科研之友
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摘要
Objective To determine the required sample size for, and feasibility of, a RCT examining the effectiveness of early acupuncture for acute ischaemic stroke. Methods Thirty-eight patients aged 40-85years with a first episode of acute ischaemic stroke presenting within 72h of stroke onset were randomly assigned to receive manual acupuncture (MA group; n=20) plus standard care or standard care only (control group, n=18). The acupuncture treatment was provided daily for 2weeks. The primary outcome was the change in the National Institutes of Health Stroke Scale (NIHSS) score between baseline and 4weeks. Secondary outcomes included changes in the Fugl-Meyer assessment (FMA) and the functional independence measure scores between baseline and 4weeks, and changes in NIHSS, Barthel Index and modified Rankin Scale scores at 12weeks. Results Thirty-one patients completed the study (dropout rate=18%) and adverse effects were minimal. No significant differences were seen between groups in the improvements in NIHSS scores, although there tended to be a greater reduction in NIHSS score after 1week in the MA group relative to the control group (p=0.066). The post-stroke motor activity at 4weeks was associated with a significantly increased FMA score in the acupuncture group compared with the control group (p<0.05), but not supported by intergroup analysis. Conclusions This pilot study indicates that acupuncture appears to be safe for patients in the acute stage of ischaemic stroke. A subsequent trial with a larger sample size (estimated at n=122) is required to confirm whether early acupuncture intervention contributes to earlier functional improvement and to assess the longer-term clinical efficacy of acupuncture. Trial registration number NCT02210988; Results.
- 出版日期2016-10
- 单位广州中医药大学
