Assessment of Registration Information on Methodological Design of Acupuncture RCTs: A Review of 453 Registration Records Retrieved from WHO International Clinical Trials Registry Platform

Abstract EN

This review provides the first methodological information assessment of protocol of acupuncture RCTs registered in WHO International Clinical Trials Registry Platform (ICTRP).

Methods.

All records of acupuncture RCTs registered in the ICTRP have been collected.

The methodological design assessment involved whether the randomization methods, allocation concealment, and blinding were adequate or not based on the information of registration records (protocols of acupuncture RCTs).

Results.

A total of 453 records, found in 11 registries, were examined.

Methodological details were insufficient in registration records; there were 76.4%, 89.0%, and 21.4% records that did not provide information on randomization methods, allocation concealment, and blinding respectively.

The proportions of adequate randomization methods, allocation concealment, and blinding were only 107 (23.6%), 48 (10.6%), and 210 (46.4%), respectively.

The methodological design improved year by year, especially after 2007.

Additionally, methodology of RCTs with ethics approval was clearly superior to those without ethics approval and different among registries.

Conclusions.

The overall methodological design based on registration records of acupuncture RCTs is not very well but improved year by year.

The insufficient information on randomization methods, allocation concealment, and blinding maybe due to the relevant description is not taken seriously in acupuncture RCTs’ registration.