The ACTIV study: acupuncture treatment in provoked vestibulodynia.

INTRODUCTION: Provoked vestibulodynia (PVD) is a distressing genital pain condition affecting 12% of women. Treatment modalities vary and although vestibulectomy has the highest efficacy rates, it is usually not a first-line option. Acupuncture has a long history in the traditional Chinese medicine (TCM) system and operates on the premise that pain results from the blockage or imbalance of important channels. The main principle of treatment is to move Qi and blood to cease genital pain. AIM: To explore effect sizes and feasibility in a pilot study of acupuncture for women with PVD. METHODS: Eight women with PVD (mean age 30 years) underwent 10 1-hour acupuncture sessions. Specific placement of the needles depended on the woman's individual TCM diagnosis. TCM practitioners made qualitative notes on participants' feedback after each session. Main Outcome Measures. Self-reported pain (investigator-developed), pain-associated cognitions (Pain Catastrophizing Scale [PCS], Pain Vigilance and Awareness Questionnaire), and sexual response (Female Sexual Function Index) were measured before and after treatment sessions 5 and 10. Qualitative analyses of TCM practitioner notes were performed along with one in-depth case report on the experience of a participant. RESULTS: A repeated measures analysis of variance revealed significant decreases in pain with manual genital stimulation and helplessness on the PCS. An examination of effect sizes also revealed strong (though nonsignificant) effects for improved ability to have intercourse and sexual desire. Qualitative analyses were overall more positive and revealed an improvement in perceived sexual health, reduced pain, and improved mental well-being in the majority of participants. CONCLUSIONS: Effect sizes and qualitative analyses of practitioner-initiated interviews showed overall positive effects of acupuncture, but there were statistically significant improvements only in pain with manual genital stimulation and helplessness. These findings require replication in a larger, controlled trial before any definitive conclusions on the efficacy of acupuncture for PVD can be made.