Comprehensive rehabilitation with integrative medicine for subacute stroke: A multicenter randomized controlled trial

Jianqiao Fang, Lifang Chen, Ruijie Ma, Crystal Lynn Keeler, Laihua Shen, Yehua Bao, Shouyu Xu, Jianqiao Fang, Lifang Chen, Ruijie Ma, Crystal Lynn Keeler, Laihua Shen, Yehua Bao, Shouyu Xu

Abstract

To determine whether integrative medicine rehabilitation (IMR) that combines conventional rehabilitation (CR) with acupuncture and Chinese herbal medicine has better effects for subacute stroke than CR alone, we conducted a multicenter randomized controlled trial that involved three hospitals in China. Three hundred sixty patients with subacute stroke were randomized into IMR and CR groups. The primary outcome was the Modified Barthel Index (MBI). The secondary outcomes were the National Institutes of Health Stroke Scale (NIHSS), the Fugl-Meyer Assessment (FMA), the mini-mental state examination (MMSE), the Montreal Cognitive Assessment (MoCA), Hamilton's Depression Scale (HAMD), and the Self-Rating Depression Scale (SDS). All variables were evaluated at week 0 (baseline), week 4 (half-way of intervention), week 8 (after treatment) and week 20 (follow-up). In comparison with the CR group, the IMR group had significantly better improvements (P < 0.01 or P < 0.05) in all the primary and secondary outcomes. There were also significantly better changes from baseline in theses outcomes in the IMR group than in the CR group (P < 0.01). A low incidence of adverse events with mild symptoms was observed in the IMR group. We conclude that conventional rehabilitation combined with integrative medicine is safe and more effective for subacute stroke rehabilitation.

Figures

Figure 1. Flow of participants through the…
Figure 1. Flow of participants through the trial.
Figure 2. Means of MBI, NIHSS, FMA,…
Figure 2. Means of MBI, NIHSS, FMA, MMSE, HAMD at Four Testing Time points.
(a) MBI score for the IMR and CR at four testing time points (mean ± SEM; IMR n = 176, CR n = 172). **P < 0.01, compared to CR group. (b) NIHSS score for the IMR and CR at four time points (mean ± SEM; IMR n = 176, CR n = 172). **P < 0.01, compared to CR group. (c) FMA score for the IMR and CR at four testing time points (mean ± SEM; IMR n = 176, CR n = 172). **P < 0.01, compared to CR group. (d) MMSE score for the IMR and CR at four testing time points (mean ± SEM; IMR n = 62, CR n = 69). *P < 0.05, compared to CR group. (e) HAMD score means for the IMR and CR at four testing time points (mean ± SEM; IMR n = 76, CR n = 77). *P < 0.05, compared to CR group.

References

    1. Liu M. et al.. Stroke in China: epidemiology, prevention, and management strategies. Lancet Neurol. 6, 456–464 (2007).
    1. Zhang W. W. et al.. Stroke rehabilitation in China: a systematic review and meta-analysis. Int J Stroke. 9, 494–502 (2014).
    1. Wang J. & Xiong X. Current situation and perspectives of clinical study in integrative medicine in China. Evid Based Complement Alternat Med. 2012, 268542 (2012).
    1. Liu H. et al.. Using microPET imaging in quantitative verification of the acupuncture effect in ischemia stroke treatment. Sci Rep. 3, 1017 (2013).
    1. Wang W. W., Xie C., Lu L. & Zheng G. Q. A systematic review and meta-analysis of Baihui (GV20)-based scalp acupuncture in experimental ischemic stroke. Sci Rep. 4, 3981 (2014).
    1. Wu P., Mills E., Moher D. & Seely D. Acupuncture in poststroke rehabilitation. A systematic review and meta-analysis of randomized trials. Stroke. 41, e171–179 (2010).
    1. Kim H. Neuroprotective herbs for stroke therapy in traditional eastern medicine. Neurol Res. 27, 287–301 (2005).
    1. Chen Y. F. Traditional Chinese medication and cerebral ischemia. Front Biosci. 4, 809–817 (2011).
    1. Junhua Z. et al.. Complex traditional Chinese medicine for post stroke motor dysfunction a systematic review. Stroke. 40, 2797–2804 (2009).
    1. Granger C. V. et al.. Stroke rehabilitation: analysis of repeated Barthel index measures. Arch of phys Med Rehabil. 60, 14–17 (1979).
    1. Loewen S. C. & Anderson B. A. Reliability of the modified motor assessment scale and the Barthel index. Phys Ther. 68, 1077–1081 (1988).
    1. Goldstein L. B. & Samsa G. P. Reliability of the National Institutes of Health Stroke Scale extension to non-neurologists in the context of a clinical trial. Stroke. 28, 307–310 (1997).
    1. Sanford J. et al.. Reliability of the Fugl-Meyer assessment for testing motor performance in patients following stroke. Phys Ther. 73, 447–454 (1993).
    1. Godefroy O. et al.. Is the Montreal Cognitive Assessment superior to the Mini-Mental State Examination to detect poststroke cognitive impairment? A study with neuropsychological evaluation. Stroke. 42, 1712–1716 (2011).
    1. Chen Y. F. Chinese classification of mental disorders (CCMD-3): towards integration in international classification. Psychopathology. 35, 171–175 (2002).
    1. Kollen B., Kwakkel G. & Lindeman E. Functional recovery after stroke: a review of current developments in stroke rehabilitation research. Rev Recent Clin Trials. 1, 75–80 (2006).
    1. Kwakkel G. et al.. Predictive value of the NIHSS for ADL outcome after ischemic hemispheric stroke: does timing of early assessment matter? J NeurolSci. 294, 57–61 (2010).
    1. Mercier L. et al.. Impact of motor, cognitive, and perceptual disorders on ability to perform activities of daily living after stroke. Stroke. 32, 2602–2608 (2001).
    1. McIntyre R. S. et al.. Measuring the severity of depression and remission in primary care: validation of the HAMD-7 scale. CMAJ. 173, 1327–1334 (2005).
    1. Nasreddine Z. S. et al.. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am GeriatrSoc. 53, 695–699 (2005).
    1. Lao L., Hamilton G. R., Fu J. & Berman B. M. Is acupuncture safe? A systematic review of case reports. Altern Ther Health Med. 1, 72–83 (2003).
    1. Maciocia G. Safety of Chinese medication. UK, Buckinghamshire, p169 (Su Wen Press, 2003).
    1. World Health Organization Regional Office for the Western Pacific. WHO international standard terminologies on traditional medicine in the western pacific region. Philippines, p233 (World Health Organization, 2007).
    1. Ranjit R. C. & Uton M. R. Traditional Medicine in Asia. India, New Delhi, p75–92 (SEARO Regional Publications, 2001).
    1. Linde K., Niemann K. & Meissner K. Are sham acupuncture interventions more effective than (other) placebos? A re-analysis of data from the Cochrane review on placebo effects. Forschende Komplementärmedizin. 5, 259–264 (2010).
    1. Fang J. et al.. Integrative medicine for subacute stroke rehabilitation: a study protocol for a multicentre, randomised, controlled trial. BMJ open. 4, e007080 (2014).
    1. Zhang T. Chinese stroke rehabilitation treatment guidelines 2011. Chin J Rehabil Theory Pract. 18, 301–318 (2012) In Chinese.
    1. Raine Sue, Meadows Linzi & Lynch-Ellerington Mary Bobath concept: theory and clinical practice in neurological rehabilitation. (Wiley-Blackwell, 2009).
    1. Gosman-Hedström G. et al.. Effects of acupuncture treatment on daily life activities and quality of life a controlled, prospective, and randomized study of acute stroke patients. Stroke. 10, 2100–2108 (1998).

Source: PubMed

3
Suscribir