Oral Corticosteroids in Vocal Fold Paralysis After Thyroid Surgery: A Randomized Clinical Trial.

IMPORTANCE

There is no consensus in the field for the management of postthyroidectomy unilateral vocal fold paralysis (VFP). In cases where recurrent laryngeal nerve transection is not present, a local inflammatory process is thought to cause VFP. The findings suggest that corticosteroids may have a beneficial effect in managing this phenomenon.

OBJECTIVE

To evaluate the efficacy of a 7-day oral corticosteroid treatment on vocal cord remobilization in patients with unilateral VFP after thyroidectomy or parathyroid surgery.

DESIGN, SETTING, AND PARTICIPANTS: This prospective randomized double-blind placebo-controlled trial was conducted between September 2018 and May 2023 at a tertiary referral hospital. Patients who underwent partial or total thyroidectomy or parathyroid surgery were included. Exclusion criteria included corticosteroid intolerance, prior cervical surgery or radiotherapy, surgery performed for a malignant tumor and multinodular intrathoracic goiters.

INTERVENTIONS

At baseline, an inclusion visit assessed vocal cord mobility via nasofibroscopy and voice quality using the GRBAS (grade, roughness, breathiness, asthenia, strain) scale. Postoperative assessments were performed the day after surgery to identify unilateral VFP. Patients with unilateral VFP were randomized to receive either a 7-day course of oral corticosteroids or a placebo.

MAIN OUTCOMES AND MEASURES

At 7 days, 1 month, and 3 months, nasofibroscopic evaluation and GRBAS scale assessment were performed to monitor vocal fold remobilization and voice quality. All analyses were intention to treat.

RESULTS

Of the 468 patients included, 26 (5.6%) developed unilateral VFP and were randomized (19.2% male; 80.8% female; median age, 68 [IQR, 62.5-73.0] years in corticosteroid group and 59 [IQR, 52.5-73.0] years in placebo group). By day 7, vocal cord remobilization occurred in 42.8% (6 of 14) of the corticosteroid group and 41.6% (5 of 12) of the placebo group (proportion difference, 1.2%; 95% CI -32.8% to 34.4%). GRBAS results showed no meaningful difference in pathological items between groups at any time point.

CONCLUSION AND RELEVANCE

Results of this randomized clinical trial suggest that oral corticosteroids do not enhance vocal cord remobilization or improve voice quality in patients with postoperative unilateral VFP. Speech therapy remains essential in the management of postoperative VFP.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT03553342.