Department of Oral and Maxillofacial Surgery, Nara Medical University, Kashihara, Japan
Institute for Clinical Translational Science, Nara Medical University, Kashihara, Japan.
BMJ Open. 2023 Aug 16;13(8):e074279. doi: 10.1136/bmjopen-2023-074279.
Oral lichen planus (OLP) is a chronic, inflammatory oral condition leading to a range of symptoms from mild discomfort to severe pain, affecting patients' quality of life. Standard therapy involves the use of topical corticosteroids, although some patients respond insufficiently or develop resistance to therapy. We aim to explore if adding cepharanthine, an herbal extract from Hayata, can enhance the efficacy of corticosteroid therapy in symptomatic OLP.
This open-label, parallel-group, multi-centre, randomised controlled study will be conducted at three Japanese hospitals. It will compare safety and efficacy of integrated oral cepharanthine and corticosteroid therapy versus standard corticosteroid therapy. 50 symptomatic OLP patients will be randomised 1:1 to receive cepharanthine (30 mg/day) plus topical dexamethasone, or topical dexamethasone alone for 8 weeks. The primary outcome will be changed in pain intensity while drinking room-temperature water, measured on a visual analogue scale. The primary outcome is the change in pain intensity from baseline when drinking room-temperature water, evaluated using a visual analogue scale. Secondary outcomes are changes in the longest diameter of the target lesion from baseline to weeks 4 and 8, improvement and deterioration rates according to appearance and severity criteria at weeks 4 and 8, change in pain intensity when drinking room-temperature water from baseline to week 4, changes in pain intensity at rest from baseline to weeks 4 and 8, and the rates of adverse events.
This protocol was approved by the Certified Review Board of Nara Medical University (CRB5200002). Participants will provide informed consent. Results will be disseminated in peer-reviewed journals and conferences.
Japan Registry of Clinical Trials (jRCTs051220130).
口腔扁平苔藓（OLP）是一种慢性炎症性口腔疾病，可引起从轻度不适到严重疼痛等各种症状，影响患者的生活质量。标准治疗包括局部皮质类固醇的应用，尽管一些患者反应不足或对治疗产生耐药性。我们旨在探讨添加 Cephalanthine（来自 Hayata 的一种草药提取物）是否可以增强皮质类固醇治疗有症状的 OLP 的疗效。
这是一项在日本三家医院进行的开放标签、平行组、多中心、随机对照研究，将比较综合口腔 Cephalanthine 和皮质类固醇治疗与标准皮质类固醇治疗的安全性和疗效。将 50 名有症状的 OLP 患者随机 1:1 分为接受 Cephalanthine（30mg/天）加局部地塞米松或局部地塞米松单独治疗 8 周。主要结局是测量时饮用室温水的疼痛强度变化，采用视觉模拟评分法。主要结局是饮用室温水时疼痛强度从基线的变化，采用视觉模拟评分法评估。次要结局是从基线到第 4 周和第 8 周目标病变最长直径的变化，第 4 周和第 8 周时根据外观和严重程度标准的改善和恶化率，第 4 周时饮用室温水时疼痛强度的变化，从基线到第 4 周和第 8 周时休息时疼痛强度的变化，以及不良事件的发生率。
该方案已获得奈良医科大学认证审查委员会（CRB5200002）的批准。参与者将提供知情同意。结果将在同行评议的期刊和会议上发表。
日本临床试验注册（jRCTs051220130）。
