Efficacy and safety of Wuling capsule, a single herbal formula, in Chinese subjects with insomnia: A multicenter, randomized, double-blind, placebo-controlled trial

• Published in: Journal of ethnopharmacology Vol. 145; no. 1; pp. 320 - 327
• Main Authors: Lin, Yan, Wang, Xiao-yun, Ye, Ren, Hu, Wan-hua, Sun, Shu-chen, Jiao, Hong-juan, Song, Xiu-hua, Yuan, Zheng-zhong, Zheng, Yuan-yuan, Zheng, Guo-qing, He, Jin-Cai
• Format: Journal Article
• Language: English
• Published: Ireland Elsevier Ireland Ltd 09.01.2013
• Subjects: administration & dosage; Adolescent; Adult; adverse effects; Capsules; Capsules - administration & dosage; central nervous system; Clinical trial; Double-Blind Method; drug therapy; Drugs, Chinese Herbal; Drugs, Chinese Herbal - administration & dosage; Drugs, Chinese Herbal - adverse effects; Drugs, Chinese Herbal - therapeutic use; Female; Humans; Hypnotics and Sedatives; Hypnotics and Sedatives - administration & dosage; Hypnotics and Sedatives - adverse effects; Hypnotics and Sedatives - therapeutic use; Insomnia; Male; methods; Middle Aged; Multi-center randomized trial; patients; Phytotherapy; Phytotherapy - adverse effects; Phytotherapy - methods; Quality of Life; randomized clinical trials; Severity of Illness Index; sleep; Sleep Initiation and Maintenance Disorders; Sleep Initiation and Maintenance Disorders - drug therapy; therapeutic use; World Health Organization; Wuling capsule; Xylaria nigripes; Clinical trial; Multi-center randomized trial; Insomnia; Wuling capsule
• ISSN: 0378-8741; 1872-7573; 1872-7573
• DOI: 10.1016/j.jep.2012.11.009

Wuling Capsule is a single herbal formula from mycelia of precious Xylaria nigripes (Kl.) Sacc and its pharmacological function have a tranquilizing effect on the central nervous system. The aim of the study to evaluate the efficacy and safety of Wuling capsule in treatment of insomnia. We performed a multicenter, randomized, double-blind, placebo-controlled study. The participants received either placebo (n=92) or Wuling capsule (n=94) for 4 weeks and a follow-up period for 2 weeks. Compared between pre-treatment and post-treatment, the global Pittsburgh sleep quality index (PSQI) scores in both Wuling capsule group and placebo group improved significantly (P<0.01). However, there was no significant difference between Wuling capsule group and placebo group (P>0.05). Scores of clinical global impressions scale (CGI-I) at each week in Wuling capsule group was similar to those in placebo group (P>0.05). Compared between pre-treatment and post-treatment, scores of the four components of world health organization on quality of life brief scale (WHOQOL-BREF) in both Wuling capsule group and placebo group improved significantly (P<0.01). However, there were no difference between the two groups (P>0.05). The rate of adverse events was 10.10% in Wuling group, and 6.73% in placebo group (P>0.05). Wuling capsule can improve insomnia when compared with pre-treatment for 4 weeks and be a well tolerated by all the patients at the 6 weeks of study period. However, there are no significant in the results of the variables tested when compared with placebo control. Further additional rigorous randomized clinical trials are still required. [Display omitted]