Sun Chuanrui, Sun Kai, Wang Shangquan, Wang Yanguo, Yuan Puwei, Li Zhenhua, Yang Shaofeng, Zhang Jianhua, Jia Yusong, Wang Wei, Qi Baoyu, Yang Bowen, Liu Jianping, Wei Xu, Zhu Liguo
Wang Jing Hospital, China Academy of Chinese Medical Sciences, Beijing, 100102, China.
Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300250, China.
Phytomedicine. 2024 Jan;122:155138. doi: 10.1016/j.phymed.2023.155138. Epub 2023 Oct 20.
Baimai ointment is a traditional Tibetan topical ointment, which is widely used for various diseases related to the skeletal muscular system and neurological rehabilitation. It has demonstrated good clinical effectiveness. However, there is currently a lack of high-quality evidence regarding the clinical effectiveness of Baimai ointment in treating lumbar disc herniation (LDH).
In this study, we conducted a prospective, multicenter, double-blind, randomized controlled trial at eight hospitals in China to investigate the clinical effectiveness of Baimai ointment in the treatment of LDH.
Participants aged 18-65 years were diagnosed as LDH and were randomly assigned to receive either Baimai ointment or placebo. The treatment duration was 2 weeks, with 1-week follow-up after treatment. The primary outcome measures included VAS and JOA score. The secondary outcome measures included Likert scale, compliance with health education and the incidence of rescue therapy. The intervention effects on these outcomes were examined by generalized estimating equations (GEE) with baseline measurement as the covariates. All statistical analysis were performed using SPSS 25.0 and Python 3.11.
In total, 228 participants were screened from August 25, 2021 to January 31, 2022 at 8 Grade-A tertiary hospitals in China. Finally, 194 eligible participants were randomly assigned to the Baimai ointment group and placebo group in a 1:1 ratio. At the end of 2-week treatment (14th day) and 1-week follow-up after treatment (21st day), the decrease of VAS reached 39.57% (95% CI: 34.29, 44.86) and 36.85% (95% CI: 32.04, 41.66), the decrease in JOA score reached 27.74% (95% CI: 23.05, 32.43) and 26.25 % (95% CI: 20.82, 31.69) in Baimai ointment group. A significant group-by-time interaction indicated a difference for VAS between intervention over time (χ = 26.81, p = 0.020), but JOA score and Likert scale did not reach statistical significance. The adjusted net difference of VAS was statistically significant from 10th day of treatment (p < 0.05). After 2-week treatment, the relief rate of VAS was 30.85% (21.95, 41.34) in Baimai ointment group and 22.73% (14.75, 33.13) in placebo group (χ = 1.53, p = 0.217). It demonstrated Baimai ointment in improving VAS and JOA score was valuable from a clinical view by measuring MCID. Moreover, the Likert scale, the incidence of rescue therapy and compliance with health education did not reach statistical significance. There was no evidence showing that Baimai ointment could cause serious adverse reactions in treating patients with LDH.
Baimai ointment demonstrated significantly higher rates of symptom relief compared to the placebo for LDH patients, particularly in terms of relieving pain. Moreover, further high-quality randomized controlled trials were necessary to confirm these positive results. The study protocol is registered with the Clinical Trials Registry (registration number: ISRCTN11912818).
白脉软膏是一种传统藏药外用膏剂，广泛用于治疗各种与骨骼肌肉系统相关的疾病及神经康复，已显示出良好的临床疗效。然而，目前缺乏关于白脉软膏治疗腰椎间盘突出症（LDH）临床疗效的高质量证据。
本研究在中国8家医院进行了一项前瞻性、多中心、双盲、随机对照试验，以探讨白脉软膏治疗LDH的临床疗效。
年龄在18 - 65岁被诊断为LDH的参与者被随机分配接受白脉软膏或安慰剂。治疗期为2周，治疗后随访1周。主要结局指标包括视觉模拟评分法（VAS）和日本骨科学会（JOA）评分。次要结局指标包括李克特量表、健康教育依从性和急救治疗发生率。采用广义估计方程（GEE）并以基线测量作为协变量来检验这些结局的干预效果。所有统计分析均使用SPSS 25.0和Python 3.11进行。
2021年8月25日至2022年1月31日期间，在中国8家三级甲等医院共筛选出228名参与者。最终，194名符合条件的参与者以1:1的比例随机分配至白脉软膏组和安慰剂组。在2周治疗结束（第14天）和治疗后1周随访（第21天）时，白脉软膏组VAS评分下降幅度分别达到39.57%（95%CI：34.29，44.86）和36.85%（95%CI：32.04，41.），JOA评分下降幅度分别达到27.74%（95%CI：23.05，32.43）和26.25%（95%CI：20.82，31.69）。显著的组×时间交互作用表明干预随时间推移在VAS方面存在差异（χ² = 26.81，p = 0.020），但JOA评分和李克特量表未达到统计学意义。从治疗第10天起，VAS的调整净差异具有统计学意义（p < 0.05）。2周治疗后，白脉软膏组VAS缓解率为30.85%（21.95，41.34），安慰剂组为22.73%（14.75，33.13）（χ² = 1.53，p = 0.217）。通过测量最小临床重要差异（MCID）表明，从临床角度来看，白脉软膏在改善VAS和JOA评分方面具有价值。此外，李克特量表、急救治疗发生率和健康教育依从性未达到统计学意义。没有证据表明白脉软膏在治疗LDH患者时会引起严重不良反应。
与安慰剂相比，白脉软膏在缓解LDH患者症状方面显示出显著更高的比率，尤其是在缓解疼痛方面。此外，需要进一步的高质量随机对照试验来证实这些阳性结果。本研究方案已在临床试验注册中心注册（注册号：ISRCTN11912818）。
