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Is Desipramine or Lidocaine an Effective Treatment for Vulvodynia?
Abstract & Commentary
By Frank W. Ling, MD, Clinical Professor, Department of Obstetrics and Gynecology, Vanderbilt University School of Medicine, Nashville, TN, is Associate Editor for OB/GYN Clinical Alert.
Dr. Ling reports no financial relationship to this field of study.
Synopsis:Topical lidocaine and oral desipramine, either in monotherapy or in combination, were no better than placebo in this randomized controlled trial.
Source: Foster DC, et al. Oral desipramine and topical lidocaine for vulvodynia. Obstet Gynecol 2010;116:583-593.
In the vulvar vestibulitis clinical trial conducted at the University of Rochester between 2002 and 2007, patients with vulvar vestibulitis syndrome (localized provoked vulvodynia) were enrolled in a 12-week randomized, placebo-controlled treatment trial. Each eligible subject was scrutinized for other causes of entry dyspareunia. Once enrolled, each patient was assigned to one of four treatment arms: oral desipramine and topical lidocaine cream; oral desipramine and placebo cream; oral placebo and topical lidocaine cream; or oral placebo and placebo cream. The 25 mg desipramine tablet (or comparable placebo) was increased by 1 tablet each week starting with 1 tablet at bedtime to a target dose of 150 mg by week six. The lidocaine (or placebo) cream was applied four times daily. Multiple measures were used to evaluate pain, but the tampon insertion test was used as the primary outcome to evaluate vaginal insertional pain. All four treatment arms resulted in substantial reduction in pain, with neither desipramine or lidocaine being significantly more effective than placebo. In the 40-week open-label phase of the study following the initial 12-week randomized trial, patients undergoing vestibulectomy were significantly improved when compared to those who chose non-surgical treatment.
Whether you realize it or not, this study is an integral part of your practice. Since I've become a regional referral center for patients with difficult vulvar pain problems, the impact is even greater in my personal practice. As a result, I know that these difficult-to-diagnose and even more difficult-to-treat patients with vestibulitis aka vestibulodynia aka localized provoked vulvodynia are being seen in every women's health practice. If nothing else, this study and the comments below should make each of us wonder whether the next patient with recurrent vaginitis or entry dyspareunia or recurrent perineal itching actually might be an undiagnosed case of this condition, which for purposes here will be referenced as "VVS," a shortened version of the old term "vulvar vestibulitis syndrome."
First, let's make sure that we understand the implications for the use of medicines used to treat neuropathic pain in general, and VVS in specific. Only one tricyclic antidepressant, desipramine, was studied. We know that several other medications have efficacy in patients with suspected neuropathies. Just because desipramine was not better than placebo in this study does not mean that there is not a role for neuropathic treatment. Was the duration of use long enough? Was the starting dose of 25 mg with weekly increases of 25 mg the right dosing pattern? Would other antidepressants or anticonvulsants have fared better? What about combinations of these drugs?
Second, the use of lidocaine as described may not have been better than placebo, but the way it was used also had limitations. Would 2% have worked better? Would overnight use of lidocaine on a cotton ball as described by Zolnoun et al been better in patients with VVS?1
Third, even though this was an extremely well-done study with great implications both for future research as well as daily patient care, we should be cautious about being overly zealous in its interpretation. The authors also bring up several good points in their discussion, some of which are included in the list below. I have included some "tips" that I have found helpful also. Some of the take-home messages from this study include:
As you can see, I'm passionate about diagnosing and treating VVS. It is particularly frustrating to see patients who have been misdiagnosed for many years, sometimes being pigeon-holed into more commonly applied categories of yeast infection, bacterial infection, herpes, chronic urinary tract infections, sperm allergy, atrophic vaginitis, or "psychosomatic." Maybe we can all take this first step forward together one small step for each of us as diagnosticians, but a giant leap for women with VVS.