Topical nifedipine for the treatment of localized provoked vulvodynia: a placebo-controlled study.
Topical application of the calcium antagonist nifedipine has demonstrated effectiveness in treating chronic anal fissure, without adverse effects. Like chronic anal fissure, vulvodynia is associated with muscle hypertonicity and an inflammatory infiltrate. We conducted a double-blind placebo-controlled study to investigate the effectiveness of 2 concentrations of topical nifedipine cream in the treatment of vulvodynia. Thirty participants were alternately assigned to 3 topical treatment groups: .2% nifedipine, .4% nifedipine, and placebo. All administered the cream to the vestibule 4 times daily for 6 weeks. For all 3 treatment groups, mean pain intensity on vestibular touch, assessed by the Q-tipped cotton test, pain from speculum insertion, and reports of pain during sexual intercourse was reduced at post-treatment compared with pre-treatment. These improvements remained at 3 months' follow-up. The effectiveness of nifedipine in treating vulvodynia did not exceed that of placebo.


CONCLUSIONS
The topical application of both nifedipine and a placebo reduced pain in women with vulvodynia. This study highlights the need for controlled trials of treatments for vulvodynia and raises doubts about studies conducted without comparison to placebo.
Department of Obstetrics and Gynecology, Western Galilee Hospital, Nahariya, Israel. mdjacob@tx.technion.ac.il
Jacob
J
Bornstein
Ruba
R
Tuma
Yaniv
Y
Farajun
Audrey
A
Azran
Doron
D
Zarfati
D000287:Administration, Topical; D000328:Adult; D002121:Calcium Channel Blockers / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D009543:Nifedipine / Q000008:administration & dosage*; D016896:Treatment Outcome; D056650:Vulvodynia / Q000188:drug therapy*; D055815:Young Adult
D002121:Calcium Channel Blockers; D009543:Nifedipine