Prospective Observational Study Of The Efficacy Of Mixed Methylene Blue Compound Injection For Treatment Of Vulvar Non-Neoplastic Epithelial Disorders

Objective To investigate the safety and efficacy of mixed methylene blue (MB) compound injection for treatment of vulvar non-neoplastic epithelial disorders (NNEDs). Methods A prospective observational study among 118 women with vulvar NNEDs treated with intradermal injection of mixed MB compound at a hospital in Wuhan, China, between 2013 and 2016. Itching score, skin hypopigmentation area percentage (SHAP), and recurrence were assessed by interview and physical examination before and after treatment. Adverse effects were recorded. Results Before treatment, mean +/- SD itching score was 7.78 +/- 1.59. It decreased rapidly immediately after treatment and remained low thereafter (1.82 +/- 2.31, 1.69 +/- 2.39, 1.97 +/- 2.73, 2.05 +/- 2.72, and 2.19 +/- 2.86 at 1, 3, 6, 12, and 24 months, respectively). Before treatment, mean +/- SD SHAP was 28.01% +/- 18.28%. SHAP decreased gradually and remained stably low 6 months later (26.28% +/- 17.95%, 21.19% +/- 18.42%, 19.19% +/- 18.67%, 18.68% +/- 18.91%, and 18.65% +/- 19.20% at 1, 3, 6, 12, and 24 months, respectively). The recurrence rate in 2 years was 21.2% (25/118) with no major complications. Conclusions Intradermal injection of mixed MB compound was found to be an effective and safe treatment for vulvar NNEDs. ClinicalTrials.gov: NCT03200808.