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

Jeannette M. Painovich, Chrisandra L. Shufelt, Ricardo Azziz, Yuching Yang, Mark O. Goodarzi, Glenn D. Braunstein, Beth Y. Karlan, Paul M. Stewart, C. Noel Bairey Merz

Research output: Contribution to journalArticle

28 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)54-61
Number of pages8
JournalMenopause
Volume19
Issue number1
DOIs
StatePublished - Jan 1 2012

Fingerprint

Acupuncture
Menopause
Placebos
Quality of Life
Hydrocortisone
Adrenocorticotropic Hormone
Clinical Trials
Control Groups
Dehydroepiandrosterone
Sleep
Anxiety
Urine
Depression

Keywords

  • Acupuncture
  • Cortisol
  • Mechanisms
  • Menopause
  • Randomized controlled trial
  • Vasomotor symptoms

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Cite this

Painovich, J. M., Shufelt, C. L., Azziz, R., Yang, Y., Goodarzi, M. O., Braunstein, G. D., ... Merz, C. N. B. (2012). A pilot randomized, single-blind, placebo-controlled trial of traditional acupuncture for vasomotor symptoms and mechanistic pathways of menopause. Menopause, 19(1), 54-61. https://doi.org/10.1097/gme.0b013e31821f9171

A pilot randomized, single-blind, placebo-controlled trial of traditional acupuncture for vasomotor symptoms and mechanistic pathways of menopause. / Painovich, Jeannette M.; Shufelt, Chrisandra L.; Azziz, Ricardo; Yang, Yuching; Goodarzi, Mark O.; Braunstein, Glenn D.; Karlan, Beth Y.; Stewart, Paul M.; Merz, C. Noel Bairey.

In: Menopause, Vol. 19, No. 1, 01.01.2012, p. 54-61.

Research output: Contribution to journalArticle

Painovich, JM, Shufelt, CL, Azziz, R, Yang, Y, Goodarzi, MO, Braunstein, GD, Karlan, BY, Stewart, PM & Merz, CNB 2012, 'A pilot randomized, single-blind, placebo-controlled trial of traditional acupuncture for vasomotor symptoms and mechanistic pathways of menopause', Menopause, vol. 19, no. 1, pp. 54-61. https://doi.org/10.1097/gme.0b013e31821f9171
Painovich, Jeannette M. ; Shufelt, Chrisandra L. ; Azziz, Ricardo ; Yang, Yuching ; Goodarzi, Mark O. ; Braunstein, Glenn D. ; Karlan, Beth Y. ; Stewart, Paul M. ; Merz, C. Noel Bairey. / A pilot randomized, single-blind, placebo-controlled trial of traditional acupuncture for vasomotor symptoms and mechanistic pathways of menopause. In: Menopause. 2012 ; Vol. 19, No. 1. pp. 54-61.
@article{9d4655c4987a4d1e8c37edcbb5ffcc02,
title = "A pilot randomized, single-blind, placebo-controlled trial of traditional acupuncture for vasomotor symptoms and mechanistic pathways of menopause",
abstract = "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.",
keywords = "Acupuncture, Cortisol, Mechanisms, Menopause, Randomized controlled trial, Vasomotor symptoms",
author = "Painovich, {Jeannette M.} and Shufelt, {Chrisandra L.} and Ricardo Azziz and Yuching Yang and Goodarzi, {Mark O.} and Braunstein, {Glenn D.} and Karlan, {Beth Y.} and Stewart, {Paul M.} and Merz, {C. Noel Bairey}",
year = "2012",
month = "1",
day = "1",
doi = "10.1097/gme.0b013e31821f9171",
language = "English (US)",
volume = "19",
pages = "54--61",
journal = "Menopause",
issn = "1072-3714",
publisher = "Lippincott Williams and Wilkins",
number = "1",

}

TY - JOUR

T1 - A pilot randomized, single-blind, placebo-controlled trial of traditional acupuncture for vasomotor symptoms and mechanistic pathways of menopause

AU - Painovich, Jeannette M.

AU - Shufelt, Chrisandra L.

AU - Azziz, Ricardo

AU - Yang, Yuching

AU - Goodarzi, Mark O.

AU - Braunstein, Glenn D.

AU - Karlan, Beth Y.

AU - Stewart, Paul M.

AU - Merz, C. Noel Bairey

PY - 2012/1/1

Y1 - 2012/1/1

N2 - 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.

AB - 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.

KW - Acupuncture

KW - Cortisol

KW - Mechanisms

KW - Menopause

KW - Randomized controlled trial

KW - Vasomotor symptoms

UR - http://www.scopus.com/inward/record.url?scp=84655167108&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84655167108&partnerID=8YFLogxK

U2 - 10.1097/gme.0b013e31821f9171

DO - 10.1097/gme.0b013e31821f9171

M3 - Article

VL - 19

SP - 54

EP - 61

JO - Menopause

JF - Menopause

SN - 1072-3714

IS - 1

ER -