Five randomised controlled trials (n=329) were included in the review.
Clinical improvement, using either the GAS or modified MAS.
A statistically significant improvement was shown in the BTX-A group compared with placebo (OR 3.38, 95% CI: 1.34, 8.52). Significant heterogeneity was found. However, reanalysis using a random-effects model did not substantially change this result (OR 3.31, 95% CI: 1.18. 9.26).
GAS (3 RCTs, n=112): the improvement in mean GAS scores was higher across all parameters in the BTX-A group at 4 to 6 weeks' follow-up. The pooled summary scores demonstrated a statistically significant effect in favour of BTX-A, compared with placebo (OR 3.27, 95% CI: 1.38, 7.74).
Modified MAS (4 RCTs, n=122): the mean clinical improvement was higher in the BTX-A group at 4 to 6 weeks' follow-up; the mean MAS score change was also found to be higher when wrist joint was included at the same end point. The pooled summary scores demonsrated a small, but non significant effect, in favour of BTX-A when compared with placebo (WMD 0.95, 95% CI: 0.74, 1.17).
There were insufficient data in the included trials to assess the safety of BTX-A.