Authors’ reply re: A systematic review of drug treatment of vulvodynia: evidence of a strong placebo effect

ies of vulvodynia treatments were not included. In the first controlled study of a treatment for vulvodynia, Bornstein et al., in a study of 40 women randomised to either a low oxalate diet with calcium citrate pills (the placebo treatment group) or placebo treatment with fluconazole, found that 30% of the placebo group compared with 15% of the fluconazole group had a satisfactory response, defined as being pain-free and able to resume comfortable sexual relations. The following year, our group published what is to our knowledge the results of the first randomised, doubleblind, placebo-controlled study of any treatment for vulvodynia. After an initial pilot study of 11 women treated with 4% cromolyn cream showed promise, we performed a study of 26 evaluable women randomised to either cromolyn or placebo creams and found that 38% of the cromolyn and 46% of the placebo subjects had a 50% or greater decrease in their overall level of comfort. At the time, both studies were considered adequately powered, as the significant placebo response described by Pereira et al. was unknown at the time. In reading the inclusion and exclusion criteria in the Pereira paper, we feel these two studies should have been included in this review. The reason for this oversight may have been that Pereira et al. did not use the term ‘vulvar vestibulitis’ in their literature search. However, ‘vulvar vestibulitis’, the term which preceded ‘localized provoked vestibulodynia’, a form of vulvodynia, remained in common use in clinical practice throughout the 1990s and into the beginning of the current millennium. Therefore, this search term should be used in any systematic review of vulvodynia that dates back to 1985 like this one. By bringing this to your readership’s attention, we hope to make future reviews of vulvodynia more complete.& References