Acupuncture for Subacute Stroke Rehabilitation: A Sham-Controlled, Subject- and Assessor-Blind, Randomized Trial

University of Exeter, Exeter, England, United Kingdom
Archives of Internal Medicine (Impact Factor: 17.33). 10/2005; 165(17):2026-31. DOI: 10.1001/archinte.165.17.2026
Source: PubMed


Any adjunctive therapy that may reduce persistent disability after stroke should be considered. Acupuncture is used for this purpose, but there is conflicting evidence on its effectiveness.
Patients with a recent (<4 weeks) episode of stroke were randomized to receive 12 sessions of either real or sham acupuncture during 2 weeks. The primary outcome was the change in Barthel activities of daily living score at the end of treatment. Secondary outcome measures included National Institutes of Health Stroke Scale score, motoricity index, and quality of life (EQ-5D [ EuroQoL-5 Dimensional form] and EQ-VAS [EuroQoL-Visual Analog Scale]). Assessments were carried out by blinded physicians.
A total of 116 patients (56 in the real acupuncture group and 60 in the sham group) were randomized, and 98 (real, 48; sham, 50) completed treatment and the 2-week assessment. Patient blinding by means of the sham acupuncture device was successful. Acupuncture was well tolerated except for 1 seizure during a real acupuncture session. The improvements in the Barthel scores were 4 points (interquartile range [IQR], 0-8) vs 3 points (IQR, 0-7) in the real and sham acupuncture groups, respectively (P = .38). The secondary outcome measures also essentially showed no significant effect of acupuncture. Post hoc analysis by baseline severity showed a greater improvement in leg function in the subgroup with baseline Barthel score less than the median (median score, 6): 22 points (IQR, 0-37) vs 0 [corrected] points (IQR, 0-4) in the acupuncture and sham control groups, respectively (P = .02).
Acupuncture is not superior to sham treatment for recovery in activities of daily living and health-related quality of life after stroke, although there may be a limited effect on leg function in more severely affected patients.

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Available from: Martin A James, Jul 19, 2014
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    • "Since the original validation studies, the Park device has been used in several acupuncture RCTs as a placebo acupuncture control [31–34]. For instance, in one RCT [35], the authors compared the efficacy of verum acupuncture (56 stroke patients) and the Park device (60 stroke patients) and they found that verum acupuncture was not superior to placebo treatment in terms of improvements in health-related quality of life after suffering a stroke. "
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    ABSTRACT: Determining an appropriate control for use in acupuncture research remains one of the largest methodological challenges acupuncture researchers face. In general, acupuncture controls fall under one of two categories: (1) sham acupuncture, in which the skin is punctured with real acupuncture needles either fully at nonacupoint locations or shallowly at acupoint locations or both and (2) placebo acupuncture, which utilizes nonpenetrating acupuncture devices. In this study, we will focus on non-penetrating placebo acupuncture devices (blunted-needle and nonneedle devices) that are currently available in acupuncture research. We will describe each device and discuss each device's validation and application in previous studies. In addition, we will outline the advantages and disadvantages of these devices and highlight how the differences among placebo devices can be used to isolate distinct components of acupuncture treatment and investigate their effects. We would like to emphasize that there is no single placebo device that can serve as the best control for all acupuncture studies; the choice of an acupuncture control should be determined by the specific aim of the study.
    Evidence-based Complementary and Alternative Medicine 06/2013; 2013(2):628907. DOI:10.1155/2013/628907 · 1.88 Impact Factor
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    • "Sham acupuncture will be applied to the same nine acupuncture points as in the standard acupuncture group. This Parksham acupuncture device has been used in several previous clinical research studies [28-30]. "
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    ABSTRACT: Acupuncture is an effective yet complex therapy, integrating syndrome differentiation, selection of appropriate acupoints and skillful needling techniques. Clinicians carefully tailor acupuncture treatment to each patient. However, most clinical trials of acupuncture have been based on a standardized formula of points for every patient without properly accounting for individualdifferences and, as a result, have not been reflective of the true efficacy of clinical practice. To determine the efficacy of meridian-based syndrome differentiation and Sa-am acupuncture, we have designed a simple pragmatic trial providing individualized treatments while working within a general framework. The study is designed to be a parallel, patient- and assessor-blind, randomized controlled trial (RCT). A total of250 patients with knee osteoarthritis (OA) will be recruited from two independent hospitals, Semyung University Oriental Medicine Hospital in Chung-ju and Dongguk University Oriental Hospital in Ilsan, South Korea. Patients will be randomly allocated into four treatment groups: 1. individualized, meridian-based syndrome differentiation and Sa-am acupuncture treatment;2. standard acupuncture treatment;3. sham acupuncture treatment; and 4. no acupuncture treatment. Patients in groups 1 to 3 will be treated by certified oriental medicine doctors twice a week for 6 weeks. The primary outcome measure will be the self-reported total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score change. The trial will also include secondary outcome measures. This trial is designed to determine the efficacy of individualized acupuncture treatment in patients with knee OA by comparing the differences between individualized, standard, sham and no acupuncture treatments. The results of this trial may validate the efficacy of individualized acupuncture therapy, encouraging its widespread use. Trial registration NCT01569230
    Trials 05/2013; 14(1):129. DOI:10.1186/1745-6215-14-129 · 1.73 Impact Factor
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    • "Previous studies found that 10.4%, 28.4%, and 62.5% of the general population have used TCM services in the previous month, year, and six years in Taiwan, respectively [13] [16] [21]. After stroke chronic symptoms such as spasticity, changed muscle tone, motor neuron excitability, and ankle plantar flexor spasticity can improve after TCM treatment, particularly acupuncture [22] [23] [24] [25] [26]. Our previous studies also proved the medical effectiveness of acupuncture [27] [28]. "
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    ABSTRACT: . The use of complementary and alternative medicine in critical illness is increasing worldwide. This study investigates how traditional Chinese medicine (TCM) is used in stroke patients. Methods . Using Taiwan National Health Insurance reimbursement claims, we compared the annual use of TCM between stroke patients and general population, identifying 15,330 patients with a new onset of stroke in 2000–2009. The sociodemographic status and medical comorbidities between stroke patients receiving TCM services and those without using the service were compared. Results . The use of TCM was higher in stroke patients than in the general population, 27.9% versus 25.4% in 2000 and 32.7% versus 27.8% in 2009, respectively, and grew consistently from 2000 to 2009. Among stroke patients, women, younger patients, white-collar employees, higher-income residents, and those living in areas with more TCM physicians were more likely to use TCM. Stroke patients using rehabilitation services were more likely to have more TCM visits (OR = 2.28, 95% CI = 1.96–2.66) and higher expenditure on TCM (OR = 2.67, 95% CI = 2.29–3.12) compared with stroke patients without rehabilitation. Conclusion . TCM is popular and well accepted in Taiwan. Patients with stroke have a higher TCM utilization rate than people without stroke.
    Evidence-based Complementary and Alternative Medicine 12/2012; 2012(6):387164. DOI:10.1155/2012/387164 · 1.88 Impact Factor
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