Abstract
BackgroundAcupuncture is not considered a conventional therapy for post-stroke sequelae but it might have some additional positive effects on early rehabilitation. We conducted this trial to determine whether acupuncture has additional effects in early comprehensive rehabilitation for acute ischemic stroke and dysfunctions secondary to stroke.MethodsTwo hundred fifty patients were randomized into two groups: acupuncture (AG) or no acupuncture (NAG). Eighteen acupuncture treatment sessions were performed over a 3-week period. The primary outcome was blindly measured with National Institutes of Health Stroke Scale (NIHSS) at week 1, week 3, and week 7. Secondary outcomes included: Fugl-Meyer Assessment (FMA) for motor function, bedside swallowing assessment (BSA) and videofluoroscopic swallowing study (VFSS) for swallowing function, the Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) for cognitive function, and the adverse reaction of acupuncture for safety assessment.ResultsSignificant improvements from acupuncture treatment were observed in NIHSS (p < 0.001), VFSS (p < 0.001), MMSE (p < 0.001), MoCA (p = 0.001), but not obtained from FMA (p = 0.228). Changes from baseline of all above variables (except FMA) also had the same favorable results. A significant improvement in FMA lower extremity subscale appeared in AG (p = 0.020), but no significant difference was found for the upper extremity subscale (p = 0.707). More patients with swallowing disorder recovered in AG (p = 0.037). Low incidence of mild reaction of acupuncture indicated its safety.ConclusionsThis trial showed acupuncture is safe and has additional multi-effect in improving neurologic deficits, swallowing disorder, cognitive impairment, and lower extremity function, but has no significant improvement for upper extremity function during this short-term study period.Trial registrationChictr.org ChiCTR-TRC −12001971 (March 2012).Electronic supplementary materialThe online version of this article (doi:10.1186/s12906-016-1193-y) contains supplementary material, which is available to authorized users.
Highlights
Acupuncture is not considered a conventional therapy for post-stroke sequelae but it might have some additional positive effects on early rehabilitation
One hundred twenty participants of acupuncture group (AG) and one hundred twenty-one participants of no acupuncture group (NAG) completed all of the treatments and measurements and were included in per protocol set (PPS)
We presented efficacy results in this paper only from the PPS, because the efficacy results of full analysis set (FAS) and PPS were consistent
Summary
Acupuncture is not considered a conventional therapy for post-stroke sequelae but it might have some additional positive effects on early rehabilitation. We conducted this trial to determine whether acupuncture has additional effects in early comprehensive rehabilitation for acute ischemic stroke and dysfunctions secondary to stroke. Some studies showed positive but limited effectiveness of acupuncture as an adjunct treatment to the conventional rehabilitation [4,5,6]. We conducted a multicenter randomized controlled trial to demonstrate whether acupuncture could improve neurological deficit (main aim), motor function, swallowing disorder, and cognitive impairment (secondary aims) during the acute ischemic stroke with a multi-effect
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