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Objectives: This research aimed to develop a guideline for evaluating safety and performance of electronic warm-acupuncture apparatus. With the development of medical devices like electronic warm-acupuncture apparatus with improved performance, convenience and safety measures compared to traditional warm-acupuncture needling, safety and performance guideline is a necessity.Methods: By referring to existing standards and guidelines of other electronic devices for Korean medicine with heating function, guideline for safety and performance assessment of electronic warm-acupuncture apparatus was draftedResults: The guideline, presents explanation for adequate temperature and settings of the apparatus, and safety measurements providing against thermal runaway situations along with guidelines for the manual. Guideline for detailed test method for the performance of the apparatus such as accuracy of temperature increase and the timer, and safety unit was also provided. The test items and suggested test methods for the requirements of biological, electrical and electromagnetic safety were referred to Korean approval documents of ministry of Food and Drug Safety.Conclusion: We proposed the relevant items to verify performance and safety of warm-acupuncture apparatus to assure patient safety and improve the quality of currently developing devices for application in clinical field.

Scoliosis is a 3-dimensional change of the spine, presenting 10° above Cobb angle. Various acupuncture methods are being increasingly performed to correct scoliosis. However, no systematic review has been published. Therefore, we report on the effectiveness of acupuncture on mild scoliosis in this systematic review. We searched various databases for acupuncture treatment for scoliosis published before June 2021. The primary outcome was Cobb angle, and the secondary outcomes were patient-centered scores. Six studies were identified. RCTs that compared combination therapy with acupuncture, and other treatment methods and showed significant improvement in the Cobb angle, and effective rate, but, with low quality evidence. Acupuncture monotherapy resulted in significant improvement in the Cobb angle and had high heterogeneity compared with other treatment methods, but no significant improvement in the effective rate was observed, and the quality of evidence was low. Regardless of the type of scoliosis, acupuncture monotherapy or combination therapy with acupuncture showed significant improvement in the Cobb angle, and the quality of evidence was moderate. No serious adverse events were observed in the 6 studies reviewed. Acupuncture is considered safe, and it is more effective when performed with other conventional treatments.

Background: Per-oral pharmacological medication is a representative treatment for rheumatoid arthritis (RA), and has improved over several guidelines. However, limitations of long-term use of these medications including adverse events, led to the introduction and utilization of complementary and alternative treatments for RA. Several herbal medicine decoctions have been reported to be effective and safe; a recent study introduced Duantengyimu-tang (DTYMT). Regardless of the pharmacological effects of the DTYMT components, there are concerns about its safety. Therefore, this systematic review (SR) will focus on the effectiveness and safety of DTYMT treatment for RA.Methods: Searches for randomized controlled trials using DTYMT treatment for RA will be performed using multiple electronic databases, manual searches, and emails (if necessary). A summary will be written using data on outcome measurements of the study participants, interventions, adverse events, and risk of bias in the studies. The primary outcomes will be disease activity scores including effective rate, tender joints, swollen joints, and morning stiffness. The secondary outcomes will include adverse events and blood tests for RA (erythrocyte sedimentation rate, C-reactive protein, and rheumatoid factors). This SR will use Review Manager software to perform a meta-analysis, the Cochrane Collaboration “risk of bias” tool, and determine the quality of evidence using the Grades of Recommendation, Assessment, Development, and Evaluation method.Results: This SR will investigate the clinical effectiveness and safety of DTYMT treatment in patients with RA.Conclusion: This SR aims to be informative for patients and clinicians in clinical practice, researchers, and policymakers in managing RA.