F K-h Sze1, F F Yeung, E Wong, J Lau. 1. Department of Medicine, Changi General Hospital, Singapore. fkhsze@hotmail.com
Abstract
OBJECTIVES: Danshen, a Chinese herb, has been used as a standard treatment for acute ischaemic stroke in China. This study assesses the quality of all randomized control trials (RCTs) comparing Danshen of any preparation to without Danshen (placebo or other western or herbal medicines), and to evaluate its effectiveness in improving disability. MATERIALS AND METHODS: Systematic review through literature search in MEDLINE, Cochrane Library, China Biological Medicine Database and others. The main outcome measure is disability improvement on the Chinese National Disability Scale (CNDS) at 2 weeks after intervention. RESULTS: Of 33 Danshen control trials for acute ischaemic stroke identified in the literature, none were placebo-controlled. Eleven RCTs comparing Danshen with one of seven Western and two herbal medicines met the inclusion criteria for review, however, these studies were of poor quality. Compared with the nine medicines, the effect of Danshen was inferior in five trials and not significantly different in another six trials. For the two trials comparing Danshen with Buflomedil, the combined odds ratio (OR) was 0.27 (95% CI: 0.12-0.61) favouring Buflomedil, but the test of homogeneity revealed heterogeneity (P = 0.083). For the two trials comparing Danshen with Naloxone, the combined OR was 0.16 (95% CI: 0.07-0.40) favouring Naloxone. However, none of the nine medicines per se has been proven effective in post-stroke disability improvement. CONCLUSIONS: The existing Danshen RCTs are not placebo-controlled and are of poor quality, therefore, there is no substantial evidence that Danshen is effective. Systematic review on RCTs comparing Danshen with other medicines does not support the notion that Danshen may be beneficial to disability improvement after acute ischaemic stroke.
OBJECTIVES: Danshen, a Chinese herb, has been used as a standard treatment for acute ischaemic stroke in China. This study assesses the quality of all randomized control trials (RCTs) comparing Danshen of any preparation to without Danshen (placebo or other western or herbal medicines), and to evaluate its effectiveness in improving disability. MATERIALS AND METHODS: Systematic review through literature search in MEDLINE, Cochrane Library, China Biological Medicine Database and others. The main outcome measure is disability improvement on the Chinese National Disability Scale (CNDS) at 2 weeks after intervention. RESULTS: Of 33 Danshen control trials for acute ischaemic stroke identified in the literature, none were placebo-controlled. Eleven RCTs comparing Danshen with one of seven Western and two herbal medicines met the inclusion criteria for review, however, these studies were of poor quality. Compared with the nine medicines, the effect of Danshen was inferior in five trials and not significantly different in another six trials. For the two trials comparing Danshen with Buflomedil, the combined odds ratio (OR) was 0.27 (95% CI: 0.12-0.61) favouring Buflomedil, but the test of homogeneity revealed heterogeneity (P = 0.083). For the two trials comparing Danshen with Naloxone, the combined OR was 0.16 (95% CI: 0.07-0.40) favouring Naloxone. However, none of the nine medicines per se has been proven effective in post-stroke disability improvement. CONCLUSIONS: The existing Danshen RCTs are not placebo-controlled and are of poor quality, therefore, there is no substantial evidence that Danshen is effective. Systematic review on RCTs comparing Danshen with other medicines does not support the notion that Danshen may be beneficial to disability improvement after acute ischaemic stroke.
Authors: Song Wen-Ting; Cheng Fa-Feng; Xu Li; Lin Cheng-Ren; Liu Jian-Xun Journal: Evid Based Complement Alternat Med Date: 2012-04-24 Impact factor: 2.629