Current Research Trends in Randomized Controlled Trials Investigating the Combined Effect of Korean Medicine and Western Medicine Treatment
Dohyung Ha 1, Seoyeon Kim 2, 3, Yong Hyeon Baek 4, Jiyoon Won 2, 3, Seri Nam 5, Jeeyoung Shin 5, Oh-Hoon Kwon 6, Soo-Yeon Kim 7,Hyangsook Lee 2, 3, *
1 Department of Medical Science of Meridian, Graduate School, Kyung Hee University, Seoul, Korea
2 Department of Korean Medical Science, Graduate School, Kyung Hee University, Seoul, Korea
3 Acupuncture and Meridian Science Research Centre, College of Korean Medicine, Kyung Hee University, Seoul, Korea
4 Department of Acupuncture and Moxibustion, Kyung Hee University Hospital at Gangdong, Seoul, Korea
5 Korean Medicine Convergence Research Information Center, Kyung Hee University, Seoul, Korea
6 Haeundae Jaseng Hospital of Korean Medicine, Pusan, Korea
7 Bundang Jaseng Oriental Hospital, Bundang, Korea
*Corresponding author: Hyangsook Lee (E-mail: erc633@khu.ac.kr)
ABSTRACT
This review examined recently published (July 2014 to June 2017), randomized controlled trials (RCTs) which investigated the safety and effectiveness of combined Korean medicine/complementary alternative medicine (CAM) and Western medicine, to indicate the direction for integrative medical practice. The Korean Medicine Convergence Research Information Center evidence-based medicine database (KMCRIC EBM DB) was used to retrieve relevant RCTs indexed in the last 3 years. Study design, country, sample size, disease/condition with the Korean Standard Classification of Diseases code, interventions, direction of outcomes, and adverse events were extracted and summarized. A total of 93 RCTs were included in this review. Acupuncture/moxibustion was the most commonly used intervention (n = 47; 51%), and 19% (n = 18) of the studies treated musculoskeletal disorders, followed by circulatory disorders (n = 16; 17%), and mental and behavioral disorders (n = 9; 10%). Integrative treatment was reported as more effective than monotherapy in approximately 83% of these studies. Adverse events were poorly reported in most studies. This review suggests that integrative treatments are feasible, effective, and safe for various diseases/conditions, based on the evidence from recently published RCTs. Future studies on integrative healthcare are warranted.
©2020 Korean Acupuncture & Moxibustion Medicine Society. This is an open access article under the CC BYNC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Keywords: acupuncture, healthcare, randomized controlled trial
Introduction
Following the amendment of the Medical Law on January 8, 2009, which enabled the consultation between doctors, dentists, and Korean medicine doctors within hospital-level medical institutions from January 31, 2010 (Medical Law Article 43),the proportion of, and needs for combined Korean medicine/complementary alternative medicine (CAM) and Western medicine treatment, has greatly increased [1]. According to a recent government report [2], most Korean patients answered that they strongly support the introduction of combined medical treatment. In addition, the government has been running a pilot project [3] from 2016, which supports an extra medical fee equivalent to 10,000–20,000 Korean Won, for the combined medical treatment.
Nevertheless, there is a widespread negative perception, or bias, in the medical community that combined Korean medicine/CAM and Western medicine treatment is not feasible or practical. According to a survey in 2012 on integrative medical practice [2], most doctors who practice Western medicine in Korea expressed their concern regarding the lack of evidence supporting Korean medicine/CAM treatment, and this was the main obstacle to integrative medical practice.
However, the quantity and quality of studies using combined Korean medicine/CAM and Western medicine treatment leaves much to be desired. Han et al [4] reported that 60% of the 89 Korean clinical research papers that were published on combined medical treatment between 2011 and 2017, were case reports or non-randomized controlled studies (nRCTs). In 93 clinical studies on combined medical treatment, the interventions were limited by inadequate communication between clinical practice physicians administering oral medications and Korean medicine doctors.
This study aimed to review and evaluate the evidence for the safety and effectiveness of combined Korean medicine/CAM and Western medicine from recently published RCTs, to inform integrative medical practice.
Materials and Methods
Data source and searching process
The Korean Medicine Convergence Research Information Center evidence-based medicine database (KMCRIC EBM DB) was used to search for all RCTs indexed in the last 3 years from July 2014 to June 2017. The KMCRIC EBM DB [5] is a Korean governmentfunded database, listing only RCTs and systematic reviews (SRs) on Korean medicine/CAM interventions. The database is regularly updated using PubMed, the Database of Abstracts of Reviews of Effects (DARE), and the Oriental Medicine Advanced Searching Integrated System (OASIS) [6].
Eligibility criteria and study selection
Only RCTs that compared the combined treatment effect for any disease/condition for Korean medicine/CAM and Western medicine interventions, against Western medicine treatment alone, were included. CAM modalities followed the definition established by the National Center for Complementary and Integrative Health [7,8]. If the study did not explicitly state the details of Western medicine treatment and used the term “usual care”, “standard therapy”, or “conventional therapy”, it was excluded.
Data extraction
Each included article was read in full, and the following information was extracted from each study: first author, year of publication, study design, study location (country), sample size, disease/condition, interventions, the direction of outcomes, and adverse events (AEs). The study design was classified as parallel, crossover, or factorial design, and countries were grouped as Australasia, Europe, North America, Africa, or South America. The disease/condition of the included studies was classified using the Korean Standard Classification of Diseases (KCD)-7, and when 2 or more KCD codes could be designated the code considered closer to the main purpose of the study, was assigned. Details of both Korean medicine/CAM and Western interventions were also extracted and tabulated. An outcome was judged as “effective” when combined treatment was statistically significantly more effective than Western medicine treatment alone. For AEs, the reporting rate, frequency, and type were extracted.
Data analysis
All extracted data were tabulated in Microsoft Excel (Microsoft Corporation, Redmond, WA, USA). For descriptive statistics, categorical variables were presented as frequencies and percentages, and continuous variables were presented as mean ± SD or median with interquartile ranges. No statistical pooling was conducted in evaluating the effectiveness of the interventions, as the included trials were too highly heterogeneous to draw any informative and meaningful conclusions.
Results
Of the 1,868 RCTs retrieved, 1,596 did not involve a combination of Korean medicine/CAM and Western medicine interventions and therefore were excluded. Of the remaining 272 studies, 179 were excluded due to no specific mention of the type of intervention (n = 64), 114 studies were excluded if Korean medicine/CAM interventions were used as adjuncts to treatment to minimize the AEs associated with Western medicine treatment, and 1 study did not have a KCD code designation (n = 1), as in the case of acupuncture anesthesia for abdominal surgery. Therefore, there were 93 studies that fulfilled the inclusion criteria and were included in the final analysis for this review (Fig. 1).
Fig. 1. Study selection flow chart.
CAM, complementary alternative medicine; KCD, Korean Standard Classification of Diseases; KMCRIC, Korean Medicine Convergence Research Information Center; RCT, randomized controlled study.
Demographic characteristics of the included studies Among the 93 included RCTs, 90 adopted a parallel design, and 3 had a factorial design. The number of participants per study ranged from 10 to 336, with a median of 68 participants. Of the 93 included studies, 68 studies were conducted in Australasia (73%), 13 in Europe (14%), 6 in Africa (7%), 5 in North America (5%), and 1 in South America (1%). The studies were conducted in 21 countries, and 1 was conducted jointly in South Africa and the US. The types of diseases/conditions were classified based on the KCD codes, and varied greatly across trials (Table 1).
Table 1. Demographic Characteristics of the Studies Included in This Review (n = 93).
