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Clinical Trial ARTICLE Provisionally accepted The full-text will be published soon. Notify me

Front. Pharmacol. | doi: 10.3389/fphar.2019.00939

Does CoQ10 and Vitamin A supplementation support voice rehabilitation? A double-blind, randomized, controlled, three-period cross-over pilot study.

 Giovanni Ruoppolo1*, Lucia Longo1, Patrizia Pescerelli1, Chiara Mango1, Maria Nicastri2, Flavia Flaccadoro1,  Patrizia Mancini1, Antonio Greco1 and Marco De Vincentiis1
  • 1Sapienza University of Rome, Italy
  • 2Policlinico Umberto I, Italy

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. 12-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-minute voice therapy in a group format once a day for four 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 towards 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 towards 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.

Keywords: CoQ10, Vitamin A, Muscle tension dysphonia, Voice rehabilitation, Dysphonia Severity Index

Received: 28 Feb 2019; Accepted: 22 Jul 2019.

Copyright: © 2019 Ruoppolo, Longo, Pescerelli, Mango, Nicastri, Flaccadoro, Mancini, Greco and De Vincentiis. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Prof. Giovanni Ruoppolo, Sapienza University of Rome, Rome, 00185, Lazio, Italy, giovanni.ruoppolo@uniroma1.it