Efficacy and safety of Chinese herbal medicine and acupuncture in the management of obesity: systematic reviews and a randomised placebo-controlled clinical trial

摘要

The obesity epidemic has risen to alarming levels in both developing and developed countries (Lobstein, 2011). The World Health Organization (WHO) estimates that 750 million adults are overweight or obese worldwide (Bray & Popkin, 1998). In Australia, approximately 63.3% of adults are overweight, out of which 28.3% are obese (Australian Bureau of Statistics, 2012). Excessive body weight (BW) has been shown to predispose an individual to various diseases, particularly cardiovascular diseases, Type 2 diabetes (T2D), sleep apnoea, and osteoarthritis. Therefore, obesity is both an individual clinical condition and increasingly a serious public health problem. The objectives of this thesis are to evaluate the effects of acupuncture and herbal medicine formulae in the management of obesity and to evaluate the efficacy of the newly formed RMIT Chinese herbal formula (RCM-104). A systematic review (SR) of randomised clinical trials (RCT) of acupuncture using methods described in the Cochrane Handbook for systematic review of intervention and in RevMan 5.1 for analysis. The search has been carried out since 2006 and it has been updated until completion of this thesis. 16 electronic databases were searched using relevant terms and key words relating to the treatment of obesity. Twenty-three RCTs were included in this review, which used sham acupuncture, no treatment, and WM as a control. The outcome measures include BW, BMI, body fat composition, and waist and hip circumferences. The meta-analysis showed that acupuncture provided more benefit than the control when used with other adjunct therapies. Acupuncture, however, did not show better effects on BW, BMI or BF composition than WM. Similarly, the SR of CHM clinical trials was conducted using the same methods as for the acupuncture SR. Fourteen RCTs were included in the review, which compared CHM with placebo, WM, or other therapies, with or without co-intervention. CHM alone did not show any significant difference from either placebo or WM for BW, BMI or BF composition. When combined with other therapy, however CHM showed some benefits for BW, BMI and WC. RCTs in the CHM review also had high risk in performance bias, and unclear risk in selection bias, detection bias and attrition bias. This indicates that the included studies in both acupuncture and CHM were of low quality. The RMIT Chinese herbal medicine formula (RCM-104) was formed using findings from current literature of both Chinese and Western medicine. The RCT of RCM-104 was rigorously designed and conducted between 2007 and 2009. The RCM-104 formula demonstrated effectiveness in the reduction of BW, BMI and BFC as well as improved quality of life compared to the placebo group. In conclusion, this thesis systematically analysed modern RCTs of CHM and acupuncture interventions for obesity and further evaluated of effectiveness of RCM-104. Both SR and RCT demonstrate the potential effectiveness of acupuncture and Chinese herbal medicine for the management of obesity. However, more rigorous RCTs are needed to confirm the evidence.