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A pilot randomized, single-blind, placebo-controlled trial of traditional acupuncture for vasomotor symptoms and mechanistic pathways of menopause

Painovich, Jeannette M. DAOM, LAc, MA1; Shufelt, Chrisandra L. MD, MS1; Azziz, Ricardo MD, MPH, MBA2; Yang, Yuching PhD1; Goodarzi, Mark O. MD, PhD3; Braunstein, Glenn D. MD3; Karlan, Beth Y. MD4; Stewart, Paul M. MD5; Merz, C. Noel Bairey MD1

Menopause: The Journal of The North American Menopause Society: January 2012 - Volume 19 - Issue 1 - p 54–61
doi: 10.1097/gme.0b013e31821f9171
Original Articles
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Objective The aim of this study was to conduct a pilot study for the feasibility of planning a definitive clinical trial comparing traditional acupuncture (TA) with sham acupuncture (SA) and waiting control (WC) on menopause-related vasomotor symptoms (VMS), quality of life, and the hypothalamic-pituitary-adrenal axis in perimenopausal and postmenopausal women.

Methods Thirty-three perimenopausal and postmenopausal women with at least seven VMS daily were randomized to TA, SA, or WC. The TA and SA groups were given three treatments per week for 12 weeks. Outcomes included the number and severity of VMS, Menopause-Specific Quality of Life Questionnaire, Beck Depression Inventory, Spielberg State-Trait Anxiety Instrument, Pittsburgh Quality Sleep Index, 24-hour urine cortisol and metabolites, and adrenocorticotropic hormone stimulation testing.

Results Both the TA and SA groups demonstrated improved VMS trends compared with the WC group (Δ −3.5 ± 3.00 vs −4.1 ± 3.79 vs −1.2 ± 2.4, respectively; P = 20) and significantly improved Menopause-Specific Quality of Life Questionnaire vasomotor scores (Δ −1.5 ± 2.02 vs −1.8 ± 1.52 vs −0.3 ± 0.64, respectively; P = 0.04). There were no psychosocial group differences. Exit 24-hour urinary measures were lower in the TA versus the SA or WC group in total cortisol metabolites (4,658.9 ± 1,670.9 vs 7,735.8 ± 3,747.9 vs 5,166.0 ± 2,234.5, P = 0.03; respectively) and dehydroepiandrosterone (41.4 ± 27.46, 161.2 ± 222.77, and 252.4 ± 385.40, respectively; P = 0.05). The response data on adrenocorticotropic hormone stimulation cortisol also trended in the hypothesized direction (P = 0.17).

Conclusions Both TA and SA reduce VMS frequency and severity and improve VMS-related quality of life compared with WC; however, TA alone may impact the hypothalamic-pituitary-adrenal axis. This association is viewed as preliminary and hypothesis generating and should be explored in a large clinical trial.

In this study, both traditional and sham acupuncture interventions improved vasomotor symptoms and menopause-related quality of life compared with control. Improvement in vasomotor symptoms seemed to be related to improvement in depression, anxiety, and sleep in both traditional and sham acupuncture, whereas traditional acupuncture only appeared to have an effect on the hypothalamic-pituitary-adrenal axis as a mechanistic and therapeutic pathway for vasomotor symptoms.

From the 1Department of Medicine, Cedars-Sinai Heart Institute, Los Angeles, CA; 2Georgia Health Sciences University, Augusta, GA; Departments of 3Endocrinology, 4Obstetrics and Gynecology, Cedars-Sinai Medical Center, Los Angeles, CA; and 5University of Birmingham, Birmingham, UK.

Received February 9, 2011; revised and accepted April 13, 2011.

Funding/support: This work was supported by grants from the National Institutes of Health–National Center for Alternative and Complementary Medicine (no. 3R01AT001482-03S1 and 3R01AT001482-04S1), and a General Clinical Research Center grant MO1-RR00425 from the National Center for Research Resources.

Financial disclosure/conflicts on interest: None reported.

The contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Center for Alternative and Complementary Medicine or the National Institutes of Health.

ClinicalTrial.gov: NCT00950482.

Address for reprints: C. Noel Bairey Merz, M.D., 444 S. San Vicente Boulevard, Suite 901, Los Angeles, CA, 90048. E-mail: merz@cshs.org

©2012The North American Menopause Society