Dropouts in randomized clinical trials of Korean medicine interventions: a systematic review and meta-analysis

Abstract Background The dropout rate is an important determinant of outcomes in randomized controlled trials (RCTs) and should be carefully controlled. This study explored the current dropout rate in studies of Korean medicine (KM) interventions by systematic evaluation of RCTs conducted in the past...

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Main Authors: Sae-rom Jeon, Dongwoo Nam, Tae-Hun Kim
Format: Article
Language:English
Published: BMC 2021-03-01
Series:Trials
Subjects:
Online Access:https://doi.org/10.1186/s13063-021-05114-x
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spelling doaj-9987c532dc344dbbaecfab99559874b62021-03-11T12:09:59ZengBMCTrials1745-62152021-03-0122111210.1186/s13063-021-05114-xDropouts in randomized clinical trials of Korean medicine interventions: a systematic review and meta-analysisSae-rom Jeon0Dongwoo Nam1Tae-Hun Kim2Department of Clinical Korean Medicine, Graduate School, Kyung Hee UniversityDepartment of Clinical Korean Medicine, Graduate School, Kyung Hee UniversityDepartment of Clinical Korean Medicine, Graduate School, Kyung Hee UniversityAbstract Background The dropout rate is an important determinant of outcomes in randomized controlled trials (RCTs) and should be carefully controlled. This study explored the current dropout rate in studies of Korean medicine (KM) interventions by systematic evaluation of RCTs conducted in the past 10 years. Methods Three clinical trial registries (Clinical Research Information Service, ClinicalTrials.gov, and World Health Organization International Clinical Trials Registry Platform) were searched to identify RCT protocols for KM interventions, such as acupuncture, herbal medicine, moxibustion, or cupping, and studies of mixed interventions, registered in Korea from 2009 to 2019. The PubMed, Embase, and OASIS databases were searched for the full reports of these RCTs, including published journal articles and theses. Dropout rates and the reasons for dropping out were analyzed in each report. The risk of bias in each of the included studies was assessed using the Cochrane risk of bias tool. The risk difference for dropping out between the treatment and control groups was calculated with the 95% confidence interval in a random effects model. Results Forty-nine published studies were included in the review. The median dropout rate was 10% in the treatment group (interquartile range 6.7%, 17.0%) and 14% in the control group (interquartile range 5.4%, 16.3%) and was highest in acupuncture studies (12%), followed by herbal medicine (10%), moxibustion (8%), and cupping (7%). Loss to follow-up was the most common reason for dropping out. The risk difference for dropping out between the intervention and control groups was estimated to be 0.01 (95% confidence interval − 0.02, 0.03) in KM intervention studies. Conclusions This review found no significant difference in the dropout rate between studies according to the type of KM intervention. We recommend allowance for a minimum dropout rate of 15% in future RCTs of KM interventions. Review protocol registration PROSPERO CRD42020141011https://doi.org/10.1186/s13063-021-05114-xRandomized clinical trialsDropoutsKorean medicineAcupunctureHerbal medicineSystematic review
collection DOAJ
language English
format Article
sources DOAJ
author Sae-rom Jeon
Dongwoo Nam
Tae-Hun Kim
spellingShingle Sae-rom Jeon
Dongwoo Nam
Tae-Hun Kim
Dropouts in randomized clinical trials of Korean medicine interventions: a systematic review and meta-analysis
Trials
Randomized clinical trials
Dropouts
Korean medicine
Acupuncture
Herbal medicine
Systematic review
author_facet Sae-rom Jeon
Dongwoo Nam
Tae-Hun Kim
author_sort Sae-rom Jeon
title Dropouts in randomized clinical trials of Korean medicine interventions: a systematic review and meta-analysis
title_short Dropouts in randomized clinical trials of Korean medicine interventions: a systematic review and meta-analysis
title_full Dropouts in randomized clinical trials of Korean medicine interventions: a systematic review and meta-analysis
title_fullStr Dropouts in randomized clinical trials of Korean medicine interventions: a systematic review and meta-analysis
title_full_unstemmed Dropouts in randomized clinical trials of Korean medicine interventions: a systematic review and meta-analysis
title_sort dropouts in randomized clinical trials of korean medicine interventions: a systematic review and meta-analysis
publisher BMC
series Trials
issn 1745-6215
publishDate 2021-03-01
description Abstract Background The dropout rate is an important determinant of outcomes in randomized controlled trials (RCTs) and should be carefully controlled. This study explored the current dropout rate in studies of Korean medicine (KM) interventions by systematic evaluation of RCTs conducted in the past 10 years. Methods Three clinical trial registries (Clinical Research Information Service, ClinicalTrials.gov, and World Health Organization International Clinical Trials Registry Platform) were searched to identify RCT protocols for KM interventions, such as acupuncture, herbal medicine, moxibustion, or cupping, and studies of mixed interventions, registered in Korea from 2009 to 2019. The PubMed, Embase, and OASIS databases were searched for the full reports of these RCTs, including published journal articles and theses. Dropout rates and the reasons for dropping out were analyzed in each report. The risk of bias in each of the included studies was assessed using the Cochrane risk of bias tool. The risk difference for dropping out between the treatment and control groups was calculated with the 95% confidence interval in a random effects model. Results Forty-nine published studies were included in the review. The median dropout rate was 10% in the treatment group (interquartile range 6.7%, 17.0%) and 14% in the control group (interquartile range 5.4%, 16.3%) and was highest in acupuncture studies (12%), followed by herbal medicine (10%), moxibustion (8%), and cupping (7%). Loss to follow-up was the most common reason for dropping out. The risk difference for dropping out between the intervention and control groups was estimated to be 0.01 (95% confidence interval − 0.02, 0.03) in KM intervention studies. Conclusions This review found no significant difference in the dropout rate between studies according to the type of KM intervention. We recommend allowance for a minimum dropout rate of 15% in future RCTs of KM interventions. Review protocol registration PROSPERO CRD42020141011
topic Randomized clinical trials
Dropouts
Korean medicine
Acupuncture
Herbal medicine
Systematic review
url https://doi.org/10.1186/s13063-021-05114-x
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