Abstract: 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/cm3; 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/cm3; 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. Current findings suggest that the beneficial effect of Chinese herbal medicines in improving BMD is still uncertain and more rigorous studies are warranted.

Plain-language summary: After searching for all relevant studies up to January 2013, we found 108 studies with 10,655 people with osteoporosis. 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 conventional medicine were compared with conventional medicine (47 trials). The average length of treatment was 5.7 months (ranging from 3 to 12 months). New fractures: We are uncertain whether Chinese herbal medicines reduce the chance of having a new bone fracture. Seven trials evaluated the incidence of fractures. However, these trials were small and had flaws in their methods. Quality of life: People who took Bushenhuoxue therapy plus calcium carbonate tablets and alfacalcidol rated their quality of life to be 5.30 points better on a scale of 0 to 100 after three months compared to people who did not take the herbal medicine. People who took Bushenhuoxue therapy plus calcium carbonate tablets and alfacalcidol rated their quality of life to be 56.05 on a scale of 0 to 100. People who took calcium carbonate tablets and alfacalcidol rated their quality of life to be 50.75 on a scale of 0 to 100. Serious side effects or deaths: No serious side effects or deaths occurred in the trials. We often do not have precise information about side effects and complications. This is particularly true for rare but serious side effects. Possible side effects may include a mild stomach ache or diarrhoea. Bone mineral density (the amount and type of minerals in the bone): We found studies that compared Chinese herbal medicines with placebo (fake treatment), with no treatment and with conventional medicine. We also found studies that compared Chinese herbal medicines plus conventional medication with just conventional medication. Compared to placebo (fake treatment), three studies showed that bone mineral density increased slightly with Chinese herbal medicines. Compared to no treatment or conventional medicine, some studies showed an increase in bone mineral density with Chinese herbal medicines while others did not. When Chinese herbal medicines plus conventional medication was compared with just conventional medicine, some studies showed an increase in bone mineral density while others did not. In people with osteoporosis: - Chinese herbal medicines may improve bone mineral density and quality of life slightly. Further research is likely to change this estimate of how Chinese herbal medicines affect bone mineral density and quality of life. - We are uncertain whether Chinese herbal medicines reduce the chance of having a new bone fracture. - No trial reported death or serious side effects.