| Background A large number of Traditional Chinese Patent Medicine (TCPM) are widely used for ischemic stroke in China. It was unknown whether there was sufficient evidence to support their routine use.Objectives To systematically review the existing clinical evidence of TCPM for ischemic stroke and to provide the best available evidence for clinical decision-making and for prioritizing the further research areas on TCPM for ischemic stroke.Methods The Chinese National Essential Drug List of 2004 and commonly used TCPM in current clinical practice were screened. Fifty-nine of TCPMs were identified for further evaluation. We searched 8 electronic databases and handsearched 7 Chinese medical journals. The reference lists of eligible studies were additionally searched. Randomized and controlled trials on any of the 59 Chinese medicine users compared with nonusers for ischemic stroke were included. Data on methodological quality and trial information was extracted by two researchers separately with the uniform. The outcome measures included 1.Primary outcome: Death or dependency at the end of long term follow up (at least 3 months); 2. Secondary outcome: Measures of neurological deficit at the end of treatment; Death from all causes within the treatment and during the whole follow-up period; Quality of life. Cochrane review methodology was used for assessing trial quality cind effectiveness. Statistical analysis were performed using Revman 4.2.7. Results were reported as odds ratio (OR) and were calculated by the Peto fixed-effect method. For continuous data weighted mean difference (WMD) was computed for outcomes measured on the same scale, and standardized mean difference (SMD) was calculated when the same outcome was measured on different scales.Results The literature search identified 191 trials (19338 cases) relevant to 22 TCPMs. 120 randomized trials and 71 controlled trials were included. Methodological quality of the included trials was generally poor. The main problem included unclear randomized method, blinding and unreasonable outcome measures. Death or dependency at the end of long term follow up (at least 3 months): One trial of puerarin evaluated death and dependence at 6 months. No significant difference between puerarin users and nonusers (Peto OR 0.86, 95%CI 0.35-2.10). One trial of Shenmai scored by Barthel index at 3 months. No significant difference between trial group and control group (WMD 11.58, 95%CI -9.04-32.20). Other trials had no the outcome on long term follow up. Measures of neurological deficit at the end of treatment: Meta-analysis of 189 trials (19180 cases) on 21 TCPMs showed improvement of neurological deficit. Meta-analysis of 118 RCTs (12543 cases) still showed the same results after excluding the non-RCTs. Milk vetch, Mailuoning, Ligustrazine, Ginkgo biloba, Xuesetong, Puerarin, Danshen agents and Acanthopanax had relatively more studies and patient number. These drugs had the tendency of improving the neurological deficit. Death from all causes within the treatment and during the whole follow-up period: Trials on Qingkailing, Xuesetong, Ligustrazine, DanShen, Puerarin and Milk vetch reported the death within the treatment and during the whole follow-up period. Only 2 trials on Qingkailing could decrease the death (Peto OR 0.24, 95%CI 0.06-0.91). No significant difference between trials group and controls group in other trials. No trials assess the quality of life. Conclusions There is insufficient reliable evidence for effectiveness of TCPM in ischemic stroke due to the poor quality of the trials. Further high-quality randomized controlled trials are needed. Milk vetch, Mailuoning, Ligustrazine, Ginkgo biloba, Xuesetong, Puerarin, Danshen agents and Acanthopanax could be the further research priorities.
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