Review question
We conducted a review of the effects of Chinese herbal medicines for people with primary osteoporosis. We found 108 studies with 10,655 people.
Background: what is primary osteoporosis and what are Chinese herbal medicines?
Bone is a living, growing part of your body. Throughout your lifetime, new bone cells grow and old bone cells break down to make room for the new, stronger bone. When you have osteoporosis, the old bone breaks down faster than the new bone can replace it. As this happens, the bones lose minerals (such as calcium). This makes bones weaker and more likely to break even after a minor injury, like a little bump or fall.
Chinese herbal medicines are products made from any part of medicinal plants (leaves, stems, buds, flowers or roots). Sometimes non-plant based components (for example insects, deer horn, snake, various shells and powdered fossil) are included. These can be used in the form of raw plant materials, or water or alcohol extracts of raw plant materials. Herbs can also be taken by mouth as capsules, tablets or liquids, or as injections.
Chinese herbal medicines are widely used in China for primary osteoporosis but their benefits and harms have not been appraised in order to inform clinical practice.
Study characteristics
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).
Key results: what happens to people with osteoporosis who take Chinese herbal medicines?
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.
Quality of the evidence
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.
Current findings suggest that the beneficial effect of Chinese herbal medicines in improving BMD is still uncertain and more rigorous studies are warranted.
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/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.