Table 1.
Randomized controlled studies on therapy for sialorrhea with BoNT (listing only first author, in alphabetic order)
| Author | Patients (n) | Criteria and methods | Results | Diagnoses toxin | Undesired effects |
|---|---|---|---|---|---|
| Chinnapongse et al. [88] |
54 PC DB RCT |
Follow-up 20 weeks DFSS Saliva quantitative assessment of sialorrhea |
Significant improvement from 4th to 16th week, dose dependent |
PD Rima-B 1500, 2500, 3500 U, placebo |
Gastrointestinal AE in 31% vs 7% of controls, mainly dry mouth |
| Guidubaldi et al. [89] |
14 DB RCT Crossover |
Saliva flow Subjective: interview |
Rima-B and Dysport effective, latency lower for Rima-B |
ALS, Parkinson 2500 U Rima-B 250 U Abo-A |
Viscous saliva |
| Jackson et al. [90] |
20 PC DB RCT |
Global impression scale |
GIS 72% vs 38% (placebo) positive 50% > 12 weeks effect |
ALS 2500 U Rima-B |
– |
| Jost et al. [1] |
184 DB PC RCT |
Global impression Quantity of salivation |
Significant reduction in salivary secretion over 12 weeks, 100 U more effective |
Various diagnoses, 70.7% PD Inco-A 75 and 100 U |
Dry mouth |
| Lagalla et al. [91] |
32 DB PC RCT |
Subjective impression of drooling (VAS), drooling frequency, social disability | Significant reduction of sialorrhea after 4 weeks |
PD Ona-A 100 MU |
– |
| Lagalla et al. [92] | 36 | Drooling severity scale, GIS, VAS social distress |
Significant improvement Effect duration 19.2 weeks |
PD Rima-B 4000 U |
Dry mouth |
| Lipp et al. [93] |
32 DB PC RCT |
Global impression Quantitative assessment of drooling |
Various diagnoses, Abo-A 18.75, 37.5, 75 U |
None | |
| Mancini et al. [80] | 20 |
DFSS salivation |
Significant reduction in drooling for > 3 months |
20 PD Abo-A 450 U |
None |
| Mazlan et al. [86] |
30 PC DB RCT |
Reduction in salivation after 2, 6, 12, 24 weeks DFSS |
Best effect with 200 U Abo-A, up to 24 weeks |
Neurogenic sialorrhea Abo-A 50, 100, 200 U |
Viscous (thick) saliva pain during injection |
| Narayanaswami et al. [82] |
10 DB PC RCT Crossover |
DFSS Quantitative assessment of saliva |
No significant effect |
PD Inco-A 100 U |
Tongue control, chewing weakness, viscous saliva |
| Ondo et al. [87] | 16 |
Assessment of drooling VAS; DFSS |
Significant improvement in VAS and DFSS |
PD Rima-B 2500 U |
– |
| Reid et al. [94] |
48 RCT Control group |
Drooling impact scale |
Significant improvement Up to 6 months |
Developmental disorder Ona-A 100 U |
– |
| Steinlechner et al. [107] |
9 DB PC |
Global impression | Reduction of sialorrhea for 8–16 weeks |
Neuroleptic therapy, PD Rima-B |
Dry mouth |
| Weikamp [69] |
20 RCT |
Global impression and patients’ satisfaction | Irradiation of the salivary glands and Ona-A with equal effects |
ALS Ona-A vs irradiation |
More local adverse effects with irradiation |
DB double blind, PC placebo controlled, RCT randomized controlled study, VAS visual analogue scale, DFSS drooling frequency and severity scale, ALS amyotrophic lateral sclerosis, Abo-A abobotulinumtoxin type A (Dysport®), Inco-A incobotulinumtoxin type A (Xeomin®), Ona-A onabotulinumtoxin type A (Botox®), Rima-B rimabotulinomtoxin type B (Neurobloc®)