Abstract
BackgroundThere 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.MethodsSeveral 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.ResultsA 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.ConclusionThe 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.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-0677-2) contains supplementary material, which is available to authorized users.
Highlights
There is no existing report on the quality of randomized controlled trials (RCTs) of melasma treatment currently conducted in China
Database of RCTs reporting in the treatment of melasma conducted in China are provided in Additional file 1
There seemed to be an improvement in time for overall quality score (OQS) as the mean OQS increased by about 0.52 for manuscripts published in the period of 5-year increments, which indicated that more and more scholars were realizing the importance of reporting in RCTs due to the widely adoption and promotion of Consolidated Standards for Reporting Trials (CONSORT)
Summary
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. The prevalence of melasma has not been investigated in most countries, melasma accounts for about 4 to 10% of new cases in dermatology hospitals [2] and is most common in Hispanics, darker-skinned patients, and Asians [3]. In China, internal Chinese medicine, acupuncture, moxibustion and combined therapies are common in the treatment of melasma. To find the more efficient therapies, more and more randomized controlled trials (RCTs) in melasma have recently emerged. It is still unknown what the reporting quality of RCTs is in melasma studies conducted in China. Description of trial design (such as parallel, factorial) including allocation ratio 0.56 to 0.75
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