Sung Soo-Hyun, Jang Soobin, Lee Gihyun, Park Jang-Kyung, Lee Sungjoo, Shin Byung-Cheul
Department of Policy Development, National Institute of Korean Medicine Development, Seoul, 04554, South Korea.
Department of Preventive Medicine, College of Korean Medicine, Daegu Haany University, 1 Haanydaero, Gyeongsan-si, Gyeongsangbuk-do, 38610, South Korea.
BMC Complement Med Ther. 2025 Apr 28;25(1):161. doi: 10.1186/s12906-025-04891-1.
An updated systematic review of randomized controlled trials (RCTs) was conducted to evaluate the clinical evidence for the use of BVA for musculoskeletal pain. We searched 13 electronic databases up to December 2024 with no language restrictions. Since 2008, nine RCTs have been additionally identified, so a total of 20 trials were included in our updated review. In a meta-analysis of 2 RCTs, pain was significantly reduced with BVA compared to sham injection of normal saline (10-cm visual analog scale [VAS]; mean difference [MD]: -16.93; 95% confidence interval [CI] = -26.35 to -7.51, P = 0.0004, n = 85; heterogeneity: I = 0%). The meta-analysis of 5 RCTs comparing BVA plus acupuncture to saline injection plus acupuncture showed significant improvements in the 10-cm VAS (MD: -1.24; 95% CI = -1.63 to -0.85, P < 0.00001, n = 152; heterogeneity: I = 16%). No severe side effects such as anaphylaxis were observed in any of the eight trials. BVA appeared to improve musculoskeletal pain conditions compared to sham injections. However, the meta-analysis included only a limited number of RCTs with small sample sizes, and there was considerable clinical heterogeneity in terms of pain types, dosage, and concentration of BVA, which restricts the ability to draw definitive conclusions.
我们进行了一项最新的随机对照试验(RCT)系统评价,以评估使用生物可吸收振动装置(BVA)治疗肌肉骨骼疼痛的临床证据。我们检索了截至2024年12月的13个电子数据库,没有语言限制。自2008年以来,又额外确定了9项RCT,因此在我们的最新评价中总共纳入了20项试验。在对2项RCT的荟萃分析中,与注射生理盐水的假注射相比,BVA显著减轻了疼痛(10厘米视觉模拟量表[VAS];平均差[MD]:-16.93;95%置信区间[CI]=-26.35至-7.51,P = 0.0004,n = 85;异质性:I = 0%)。对5项比较BVA加针灸与生理盐水注射加针灸的RCT进行的荟萃分析显示,10厘米VAS有显著改善(MD:-1.24;95%CI=-1.63至-0.85,P < 0.00001,n = 152;异质性:I = 16%)。在八项试验中的任何一项中均未观察到如过敏反应等严重副作用。与假注射相比,BVA似乎改善了肌肉骨骼疼痛状况。然而,荟萃分析仅纳入了数量有限、样本量较小的RCT,并且在疼痛类型、BVA的剂量和浓度方面存在相当大的临床异质性,这限制了得出明确结论的能力。