Gopinath Divya, Hui Lai Mong, Veettil Sajesh K, Balakrishnan Nair Athira, Maharajan Mari Kannan
Clinical Oral Health Sciences, International Medical University, Kuala Lumpur 57000, Malaysia.
School of Postgraduate Studies, International Medical University, Kuala Lumpur 57000, Malaysia.
J Pers Med. 2022 Aug 1;12(8):1272. doi: 10.3390/jpm12081272.
Oral submucous fibrosis (OSMF) is a chronic premalignant condition and is characterized by fibroblastic change of lamina propria and stiffness of oral mucosa. Though there are several treatment options available, the best agent is not yet identified. This study assessed the comparative efficacy and safety of medical interventions in the management of OSMF. A systematic review was performed to identify randomized controlled trials (RCTs) that compared the efficacy of interventions for OSMF with each other, or placebo. A network meta-analysis was performed, and the interventions were ranked according to their efficacy based on the surface under the cumulative ranking. (PROSPERO Registration no: CRD42021255094). Thirty-two RCTs comprising 2063 patients were eligible for quantitative analysis. In terms of therapeutic efficacy in the improvement of mouth opening Oxitard, a herbal formulation was ranked as the most efficacious agent, [MD, 10.29 (95%CI 6.34-14.25)] followed by combination therapy of Lycopene with corticosteroids and hyaluronidase [MD, 7.07 (95%CI 1.82-12.31)]. For improvement of burning sensation aloe vera was ranked first [MD, 6.14 (95%CI 4.58-7.70)] followed by corticosteroids with antioxidants [MD, 6.13 (95%CI 4.12-8.14)] and corticosteroids in combination with hyaluronidase with antioxidants [MD, 5.95 (95%CI 3.79-8.11)]. In terms of safety, most of the drugs were reported to cause mild adverse effects only. Significant inconsistencies could be identified in the analysis for both the outcomes assessed and were further explored. Our study highlighted the potential efficacy of several agents over placebo in the improvement of mouth opening and burning sensation in OSMF patients. However, the RCTs lacked methodological soundness. Well-designed studies with a larger number of participants with a rigorous randomization process and stringent methodology are recommended to strengthen the results obtained, which may help to construct a clinical guideline for OSMF management.
口腔黏膜下纤维化（OSMF）是一种慢性癌前病变，其特征在于固有层的成纤维细胞变化和口腔黏膜的僵硬。尽管有几种治疗选择，但最佳药物尚未确定。本研究评估了医学干预措施在OSMF管理中的比较疗效和安全性。进行了一项系统评价，以确定将OSMF干预措施相互比较或与安慰剂比较疗效的随机对照试验（RCT）。进行了网络荟萃分析，并根据累积排名曲线下面积按疗效对干预措施进行排名。（PROSPERO注册号：CRD42021255094）。32项包含2063名患者的RCT符合定量分析要求。在改善张口方面，草药配方Oxitard被列为最有效的药物，[平均差（MD），10.29（95%置信区间6.34 - 14.25）]，其次是番茄红素与皮质类固醇和透明质酸酶的联合治疗[MD，7.07（95%置信区间1.82 - 12.31）]。在改善灼痛方面，芦荟排名第一[MD，6.14（95%置信区间4.58 - 7.70）]，其次是皮质类固醇与抗氧化剂[MD，6.13（95%置信区间4.12 - 8.14）]以及皮质类固醇与透明质酸酶和抗氧化剂联合使用[MD，5.95（95%置信区间3.79 - 8.11）]。在安全性方面，据报道大多数药物仅引起轻微不良反应。在所评估的两个结果分析中都发现了显著的不一致性，并进一步进行了探讨。我们的研究强调了几种药物相对于安慰剂在改善OSMF患者张口和灼痛方面具有潜在疗效。然而，这些RCT缺乏方法学上的严谨性。建议进行设计良好、参与者数量更多、随机化过程严格且方法学严谨的研究，以加强所得结果，这可能有助于构建OSMF管理的临床指南。
