Keywords
Adults
Botulinum Toxin Type B
Botulinum Toxin Type A
Botulinum Toxin Type A Resistance
Placebo
Randomized Controlled Trials
Safety
Efficacy (DeCS)
Diana M. Prada GT. Botulinum Toxin Type B vs Type A in Cervical Dystonia: A Meta - analysis of high quality trials. Acta Neurol Colomb 2013;29:27-35
Resistencia a Toxina Botulínica Tipo A
Abstract
Introduction: cervical dystonia (CD) is a frequent disabling condition. Botulinum Toxin (BT) type A is effective for CD. BT type B is an alternative, but its use for patients who develop neutralizing antibodies against BT type A is debatable.
Objetive: the aim of this study was to compare the efficacy of BT type B (>5000 U) versus type A and placebo patients with CD.
Materials and methods: we identified RCTs comparing interventions. Quality assessment was made according to Cochrane Collaboration. A pooled analysis was conducted for continuous and dichotomous data using a random effect model identifying OR [CI95%, p < 0.05]. Primary outcomes were improvement in TWSTRS until week sixteen. Secondary outcomes were adverse effects and costs.
Results: five RCTs fulfilled inclusion criteria (217 patients treated with BT type B; 224 patients in placebo group or type A). Two trials compared BT type B versus type A and three versus placebo. Quality assessment showed high quality of trials. BT type B improved TWSTRS scores at 4 weeks versus placebo [OR: 6.54 (CI 95%: 2.68 - 10.39; p<0.00001)]. No significant difference in efficacy was found in BT type B versus type A patients [OR:-2.16 (CI 95%:-2.64-1.88; p<0.0001)]. At week sixteen, BT type B demonstrated a sustained efficacy versus placebo. Dry mouth was significantly more frequent with BT type B compared to BT type A. Adverse events such as dry mouth and dysphagia were significantly more frequent in the BT type B group when compared to placebo. There was no information about costs.
Conclusions: no significant differences in safety and efficacy were found between BT type B when compared to type A in CD patients. BT type B is more frequently associated with dry mouth than the A serotype. More studies are needed to evaluate therapeutic options in type A resistant patients. Further evidence is required to evaluate the efficacy of BT types A and B prospectively.
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