Comparative Study on Efficacy Between Ultrasound-Guided Botulinum Toxin Type-A Injection to Salivary Glands and Oral Glycopyrrolate Therapy for Sialorrhea in Cerebral Palsy: A Randomized Controlled Trial

Abstract Purpose: Sialorrhea is one of the most common complications in children with cerebral palsy (CP), with an incidence rate of up to 10%–58% among CP children. Glycopyrrolate has multiple anticholinergic adverse effects in the long term, while ultrasound (USG)-guided Botulinum toxin type-A (BoNT-A) injection can prove to be an effective alternative. But there is no comparative data on their efficacy. So, our purpose was to assess the comparative efficacy of the two approaches for managing sialorrhea. Materials and Methods: A single-center, open-label, randomized controlled trial was conducted over 18 months to assess improvement in sialorrhea after USG-guided BoNT-A injection to salivary glands and oral Glycopyrrolate therapy. A total of 44 CP patients were selected (22 in each group), between 4 and 12 years with Drooling severity scale (DSS) ≥3 and Drooling frequency scale (DFS) ≥3. USG-guided BoNT-A injection was given for Group-A and oral Glycopyrrolate for Group-B. Assessment was done at baseline, 2, 4, and 12 weeks post-procedure. A total of 38 patients (19 in each group) were analyzed after 6 dropouts (3 from each group). Results: A similar reduction in both DSS and DFS was seen, from baseline (Group-A DSS 3.89 ± 0.66 and DFS 3.21 ± 0.42, Group-B DSS 3.95 ± 0.71 and DFS 3.42 ± 0.51) to 4 weeks in both groups, but at 12 weeks, statistically greater reduction ( P > 0.05) in both mean DSS and DFS for Group-A compared with Group-B. Complications were also less for Group-A compared with the others. Conclusion: USG-guided BoNT-A injection and oral Glycopyrrolate were equally effective in controlling sialorrhea at the initial stage, till 4 weeks, whereas BoNT-A showed statistically more improvement at the later stage of the study.