Randomized controlled trial comparing botulinum vs surgery for drooling in neurodisabilities

Area of Science:

• Pediatric Otolaryngology
• Neurodevelopmental Disabilities
• Sialorrhea Management

Background:

• Excessive drooling (sialorrhea) is a common challenge in children and adolescents with neurodevelopmental disabilities.
• Current treatments aim to reduce saliva production and improve quality of life.
• Comparing surgical and pharmacological interventions is crucial for optimizing care.

Purpose of the Study:

• To compare the efficacy and safety of submandibular duct ligation (2-DL) versus submandibular botulinum neurotoxin type A (BoNT-A) injections for treating drooling.
• To evaluate outcomes using standardized measures of drooling severity and frequency.

Main Methods:

• A randomized, controlled, partly single-blinded study involving 53 pediatric patients with neurodevelopmental disabilities and excessive drooling.
• Patients were randomized to receive either 2-DL or a one-time intraglandular BoNT-A injection.
• Outcomes assessed included Visual Analog Scale (VAS), drooling quotient (DQ), drooling severity (DS), and drooling frequency (DF) at baseline, 8, and 32 weeks post-treatment.

Main Results:

• Submandibular duct ligation (2-DL) demonstrated significantly higher treatment response rates (63.0% vs 26.9%, p=0.008) at 32 weeks compared to BoNT-A.
• Both VAS scores and DQ were significantly reduced post-2-DL compared to BoNT-A (p<0.001 and p=0.022, respectively).
• Adverse events and postoperative complaints were more frequent and prolonged following 2-DL than BoNT-A.

Conclusions:

• Submandibular duct ligation (2-DL) is a more effective treatment for reducing drooling in children with neurodevelopmental disabilities compared to a single BoNT-A injection.
• While 2-DL offers superior efficacy, it is associated with a slightly higher risk of complications and morbidity.
• This study provides Class III evidence supporting 2-DL as a more effective long-term solution for severe drooling in this population.