Liu Yunxia, Liu Jian Ping, Xia Yun
Department of Epidemiology and Biostatistics, School of Public Health, Shandong University, 44 Wenhua Xilu Road, Jinan, China, 250012.
Cochrane Database Syst Rev. 2014 Mar 6;2014(3):CD005467. doi: 10.1002/14651858.CD005467.pub2.
Chinese herbal medicines have been used for a long time to treat osteoporosis. The evidence of their benefits and harms needs to be systematically reviewed.
To assess the beneficial and harmful effects of Chinese herbal medicines as a general experimental intervention for treating primary osteoporosis by comparing herbal treatments with placebo, no intervention and conventional medicine.
We searched the following electronic databases to January 2013: the Specialised Register of the Cochrane Complementary Medicine Field, CENTRAL, MEDLINE, EMBASE, LILACS, JICST-E, AMED, Chinese Biomedical Database and CINAHL.
Randomised controlled trials of Chinese herbal medicines compared with placebo, no intervention or conventional medicine were included.
Two authors extracted data and assessed risk of bias independently. Disagreement was resolved by discussion.
One hundred and eight randomised trials involving 10,655 participants were included. Ninety-nine different Chinese herbal medicines were tested and compared with placebo (three trials), no intervention (five trials) or conventional medicine (61 trials), or Chinese herbal medicines plus western medicine were compared with western medicine (47 trials). The risk of bias across all studies was unclear for most domains primarily due to inadequate reporting of study design. Although we rated the risk of selective reporting for all studies as unclear, only a few studies contributed numerical data to the key outcomes.Seven trials reported fracture incidence, but they were small in sample size, suffered from various biases and tested different Chinese herbal medicines. These trials compared Kanggusong capsules versus placebo, Kanggusong granule versus Caltrate or ipriflavone plus Caltrate, Yigu capsule plus calcium versus placebo plus calcium, Xianlinggubao capsule plus Caltrate versus placebo plus Caltrate, Bushen Zhuanggu granules plus Caltrate versus placebo granules plus Caltrate, Kanggusong soup plus Caltrate versus Caltrate, Zhuangguqiangjin tablets and Shujinbogu tablets plus calcitonin ampoule versus calcitonin ampoule. The results were inconsistent.One trial showed that Bushenhuoxue therapy plus calcium carbonate tablets and alfacalcidol had a better effect on quality of life score (scale 0 to 100, higher is better) than calcium carbonate tablets and alfacalcidol (mean difference (MD) 5.30; 95% confidence interval (CI) 3.67 to 6.93).Compared with placebo in three separate trials, Chinese herbal medicines (Migu decoction, Bushen Yigu soft extract, Kanggusong capsules) showed a statistically significant increase in bone mineral density (BMD) (e.g. Kanggusong capsules, MD 0.06 g/cm(3); 95% CI 0.02 to 0.10). Compared with no intervention in five trials, only two showed that Chinese herbal medicines had a statistically significant effect on increase in BMD (e.g. Shigu yin, MD 0.08 g/cm(3); 95% CI 0.03 to 0.13). Compared with conventional medicine in 61 trials, 23 showed that Chinese herbal medicines had a statistically significant effect on increase in BMD. In 48 trials evaluating Chinese herbal medicines plus western medication against western medication, 26 showed better effects of the combination therapy on increase in BMD.No trial reported death or serious adverse events of Chinese herbal medicines, while some trials reported minor adverse effects such as nausea, diarrhoea, etc.
AUTHORS' CONCLUSIONS: Current findings suggest that the beneficial effect of Chinese herbal medicines in improving BMD is still uncertain and more rigorous studies are warranted.
中草药用于治疗骨质疏松症已有很长时间。其利弊证据需要进行系统评价。
通过将草药治疗与安慰剂、无干预措施及传统药物进行比较,评估中草药作为治疗原发性骨质疏松症的一般实验性干预措施的有益和有害作用。
我们检索了以下电子数据库至2013年1月:Cochrane补充医学领域专业注册库、Cochrane系统评价数据库、医学期刊数据库、荷兰医学文摘数据库、拉丁美洲和加勒比地区卫生科学数据库、日本科学技术振兴机构科学技术信息聚合数据库、澳大利亚和新西兰补充医学数据库、中国生物医学数据库及护理学与健康领域数据库。
纳入将中草药与安慰剂、无干预措施或传统药物进行比较的随机对照试验。
两名作者独立提取数据并评估偏倚风险。通过讨论解决分歧。
纳入了108项随机试验,涉及10655名参与者。测试了99种不同的中草药,并与安慰剂(3项试验)、无干预措施(5项试验)或传统药物(61项试验)进行比较,或将中草药加西药与西药进行比较(47项试验)。由于研究设计报告不充分,大多数领域所有研究的偏倚风险尚不清楚。尽管我们将所有研究的选择性报告偏倚风险评为不清楚,但只有少数研究提供了关键结局的数值数据。7项试验报告了骨折发生率,但样本量小,存在各种偏倚,且测试的是不同的中草药。这些试验比较了抗骨松胶囊与安慰剂、抗骨松颗粒与钙尔奇或依普黄酮加钙尔奇、益骨胶囊加钙剂与安慰剂加钙剂、仙灵骨葆胶囊加钙尔奇与安慰剂加钙尔奇、补肾壮骨颗粒加钙尔奇与安慰剂颗粒加钙尔奇、抗骨松汤加钙尔奇与钙尔奇、壮骨强筋片和舒筋补骨片加降钙素针剂与降钙素针剂。结果不一致。一项试验表明,补肾活血疗法加碳酸钙片和阿法骨化醇在生活质量评分(0至100分,分数越高越好)方面比碳酸钙片和阿法骨化醇效果更好(平均差(MD)5.30;95%置信区间(CI)3.67至6.93)。在三项单独试验中,与安慰剂相比,中草药(密骨汤、补肾益骨软胶囊、抗骨松胶囊)的骨密度(BMD)有统计学显著增加(如抗骨松胶囊,MD 0.06g/cm³;95%CI 0.02至0.10)。在五项试验中,与无干预措施相比,只有两项试验表明中草药对BMD增加有统计学显著效果(如石骨饮,MD 0.08g/cm³;95%CI 0.03至0.13)。在61项试验中,与传统药物相比,23项试验表明中草药对BMD增加有统计学显著效果。在48项评估中草药加西药与西药的试验中,26项试验表明联合治疗对BMD增加效果更好。没有试验报告中草药导致死亡或严重不良事件,而一些试验报告了轻微不良反应,如恶心、腹泻等。
目前的研究结果表明,中草药在改善BMD方面的有益作用仍不确定,需要更严格的研究。