Department of Orofacial Pain, Institute of Dental Surgery, Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France.
Department of Orofacial Neurobiology (LabNOF EA7543), Orofacial Pathologies, Imaging and Biotherapies URP2496, Université Paris Cité, Montrouge, France.
Headache. 2024 Oct;64(9):1167-1173. doi: 10.1111/head.14818. Epub 2024 Aug 23.
To evaluate the effectiveness, tolerability, and safety of topical amitriptyline as a potential route of administration for the management of burning mouth syndrome.
Burning mouth syndrome is a complex, idiopathic, and debilitating orofacial pain disorder that impairs quality of life, with a prevalence of up to 18% in menopausal women. Available drugs to alleviate its burning sensation have inconsistent and limited efficacy. Given its physicochemical properties, excellent tolerability, and ability to target peripheral pathways, topical amitriptyline seems a promising mechanistically specific analgesic drug for burning mouth syndrome.
In this retrospective cross-sectional real-world evidence study, patients with burning mouth syndrome who were prescribed topical amitriptyline for 8 weeks were identified. Eligibility criteria stemmed from ICHD-3, ICOP, and consensus definitions. The primary outcome measure was mean daily pain intensity (on a 0-10 scale); secondary outcomes included adverse events and patient global impression of improvement. Data are given as the mean ± SD.
A total of 15 patients fulfilling the eligibility criteria were included and analyzed. Mean daily pain was 6.7 ± 2.1 at baseline and 3.7 ± 2.3 after treatment, with a mean reduction of 3.1 ± 2.8 (p = 0.002). Half of the patients experienced a decrease in pain by at least 50% (p = 0.008). Several mild adverse events were reported, such as somnolence or dry mouth.
Topical amitriptyline may be a safe and potent route of administration in the treatment of burning mouth syndrome, a hypothesis to be tested in further controlled trials.
评估外用阿米替林作为治疗灼口综合征的一种潜在给药途径的有效性、耐受性和安全性。
灼口综合征是一种复杂的、特发性的、使人衰弱的口面疼痛障碍，会损害生活质量，在绝经后妇女中的患病率高达 18%。可缓解其烧灼感的现有药物疗效不一致且有限。鉴于其物理化学性质、良好的耐受性和靶向外周途径的能力，外用阿米替林似乎是一种有前途的、机制特异性的用于治疗灼口综合征的镇痛药。
在这项回顾性、横断面真实世界证据研究中，确定了被处方外用阿米替林治疗 8 周的灼口综合征患者。入选标准源于 ICHD-3、ICOP 和共识定义。主要观察指标为平均每日疼痛强度（0-10 分）；次要观察指标包括不良反应和患者对改善的总体印象。数据以均值±标准差表示。
共纳入并分析了符合入选标准的 15 名患者。基线时平均每日疼痛为 6.7±2.1，治疗后为 3.7±2.3，平均降低 3.1±2.8（p=0.002）。一半的患者疼痛至少减轻了 50%（p=0.008）。报告了一些轻度不良反应，如嗜睡或口干。
外用阿米替林可能是治疗灼口综合征的一种安全且有效的给药途径，这一假设有待进一步的对照试验来验证。
