Perspectives on Integrative Medicine

Protocols

Chinese Herbal Medicine Treatment for Restless Legs Syndrome: A Protocol for a Systematic Review with Meta-Analysis: Yadi Liu, Xiaoqin Wu, Yue Wang, Guoyan Yang, Di Wang, Yoann Birling; Perspect Integr Med. 2026;5(1):65-71. Published online February 11, 2026; DOI: https://doi.org/10.56986/pim.2026.02.010

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Abstract PDF: Background
Restless Legs Syndrome (RLS) significantly impairs sleep and daily life. Conventional treatments often cause side effects leading patients to seek alternative treatments like Chinese Herbal Medicine (CHM). A systematic review and meta-analysis of studies which used CHM treatment for RLS will facilitate the evaluation of its efficacy and safety.
Methods
Randomized controlled trials will be retrieved systematically from electronic databases including PubMed, the Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Wanfang and Chongqing Value-added Information Platform. Comparisons between the effects of CHM (as monotherapy or adjunct therapy), placebos, and conventional interventions will be made. Two reviewers will independently perform study selection, data extraction, and risk of bias assessments using the Cochrane RoB 2.0 tool. The primary outcomes will be RLS symptom severity (e.g., IRLSSG rating scale), quality of life, and adverse events. Data will be pooled using a random-effects meta-analysis, and the overall certainty of evidence will be assessed for quality of evidence and strength of recommendation using the Grading of Recommendations, Assessment, Development, and Evaluation system.
Conclusion
This review aims to synthesize high-quality evidence to determine the effectiveness and safety of CHM treatment for RLS, provide valuable insights for clinicians, patients, and policymakers, and identify gaps for future research.

Protocol for a Scoping Review of Traditional and Complementary Medicine Governance Across Sub-Saharan Africa: Tendayi R. Chihaka, Nadine Ijaz, Ossy M.J. Kasilo, Peter B. James, Daniel F. Gallego Pérez, Jon Wardle, Razak M. Gyasi; Perspect Integr Med. 2024;3(2):123-128. Published online June 21, 2024; DOI: https://doi.org/10.56986/pim.2024.06.008

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Abstract PDF Supplementary Material: Background
Since 1978, the World Health Organization (WHO) has repeatedly called on Member States to recognize the role of traditional and complementary medicine (T&CM) in primary healthcare, improve safety, and accessibility by governing T&CM. In the 2019 Global Report on T&CM, the WHO reported that 40 out of 47 (85%) Member States from African Region had enacted governance policies, and 20 out of 47 (43%) had regulatory policies on herbal medicines. The primary barriers to implementing T&CM policy were identified as an absence of data and inadequate financial support for research. The objective of this protocol was to detail how to perform a scoping review that will examine the policy, legislative, and regulatory landscape for T&CM practitioners and products in sub-Saharan Africa.
Methods
Databases will be searched (AMED, CINAHL Plus with Full Text, MEDLINE Plus with Full text, Web of Science, Scopus, PubMed, Google Scholar) for relevant articles. Searches will be limited to English, French, Portuguese, and Spanish language studies in peer-reviewed journals (1963-2023) that substantively report on legislation, bills, policies, governance approaches and regulations on T&CM (including successes and/or challenges in their design and implementation). Actual legislation, policies, and regulatory documents on T&CM and peer-reviewed studies with emphasis on integrating T&CM and biomedicine into healthcare systems will be excluded.
Expected Outcomes
This protocol has formulated the objectives for a scoping review to identify, map, and synthesize evidence on the governance of T&CM in sub-Saharan Africa.

A Study Protocol for a Multicenter, Pragmatic, Randomized Controlled, Parallel-Grouped Pilot Clinical Trial: Effectiveness of Non-Pharmacological Versus Pharmacological Treatments for Non-Acute Lumbar Disc Herniation: Hui Yan Zhao, Purumea Jun, Chaewon Lee, In-Hyuk Ha, Chang-Hyun Han; Perspect Integr Med. 2023;2(1):59-64. Published online February 21, 2023; DOI: https://doi.org/10.56986/pim.2023.02.009

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Graphical Abstract Abstract PDF Supplementary Material

Background
This study was the development of a protocol for the comparison between the efficacy of non-pharmacological and pharmacological treatment approaches for lumbar disc herniation in a pragmatic environment to obtain real-world based study data.
Methods
The protocol sets out a two-armed, parallel, multicenter pragmatic, randomized-controlled trial (RCT) which will be conducted in four spine specialist hospitals in Korea to determine cost-efficiency.
Results
The study will enroll 36 participants and allocate patients into either the non-pharmacological treatment group or the pharmacological treatment group in a 1:2 ratio. Patients must have evidence of disc-related disease diagnosed using MRI, as well as having lower back pain or radiating leg pain (numeric rating scale score ≥ 5). The treatment will last for 8 weeks with a 26-week follow-up. The primary outcome will be measured using the Oswestry Disability Index score from Week 9. Secondary outcomes related to lower back pain and radiating leg pain will be measured using the scores from the numeric rating scale, the visual analogue scale, the European Quality of Life 5 Dimensions 5 Level Version), the 12-item Short Form Survey, and the patient global impression of change.
Conclusion
This is the first protocol for a pragmatic RCT evaluating the efficacy, safety, and cost-efficiency of non-pharmacological and pharmacological treatment strategies in a clinical setting. Following the basis of this protocol, RCTs may play an important role in establishing guidelines for treating radiating leg pain and lower back pain and provide effective information to clinicians in practical settings.

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Comparative Effectiveness of Non-Pharmacological and Pharmacological Treatments for Non-Acute Lumbar Disc Herniation: A Multicenter, Pragmatic, Randomized Controlled, Parallel-Grouped Pilot Study
Doori Kim, Jee Young Lee, Yoon Jae Lee, Chang Sop Yang, Chang-Hyun Han, In-Hyuk Ha
Journal of Clinical Medicine.2025; 14(4): 1204. CrossRef
Non-Pharmacological and Pharmacological Treatments for Non-Acute Lumbar Disc Herniation: A Protocol for a Multicenter Pragmatic Trial
Doori Kim, Yoon Lee, Changsop Yang, Yong-Jun Ahn, Suna Kim, YeonSun Lee, Hyun-Woo Cho, Chang-Hyun Han, In-Hyuk Ha
Journal of Pain Research.2025; Volume 18: 7167. CrossRef

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