Abstract
Objectives: To evaluate the effectiveness of an adjuvant therapy (CoQ10 in its water-soluble form and vitamin A) in supporting voice rehabilitation in a large group of patients with muscle tension dysphonia (MTD). Study Design: Twelve-week, double-blind, randomized, controlled, three-period cross-over pilot study. The primary endpoint was the change in the Dysphonia Severity Index (DSI) over the 12-week study period. Secondary endpoints were the changes in the subcomponents of DSI, including MPT, F0-high, I-low, and jitter. Exploratory endpoints were the changes in the Shimmer and in Voice Handicap Index (VHI). Methods: Patients were randomly assigned in a 1:1 ratio to two counter-balanced arms. Group A (ADJ-PLA) patients were administered QTer 300 mg and Vit A acetate 500.000 Ul/g 1 mg twice daily for a 4-week intervention period, followed by a 4-week period of wash-out, and then were submitted to a last 4-week period of placebo. Patients in Group B (PLB-ADJ) were given the treatment period in reverse order. Both groups received a 45-min voice therapy in a group format once a day for 4 weeks during the first and the second active periods. The therapy was held during the wash-out period. Results: The analysis of main time effect indicated a trend toward recovery of vocal function regardless of group assignment. A significant time by group effect was found on DSI [F = 3.4 (2.5, 80.5), p = 0.03], F0-high [F = 4.5 (2.6, 82.9), p = 0.008] and Shimmer [F = 3.6 (1.5, 46.9), p = 0.048], under CoQ10 and Vit A treatment, with a small effect size. There was no significant time by group effect on the other study measures, namely MPT, I-low, VHI. Conclusions: A trend toward recovery of vocal function was observed in all the patients, likely due to voice rehabilitation. The improvement of DSI was greater under CoQ10 and Vitamin treatment, indicating a more pronounced improvement of vocal quality under adjuvant therapy. The study protocol was reviewed and approved by the Ethics Committee of Policlinico Umberto I Hospital, Rome, Italy Rif. 3069/13.02.2014.
Highlights
Functional disorders of voice are frequent in the general population and common among professional voice users
In a study on 2019 patients with dysphonia of different etiologies, functional dysphonia was found in 17% of subjects (Mozzanica et al, 2016), whereas in a Belgic treatment-seeking population, the functional voice disorders were diagnosed in 30% of patients. (Martins et al, 2016)
The main cause of vocal dysfunction has been identified in the increased muscle tension or effort: similar voice pathologies, previously labeled as vocal hyperfunction, hyperkinetic dysphonia, tensionfatigue syndrome, muscle misuse, functional, nonorganic dysphonia, have been grouped together in the broader definition of primary muscle tension dysphonia (MTD) (Roy et al, 2019)
Summary
Functional disorders of voice are frequent in the general population and common among professional voice users. The main cause of vocal dysfunction has been identified in the increased muscle tension or effort: similar voice pathologies, previously labeled as vocal hyperfunction, hyperkinetic dysphonia, tensionfatigue syndrome, muscle misuse, functional, nonorganic dysphonia, have been grouped together in the broader definition of primary muscle tension dysphonia (MTD) (Roy et al, 2019). Voice therapy, aimed both to restore a proper vocal behavior and to treat specific alterations in voice-producing mechanisms, is the first-line treatment of functional voice disorders, even if poor evidence supports its effectiveness (Ruotsalainen et al, 2007). Only one appears in international databases (Sensini et al, 2011)
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