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EUROPEAN JOURNAL OF PHYSICAL AND REHABILITATION MEDICINE
A Journal on Physical Medicine and Rehabilitation after Pathological Events
Official Journal of the , , , ,
In association with
Indexed/Abstracted in: CINAHL, Current Contents/Clinical Medicine, EMBASE, PubMed/MEDLINE, Science Citation Index Expanded (SciSearch), Scopus
Impact Factor 2,063
European Journal of Physical and Rehabilitation Medicine 2016 Nov 11
Efficacy and safety of Botulinum Toxin type A for upper limb spasticity after stroke or traumatic brain injury: a systematic review with meta-analysis and trial sequential analysis
Yan DONG 1, 2, Tao WU 3, Xiaohua HU 2, Tong WANG 4 ✉
1 Nanjing Medical University, Nanjing, PR China; 2 Department of Rehabilitation Medicine, Hangzhou Hospital of Zhejiang Chinese Armed Police Force, Hangzhou, PR China; 3 Department of Rehabilitation Medicine, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, PR China; 4 Department of Rehabilitation Medicine, First Affiliated Hospital of Nanjing Medical University, Nanjing, PR China
INTRODUCTION: Muscle spasticity is a positive symptom after stroke and traumatic brain injury. Botulinum Toxin type A injection is widely used for treating post stroke and traumatic brain injury spasticity. This study aimed to evaluate efficacy and safety of Botulinum Toxin type A for upper limb spasticity after stroke and traumatic brain injury and investigate reliability and conclusiveness of available evidence for Botulinum Toxin type A intervention.
EVIDENCE ACQUISITION: We searched electronic databases from inception to September 10 of 2016. Randomized controlled trials comparing the effectiveness between Botulinum Toxin type A and placebo in stroke or traumatic brain injury adults with upper limb spasticity were included. Reliability and conclusiveness of the available evidence were examined with trial sequential analysis.
EVIDENCE SYNTHESIS: From 489 citations identified, 22 studies were included, reporting results for 1804 participants. A statistically significant decrease of muscle tone was observed at each time point after Botulinum Toxin type A injection compared to placebo (SMD at week4 = -0.98, 95% CI: -1.28 to -0.68; I2=66%, p=0.004; SMD at week 6 = -0.85, 95% CI: -1.11 to -0.59, I2=1.2%, p=0.409; SMD at week 8 = -0.87, 95% CI: -1.15 to -0.6, I2=0%, p=0.713; SMD at week 12 = -0.67, 95% CI: -0.88 to -0.46, I2=0%, p=0.896; and SMD over week 12 = -0.73, 95% CI: -1.21 to -0.24,I2=63.5%, p=0.065).Trial sequential analysis showed that as of year 2004 sufficient evidence had been accrued to show significant benefit of Botulinum Toxin type A four weeks after injection over placebo control. Botulinum Toxin type A treatment also significantly reduced Disability Assessment Scale score than placebo at 4, 6 and 12-week follow-up period (WMD = -0.33, 95%CI: -0.63 to -0.03, I2=60%, p=0.114; WMD =-0.54, 95%CI: -0.74 to -0.33, I2= 0%, p=0.596 and WMD =-0.3, 95%CI: -0.45 to -0.14, I2= 0%, p=0.426 respectively), and significantly increased patients’ global assessment score at week 4 and 6 after injection (SMD = 0.56, 95% CI: 0.28 to 0.83; I2=0%, p=0.681 and SMD = 1.11, 95% CI: 0.4 to 1.77; I2=72.8%, p=0.025 respectively). No statistical difference was observed in the frequency of adverse events between Botulinum Toxin type A and placebo group (RR =1.36, 95% CI [0.82, 2.27]; I2=0%, p=0.619).
CONCLUSIONS: As compared with placebo, Botulinum Toxin type A injections have beneficial effects with improved muscle tone and well-tolerated treatment for patients with upper limb spasticity post stroke or traumatic brain injury.