OBJECTIVE: To estimate the effectiveness of enoxaparin—a low-molecular-weight heparin with antiheparanase properties—in treating localized provoked vulvodynia.
METHODS: Forty women with severe localized provoked vulvodynia were randomly and blindly assigned to self-administer either 40 mg enoxaparin or saline subcutaneously for 90 days. Dyspareunia and local sensitivity were evaluated before, at the end, and 90 days after treatment. The most painful focus was biopsied at the beginning of the study and a parallel site at the end of study for mast cells, PGP 9.5 nerve fiber staining, and heparanase quantification.
RESULTS: The enoxaparin-treated women showed a greater reduction in vestibular sensitivity at the end of treatment and 3 months later (29.6% compared with 11.2%, P=.004). Seventy-five percent (15 of 20) of them reported more than 20% pain reduction compared with 27.8% (five of 18) in the placebo group (P=.004). Seven enoxaparin-treated women compared with three in the placebo group had almost painless intercourse at the end of the study. In women who had improvement of sensitivity at the site parallel to the original biopsy site, there was a histologically documented reduction in the number of intraepithelial-free nerve fibers in the enoxaparin group.
CONCLUSION: Enoxaparin reduced the vestibular sensitivity and dyspareunia, concomitant with a reduction in intraepithelial free nerve fibers, in women with localized provoked vulvodynia.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00874484.
LEVEL OF EVIDENCE: I
Enoxaparin reduces pain in women with localized provoked vulvodynia, possibly by inhibiting heparanase activity and reducing proliferation of nerve fibers in the vestibule.
From the Department of Obstetrics and Gynecology, Western Galilee Hospital, Bar-Ilan Faculty of Medicine, and the Pathology Department, Western Galilee Hospital, Nahariya, the Sex Therapy Clinic, Lis Maternity Hospital, Tel Aviv Medical Center, Tel Aviv, Israel.
Supported in part by the chief scientist, the Israeli Ministry of Health, and by a matching grant from the NVA Marinoff's career development program.
The authors thank Professor Israel Vlodavsky and Dr Neta Ilan of the Cancer and Vascular Biology Research Center, Faculty of Medicine, Technion, Haifa, Israel, for assistance in staining the specimens for heparanase, and Ms Orly Yakir for statistical assistance.
Corresponding author: Jacob Bornstein, MD, MPA, Department of Obstetrics and Gynecology, Western Galilee Hospital, PO Box 21, Nahariya, 22100, Israel; e-mail: firstname.lastname@example.org.
Financial Disclosure The authors did not report any potential conflicts of interest.