The First School of Clinical Medicine (Dongzhimen Hospital), Beijing University of Chinese Medicine, Beijing, China.
The Second School of Clinical Medicine (Dongfang Hospital), Beijing University of Chinese Medicine, Beijing, China.
Front Endocrinol (Lausanne). 2022 Apr 7;13:870277. doi: 10.3389/fendo.2022.870277. eCollection 2022.
To assess the benefit and harm of Chinese medicine Xianling Gubao (XLGB) capsule compared to conventional medication or placebo to inform clinical practice.
We included randomized controlled trials (RCTs) with Jadad score ≥3 of XLGB capsule compared to pharmaceutical medication, placebo, or no treatment for primary osteoporosis. We conducted searches in EMBASE, Cochrane CENTRAL, MEDLINE, China National Knowledge Infrastructure, VIP, Wanfang, and Chinese Biomedical Literature Database (Sino-Med) from their inception till November 13, 2021. Study selection and data extraction were done by two authors independently. The methodological quality of the RCTs was assessed using Cochrane's risk of bias tool. The effect size was presented as risk ratio (RR) or mean difference (MD) with their 95% confidence interval (CI).
Our searches identified 2292 records and after exclusions, eight trials involving 846 participants were included. There was no statistically significant difference between conventional medications with or without XLGB on new fracture (RR: 0.50, 95% CI: [0.13, 1.87]). Quality of life by SF-36 questionnaire of XLGB plus calcium carbonate, vitamin D, and calcitriol was improved than that of without XLGB (MD: 6.72 scores, 95% CI: [2.82, 10.62]). XLGB increased bone mineral density similarly as calcium carbonate plus vitamin D (MD: 0.21, 95% CI: [-0.16, 0.58]) or as alendronate sodium, calcium carbonate plus vitamin D (MD: 0.00, 95% CI: [-0.10, 0.10]), but it had no additional effect as an add-on treatment to conventional medications (MD: 0.13, 95% CI: [-0.12, 0.37]). XLGB relieved pain visual analog scale more effectively when combined with medications (MD: -1.55 score, 95% CI: [-2.47, -0.63]). XLGB as monotherapy did not increase adverse events (RR: 0.63, 95% CI: [0.28, 1.41]), or as an add-on treatment (RR: 0.25, 95% CI: [0.03, 2.16]).
This systematic review shows that XLGB capsule appears to be safe and has a beneficial effect on the quality of life and pain relief when used alone or in combination with conventional medications in osteoporosis patients. Further large, rigorous trials are warranted to test its long-term benefit.
评估中药仙灵骨葆胶囊与常规药物或安慰剂相比在治疗原发性骨质疏松症方面的益处和危害，为临床实践提供参考。
我们纳入了仙灵骨葆胶囊与药物治疗、安慰剂或不治疗原发性骨质疏松症的随机对照试验（RCT），且 Jadad 评分≥3 分。我们检索了 EMBASE、Cochrane 中央对照试验注册库、MEDLINE、中国知网、维普、万方和中国生物医学文献数据库（SinoMed），检索时间截至 2021 年 11 月 13 日。两名作者独立进行研究选择和数据提取。使用 Cochrane 偏倚风险工具评估 RCT 的方法学质量。效应大小以风险比（RR）或均数差（MD）及其 95%置信区间（CI）表示。
我们的检索共识别出 2292 条记录，排除后，纳入了 8 项涉及 846 名参与者的试验。与常规药物加或不加仙灵骨葆胶囊相比，新骨折发生率无统计学差异（RR：0.50，95%CI：[0.13，1.87]）。仙灵骨葆胶囊联合碳酸钙、维生素 D 和骨化三醇治疗的 SF-36 问卷生活质量评分改善优于无仙灵骨葆胶囊组（MD：6.72 分，95%CI：[2.82，10.62]）。仙灵骨葆胶囊增加骨密度的效果与碳酸钙加维生素 D 相似（MD：0.21，95%CI：[-0.16，0.58]）或与阿仑膦酸钠、碳酸钙加维生素 D 相似（MD：0.00，95%CI：[-0.10，0.10]），但作为常规药物的附加治疗并无额外效果（MD：0.13，95%CI：[-0.12，0.37]）。仙灵骨葆胶囊联合药物治疗时更有效地缓解疼痛视觉模拟评分（MD：-1.55 分，95%CI：[-2.47，-0.63]）。仙灵骨葆胶囊作为单一疗法不会增加不良反应（RR：0.63，95%CI：[0.28，1.41]），或作为附加治疗（RR：0.25，95%CI：[0.03，2.16]）。
本系统评价表明，仙灵骨葆胶囊在治疗骨质疏松症患者时，单独使用或与常规药物联合使用，似乎安全且对生活质量和疼痛缓解有益。需要进一步开展大型、严格的试验来检验其长期疗效。
