Li Wenxiong, Liu Zhu, Liu Li, Yang Feng, Li Wenxiong, Zhang Kuaiqiang, Liu Zhu, Cheng Yan, Yin Jichao, Sun Yindi
Institute of Orthopedics, Shaanxi University of Traditional Chinese Medicine, Xi?an 712000, China.
Department of Orthopedics, Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine, Xi?an 712083, China.
J Tradit Chin Med. 2018 Feb;38(1):33-42.
To evaluate the effect and safety of Zuogui pill and Yougui pill, classic Yin and Yang tonic formula (CYYTF), in the treatment of osteoporosis and the underlying mechanism.
Participants aged 55 to 75 with osteoporosis and Kidney deficiency in Traditional Chinese Medicine (TCM) will be included and randomly allocated into two groups: treatment group and control group. Participants in the treatment group were treated with Zuogui pill or Yougui pill TCM formula granule, while the control group received placebo. Primary outcomes are the lumbar spine on bone mineral density (BMD) (L1-4) and femoral BMD. Secondary outcomes include pain intensity, health-related quality of life (HRQoL), bone turnover markers and safety.
Totally 200 patients were enrolled from December 2014 to April 2016 from four hospitals. There were no statistically significant differences between the two groups at baseline (P > 0.05) and it was good to comparability. Statistically significant differences between the two groups were observed for the lumbar BMD (L1-4), pain VAS scores and HRQoL at six months and twelve months and femoral BMD at twelve months (P < 0.05), but no significant differences for femoral BMD and bone turnover markers at six months (P > 0.05). Moreover, significant difference was observed at different time before and after treatment in terms of lumbar spine (L1-4) BMD, femoral BMD, pain VAS scores and health-related quality of life, and there was an crossover effect between the time and groups before and after treatment. In additional, in the treatment group, 8 patients lost to follow-up and 3 patients had adverse events (AEs) and in the control group, 10 patients lost to follow-up and 2 patients had AEs. No remarkable differences were observed between the two groups with regard to AEs, lost rate and safety (P > 0.05).
Zuogui pill or Yougui pill could improve BMD, ease pain, relieve Kidney deficiency syndrome, improve the quality of life osteoporosis patients, inhibit bone conversion and regulate the coupling balance of bone formation and bone resorption, but long-term efficacy should be confirmed by a longer term follow-up and larger of samples clinical randomized controlled trials.
评价经典阴阳双补方剂左归丸和右归丸治疗骨质疏松症的疗效及安全性，并探讨其潜在机制。
纳入年龄在55至75岁之间、患有骨质疏松症且中医辨证为肾虚的参与者，随机分为两组：治疗组和对照组。治疗组参与者服用左归丸或右归丸中药配方颗粒，而对照组接受安慰剂。主要结局指标为腰椎骨密度（L1-4）和股骨骨密度。次要结局指标包括疼痛强度、健康相关生活质量（HRQoL）、骨转换标志物和安全性。
2014年12月至2016年4月期间，从四家医院共招募了200名患者。两组在基线时无统计学显著差异（P>0.05），具有良好的可比性。在6个月和12个月时，两组在腰椎骨密度（L1-4）、疼痛视觉模拟评分（VAS）和HRQoL方面以及在12个月时股骨骨密度方面存在统计学显著差异（P<0.05），但在6个月时股骨骨密度和骨转换标志物方面无显著差异（P>0.05）。此外，治疗前后不同时间点在腰椎（L1-4）骨密度、股骨骨密度、疼痛VAS评分和健康相关生活质量方面存在显著差异，且治疗前后时间和组间存在交互作用。另外，治疗组有8例患者失访，3例患者发生不良事件（AE）；对照组有10例患者失访，2例患者发生AE。两组在AE、失访率和安全性方面无显著差异（P>0.05）。
左归丸或右归丸可提高骨密度、缓解疼痛、改善肾虚症状、提高骨质疏松症患者的生活质量、抑制骨转换并调节骨形成与骨吸收的偶联平衡，但长期疗效有待通过更长时间的随访和更大样本量的临床随机对照试验来证实。
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