So Yun Kim

Quality Assessment of Randomized Controlled Trials of Moxibustion Using STandards for Reporting Interventions in Clinical Trials of Moxibustion (STRICTOM) and Risk of Bias (ROB)

OBJECTIVES To assess the quality and completeness of published reports of randomized controlled trials (RCTs) of moxibustion. METHOD We searched six databases to retrieve eligible RCTs of moxibustion published from 2000 to December 2015. We used the STandards for Reporting Interventions in Clinical Trials of Moxibustion (STRICTOM) and Risk of Bias (ROB) tool to assess the completeness of reporting of RCTs of moxibustion and evaluate the reporting quality of included RCTs. RESULTS Thirty-four studies of moxibustion were analyzed using STRICTOM and ROB. Of the 34 studies, the completeness percentage of STRICTOM varied from 33% to 100% (mean 68%, median 67%). The completeness of STRICTOM items showed a rising tendency along with the publication year. The STRICTOM items of setting and context (14.7%), rationale for the control (17.6%), and response (26.4%) showed incomplete reporting. The number of RCTs that rated a low risk of bias for allocation concealment (n=6), blinding of participants and personnel (n=1), and blinding of outcome assessment (n=4) appeared to be small. CONCLUSION The quality of reporting of RCTs of moxibustion remains incomplete according to the STRICTOM and ROB tool at present. Researchers should consider the STRICTOM and ROB for improving not only the completeness of reporting but also the study design. General guidelines for RCTs of moxibustion are also required.

Effectiveness and safety of acupotomy for lumbar disc herniation: a study protocol for a randomized, assessor-blinded, controlled pilot trial

Background Acupotomy aims to reduce pressure on the nerve, improve surrounding blood circulation, and recover the kinetic state of soft tissue in treating lumbar disc herniation. Although several previous studies have suggested the potential use and substantial benefits of acupotomy, there is still insufficient evidence regarding this technique. This trial is designed to determine if acupotomy is more effective than manual acupuncture in improving low back pain and/or leg pain, disability, lumbar mobility, and quality of life in patients with herniated lumbar disc. Methods Fifty eligible patients will be randomly assigned to an acupotomy group or a manual acupuncture group in a 1:1 ratio. The experimental group will receive acupotomy at the affected side’s inner core muscles and soft tissue at the level of the herniated disc where tenderness appears (twice per week for 2 weeks). The control group will receive manual acupuncture (thrice per week for 2 weeks) at GV3 (Yaoyangguan) and the bilateral BL23 (Shenshu), BL24 (Qihaishu), BL25 (Dachangshu), and BL26 (guanyuanshu) for local points and the bilateral GB30 (Huantio), BL40 (Weizhong), and BL60 (Kunlun) for distant points. The primary outcome will be the mean change in the visual analog scale from baseline to 4 weeks (2 weeks after final treatment). The Oswestry Disability Index, Modified-Modified Schober Test, and EuroQol five dimensions questionnaire will determine secondary outcomes. Adverse events will be evaluated at every visit. Discussion This study will provide valuable data and insights for a confirmative, full-scale randomized controlled trial to determine the clinical effects of acupotomy.

Effectiveness and Safety of Acupotomy for Lumbar Disc Herniation: A Randomized, Assessor-Blinded, Controlled Pilot Study

Objective Patients with lumbar disc herniation (LDH) suffer from pain, physical disabilities, and low quality of life. This study was designed to evaluate the effectiveness and safety of acupotomy in patients with LDH. Method Fifty participants with LDH were recruited to this randomized, assessor-blinded, controlled study and randomly assigned to the acupotomy (n = 25) or manual acupuncture (n = 25) group. The acupotomy group received acupotomy four times in 2 weeks, while the manual acupuncture group received manual acupuncture six times in 2 weeks. The follow-up visit was planned in the 4th week (i.e., 2 weeks after the final intervention). The primary outcome was the change in the Visual Analogue Scale (VAS) at follow-up. The changes in the Oswestry Disability Index (ODI), Modified-Modified Schober Test (MMST), and EuroQol Five Dimensions (EQ-5D) questionnaire were also evaluated. An intention-to-treat analysis was applied and adverse events were recorded. Results The acupotomy group showed significant changes in VAS, ODI, and EQ-5D after intervention. VAS and ODI in the 4th week were lower in the acupotomy than in the manual acupuncture group. The acupotomy group showed consistent changes in VAS and ODI in the 1st, 2nd, and 4th week. No serious adverse event was reported in the acupotomy group. Conclusion This study suggests greater therapeutic effects of acupotomy on relieving pain and improving the functional disability associated with LDH than those observed with manual acupuncture.