Registration quality assessment of acupuncture clinical trials.

ABSTRACT: BACKGROUND: Registration can help with transparency of acupuncture clinical trials (ACTs) by making protocol information and results available to the public. Recently, the number of registered ACTs has increased greatly, but only a few researchers have focused on the quality of ACTs registration. This review provides the first assessment of the registration quality of ACTs and the baseline information for future development. METHODS: All records of ACTs registered in the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) were collected. Data was extracted and input to Excel spreadsheets. The current 20 items of the WHO Trial Registration Data Set (TRDS) and the special prepared items for acupuncture intervention details were used to assess the registration quality of ACTs. RESULTS: A total of 740 records, found in 11 registries, were examined. The number of registered ACTs increased rapidly and involved a number of different diseases. The completeness of 20 items was not too poor due to 16 of them had a higher reported percentage (>85%). The completeness of the 20 items was different among registries. For example, the average registration percentage of 20 items in Clinicaltrials.gov, ChiCTR, ISRCTN and ANZCTR were 89.6%, 92.2%, 82.4% and 91.6% respectively. Detailed information regarding acupuncture intervention was seriously insufficient. Among the 740 registration records, 89.2% lacked information on the style of acupuncture, 80.8% did not contain details regarding the needles used, 53.5% lacked information on the treatment regimen and 76.2% did not give details of other interventions administered with acupuncture. CONCLUSIONS: The overall registration quality of ACTs is not high enough due to the serious lack of information on the specifics of acupuncture intervention. It is vital that a number of special items be set regarding acupuncture in order to develop a suitable system for the registration of ACTs.

SUBMITTER: Gu J 

PROVIDER: S-EPMC3610907 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature