Is the topical application of sesame oil (Sesamum indicum L.) combined with standard care valuable and safe for managing infusion-related phlebitis: Evidence from a systematic review with meta-analysis of randomized controlled trials.

Objectives: Recent randomized controlled trials (RCTs) have studied the potential effect of the topical use of sesame oil (SO), obtained from the sesame plant seeds (Sesamum indicum L., Pedaliaceae family), in preventing or alleviating the symptoms of infusion-related phlebitis (IRP); nevertheless, their data are inconsistent. Thus, this review sought to qualitatively and quantitatively synthesize data from all available RCTs concerning the effect of the topical administration of SO on managing IRP.

Methods: The online databases were searched up to July 13, 2024. Studies were eligible if they compared administering standard care plus topical SO to applying an alternative modality and/or standard care. The Cochrane risk-of-bias tool and GRADE framework were employed to appraise the quality of the evidence.

Results: Eight studies of 755 records in the initial search met the inclusion criteria, which investigated inpatients and/or outpatients with chemotherapy-induced phlebitis (n=6) and amiodarone-induced phlebitis (n=2). According to the quantitative analysis, adults who had received coadministration of standard care and topical SO on the infusion site were significantly less affected by IRP than those who had received a control condition (effect sizes= 5, risk ratio= 0.54; 95% confidence interval]0.32, 0.92[; P= 0.025). Also, based on the qualitative syntheses, SO can potentially prevent the formation of advanced stages of IRP, delay the appearance of IRP symptoms, and reduce IRP-induced pain severity.

Conclusion: Topical SO had a favorable effect on caring for adults with IRP. However, uncertainty remains because the evidence quality was moderate, some RCTs needed better methodological rigor, and most required to address the safety of the intervention or independent verification of SO used in terms of purity and potency. Thus, to build a valid conclusion about the efficacy and safety of SO in managing IRP, more high-quality RCTs must be conducted considering an active placebo control intervention along with a well-designed randomization and blinding approach, as well as a better description of safety parameters and the quality control information of the SO used.

Prospero Registration Number: CRD42024542497.