Vortioxetine versus SSRI/SNRI with Pregabalin Augmentation in Treatment-Resistant Burning Mouth Syndrome: A Prospective Clinical Trial.

IF 4.8 2区医学 Q1 NEUROSCIENCES

Current Neuropharmacology Pub Date : 2025-01-01 DOI:10.2174/1570159X22999240729103717

Daniela Adamo, Federica Canfora, Giuseppe Pecoraro, Stefania Leuci, Noemi Coppola, Gaetano Marenzi, Giulia Ottaviani, Katia Rupel, Luca Pellegrini, Massimo Aria, Luca D'Aniello, Michele Davide Mignogna, Umberto Albert

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引用次数: 0

Abstract

Objectives: The treatment of Burning Mouth Syndrome (BMS) represents a challenge in tailoring appropriate medication for individual patients. The augmentation of pregabalin to conventional treatment has shown promising outcomes in relieving pain and improving the quality of life in chronic pain conditions. This study aimed to compare the efficacy of vortioxetine with other antidepressants (SSRIs/SNRIs) in combination with pregabalin in a cohort of unresponsive BMS patients and to predict treatment response by using clinical data.

Methods: A 52-week randomized, open-label, comparative clinical study was conducted, enrolling 203 BMS patients previously treated with one antidepressant for 12 weeks and non-responders to the treatment (clinical trial registration: NCT06025474). The study sample included two groups: Group A (136) received vortioxetine, while Group B (67) received SSRIs/SNRIs. Pregabalin (75 mg/day) was added to both groups, with a potential dosage increase to 150 mg/day for inadequate responders after 12 weeks. Treatment response was assessed with VAS and SF-MPQ, HAM-A, and HAM-D scores at 12, 24, 36, and 52 weeks. Stepwise logistic regression analysis was used to predict treatment response.

Results: A total of 84 (61.8%) BMS patients in Group A and 39 (58.2%) in Group B showed treatment response. Group A reported a faster onset of action compared to Group B (44.8% versus 22.4% at time 1; p:0.002**) and lower adverse event rates (8.8% versus 20.8%; p:0.001).

Conclusion: The addition of pregabalin to vortioxetine may be considered a potential treatment option for BMS. Further research is required to corroborate these findings and optimize personalized treatment approaches for BMS patients.

Clinical trial registration number: ClinicalTrials.gov (NCT06025474).

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目的：口腔烧灼综合征（BMS）的治疗是一项挑战，需要为不同患者量身定制合适的药物。在常规治疗的基础上加用普瑞巴林（pregabalin），在缓解疼痛和改善慢性疼痛患者的生活质量方面取得了可喜的成果。本研究旨在比较伏替西汀与其他抗抑郁药（SSRIs/SNRIs）联合普瑞巴林在一组无反应的 BMS 患者中的疗效，并通过临床数据预测治疗反应：进行了一项为期 52 周的随机、开放标签、对比临床研究，共招募了 203 名曾接受一种抗抑郁药治疗 12 周且对治疗无应答的 BMS 患者（临床试验注册号：NCT06025474）。研究样本包括两组：A 组（136 人）接受伏替西汀治疗，B 组（67 人）接受 SSRIs/SNRIs 治疗。两组患者均加用普瑞巴林（75 毫克/天），12 周后疗效不佳者可将剂量增加到 150 毫克/天。治疗反应通过 12、24、36 和 52 周的 VAS 和 SF-MPQ、HAM-A 和 HAM-D 评分进行评估。采用逐步逻辑回归分析预测治疗反应：A组共有84名（61.8%）BMS患者出现治疗反应，B组有39名（58.2%）患者出现治疗反应。与 B 组相比，A 组起效更快（1 时为 44.8% 对 22.4%；P:0.002**），不良反应发生率更低（8.8% 对 20.8%；P:0.001）：结论：在伏替西汀中添加普瑞巴林可被视为BMS的一种潜在治疗方案。临床试验注册号：ClinicalTrials.gov：临床试验注册号：ClinicalTrials.gov (NCT06025474)。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Current Neuropharmacology 医学-神经科学

CiteScore

8.70

自引率

1.90%

发文量

369

审稿时长

>12 weeks

期刊介绍： Current Neuropharmacology aims to provide current, comprehensive/mini reviews and guest edited issues of all areas of neuropharmacology and related matters of neuroscience. The reviews cover the fields of molecular, cellular, and systems/behavioural aspects of neuropharmacology and neuroscience. The journal serves as a comprehensive, multidisciplinary expert forum for neuropharmacologists and neuroscientists.