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Vulval vestibulitis (vestibulodynia) is characterised by penetrative introital pain and erythema and tenderness localised to the vestibular glands.1 The aetiology is unknown and most treatment strategies are based on anecdote.2–5 Some clinicians recommend the use of a topical steroid but there are no published data to support this.
We designed a randomised double blind crossover study to compare a potent topical steroid, Dermovate ointment (clobetasol propionate 0.05%), with a very mild steroid, 0.5% hydrocortisone ointment. The hydrocortisone acted as a placebo as it was impossible to obtain a matching placebo for Dermovate ointment. To demonstrate a 20% difference between Dermovate and hydrocortisone treated episodes if the placebo effect was 40%, 110 patients were needed. Unfortunately, recruitment was slow and the study ended when the expiry date of the medications was reached.
This report describes the outcomes in the patients who participated. The ethics committee of Mount Vernon and Watford Hospitals NHS Trust approved the study; patients gave written informed consent. All patients had introital pain, tenderness, and erythema compatible with a diagnosis of vulval vestibulitis. The study comprised three phases:
emollients only for 2–8 weeks,
tube one of the study medication, applied to the vestibule each night for 28 nights,
tube two of medication used similarly.
The tubes were identical and the study was designed so that within blocks of 10 patients, half would use each medication first. The same clinician assessed each patient at 14 day intervals using a three point scale for each of the parameters—pain, tenderness, and erythema (maximum score 9; minimum score 0 for each visit). The scores obtained at entry (minimum 3) and after each phase were noted.
Twenty two patients were recruited, but some patients withdrew or were excluded for protocol violations. Fourteen patients completed all phases of the study and two completed the first two phases. After emollient use, nine patients had improved (mean score −1.1; range −0.5 to −2); after Dermovate, 11 improved (mean score −2.7; ranges −0.5 to −8); and after hydrocortisone nine improved (mean score −1.8; range −1 to −3) (table 1). Eight patients who used both treatments had a better response to Dermovate and four had a better response to hydrocortisone (p<0.07). Eight patients expressed a definite preference, seven for Dermovate and one for hydrocortisone. There may, however, have been an effect of the order of the treatments as two patients did better on their first treatment whereas nine did better on their second (p<0.06).
Although this study was not completed, some conclusions can be reached. Short term use of a potent topical steroid preparation did not produce a clinically important improvement in all cases but some patients had very good responses, which were maintained. This may reflect the fact that the aetiology of vulval vestibulitis is multifactorial and where there has been an inflammatory, infective, or irritant cause, topical steroids may be helpful. There is an urgent need to identify and classify the causes of this syndrome so that appropriate treatment can be targeted more accurately.
I wish to thank Glaxo-Wellcome (now Glaxo-Smith Kline) for the supply of the study medication.