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      Comparing the Effect of Botulinum Toxin Type B Injection at Different Dosages for Patient with Drooling due to Brain Lesion

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          Abstract

          Objective

          To investigate Botulinum toxin type B (BNT-B) injection's effect and duration depending on dose for patients with brain lesion.

          Method

          Twenty one patients with brain lesion and severe drooling were included and divided into three groups. All patients received conventional dysphagia therapy. Group A patients (n=7) received an injection of 1,500 units and group B patients (n=7) received an injection of 2,500 units of BNT-B in submandibular gland under ultrasound guidance. Group C patients (n=7) received conventional dysphagia therapy. Saliva secretion was assessed quantitatively at baseline and at weeks 1, 2, 4, 8, and 12. The severity and frequency of drooling was assessed using the Drooling Quotient (DQ) by patients and/or caregivers.

          Results

          Group A and B reported a distinct improvement of the symptoms within 2 weeks after BNT-B injection. Compared to the baseline, the mean amount of saliva decreased significantly throughout the study. However, there was no meaningful difference between the two groups. The greatest reductions were achieved at 2 weeks and lasted up to 8 weeks after BNT-B injection. Group C did not show any differences.

          Conclusion

          Local injection of 1,500 units of BNT-B into salivary glands under ultrasonic guidance proved to be a safe and effective dose for drooling in patient with brain lesion, as did 2,500 units.

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          Most cited references18

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          Electrical stimulation for swallowing disorders caused by stroke.

          An estimated 15 million adults in the United States are affected by dysphagia (difficulty swallowing). Severe dysphagia predisposes to medical complications such as aspiration pneumonia, bronchospasm, dehydration, malnutrition, and asphyxia. These can cause death or increased health care costs from increased severity of illness and prolonged length of stay. Existing modalities for treating dysphagia are generally ineffective, and at best it may take weeks to months to show improvement. One common conventional therapy, application of cold stimulus to the base of the anterior faucial arch, has been reported to be somewhat effective. We describe an alternative treatment consisting of transcutaneous electrical stimulation (ES) applied through electrodes placed on the neck. Compare the effectiveness of ES treatment to thermal-tactile stimulation (TS) treatment in patients with dysphagia caused by stroke and assess the safety of the technique. In this controlled study, stroke patients with swallowing disorder were alternately assigned to one of the two treatment groups (TS or ES). Entry criteria included a primary diagnosis of stroke and confirmation of swallowing disorder by modified barium swallow (MBS). TS consisted of touching the base of the anterior faucial arch with a metal probe chilled by immersion in ice. ES was administered with a modified hand-held battery-powered electrical stimulator connected to a pair of electrodes positioned on the neck. Daily treatments of TS or ES lasted 1 hour. Swallow function before and after the treatment regimen was scored from 0 (aspirates own saliva) to 6 (normal swallow) based on substances the patients could swallow during a modified barium swallow. Demographic data were compared with the test and Fisher exact test. Swallow scores were compared with the Mann-Whitney U test and Wilcoxon signed-rank test. The treatment groups were of similar age and gender (p > 0.27), co-morbid conditions (p = 0.0044), and initial swallow score (p = 0.74). Both treatment groups showed improvement in swallow score, but the final swallow scores were higher in the ES group (p > 0.0001). In addition, 98% of ES patients showed some improvement, whereas 27% of TS patients remained at initial swallow score and 11% got worse. These results are based on similar numbers of treatments (average of 5.5 for ES and 6.0 for TS, p = 0.36). ES appears to be a safe and effective treatment for dysphagia due to stroke and results in better swallow function than conventional TS treatment.
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            A double-blind placebo-controlled trial of botulinum toxin B for sialorrhea in Parkinson's disease.

            Injections of botulinum toxin A are an effective treatment for sialorrhea in Parkinson's disease (PD). Based on the relatively high rates of dry mouth seen with botulinum toxin B, there is reason to suspect that it may also improve sialorrhea. To determine whether botulinum toxin B (Myobloc; Elan Pharmaceuticals, New York, NY) is a safe and effective treatment for sialorrhea in patients with PD. Demographics, PD treatments, head posture, the Unified Parkinson's Disease Rating Scale (UPDRS), two questionnaires regarding drooling, Visual Analogue Scale, global impressions, salivary gland imaging, and a dysphagia questionnaire were assessed in 16 PD subjects with problematic sialorrhea. Patients were then randomized to receive either botulinum toxin B (1,000 units into each parotid gland and 250 units into each submandibular gland) or a pH-matched placebo, using only anatomic landmarks. Patients returned 1 month later to undergo an identical assessment. Compared with placebo, those randomized to drug reported improvement on the Visual Analogue Scale (p < 0.001), global impressions of change (p < 0.005), Drooling Rating Scale (p < 0.05), and Drooling Severity and Frequency Scale (p < 0.001). There was no change in UPDRS, head posture, or Dysphagia Scale. Adverse events were mild and included dry mouth (three patients), worsened gait (two), diarrhea (one), and neck pain (one) in the botulinum toxin B group. Anatomically guided injections of botulinum toxin B into the parotid and submandibular glands appear to effectively improve sialorrhea without compromising dysphagia in patients with PD.
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              Salivary production in Parkinson's disease.

              Hypersialorrhea is a common phenomenon in Parkinson disease (PD). The objective of this study was to determine whether patients with PD had an abnormally increased production of saliva and whether the production of saliva could be associated to factors related to either the disease characteristics or to its treatment. A total of 83 patients with PD and 55 control subjects participated in this study. Because of the age difference between the two groups, comparisons were made on a +/-2-year age-matched sample of 44 PD patients and 44 control subjects. PD patients produced significantly less saliva than control subjects. Correlations were obtained with the 83 PD patients between unstimulated salivary flow and patients characteristics. When controlling for age, sex, and Hoehn and Yahr scale, decreased production of saliva correlated significantly with the dose of levodopa and the symptoms of xerostomia. When controlling for medications, there was no relationship between the production of saliva and the evolution of the disease. This study shows that patients with PD produce less saliva than normal. Factors influencing the production of saliva include the use of levodopa and female gender. Our results may have implications for the treatment of drooling in PD. Copyright 2004 Movement Disorder Society.
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                Author and article information

                Journal
                Ann Rehabil Med
                Ann Rehabil Med
                ARM
                Annals of Rehabilitation Medicine
                Korean Academy of Rehabilitation Medicine
                2234-0645
                2234-0653
                December 2012
                28 December 2012
                : 36
                : 6
                : 841-848
                Affiliations
                Department of Physical Medicine and Rehabilitation, Seoul Medical Center, Seoul 131-130, Korea.
                Author notes
                Corresponding author: Hyo Jae Kim. Department of Physical Medicine and Rehabilitation, Seoul Medical Center, 156, Sinnae-ro, Jungnang-gu, Seoul 131-130, Korea. Tel: +82-2-2276-7474, Fax: +82-2-2276-8504, amaranth@ 123456hanmail.net
                Article
                10.5535/arm.2012.36.6.841
                3546188
                23342318
                ac4c5a4c-df03-44ba-a7a9-3876f89233eb
                Copyright © 2012 by Korean Academy of Rehabilitation Medicine

                This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 10 May 2012
                : 19 August 2012
                Categories
                Original Article

                Medicine
                botulinum toxin,drooling,brain lesion,ultrasound,submandibular gland
                Medicine
                botulinum toxin, drooling, brain lesion, ultrasound, submandibular gland

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