Surgery versus botulinum neurotoxin A to reduce drooling and improve daily life for children with neurodevelopmental disabilities: a randomized controlled trial.

Caregivers and patients were not blinded to treatment allocation because sham surgery was considered unethical, which may have introduced assessment bias in reporting subjective outcomes like well-being. The questionnaire used to measure impact on daily life and well-being was developed by the study team and was not validated against standard tools like the Drooling Impact Scale. Baseline drooling severity was not equal between groups in several positions, with the BoNT-A group having higher excessive drooling in specific activities. The follow-up period was limited to 32 weeks, so long-term effects beyond this timeframe are not known. Questionnaires were not always completed by the same caregiver, and some were filled out before inclusion, potentially exaggerating complaints.

The study sponsors had no influence on the study design, data collection, analysis, interpretation, writing, or decision to submit for publication.

Do not interpret the superior efficacy of surgery as an absence of risk. The surgical group experienced more than double the rate of adverse events (40.7% vs 19.2%) and nearly three times the days with postoperative complaints compared to the injection group. Additionally, caregivers were not blinded, so reported improvements in subjective well-being may be influenced by expectations of the more invasive treatment.