Abstract
Objective: Patients with chronic idiopathic vulvar vestibulitis have increased mast cells when biopsied, and cromolyn has been suggested as a treatment. The purpose of this study was to assess the efficacy of 4% cromolyn cream in women with vulvar vestibulitis.
Methods: A prospective, double blind, randomised, placebo controlled study was initiated at two centres. Patients with vulvar vestibulitis were assigned to apply cromolyn or placebo cream to the vestibule. Symptoms (burning, irritation) and signs (erythema, extent of erythema, tenderness) were recorded on a 0–3 scale. In the sexually active patient subgroup, dyspareunia was also evaluated.
Results: 13 of the 26 evaluable patients received cromolyn. Patients in the cromolyn arm were more likely to have failed therapy with amitriptyline (p = 0.05), but the two groups were otherwise similar upon study entry. Overall, scores decreased from a median of 9 to 5 (p = 0.001) during the study, but the level of improvement was similar between both groups. Improvement was unrelated to duration of symptoms, fluconazole use, or sexual activity. Five patients (38%) taking cromolyn and six (46%) taking placebo felt they had a 50% or greater reduction in symptoms. In the 21 sexually active patients, the total score decreased from a mean of 12 to 8 (p = 0.005), but there was no statistically significant difference between study arms.
Conclusions: Cromolyn cream did not confer a significant benefit in patients with vulvar vestibulitis. The large placebo response suggests the need for large well controlled studies of other treatment modalities.
Key Words: cromolyn cream; vulvar vestibulitis
Full Text
The Full Text of this article is available as a PDF (85.8 KB).
Selected References
These references are in PubMed. This may not be the complete list of references from this article.
- Ashman R. B., Ott A. K. Autoimmunity as a factor in recurrent vaginal candidosis and the minor vestibular gland syndrome. J Reprod Med. 1989 Apr;34(4):264–266. [PubMed] [Google Scholar]
- Bazin S., Bouchard C., Brisson J., Morin C., Meisels A., Fortier M. Vulvar vestibulitis syndrome: an exploratory case-control study. Obstet Gynecol. 1994 Jan;83(1):47–50. [PubMed] [Google Scholar]
- Bornstein J., Goldik Z., Stolar Z., Zarfati D., Abramovici H. Predicting the outcome of surgical treatment of vulvar vestibulitis. Obstet Gynecol. 1997 May;89(5 Pt 1):695–698. doi: 10.1016/s0029-7844(97)00102-6. [DOI] [PubMed] [Google Scholar]
- Bosso J. V., Aiken M. J., Simon R. A. Successful prevention of local and cutaneous hypersensitivity reactions to seminal fluid with intravaginal cromolyn. Allergy Proc. 1991 Mar-Apr;12(2):113–116. doi: 10.2500/108854191779011828. [DOI] [PubMed] [Google Scholar]
- Chaim W., Meriwether C., Gonik B., Qureshi F., Sobel J. D. Vulvar vestibulitis subjects undergoing surgical intervention: a descriptive analysis and histopathological correlates. Eur J Obstet Gynecol Reprod Biol. 1996 Sep;68(1-2):165–168. doi: 10.1016/0301-2115(96)02502-x. [DOI] [PubMed] [Google Scholar]
- Glazer H. I., Rodke G., Swencionis C., Hertz R., Young A. W. Treatment of vulvar vestibulitis syndrome with electromyographic biofeedback of pelvic floor musculature. J Reprod Med. 1995 Apr;40(4):283–290. [PubMed] [Google Scholar]
- Kent H. L., Wisniewski P. M. Interferon for vulvar vestibulitis. J Reprod Med. 1990 Dec;35(12):1138–1140. [PubMed] [Google Scholar]
- Nyirjesy P., Weitz M. V., Grody M. H., Lorber B. Over-the-counter and alternative medicines in the treatment of chronic vaginal symptoms. Obstet Gynecol. 1997 Jul;90(1):50–53. doi: 10.1016/S0029-7844(97)00242-1. [DOI] [PubMed] [Google Scholar]
- Pyka R. E., Wilkinson E. J., Friedrich E. G., Jr, Croker B. P. The histopathology of vulvar vestibulitis syndrome. Int J Gynecol Pathol. 1988;7(3):249–257. doi: 10.1097/00004347-198809000-00005. [DOI] [PubMed] [Google Scholar]
- Sarma A. V., Foxman B., Bayirli B., Haefner H., Sobel J. D. Epidemiology of vulvar vestibulitis syndrome: an exploratory case-control study. Sex Transm Infect. 1999 Oct;75(5):320–326. doi: 10.1136/sti.75.5.320. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Solomons C. C., Melmed M. H., Heitler S. M. Calcium citrate for vulvar vestibulitis. A case report. J Reprod Med. 1991 Dec;36(12):879–882. [PubMed] [Google Scholar]
- Umpierre S. A., Kaufman R. H., Adam E., Woods K. V., Adler-Storthz K. Human papillomavirus DNA in tissue biopsy specimens of vulvar vestibulitis patients treated with interferon. Obstet Gynecol. 1991 Oct;78(4):693–695. [PubMed] [Google Scholar]
- White G., Jantos M. Sexual behavior changes with vulvar vestibulitis syndrome. J Reprod Med. 1998 Sep;43(9):783–789. [PubMed] [Google Scholar]