Quantitative assessment of oral phase efficiency: validation of the Test of Masticating and Swallowing Solids (TOMASS).

BACKGROUND: The Test of Masticating and Swallowing Solids (TOMASS) has been developed to provide clinicians with objective data regarding the efficiency of oral phase function and solid bolus ingestion. AIMS: To determine if the TOMASS will detect changes in the oral phase of swallowing imposed by topical anaesthesia, thus providing validation of its clinical utility. METHODS & PROCEDURES: Per the standard protocol, 10 healthy participants ate one-quarter of an Arnotts SaladaTM biscuit. The number of bites per cracker, number of masticatory cycles, number of swallows and total time taken were recorded at baseline, following application of topical oral anaesthetic; this was additionally compared with a post-anaesthetic condition. Median and interquartile range (IQR) were calculated. Wilcoxon signed-rank tests were conducted to evaluate trial effect, and Friedman's tests were used to detect differences in the number of bites, number of swallows, number of chews and time taken to eat the crackers. OUTCOMES & RESULTS: Results indicated that the number of both bites and swallows did not significantly change across conditions (χ²(2) = 0.105, p = 0.949, χ²(2) = 1.357, p = 0.507); however, the number of chews for the anaesthetic condition was significantly higher when compared with the baseline (p = 0.02) and post-anaesthesia conditions (p = 0.02). Further, the durations of ingestion in the anaesthetic condition were significantly longer than the baseline (p = 0.01) and post-anaesthesia (p = 0.01) conditions. Across all measures, there were no differences between baseline and post-anaesthesia conditions. CONCLUSIONS & IMPLICATIONS: Although further exploration is required, these early data suggest the TOMASS is a sensitive measure in the evaluation of the oral-phase preparation of solid textures.

Utility of the sore throat pain model in a multiple-dose assessment of the acute analgesic flurbiprofen: a randomized controlled study.

BACKGROUND: The sore throat pain model has been conducted by different clinical investigators to demonstrate the efficacy of acute analgesic drugs in single-dose randomized clinical trials. The model used here was designed to study the multiple-dose safety and efficacy of lozenges containing flurbiprofen at 8.75 mg. METHODS: Adults (n=198) with moderate or severe acute sore throat and findings of pharyngitis on a Tonsillo-Pharyngitis Assessment (TPA) were randomly assigned to use either flurbiprofen 8.75 mg lozenges (n=101) or matching placebo lozenges (n=97) under double-blind conditions. Patients sucked one lozenge every three to six hours as needed, up to five lozenges per day, and rated symptoms on 100-mm scales: the Sore Throat Pain Intensity Scale (STPIS), the Difficulty Swallowing Scale (DSS), and the Swollen Throat Scale (SwoTS). RESULTS: Reductions in pain (lasting for three hours) and in difficulty swallowing and throat swelling (for four hours) were observed after a single dose of the flurbiprofen 8.75 mg lozenge (P<0.05 compared with placebo). After using multiple doses over 24 hours, flurbiprofen-treated patients experienced a 59% greater reduction in throat pain, 45% less difficulty swallowing, and 44% less throat swelling than placebo-treated patients (all P<0.01). There were no serious adverse events. CONCLUSIONS: Utilizing the sore throat pain model with multiple doses over 24 hours, flurbiprofen 8.75 mg lozenges were shown to be an effective, well-tolerated treatment for sore throat pain. Other pharmacologic actions (reduced difficulty swallowing and reduced throat swelling) and overall patient satisfaction from the flurbiprofen lozenges were also demonstrated in this multiple-dose implementation of the sore throat pain model. TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov, registration number: NCT01048866, registration date: January 13, 2010.

The point-touch technique for botulinum toxin injection in adductor spasmodic dysphonia: quality of life assessment.

BACKGROUND: Botulinum toxin injection under electromyographic guidance is the 'gold standard' for adductor spasmodic dysphonia treatment. The point-touch technique, an alternative injection method which relies on anatomical landmarks, is cheaper, quicker and more accessible, but has not yet gained widespread acceptance due to concerns about patient satisfaction. OBJECTIVE: To assess swallowing and voice-related quality of life following point-touch botulinum toxin injection in adductor spasmodic dysphonia patients. SETTING: Stanford University Voice and Swallowing Center. DESIGN: Prospective case series (evidence level four). METHODS: Consecutive adductor spasmodic dysphonia patients with a stable botulinum toxin dose-response relationship were recruited prospectively. The Eating Assessment Tool and Voice-Related Quality of Life questionnaires were completed pre-treatment and at 10 and 30 per cent completion of the injection cycle, respectively. RESULTS: Thirty-seven patients completed follow up. The mean total botulinum toxin dose was 0.88 units. Pre-treatment Voice-Related Quality of Life questionnaire results reflected the burden of disease. Post-treatment Eating Assessment Tool and Voice-Related Quality of Life questionnaire results were collected at 2.53 and 7.84 weeks, respectively; the former showed an increase in dysphagia, albeit statistically insignificant, while the latter showed significantly improved scores (both domain and total). CONCLUSION: The point-touch technique is a viable alternative for botulinum toxin injection in the treatment of adductor spasmodic dysphonia.

Objective assessment of swallowing function after definitive concurrent (chemo)radiotherapy in patients with head and neck cancer.

The aim of this study was to objectively assess swallowing function and factors impacting it after curative intent definitive (chemo)radiotherapy (CRT) for head and neck squamous cell carcinoma (HNSCC). Swallowing function was studied in a cohort of 47 patients with locoregionally advanced (T1-4, N0-3) HNSCC treated with definitive CRT. Objective assessment of swallowing function was done using modified barium swallow (MBS) at baseline (pre-CRT) and subsequent follow-ups. Scoring of MBS was done using penetration-aspiration scale (PAS). Abnormal swallowing was defined in terms of incidence and severity of penetration-aspiration, pharyngeal residue, postural change, and regurgitation. Aspiration, residual, postural change, and regurgitation were present on baseline pre-CRT assessment in 9 (19%), 11 (23%), 10 (21%), and 5 (10%) patients that increased to 11 (29%), 11 (29%), 12 (32%), and 10 (26%) patients, respectively, at 6-month post-CRT evaluation. The proportion of patients with high PAS scores (3-7) increased from 27% at baseline to 37% at 6-month post-CRT evaluation. Among patients (n = 34) with low PAS scores (≤2) at baseline, additional impairment of swallowing function was seen in 53 and 46% at 2- and 6-month assessment, respectively. Residue (44%) and aspiration (18%) domains were impaired in a higher proportion of patients after CRT. Thin and thick barium had higher aspiration and residue function impairment, respectively. Patients with pre-CRT poor subjective swallowing function (P = 0.004), hypopharyngeal primary (P = 0.05), and large tumor volume (P = 0.05) had significantly worse objective swallowing function at baseline as demonstrated by pretreatment PAS scores. This study provides useful information regarding patterns of objective swallowing dysfunction in patients treated with definitive (chemo)radiotherapy. There is significant impairment of objective swallowing function in all domains following CRT, with residue and aspiration domains being affected most significantly.

Assessment of the use of sialogogues in the clinical management of patients with xerostomia.

This study was conducted to assess the clinical efficacy and adverse effects of pilocarpine, bethanechol and cevimeline in patients with xerostomia. In this open-label crossover assessment in 20 patients with xerostomia, a one- to two-week course of each medication with a one-week washout period was prescribed. Side effects, symptoms, whole stimulated and unstimulated saliva were measured. Each sialogogue was found to increase saliva and decrease symptoms. A mixed-effects analysis showed a greater increase in stimulated saliva on bethanechol compared to pilocarpine (0.106, p = 0.0272). Increased sweating was the most common side effect, experienced more frequently with pilocarpine as compared to bethanechol (p = 0.0588) or cevimeline (p = 0.0143). A carryover effect beyond the washout period was seen. Effects on saliva and side effects vary between sialogogues, suggesting a benefit of trials with different sialogogues to determine individual patient preference. The observed carryover effect suggests that intermittent treatment may be an alternative to continuous treatment with sialogogues.

Assessment of swallowing function in patients with head and neck cancer.

Difficulty in swallowing is a common complaint among patients with head and neck cancer. Preexistent dysphagia is often compounded by any of the side effects and sequelae of the current treatment modalities for malignancies of the head and neck. Surgery, radiotherapy, and chemoradiotherapy produce sensory and motor denervation and fibrosis of the upper aerodigestive tract musculature and mucosa. Clinicians must learn to anticipate and identify the various deficits of swallowing function in these patients. Flexible fiberoptic evaluation of swallowing and the modified barium swallow are critical tests for delineating the pathophysiology of these patients and establishing a protocol for their rehabilitation. Rehabilitation for patients with swallowing disorders decreases the morbidity of aspiration and allows for better nutrition, better hydration, and overall improvement in quality of life.