title: [A multi-center, randomized, double-blind, placebo-controlled trial of glyceryl trinitrate ointment in the treatment of anal fissure].
abstract: OBJECTIVE
  To evaluate the clinical efficacy and safety of glyceryl trinitrate (GTN) ointment in the treatment of anal fissure.
  
  
  METHODS
  In this multi-center, randomized, double-blind and placebo-controlled trial, 240 chronic anal fissure patients from 7 clinical centers were randomized to receive eight-week treatment with GTN ointment (treatment group) or vaseline ointment (control group) respectively. Healing rate, visual analogue score (VAS), maximum anal resting pressure (MARP) and adverse reactions were recorded and compared.
  
  
  RESULTS
  A total of 221 patients (92.1%) finished the trial, including 114 patients in treatment group (95.0%, 114/120) and 107 in control group (89.2%, 107/120). At the endpoint of treatment (56 d), 90 patients in treatment group (78.9%, 90/114) healed completely compared to 31 patients in control group (29.0%, 31/107), and decrease rates of VAS in the two groups were (94.8±15.7)% and (61.2±35.7)% respectively, both differences were statistically significant (P<0.01). MARP after first administration was (20.2±18.5) mm Hg in treatment group (n=12) and (7.1±14.7) mm Hg in control group (n=6), which was not significantly different (P=0.152). Adverse reaction incidence was higher in treatment group (42.1% vs. 9.3%, P<0.05), while these adverse reactions were mainly headache and fullness in head, which were self-limiting.
  
  
  CONCLUSIONS
  GTN ointment can effectively promote healing and relieve pain in anal fissure with safety and tolerance.
authors.affiliation: Department of Colorectal Surgery, Beijing Chaoyang Hospital, Beijing, China.
authors.forename: Hui
authors.initials: H
authors.lastname: Peng
authors.forename: Jian-ping
authors.initials: JP
authors.lastname: Wang
authors.forename: Xin-qing
authors.initials: XQ
authors.lastname: Yang
authors.forename: Yi
authors.initials: Y
authors.lastname: Zheng
authors.forename: Yi-jiang
authors.initials: YJ
authors.lastname: Ding
authors.forename: Shu-qing
authors.initials: SQ
authors.lastname: Ding
authors.forename: Guo-dong
authors.initials: GD
authors.lastname: Li
authors.forename: Jian-zhong
authors.initials: JZ
authors.lastname: Jing
authors.forename: Bao-ming
authors.initials: BM
authors.lastname: Zhao
authors.forename: Shu-xin
authors.initials: SX
authors.lastname: Zhang
authors.forename: Chao-wen
authors.initials: CW
authors.lastname: Chen
authors.forename: Xue-bing
authors.initials: XB
authors.lastname: Zhan
authors.forename: Li-qing
authors.initials: LQ
authors.lastname: Yao
authors.forename: Wei-feng
authors.initials: WF
authors.lastname: Chen
authors.forename: Qing-shan
authors.initials: QS
authors.lastname: Zheng
authors.forename: Ji-han
authors.initials: JH
authors.lastname: Huang
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D005260:Female; D005401:Fissure in Ano / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D005996:Nitroglycerin / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D005996:Nitroglycerin