Pushpa Narayanaswami1, Thomas Geisbush2, Andrew Tarulli3, Elizabeth Raynor4, Shiva Gautam5, Daniel Tarsy6, Gary Gronseth7. 1. Department of Neurology, Beth Israel Deaconess Medical Center/Harvard Medical School, BIDMC, 330 Brookline Ave, Boston, MA 02215, USA. Electronic address: pnarayan@bidmc.harvard.edu. 2. Department of Neurology, Beth Israel Deaconess Medical Center/Harvard Medical School, BIDMC, 330 Brookline Ave, Boston, MA 02215, USA. Electronic address: thomas.geisbush@my.rfums.org. 3. Department of Neurology, Beth Israel Deaconess Medical Center/Harvard Medical School, BIDMC, 330 Brookline Ave, Boston, MA 02215, USA. Electronic address: Andrew.Tarulli@atlantichealth.org. 4. Department of Neurology, Beth Israel Deaconess Medical Center/Harvard Medical School, BIDMC, 330 Brookline Ave, Boston, MA 02215, USA. Electronic address: eraynor@bidmc.harvard.edu. 5. Department of Medicine, Beth Israel Deaconess Medical Center/Harvard Medical School, BIDMC, 330 Brookline Ave, Boston, MA 02215, USA. Electronic address: sgautam@bidmc.harvard.edu. 6. Department of Neurology, Beth Israel Deaconess Medical Center/Harvard Medical School, BIDMC, 330 Brookline Ave, Boston, MA 02215, USA. Electronic address: dtarsy@bidmc.harvard.edu. 7. Department of Neurology, Kansas University Medical Center, 3901 Rainbow Blvd, Mail Stop 1033, Kansas City, KS 66160, USA. Electronic address: ggronseth@kumc.edu.
Abstract
INTRODUCTION:Botulinum toxins are a therapeutic option for drooling in Parkinson's Disease (PD). The aims of this study were to: 1. evaluate the efficacy of incobotulinum toxin A for drooling in PD. 2. Perform a meta-analysis of studies of Botulinum toxins for drooling in PD. METHODS: 1. Primary study: Randomized, double blind, placebo controlled, cross over trial. Incobotulinum toxin (100 units) or saline was injected into the parotid (20 units) and submandibular (30 units) glands. Subjects returned monthly for three evaluations after each injection. Outcome measures were saliva weight and Drooling Frequency and Severity Scale. 2. Systematic review of literature, followed by inverse variance meta-analyses using random effects models. RESULTS: 1. Primary Study: Nine of 10 subjects completed both arms. There was no significant change in the primary outcome of saliva weight one month after injection in the treatment period compared to placebo period (mean difference, gm ± SD: -0.194 ± 0.61, range: -1.28 to 0.97, 95% CI -0.71 to 0.32). Secondary outcomes also did not change. 2. Meta-analysis of six studies demonstrated significant benefit of Botulinum toxin on functional outcomes (effect size, Cohen's d: -1.32, CI -1.86 to -0.78). The other studies used a higher dose of Botulinum toxin A into the parotid glands. CONCLUSIONS: This study did not demonstrate efficacy of incobotulinum toxin A for drooling in PD, but lacked precision to exclude moderate benefit. The parotid/submandibular dose-ratio may have influenced results. Studies evaluating higher doses of incobotulinum toxin A into the parotid glands may be useful.
RCT Entities:
INTRODUCTION: Botulinum toxins are a therapeutic option for drooling in Parkinson's Disease (PD). The aims of this study were to: 1. evaluate the efficacy of incobotulinum toxin A for drooling in PD. 2. Perform a meta-analysis of studies of Botulinum toxins for drooling in PD. METHODS: 1. Primary study: Randomized, double blind, placebo controlled, cross over trial. Incobotulinum toxin (100 units) or saline was injected into the parotid (20 units) and submandibular (30 units) glands. Subjects returned monthly for three evaluations after each injection. Outcome measures were saliva weight and Drooling Frequency and Severity Scale. 2. Systematic review of literature, followed by inverse variance meta-analyses using random effects models. RESULTS: 1. Primary Study: Nine of 10 subjects completed both arms. There was no significant change in the primary outcome of saliva weight one month after injection in the treatment period compared to placebo period (mean difference, gm ± SD: -0.194 ± 0.61, range: -1.28 to 0.97, 95% CI -0.71 to 0.32). Secondary outcomes also did not change. 2. Meta-analysis of six studies demonstrated significant benefit of Botulinum toxin on functional outcomes (effect size, Cohen's d: -1.32, CI -1.86 to -0.78). The other studies used a higher dose of Botulinum toxin A into the parotid glands. CONCLUSIONS: This study did not demonstrate efficacy of incobotulinum toxin A for drooling in PD, but lacked precision to exclude moderate benefit. The parotid/submandibular dose-ratio may have influenced results. Studies evaluating higher doses of incobotulinum toxin A into the parotid glands may be useful.
Authors: Javier Martínez-Poles; Velina Nedkova-Hristova; José Bernardo Escribano-Paredes; Sebastián García-Madrona; Elena Natera-Villalba; Carlos Estévez-Fraga; José Luis López-Sendón Moreno; Icíar Avilés-Olmos; Gema Sánchez Díaz; Juan Carlos Martínez Castrillo; Araceli Alonso-Canovas Journal: Toxins (Basel) Date: 2018-05-28 Impact factor: 4.546
Authors: Wolfgang H Jost; Andrzej Friedman; Olaf Michel; Christian Oehlwein; Jaroslaw Slawek; Andrzej Bogucki; Stanislaw Ochudlo; Marta Banach; Fernando Pagan; Birgit Flatau-Baqué; János Csikós; Claire J Cairney; Andrew Blitzer Journal: Neurology Date: 2019-03-27 Impact factor: 9.910