title: Efficacy and safety of Wuling capsule, a single herbal formula, in Chinese subjects with insomnia: a multicenter, randomized, double-blind, placebo-controlled trial.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: The Second Affiliated Hospital of Wenzhou Medical College, Wenzhou 325027, China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Lin
authors.forename: Xiao-yun
authors.initials: XY
authors.lastname: Wang
authors.forename: Ren
authors.initials: R
authors.lastname: Ye
authors.forename: Wan-hua
authors.initials: WH
authors.lastname: Hu
authors.forename: Shu-chen
authors.initials: SC
authors.lastname: Sun
authors.forename: Hong-juan
authors.initials: HJ
authors.lastname: Jiao
authors.forename: Xiu-hua
authors.initials: XH
authors.lastname: Song
authors.forename: Zheng-zhong
authors.initials: ZZ
authors.lastname: Yuan
authors.forename: Yuan-yuan
authors.initials: YY
authors.lastname: Zheng
authors.forename: Guo-qing
authors.initials: GQ
authors.lastname: Zheng
authors.forename: Jin-Cai
authors.initials: JC
authors.lastname: He
mesh_terms: D000293:Adolescent; D000328:Adult; D002214:Capsules / Q000008:administration & dosage; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy / Q000009:adverse effects* / Q000379:methods; D011788:Quality of Life; D012720:Severity of Illness Index; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*
chemical_list: D002214:Capsules; D004365:Drugs, Chinese Herbal; D006993:Hypnotics and Sedatives; C533472:wuling