title: Quality of randomized controlled trials reporting in the treatment of melasma conducted in China.
abstract: BACKGROUND
  There is no existing report on the quality of randomized controlled trials (RCTs) of melasma treatment currently conducted in China. This study aims to assess the quality of RCT- reporting in the treatment of melasma conducted in China.
  
  
  METHODS
  Several databases were searched from their inception through to August 2014. In order to rate the report quality, we scored 1 for the item if it was reported in CONSORT 2010 and 0 for the item if it was not definitely stated or was not clear. For overall quality score (OQS), 13 items were scored and calculated with a range of 0 to 13. Five items ('randomization', 'allocation concealment', 'blinding', 'baseline characteristics' and 'intention-to-treat (ITT) analysis') were scored and a key methodological index score (MIS) was calculated with a range of 0 to 5 for each trial.
  
  
  RESULTS
  A total of 246 relevant RCTs were included in the final analysis. The median OQS was 7, with a minimum of 4 and a maximum of 11. Some items' information was insufficient, especially in the categories of 'trial design', 'sample size', 'recruitment' and 'ancillary analyses' with a positive rate of less than 20%. The median MIS was 1 with a minimum of 0 and a maximum of 3. Some items' reporting was poor, especially in the categories of 'randomization', 'allocation concealment and implementation', 'blinding' and 'ITT analysis' with a positive rate of less than 10%. The mean OQS increased by about 0.52 for manuscripts published in the period of 5-year increments (95% CI: 0.32 to 0.72; P < 0.001). With regard to the MIS, no variable was statistically significant in the ordinal regression model.
  
  
  CONCLUSIONS
  The reporting quality of RCTs in the treatment of melasma conducted in China is not satisfactory especially in key methodological items. Reporting of RCTs in this field should meet and keep up with the standards of the CONSORT statement.
authors: Department of Dermatology, Wenzhou Hospital of Integrated Traditional Chinese and Western Medicine, Wenzhou Children's Hospital, Wenzhou, 325000, Zhejiang Province, China. wz75czw@sina.cn.
authors: Zhiwei
authors: Z
authors: Chen
authors: College of Life Sciences, Zhejiang Chinese Medical University, Hangzhou, 310053, Zhejiang Province, China. btcyc@sina.com.
authors: Yuchi
authors: Y
authors: Chen
authors: Guangzhou University of Chinese Medicine, Guangzhou, 510405, China. tcm_zjc@126.com.
authors: Jingchun
authors: J
authors: Zeng
authors: Department of Dermatology, Wenzhou Hospital of Integrated Traditional Chinese and Western Medicine, Wenzhou Children's Hospital, Wenzhou, 325000, Zhejiang Province, China. 5486842@163.com.
authors: Yang
authors: Y
authors: Wang
authors: Department of Dermatology, Wenzhou Hospital of Integrated Traditional Chinese and Western Medicine, Wenzhou Children's Hospital, Wenzhou, 325000, Zhejiang Province, China. yeteng902@163.com.
authors: Teng
authors: T
authors: Ye
authors: Department of Dermatology, Wenzhou Hospital of Integrated Traditional Chinese and Western Medicine, Wenzhou Children's Hospital, Wenzhou, 325000, Zhejiang Province, China. transferzhou@163.com.
authors: Qiaochu
authors: Q
authors: Zhou
authors: Department of Dermatology, Wenzhou Hospital of Integrated Traditional Chinese and Western Medicine, Wenzhou Children's Hospital, Wenzhou, 325000, Zhejiang Province, China. 173046023@qq.com.
authors: Xiaojing
authors: X
authors: Du
authors: Department of Dermatology, Wenzhou Hospital of Integrated Traditional Chinese and Western Medicine, Wenzhou Children's Hospital, Wenzhou, 325000, Zhejiang Province, China. tinasu1211@163.com.
authors: Wenting
authors: W
authors: Su
authors: Zhejiang Chinese Medical University, Hangzhou, 310053, Zhejiang Province, China. 531749507@qq.com.
authors: Zhishan
authors: Z
authors: Ding
mesh_terms: D015706:Bibliometrics; D002681:China; D003627:Data Interpretation, Statistical; D006801:Humans; D008548:Melanosis / Q000175:diagnosis / Q000628:therapy*; D017410:Practice Guidelines as Topic; D011786:Quality Control; D016032:Randomized Controlled Trials as Topic / Q000592:standards* / Q000706:statistics & numerical data; D012107:Research Design / Q000592:standards* / Q000706:statistics & numerical data; D013997:Time Factors; D016896:Treatment Outcome