Efficacy of injecting platelet concentrate combined with hyaluronic acid for the treatment of vulvovaginal atrophy in postmenopausal women with history of breast cancer: a phase 2 pilot study

Menopause. 2018 Oct;25(10):1124-1130. doi: 10.1097/GME.0000000000001122.

Abstract

Objective: Approximately 50% to 70% of breast cancer survivors are affected by one or more symptoms of vulvovaginal atrophy (VVA). For those who cannot take hormone therapy, autologous platelet-rich plasma combined with hyaluronic acid (A-PRP-HA) may provide a new alternative therapy for the treatment of VVA in postmenopausal women with history of breast cancer.

Methods: We enrolled 20 postmenopausal breast cancers survivors with VVA and a score of <15 on the Gloria Bachman Vaginal Health Index (VHI) comprised of five items including: vaginal pH, elasticity, fluid volume (secretions), epithelial integrity, and moisture.We administered intramucosal injections of A-PRP combined with HA (Regenkit) and performed clinical evaluations at 0, 1, 3, and 6 months. Primary endpoint: evaluation of vulvovaginal mucosa changes using the VHI; secondary endpoint: evaluation of dyspareunia and sexual dysfunction based on the Female Sexual Distress (FSD) score.

Results: All participants (20 women) showed improvement in the clinical symptoms of vaginal dryness and dyspareunia. The VHI score showed a significant increase at 6 months, going from a total baseline score (pretreatment) of 10.7 ± 2.12 to 20.75 ± 4.8 (P < 0.0001) at 6 months. Improvement in hydration and vaginal epithelial integrity was reported. A VHI score of > 15 showed a successful treatment outcome. The FSD score decreased significantly during the study, from a baseline score of 36.35 ± 2.53 pretreatment to 30.15 ± 2.47 6 months after treatment, representing improvement of 17% (P < 0.0001, respectively). No adverse events were reported.

Conclusions: The injection of A-PRP-HA appeared to be a promising method to improve the trophicity and hydration of vaginal mucosa for the treatment of VVA in postmenopausal breast cancer survivors with contraindications to hormone therapy.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Adjuvants, Immunologic / administration & dosage
  • Adjuvants, Immunologic / adverse effects
  • Adjuvants, Immunologic / therapeutic use*
  • Administration, Mucosal
  • Aged
  • Analysis of Variance
  • Atrophy / drug therapy
  • Breast Neoplasms*
  • Cancer Survivors*
  • Complementary Therapies / methods
  • Female
  • Follow-Up Studies
  • France
  • Hospitals, University
  • Humans
  • Hyaluronic Acid / administration & dosage
  • Hyaluronic Acid / adverse effects
  • Hyaluronic Acid / therapeutic use*
  • Middle Aged
  • Patient Satisfaction
  • Pilot Projects
  • Platelet-Rich Plasma*
  • Postmenopause / physiology*
  • Prospective Studies
  • Regenerative Medicine / methods
  • Sexual Dysfunction, Physiological / drug therapy
  • Treatment Outcome
  • Vagina / pathology*
  • Vulva / pathology*

Substances

  • Adjuvants, Immunologic
  • Hyaluronic Acid