Efficacy of ALA‐PDT in treating cervical low‐grade squamous intraepithelial lesions with high‐risk HPV patients: A multicentre randomized controlled trial

Persistent infection with high-risk human papillomavirus (hrHPV) is a major cause of cervical cancer. Current management of low-grade squamous intraepithelial lesions (LSIL) primarily involves monitoring, though some cases progress to cervical precancer or cancer, requiring timely intervention. This study aimed to evaluate the efficacy of 5-aminolevulinic acid photodynamic therapy (ALA-PDT) in treating cervical LSIL with hrHPV infection. A total of 155 women with LSIL and hrHPV infection were enrolled and randomly assigned to either the treatment group, which received six sessions of ALA-PDT, or the control group, which underwent routine follow-up. Outcomes were assessed at 6 and 12 months using hrHPV testing, cytology, colposcopy, and biopsy. Results showed that ALA-PDT significantly improved lesion regression and hrHPV clearance rates at both 6 and 12 months. At 6 months, the lesion regression rate in the treatment group was 80.43% versus 56.10% in the control group (p = 0.0203), and the hrHPV clearance rate was 61.96% versus 29.27% (p = 0.0005). At 12 months, both rates remained significantly higher in the treatment group. Age was found to influence hrHPV clearance, with younger women (<45 years) showing significantly higher clearance rates. ALA-PDT was well tolerated, with only minor side effects, such as localized pain and pruritus, reported. The study suggests that ALA-PDT is a safe, effective, and non-invasive treatment option for patients with cervical LSIL and hrHPV infection who require active intervention.