and observation group,with 60 cases in each group. The patients in the two groups were treated with mesalazine sustained release granules 1 g by oral,4 times a day for 4 weeks. Based on this,the patients in the observation group were given retention enema with Qingbaikuijietang,once a day for 4 weeks. The score of colonic mucosa healing under endoscopy were evaluated before and at 4 weeks after treatment. The levels of serum tumor necrosis factor-α(TNF-α)and interleukin-6(IL-6)were determined by enzyme linked immunosorbent assay,and the level of C-reactive protein(CRP)was determined by scattering turbidimetry be-fore and after 4 weeks of treatment. The endoscopic colonic lesions of all patients were scored by Rachmilewitz scoring standard before and after treatment. The clinical effect was evaluated by the standard set by the Cooperative Group of Inflammatory Bow-el Disease in Digestive Diseases Branch of Chinese Medical Association after 2 and 4 weeks of treatment. Results There was no significant difference in the score of colon mucosa healing between the two groups before treatment(P > 0. 05). The score of colonic lesions in the observation group was significantly lower than that in the control group after 4 weeks of treatment(P <0. 05). A total of 53 cases(88. 33％)in the observation group and 43 cases(71. 67％)in the control group were endoscopi-cally remission,the remission rate in the observation group was significantly higher than that in the control group(χ2 = 5. 208, P < 0. 05). There was no significant difference in serum IL-6,TNF-α and CRP levels between the two groups before treatment (P > 0. 05). The levels of serum IL-6,TNF-α and CRP after 4 weeks of treatment were significantly lower than those before treatment in the two groups(P < 0. 05). The levels of serum IL-6,TNF-α and CRP in the observation group were significantly lower than those in the control group after 4 weeks of treatment(P < 0. 05). The total effective rate in the control group and the observation group was 40. 00％ and 88. 34％ respectively after 2 weeks of treatment,and it was 86. 67％ and 96. 67％ respec-tively after 4 weeks of treatment,the total effective rate in the observation group was significantly higher than that in the control group after 2 and 4 weeks of treatment(χ2 = 30. 480,3. 927;P < 0. 05). Conclusion Qingbaikuijietang enema combined with mesalazine sustained release granules can reduce the levels of serum inflammatory inflammatory factors,inhibit the inflammato-ry reaction,promote the healing of colonic mucosa and alleviate the clinical symptoms in patients with UC.