title: [Sucrose gel for treatment of bacterial vaginosis: a randomized, double-blind, multi-center, parallel-group, phase III clinical trial].
abstract: OBJECTIVE
  To evaluate the cure effectiveness and safety of sucrose gel in the treatment of bacterial vaginosis through a multi-center, randomized, double-blind, parallel controlled clinical study.
  
  
  METHODS
  A clinical research method of multi-center, randomly double-blind, and dose group parallel comparison was adopted. In the study, 533 patients with bacterial vaginosis were randomly divided into two groups, which included 214 cases in the control group (5.0 g metronidazole gel) and 319 cases in the trial group (5.0 g sucrose gel ). The patients were treated with different medication according to the group where they were. All the cases in these two groups were treated with drugs vaginally twice in a day, morning and evening separately, for 5 days. The curative effect and safety evaluation were assessed from 7 to 10 days and 21 to 30 days after treatment respectively.
  
  
  RESULTS
  The efficacy of the comprehensive clinical treatment showed that the cure rate of metronidazole gel group and sucrose gel group were 70.53% and 80.83% respectively 7 to 10 days after treatment. The recovery rate of Nugent score for vaginal smear were 71.50% and 81.15% respectively. The differences in the efficacy between these two groups were significant statistically (P<0.05). However, the cure rates of metronidazole gel group and sucrose gel group were 63.29% and 61.98% respectively 21 to 30 days after treatment. No statistically significant difference (P>0.05) could be found in the cure rates of the two groups.
  
  
  CONCLUSIONS
  The clinical comprehensive efficacy and recovery of vaginal bacteria of sucrose gel group in the treatment of bacterial vaginosis were obviously superior to those of metronidazole gel 7 to 10 days after treatment. The susucrose gel could improve the clinical efficacy index and laboratory index of bacterial vaginosis. Other effects included the release of clinical symptoms, and the recovery of the normal micro-environment in the vagina according to the Nugent score. The curative efficacy of sucrose gel was equal to that of metronidazole gel 21 to 30 days after treatment. In the future, sucrose gel treatment can be a new strategy for the treatment of bacterial vaginosis. Various advantages can be taken to improve the cure rate of bacterial vaginosis and reduce the shortcomings produced by this disease.
authors.affiliation: Department of Obstetrics and Gynecology, Peking University First Hospital, Beijing 100034, China.
authors.forename: Bing-bing
authors.initials: BB
authors.lastname: Xiao
authors.affiliation: Department of Obstetrics and Gynecology, Peking University First Hospital, Beijing 100034, China.
authors.forename: Dai
authors.initials: D
authors.lastname: Zhang
authors.affiliation: Department of Obstetrics and Gynecology, Peking University First Hospital, Beijing 100034, China; Department of Obstetrics and Gynecology, Beijing Tsinghua Changgung Hospital,100044, China.
authors.forename: Rui
authors.initials: R
authors.lastname: Chen
authors.affiliation: Department of Obstetrics and Gynecology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052,China.
authors.forename: Hui-rong
authors.initials: HR
authors.lastname: Shi
authors.affiliation: Department of Obstetrics and Gynecology, Xijing Fourth Military Medical University Hospital,Xi'an 710032, China.
authors.forename: Xiao-ran
authors.initials: XR
authors.lastname: Xin
authors.affiliation: Department of Obstetrics and Gynecology,The Second Hospital of Hebei Medical University,Shijiazhuang 050000, China.
authors.forename: Hui-lan
authors.initials: HL
authors.lastname: Wang
authors.affiliation: Department of Obstetrics and Gynecology,The Third Hospital of Hebei Medical University,Shijiazhuang 050051, China.
authors.forename: Yi-cun
authors.initials: YC
authors.lastname: Pang
authors.affiliation: Department of Medical Statistics, Peking University First Hospital, Beijing 100034,China.
authors.forename: Sai-nan
authors.initials: SN
authors.lastname: Zhu
authors.affiliation: Department of Medical Statistics, Peking University First Hospital, Beijing 100034,China.
authors.forename: Chen
authors.initials: C
authors.lastname: Yao
authors.affiliation: Department of Obstetrics and Gynecology, Peking University First Hospital, Beijing 100034, China; Department of Obstetrics and Gynecology, Beijing Tsinghua Changgung Hospital,100044, China.
authors.forename: Qin-ping
authors.initials: QP
authors.lastname: Liao
mesh_terms: D000282:Administration, Intravaginal; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005782:Gels / Q000737:chemistry; D006801:Humans; D008795:Metronidazole / Q000627:therapeutic use; D013395:Sucrose / Q000627:therapeutic use*; D016585:Vaginosis, Bacterial / Q000188:drug therapy*
chemical_list: D005782:Gels; D008795:Metronidazole; D013395:Sucrose