Acupuncture for a first episode of acute ischaemic stroke: an observer-blinded randomised controlled pilot study.
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 40-85 years with a first episode of acute ischaemic stroke presenting within 72 h 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 2 weeks. The primary outcome was the change in the National Institutes of Health Stroke Scale (NIHSS) score between baseline and 4 weeks. Secondary outcomes included changes in the Fugl-Meyer assessment (FMA) and the functional independence measure scores between baseline and 4 weeks, and changes in NIHSS, Barthel Index and modified Rankin Scale scores at 12 weeks.


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 1 week in the MA group relative to the control group (p=0.066). The post-stroke motor activity at 4 weeks 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.


BACKGROUND
NCT02210988; Results.
Department of Neurology, Lotung Poh-Ai Hospital, Ilan, Taiwan Institute of Traditional Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan.
Ching-Hsiung
CH
Liu
Department of Physical Medicine and Rehabilitation, Lotung Poh-Ai Hospital, Ilan, Taiwan.
Yu-Ting
YT
Hsieh
Department of Neurology, Lotung Poh-Ai Hospital, Ilan, Taiwan.
Hung-Pin
HP
Tseng
Department of Neurology, Lotung Poh-Ai Hospital, Ilan, Taiwan.
Hung-Chih
HC
Lin
Department of Neurology, Lotung Poh-Ai Hospital, Ilan, Taiwan.
Chun-Liang
CL
Lin
Department of Physical Medicine and Rehabilitation, Lotung Poh-Ai Hospital, Ilan, Taiwan.
Tai-Yi
TY
Wu
Department of Physical Medicine and Rehabilitation, Lotung Poh-Ai Hospital, Ilan, Taiwan.
Shu-Hua
SH
Lin
Department of Physical Medicine and Rehabilitation, Lotung Poh-Ai Hospital, Ilan, Taiwan.
Szu-Hung
SH
Tsao
College of Acupuncture and Tuina, Guangzhou University of Chinese Medicine, Guangdong, China.
Hong
H
Zhang
D015670:Acupuncture Therapy / Q000379:methods*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012720:Severity of Illness Index; D016037:Single-Blind Method; D020521:Stroke / Q000628:therapy*; D013997:Time Factors; D016896:Treatment Outcome
ACUPUNCTURE