Letters 1680 Am J Health-Syst Pharm—Vol 68 Sep 15, 2011 Severity of drooling score b Frequency of drooling score d Total drooling score Unstimulated whole saliva test flow rate (mL/5 min) 4.2 ± 0.6 1.8 ± 0.6 (–57.4 ± 12.9) 2.0 ± 0.8 (–46.3 ± 20.4) c 3.8 ± 0.4 1.7 ± 0.5 (–54.9 ± 13.1) 2.0 ± 0.9 (–44.2 ± 22.6) c 8.0 ± 0.9 3.5 ± 1.0 (–56.2 ± 12.5) 4.0 ± 1.7 (–49.7 ± 20.3) c 2.5 ± 1.2 0.2 ± 1.4 (–81.6 ± 9.2) 0.2 ± 0.7 (–77.1 ± 17.3) e a Wilcoxon signed rank test and Student’s t test were used for nonparametric and parametric paired samples, respectively, using SPSS software, version 12.0 (SPSS Inc., Chicago, IL). The a priori level of significance was set at 0.05. b Scale of 1 (dry) to 5 (profuse). c p < 0.004. d Scale of 1 (never) to 4 (constant). e p < 0.001. Drooling Scores and Saliva Flow Before and After Bilateral Submandibular Gland Injection Variable Mean ± S.D. Value (Mean ± S.D. % Reduction from Baseline) a Baseline Week 4 Week 12 Manually guided botulinum toxin type A submandibular injections for the treatment of sialorrhea in tube-fed patients with advanced amyotrophic lateral sclerosis Ireland, Westport, Ireland) was diluted in 1 mL of 0.9% sodium chloride injection, under aseptic conditions at the pharmacy service, and dispensed in insulin syringes at a final Clostridium botulinum toxin type A concentration of 10 units/0.1 mL. Submandibular glands were iden- tified by simple direct hand palpation, and each set of glands were transcutane- ously injected with a C. botulinum toxin type A dose of 40 units using an ultra- fine (25-gauge) needle. Submandibular glands were chosen because they con- tribute 70% of the whole salivary basal flow, which predominates in artificially tube-fed patients. Treatment effects were assessed at weeks 4 and 12 after injection, using both subjective clinical scales 6 (drooling severity and drooling frequency scales) routinely used in most sialorrhea studies and a quantitative measure of saliva flow (milliliters per five minutes). 7 Intraglandular botulinum toxin type A (40 units) induced a marked and statis- tically significant reduction in all drool- ing parameters at week 4, which was maintained up to week 12 (table). The magnitude of the reduction of the total drooling subjective score approached ap- proximately 50% of baseline values. Sali- vary flow was reduced by a mean ± S.D. percentage of 81% ± 9.21%. The effect was observed in all but one patient and was maintained up to week 12 after injec- tion. No xerostomia, dysphagia, or other potential adverse effects were reported Continued from page 1679 A pproximately 50% of patients with amyotrophic lateral sclerosis (ALS) develop sialorrhea and drooling. 1 This condition causes soiling and damage of clothing, facial skin maceration, lo- cal bacterial infections, and loss of self- esteem and quality of life. Moreover, when it is accompanied by difficulties in swal- lowing, it may evoke salivary aspiration and choking—a significant cause of mor- bidity and distress in patients with ALS. 2 Traditional pharmacologic treatments (e.g., atropine, glycopyrrolate, amitripty- line) are not effective in a large percentage of patients 1 and induce frequent, severe adverse effects (e.g., blurred vision, con- fusion, cardiac abnormalities, xerosto- mia). Other aggressive approaches, such as surgical and radiological procedures, have yielded conflicting results. 3,4 Botulinum neurotoxins, traditionally used for the treatment of muscular dys- tonia and spasticity, have been introduced as a treatment to reduce salivary produc- tion due to their temporal anticholiner- gic blockade action on saliva secretion. The use of botulinum neurotoxins in the treatment of sialorrhea under a va- riety of conditions (i.e., various brands, dosage ranges, glands injected, and ap- plication techniques) has been described with promising results and minor or no adverse effects. 5 We describe the feasibil- ity of a simple botulinum toxin type A dosage regimen in patients with advanced ALS who are artificially fed via a percuta- neous gastrostomy tube due to advanced dysphagia and severe drooling refractory to traditional pharmacologic treatments. Ten patients (four men; mean ± S.D. age of 68.5 ± 12.2 years), diagnosed with ALS at a mean ± S.D. time before study inclusion of 20.9 ± 2.23 months and complaining of severe distressing drool- ing for a mean ± S.D. duration of 6 ± 2 months before receiving an injection, were recruited between October 2008 and February 2010 from among consecu- tive outpatients admitted to our clinical nutrition facility in the pharmacy depart- ment. All patients included in the study had not responded to previous standard pharmacotherapy, including amitripty- line hydrochloride (75 mg once daily) and ipratropium bromide (0.03% nasal solution, two sprays under the tongue twice daily). Patients were treated under compassionate-use conditions and gave their written consent. Botulinum toxin type A (Botox, Allergan Pharmaceuticals