New treatment eyed for pain of vulvodynia
Executive Summary
Results of a new study indicate that vulvodynia incidence varies by age, ethnicity, and marital status, with a potential higher risk for women with pre-existing depression, sleep, or pain disorders.
• Vulvodynia is a chronic condition characterized by pain and burning in the vulva in the absence of infection or other known disease. The pain can vary from mild to excruciating and might be provoked, spontaneous, or both
• The first national, multicenter study of a treatment to reduce vulvar pain in women is underway. Scientists are examining use of gabapentin, an anticonvulsant treatment that has appeared to be effective in previous, localized trials.
Your next patient tells you she has been experiencing sharp pain near the opening of the vagina that ranges from slightly uncomfortable to knife-like in severity. She is reluctant to use tampons and has been abstaining from intercourse due to the pain. What is your diagnosis?
Consider vulvodynia, a chronic condition characterized by pain and burning in the vulva in the absence of infection or other known disease. The pain can vary from mild to excruciating and might be provoked, spontaneous, or both.1 Results of a new study indicate that vulvodynia incidence varies by age, ethnicity, and marital status, with a potential higher risk for women with pre-existing depression, sleep, or pain disorders.1
"We had a good idea of what the prevalence of vulvodynia was, but this data gives us a better understanding of how often new cases develop and the potential risk factors that may be involved," said lead author Barbara Reed, MD, MSPH, professor of family medicine at the University of Michigan Medical School in Ann Arbor in a statement accompanying the publication of results. "We found the most striking and unexplainable differences between ethnic and racial groups; other predictors included younger age, sleep dysfunction, comorbid pain conditions, genital symptoms not yet meeting diagnostic criteria, and psychological distress."
Researchers conducted the longitudinal population-based study in southeast Michigan women ages 18 and older using a validated survey-based vulvodynia screening test, repeated at six-month intervals over 30 months. Average age was 50, with 42% of women ages 40-59. The overall incidence rate was 4.2 cases per 100 person-years, and rates per 100 person-years were greater in women who were younger (7.6 cases per 100 person-years at age 20, compared with 3.3 cases per 100 person-years at age 60), Hispanic (9.5 cases per 100 person-years), married, or living as married (4.9 cases per 100 person-years); had reported symptoms of vulvar pain but did not meet vulvodynia criteria on the initial survey (11.5 cases per 100 person-years); or had reported past symptoms suggesting a history of vulvodynia (7.5 cases per 100 person-years).
"One of the major problems with vulvodynia is physicians tend not to recognize it, diagnose it, or treat it, so many women suffer without knowing their symptoms have a name and that treatment is possible," said Reed. "The more physicians become aware of how often this happens and who the condition affects, the more likely they are to teach patients about vulvodynia and treat them or refer them for care."
Focus on gabapentin
The first national, multicenter study of a treatment to reduce vulvar pain in women is being led by Candace Brown, MSN, PharmD, a professor in the department of pharmacy, obstetrics and gynecology, and psychiatry at the University of Tennessee Health Science Center in Memphis. The study is examining use of gabapentin, an anticonvulsant treatment, that has appeared to be effective in previous, localized trials.2 The aim of the multicenter study is to prove the effectiveness of gabapentin as a treatment for provoked vestibulodynia and to determine what causes the condition. While clinicians have used gabapentin off label for vulvodynia treatment, there is no treatment approved by the Food and Drug Administration for the condition, says Brown.
The $2.6 million grant was awarded to the Memphis institution in 2012 by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, a division of the National Institutes of Health. Collaborators include the University of Medicine and Dentistry of New Jersey in New Brunswick and the University of Rochester (NY).
There will be two components to the study, explains Brown. One component, which comprises the clinical trial, will measure how effective gabapentin is compared to placebo. The other component will determine what causes the disorder, and which women will respond to the study drug.
Women participating in the research will be examined over a 16-week period. For the first eight weeks, they will be randomly selected to receive gabapentin or a placebo. During the following eight weeks, participants will alternate and take the study drug or a placebo that was not taken initially. Researchers will use a pain questionnaire to measure changes in qualitative pain using a pain rating index, and they will analyze responses to determine gabapentin’s effectiveness.
Enrollment is still ongoing, says Brown. More information about the study is available at its dedicated web site, http://www.hopeformypain.org.
Give patients options
What can clinicians advise women to do to relieve chronic vulvar pain? Offer the following suggestions from the American College of Obstetricians and Gynecologists:
• Wear 100% cotton underwear, with no underwear at night.
• Avoid tight-fitting undergarments and pantyhose.
• Avoid douching.
• Use mild soaps for bathing and clean the vulva with water only.
• Do not use vaginal wipes or deodorants or bubble bath.
• Do not use pads or tampons with deodorants.
• Use lubrication for intercourse.
• Apply cool gel packs to the vulva area to reduce pain and itching.
• Avoid exercises that put pressure directly on the vulva, such as bicycling.3
- Reed BD, Legocki LJ, Plegue MA, et al. Factors associated with vulvodynia incidence. Obstet Gynecol 2014; 123(2 Pt 1):225-231.
- Boardman LA, Cooper AS, Blais LR, et al. Topical gabapentin in the treatment of localized and generalized vulvodynia. Obstet Gynecol 2008; 112(3):579-585.
- American College of Obstetricians and Gynecologists. Vulvodynia. Accessed at http://bit.ly/1lwqJh8.
