VULVODYNIA SYSTEMATIC REVIEW ON DRUGTREATMENT
M. MONTEIRO 1, G. M.PEREIRA2, M. MARCOLINO 2, J. SENRA 2;
1FEDERAL Univ. OF MINAS GERAIS, BELO HORIZONTE,Brazil, 2Department of Obstetrics and Gynaecology, Univ.eFederal de Minas Gerais, Belo Horizonte, Brazil.
Introduction: Vulvodynia hasbeen defined as a vulvar pain of at least 3 months’ duration,without clear identifiable cause, which may have potential associatedfactors. The description is based on the site of pain, whether it islocalized (vestibulodynia, clitorodynia), generalized or mixed andwhether it is provoked, spontaneous or mixed; onset (primary orsecondary) and temporal pattern (intermittent, persistent, constant,immediate, delayed)1. Drug treatments have been proposedfor some studies over the years and its success rates vary in itsefficacy of reducing the pain. The modalities of drug treatment forvulvar pain include topical, oral, and injectablemedications.
Objective: The aim of this systematic reviewis to present an overview of the current available evidence for thetypes of medications used in randomized clinical trials to treatvulvar pain.
Methods: The present Systematic Review wasperformed using PRISMA - Preferred Reporting Items for SystematicReviews and Meta-Analyses Statement. We selected only randomizedcontrolled trials comparing the use of oral and topical medicationsand injectable drugs in the treatment of vulvodynia. The populationof interest was women, not specified the age, diagnosed withvulvodynia without specific description and the interventionsanalyzed were topical, oral and injectable medications for thetreatment of vulvar pain. The primary outcome evaluated was thereduction of vulvar pain. Studies were screened from 1985 to 2016 inthe electronic databases: WEB OF SCIENCE ( total of 334 articles),COCHRANE LIBRARY (total of 38 articles), EBSCO Academic (total of 104articles), LILACS (total of 08 articles) and MEDLINE (total of 342articles) in June and September 2016. The electronic databases were:vulvodynia AND (“drug therapy” OR treatment OR therapy) including‘title and abstract’ and medical subject heading terms. Tworesearchers screened manually and independently for relevant articlesfor eligibility and applied the inclusion criteria. Any disagreementsamong researchers related to the eligibility criteria of the selectedstudies were discussed in a meeting. A third researcher helped inthis process. We found 826 articles. After evaluating the full textof fourteen randomized clinical trials for eligibility, 6 studieswere selected to this review. We excluded studies comparing drugtreatments with other modalities of treatment. The judgment of riskof bias in the full text of the included studies was performedaccording to the criteria of the Cochrane Handbook for SystematicReviews of Interventions2. During the review period wasobserved a high degree of heterogeneity of the selected studies, thusit was not possible to perform a meta-analysis. The analysis wastherefore restricted to systematic review.
Results: Thenumber of the participants varied from 30 to 133 among the eligiblestudies. Regarding the interventions, two drugs presented systemiceffect and administered orally, such as Amitriptyline andDesipramine. Two other drugs administered injectable, such asBotulinum toxin A and Enoxaparin. In addition, three drugs wereindicated to be used as topical medication. Among the control group,five trials were placebo-controlled, differing considerably from onlyone trial that was not placebo-controlled. The pain reduction indexwas assessed using mean and standard deviation. Three of the sixstudies included did not inform the data as required. Only one trialused the validated pain rating scale of McGill Pain Questionnaire forassessing vulvar pain. The highest rate of pain reduction wasobserved in the study by Foster et al. This study associated oralDesipramine and 5% topical Lidocaine in one of its study groups andthis association presented the highest index of reduction of vulvarpain.
Conclusions: There is not sufficient evidence tosupport which drug is more indicated do treat vulvar pain, althoughone study showed the association of oral Desipramine and 5% topicalLidocaine with the highest pain reduction index. Regarding thisfinding, the evidence was insufficient to draw reliable conclusionsabout the efficacy of these drugs.
References: 1. BornsteinJ, Goldstein AT, Stockdale CK, Bergeron S, Pukall C, Zolnoun D, etal. 2015 ISSVD, ISSWSH, and IPPS Consensus Terminology andClassification of Persistent Vulvar Pain and Vulvodynia. The Journalof Sexual Medicine. 2016;13(4):607-12. 2. Higgins JPT, Green S(editors). Cochrane Handbook for Systematic Reviews ofInterventions Version 5.1.0 [updated March 2011]. The CochraneCollaboration, 2011. Available from www.handbook.cochrane.org.