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

Abstract 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.