Clinical effectiveness of compounded topical medications in oral medicine: a meta-analysis

Abstract

Aim: To assess the evidence of the efficacy and safety of compounded topical medications in oral medicine cases. Methods: Electronic databases were searched from inception to October 2019 for studies that evaluated compounded topical medications in oral medicine cases to assess their efficacy and safety. Search terms included drug compounding, topical administration, clinical efficacy, and oral lesions. Only randomized controlled trials (RCTs) or cross-over trials of compounded topical drug versus non-compounded drug or placebo or standard treatment were included. The exclusion criteria included compounded topical medications with herbal ingredients in the intervention group to compare with the non-compounded drug. The primary outcome measure was a clinical resolution of the oral lesions. The secondary outcome measure was pain resolution. Adverse events of interventions were discussed. The quality of RCTs was assessed using the Cochrane risk of bias tool (RoB 2.0). The data were synthesised in a fixed-effect model using RevMan 5. The evidence across studies for an outcome and decision of recommendations was assessed using GRADE criteria for the subgroup of included studies selected in meta-analysis. Results: Of 90 studies, 27 studies were included in the meta-analysis. Overall, only 8% of included studies were assessed as being at low risk of bias. The compounded topical preparation of antiviral with corticosteroids appeared to be effective for reducing oral ulcers but not pain resolution in herpes labialis. The use clobetasol propionate 0.05% in mucoadhesive base for oral lichen planus, pilocarpine HCl 5 mg lozenge for radiation-induced xerostomia in head and neck cancer patients, amlexanox 5% in mucoadhesive base and doxycycline hyclate 100 mg in denture adhesive base for recurrent aphthous stomatitis, and morphine 0.2% mouthwash in controlling oral Conclusion: Some compounded topical medications may be effective for the treatment of oral medicine cases. Future well-designed studies using standardised measures are needed to provide high-quality evidence in evaluating the efficacy and safety of compounded topical medications for the management of oral mucosal diseases.