title: Quality of randomized controlled trials in acupuncture treatment of hepatitis B virus infection--a systematic review.
abstract: The purpose of this work was to evaluate the quality of randomized controlled trials (RCTs) with acupuncture treatment for hepatitis B virus (HBV) infection. A systematic review of the literature for clinical trials was performed up to September 2008. RCTs assessing acupuncture point stimulation for patients with HBV infection were considered for inclusion. The search identified 70 relevant trials meeting the inclusion. The quality of each trial was assessed using the revised Consolidated Standards for Reporting of Trials (CONSORT) statement, facilitating critical appraisal and interpretation of RCTs by providing guidance to authors; the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) recommendations, acting as an extension of the CONSORT guidelines for the specific requirements of acupuncture studies; and the Jadad scale, widely used in different settings to assess methodological quality. All trials were reported "randomization", but only 2 mentioned the methods. None reported allocation concealment, a method used to keep clinicians and participants unaware of upcoming assignments. None reported blinding. 3 studies described the number of withdrawals/dropouts, while none used the analysis of "intention to treat". The reported items of the STRICTA recommendations were assigned for 65% (13 out of 20). Only 2 studies had a high quality Jadad score. The results from our work show that the quality was low caused by their methodological flaws and inadequate reports. Further rigorous clinical trials for HBV infection would be necessary to evaluate the efficacy of acupuncture.
authors.affiliation: School of Public Health & Family Medicine, Capital Medical University, Beijing, 100069, China. shumei79@126.com
authors.forename: Shumei
authors.initials: S
authors.lastname: Zheng
authors.forename: Juan
authors.initials: J
authors.lastname: Du
authors.forename: Xiaoqin
authors.initials: X
authors.lastname: Lu
authors.forename: Yajun
authors.initials: Y
authors.lastname: Zhang
authors.forename: Lisheng
authors.initials: L
authors.lastname: Hu
authors.forename: Wei
authors.initials: W
authors.lastname: Wang
mesh_terms: D015670:Acupuncture Therapy / Q000592:standards*; D006509:Hepatitis B / Q000628:therapy* / Q000821:virology; D006515:Hepatitis B virus / Q000235:genetics / Q000502:physiology*; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000592:standards*