Association of Trial Registration with Reporting Biases in Randomized Controlled Trials of Acupuncture
침 무작위 대조 임상 시험에서 보고 비뚤림과 프로토콜 등록 여부의 관련성 연구
Seoyeon Kim1,2 
, Jiyoon Won1,2 , Hi-Joon Park1,2 , Hyangsook Lee1,2
김서연1,2ㆍ원지윤1,2ㆍ박히준1,2ㆍ이향숙1,2
, Jiyoon Won1,2 , Hi-Joon Park1,2 , Hyangsook Lee1,2 김서연1,2ㆍ원지윤1,2ㆍ박히준1,2ㆍ이향숙1,2
1경희대학교 대학원 기초한의과학과, 2경희대학교 침구경락융합연구센터
1Department of Korean Medical Science, Graduate School, Kyung Hee University, 2Acupuncture & Meridian Science Research Centre, College of Korean Medicine, Kyung Hee University
1Department of Korean Medical Science, Graduate School, Kyung Hee University, 2Acupuncture & Meridian Science Research Centre, College of Korean Medicine, Kyung Hee University
Correspondence to: Hyangsook Lee
Acupuncture and Meridian Science Research Centre, College of Korean Medicine, Kyung Hee University, 26 Kyung Hee Dae-ro, Dongdaemun-gu, Seoul 02447, Korea
Tel: +82-2-961-0703, Fax: +82-2-963-2175, E-mail: erc633@khu.ac.kr
Acupuncture and Meridian Science Research Centre, College of Korean Medicine, Kyung Hee University, 26 Kyung Hee Dae-ro, Dongdaemun-gu, Seoul 02447, Korea
Tel: +82-2-961-0703, Fax: +82-2-963-2175, E-mail: erc633@khu.ac.kr
Received April 13, 2018; Revised May 12, 2018; Accepted May 21, 2018.
This is an open access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
- Abstract
Objectives : To investigate the association of trial registration status with presence of reporting bias including publication bias and outcome reporting bias in recently published randomized controlled trials (RCTs) of acupuncture.Methods : A PubMed search for RCTs of acupuncture published from March 2016 to February 2017 was conducted. Primary outcomes were identified and the direction of the results was judged as positive (i.e., statistically significant) or negative. The trial registration was identified by manually screening the trial registration number in the main text of the published article and classified into 1) prospective registration; 2) retrospective registration based on the registration date or; 3) no registration.Results : Of the 125 included RCTs, only 40 studies (32.0%) prospectively registered the study protocols. Among 65 RCTs that adequately reported the primary outcome, unregistered trials were more likely to report positive results than the registered ones (p=0.013). Of the 40 prospectively registered studies, 19 trials (47.5%) had the discrepancies between the registered and published primary outcomes and furthermore, 40% of them reported the positive findings.Conclusions : Unregistered trials were more likely to report positive results and the discrepancies between the registered and published primary outcomes were detected in about a half of the prospectively registered studies, 42.1% of which tended to report positive findings. Journal editors and researchers in this field should be alerted to various reporting biases.- Keywords: reporting bias, publication bias, trial registration, outcome reporting bias, acupuncture
- June 2018, 35 (2)
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