title: [Randomized controlled trial on haiguiyuyang capsule in the treatment of duodenal ulcer].
abstract: OBJECTIVE
  To assess the efficacy and safety of haiguiyuyang capsule in the treatment of duodenal ulcer (also diagnosed as weiwan pain and hanrecuoza syndrome according to the theory of TCM).
  
  
  METHODS
  This is a multi-center clinical trial cooperatively conducted from May 2003 to March 2004 in accordance to the principle of informed consent, to the criteria for subject inclusion, exclusion, discontinuation, and to the relevant guidelines for evaluating the therapeutic effects of new TCM drugs. The design of double-blind, double-dummy and randomized controlled trial was adopted. 438 patients were randomized to the Test group (n = 330, treated with haiguiyuyang capsule) and to the Control group (n = 108, treated with ranitidine). The therapeutic course for both groups was 6 weeks.
  
  
  RESULTS
  Regarding the efficacy in treating duodenal ulcer, in the Test group, the Marked Efficacy Rate was 66.37% and the Total Efficacy Rate was 82.13%; in the Control group, the Marked Efficacy Rate was 68.61% and the Total Efficacy Rate was 93.34%; there was no significant difference between the two groups (P>0.05). Regarding the efficacy in treating the syndrome diagnosed by TCM, in the Test group, the Marked Efficacy Rate was 70.31% and the Total Efficacy Rate was 93.34%; in the control group, the rates were 71.29% and 91.66% respectively; there was no significant difference between the two groups (P>0.05). Besides, regarding the abatement of distention and fullness of stomach after treatment, the haiguiyuyang capsule was better than ranitidine (P<0.05). No adverse side-effect was observed.
  
  
  CONCLUSIONS
  The efficacy of haiguiyuyang capsule in treating duodenal ulcer is similar to that of ranitidine. No obvious adverse effect of it was observed in this trial.
authors.affiliation: Department of Integrated Traditional Chinese Medicine and Western Medicine, West China Hospital, Sichuan University, Chengdu 610041, China.
authors.forename: Rui-ming
authors.initials: RM
authors.lastname: Zhang
authors.forename: Lei
authors.initials: L
authors.lastname: Wang
authors.forename: Guang-yuan
authors.initials: GY
authors.lastname: Chen
authors.forename: Bing
authors.initials: B
authors.lastname: Mao
authors.forename: Jing
authors.initials: J
authors.lastname: Chang
authors.forename: Ying
authors.initials: Y
authors.lastname: Zhang
authors.forename: Ting-qian
authors.initials: TQ
authors.lastname: Li
authors.forename: Mei
authors.initials: M
authors.lastname: Gong
authors.forename: Yi-qing
authors.initials: YQ
authors.lastname: Wang
authors.forename: Wu-jin
authors.initials: WJ
authors.lastname: Feng
authors.forename: Xue-wu
authors.initials: XW
authors.lastname: Li
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D002214:Capsules; D003937:Diagnosis, Differential; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D004381:Duodenal Ulcer / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008516:Medicine, Chinese Traditional; D008875:Middle Aged; D008517:Phytotherapy
chemical_list: D000897:Anti-Ulcer Agents; D002214:Capsules; D004365:Drugs, Chinese Herbal