The aim of the study was to assess the feasibility and acceptability of acupuncture's augmentation of lidocaine therapy in the treatment of provoked localized vulvodynia (PLV).
For 12 weeks, women with moderate to severe PLV were randomized to either 18 sessions of traditional acupuncture (TA) or non-TA (NTA). All participants applied lidocaine 5% cream 4 times daily to the vestibule. Feasibility was assessed by recruitment, enrollment, assessment completion, and blinding. Acceptability was assessed by study visit attendance and satisfaction. The primary outcome was change in tampon test scores from baseline to week 12 and follow-up at week 24.
Nineteen women enrolled and 14 completed the study. Five withdrew because of lidocaine reaction (n = 2), inability to insert tampon (n = 1), starting a new medication (n = 1), or change in vulvar diagnosis (n = 1). Participants in both groups reported pain reduction for 12 weeks. There was no statistically significant difference between groups. Women in the TA group (n = 7) experienced less pain from baseline to 12 weeks (mean difference [MD] = 42.4 ± 19.4 and MD = 35.7 ± 17.8 at week 24). In the non-TA group (n = 7), women experienced a within-group MD of 28.7 ± 28.5 at 12 weeks and an MD of 36.7 ± 17.7.
In this early-phase research, acupuncture augmentation of lidocaine was acceptable. The study procedures, with modifications, may be feasible for future investigation. Both acupuncture techniques showed a favorable effect; however, the contribution to pain relief is undetermined.
1Osher Center for Integrative Medicine, University of California San Francisco, San Francisco, CA
2Department of Anesthesiology and Perioperative Medicine, Oregon Health & Science University, Portland, OR
3Department of Nursing, University of Texas, Austin, TX
4Osher Center for Integrative Medicine, University of California San Francisco, San Francisco, CA
5Department of Obstetrics and Gynecology, Oregon Health & Science University, San Francisco, CA
Reprint requests to: Lee E. Hullender Rubin, DAOM, MS, BS, Osher Center for Integrative Medicine, University of California San Francisco, 1545 Divisadero St, 4th Floor San Francisco, CA 94115. E-mail: email@example.com
The authors have declared they have no conflicts of interest.
This study was supported by the National Vulvodynia Association, Oregon Health & Science University Women's Health Research Unit, Council of College of Oriental Medicine, Oregon College of Oriental Medicine, and Oregon Clinical and Translational Research Institute (OCTRI), grant number (UL1TR000128) from the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. Data collection was completed with REDCap and funded by an Oregon Clinical and Translational Research Institute NIH NCATS grant (1UL1RR02414001). Acupuncture needles were provided by Golden Flower Chinese Herbs.
IRB Status: Active, OHSU IRB # 9664.