光生物调节联合口服冷冻疗法治疗灼口综合征患者口腔黏膜疼痛的疗效与安全性：一项多机构、随机、对照试验

Efficacy and safety of photobiomodulation combined with oral cryotherapy on oral mucosa pain in patients with burning mouth syndrome: a multi-institutional, randomized, controlled trial.

作者信息

Lu Chenghui, Zhou Xuan, Yang Chenglong, Jiang Xinxiang, Li Xin, Huang Zefan, Du Qing, Tang Guoyao

机构信息

Department of Stomatology, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Core Unit of National Clinical Research Center for Oral Diseases, Shanghai, 200092, China.

Department of Oral Medicine, The Affiliated Stomatology Hospital of Guilin Medical University, Guilin, 541004, China.

出版信息

BMC Med. 2025 Apr 7;23(1):196. doi: 10.1186/s12916-025-04015-z.

DOI:10.1186/s12916-025-04015-z

PMID:40189502

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11974006/

Abstract

BACKGROUND

The prevalence of burning mouth syndrome (BMS) is approximately 8% in clinical patients; thus, BMS remains a therapeutic challenge. Photobiomodulation (PBM) and oral cryotherapy (OCT) have been evaluated for the treatment of burning pain, but no confirmatory trials have been performed. To evaluate the comparative effectiveness of PBM combined with OCT at reducing pain and psychological distress compared with PBM alone, OCT alone, or drug therapy (DT) alone in a cohort of patients with BMS.

METHODS

This multi-institutional, single-blinded (assessor-blinded), randomized controlled trial with 4 treatment groups was conducted at Xinhua Hospital, Shanghai Jiao Tong University School of Medicine and Affiliated Stomatology Hospital of Guilin Medical University from December 12, 2022, to January 24, 2024. Among the 156 patients assessed for eligibility, 28 were excluded, and 128 patients with a BMS qualified for randomization to 1 of the 4 treatment groups. The participants received 7 treatment sessions of (1) PBM combined with OCT, (2) PBM, (3) OCT, or (4) DT during a 7-week period. The coprimary outcome measures were changes in visual analogue scale (VAS) scores and the overall response rate between baseline and 7 weeks of treatment.

RESULTS

After 7 weeks of treatment, the PBM + OCT group achieved a high overall response rate for pain reduction (81.25%). This difference in pain reduction trends between the groups resulted in a nearly fivefold greater mean change in the VAS score at the 12-week assessment for the PBM + OCT group than for the DT group (p < 0.0083). Furthermore, anxiety symptoms were also significantly alleviated by PBM combined with OCT, resulting in a nearly tenfold greater mean change in the GAD-7 score at the 7-week assessment in the PBM + OCT group than in the DT group (p < 0.0083). No severe adverse events were reported during the study period.

CONCLUSIONS

PBM and OCT combination therapy reduces oral mucosa pain and alleviates anxiety symptoms in patients with BMS; thus, this combination therapy is expected to become a promising pain management option for patients with BMS.

TRIAL REGISTRATION

Chinese Clinical Trial Registry Identifier: ChiCTR2300074518.

摘要

背景

灼口综合征（BMS）在临床患者中的患病率约为8%；因此，BMS仍然是一个治疗难题。光生物调节（PBM）和口腔冷冻疗法（OCT）已被评估用于治疗灼痛，但尚未进行确证性试验。本研究旨在评估在一组BMS患者中，与单独使用PBM、单独使用OCT或单独药物治疗（DT）相比，PBM联合OCT在减轻疼痛和心理困扰方面的相对有效性。

方法

本多机构、单盲（评估者盲法）、随机对照试验于2022年12月12日至2024年1月24日在上海交通大学医学院新华医院和桂林医学院附属口腔医院进行，共设4个治疗组。在156名评估合格的患者中，28名被排除，128名BMS患者被随机分配至4个治疗组之一。参与者在7周内接受7次治疗，治疗方式分别为：（1）PBM联合OCT，（2）PBM，（3）OCT，或（4）DT。共同主要结局指标为基线至治疗7周期间视觉模拟量表（VAS）评分的变化以及总体缓解率。

结果

治疗7周后，PBM + OCT组在减轻疼痛方面取得了较高的总体缓解率（81.25%）。各治疗组之间疼痛减轻趋势的差异导致在12周评估时，PBM + OCT组的VAS评分平均变化比DT组大近五倍（p < 0.0083）。此外，PBM联合OCT也显著缓解了焦虑症状，在7周评估时，PBM + OCT组的广泛性焦虑量表（GAD-7）评分平均变化比DT组大近十倍（p < 0.0083）。研究期间未报告严重不良事件。