A non-inferiority study of 5-aminolevulinic acid photodynamic therapy (5-ALA-PDT) for high-grade squamous intraepithelial lesions of the cervix in patients of childbearing age: A non-randomized controlled prospective study

The objective of this study was to compare the effectiveness of 5-aminolevulinic acid photodynamic therapy (5-ALA-PDT) and loop electrosurgical excision procedure (LEEP) for treating cervical high-grade intraepithelial lesions (HSIL) in patients of childbearing age. We conducted a prospective study of 67 women diagnosed with cervical HSIL from January 2022 to June 2024 in Minhang Hospital, Affiliated to Fudan University. A total of 60 patients were finally included in this clinical trial. They were assigned to two groups. 30 cases received 5-ALA-PDT, and 30 cases underwent LEEP. All patients were followed up at 6 months and 12 months after treatment, including HPV testing, cytology, and colposcopy examination. 6 months after treatment, the HPV clearance rates in the 5-ALA-PDT group were similar to the LEEP group, both groups were 80.00 % (P = 1.00). The cure rates in both groups were 80.00 %, and the improvement rates were 20.00 % (P = 1.00). 12 months after treatment, the HPV clearance rate in the 5-ALA-PDT group was marginally higher than the rate observed in the LEEP group (90.00 % vs. 83.33 %, P = 0.448). The cure rate in the 5-ALA-PDT group was marginally higher than that in the LEEP group (86.67 % vs. 83.33 %, P = 0.718). The incidence of adverse reactions in the 5-ALA-PDT group was significantly lower than that in the LEEP group for the treatment of cervical HSIL (3.33 % vs. 30.00 %, P < 0.05). For patients of reproductive age with cervical HSIL, 5-ALA-PDT treatment for cervical HSIL is an effective and safe treatment option.