The report is a product of the VA/HSR Evidence Synthesis Program.

Evidence Report: Non-Pharmacologic Treatments for Vasomotor Symptoms Associated with Menopause

Vasomotor symptoms (VMS), which include hot flashes and night sweats, are the most common symptoms reported during the menopausal transition. VMS symptoms are experienced by as many as 80% of women with a mean age of onset of 51 years, and can last more than seven years. VMS can lead to increased healthcare encounters for symptom relief and reductions in quality of life. The degree to which VMS are bothersome is determined not only by how frequently they occur, but also by other factors such as duration, coexisting sleep problems, and the extent to which VMS interferes with daily activities or job-related activities. For some populations of women, VMS exerts an especially strong, negative impact on quality of life, which appears to be the case for women Veterans. Based on the age (>45 years) of the current women Veterans population, half of the approximately 360,000 women Veterans who use VA healthcare are perimenopausal (around menopause) or postmenopausal.

Hormone therapy (HT) is an effective treatment for reducing VMS, but the use of HT must be individualized through weighing benefits with known risks, such as cardiovascular events or uterine and breast cancers. Despite this, recent evidence indicates that compared with the general population of women in the United States, women Veterans using VA healthcare are twice as likely to use hormone therapy for relief of menopausal symptoms. Due in part to concerns about possible harms from long-term hormone therapy and, in part, to uncertain efficacy and safety of pharmacologic treatments, many women with VMS seek non-hormonal, non-pharmacologic treatment options (i.e., herbal remedies, yoga, tai chi). Therefore, investigators with VA's Evidence-based Synthesis Program (ESP) located in Durham, NC, have summarized and updated the evidence from systematic reviews on selected non-pharmacologic approaches for the management of menopause-associated VMS and health-related quality of life. Investigators searched MEDLINE and the Cochrane Database of Systematic Reviews from January 2010 through November 2015, with additional searches for more recent (since 2012) randomized controlled trials (RCTs) through February 2016. From this search, 10 systematic reviews and 14 RCTs were eligible and analyzed in this ESP Evidence Report.

Summary of Report
Compared with waitlist controls, evidence from RCTs supports acupuncture and yoga for reducing VMS and the impact of such symptoms on women's activities and health-related quality of life. The strength of evidence, however, is low to moderate. Moderately good evidence shows no benefit from structured exercise for VMS, but engaging in exercise is known to be important for other reasons. The evidence in support of the effectiveness of mindfulness or relaxation is mixed, with some promising evidence that needs replication for hypnosis.

There is insufficient evidence to draw conclusions about the effectiveness of these non-pharmacologic therapies for improving sleep, depression, or anxiety. The safety of the non-pharmacologic, non-hormonal approaches evaluated in this report has not been rigorously examined, but there is no clear signal for a significant potential for harm. Overall, most of the data included in this report comes from smaller studies with homogenous participant populations. Larger trials of populations more reflective of the diversity of women experiencing VMS will be necessary to discern the effectiveness of non-pharmacologic interventions in symptomatic menopausal women. Following are some specific findings.

Acupuncture

• Investigators conducted an updated meta-analysis and found that acupuncture is effective in reducing VMS frequency and severity – and improving quality of life when compared with no acupuncture, but not when compared with sham acupuncture.
  • This translates to an average of three fewer hot flashes per day.

Yoga, Tai Chi, and Qigong

• Investigators conducted an updated meta-analysis examining the effect of yoga compared with active and inactive controls on hot flash severity change scores using data from two new RCTs and two RCTs identified in a prior systematic review. Results indicate that yoga is significantly associated with a reduction in hot flash severity.
• Investigators did not identify any eligible systematic reviews or RCTs that evaluated the effectiveness of tai chi or qigong (Chinese system of physical exercises and breathing control related to tai chi).

Structured Exercise

• Investigators identified one good-quality systematic review that included five RCTs and involved 762 sedentary, perimenopausal and postmenopausal women with VMS. Updated meta-analyses showed no evidence that exercise significantly reduced hot flash frequency or severity compared with inactive control.
• Two new RCTs examined the effect of exercise compared with inactive control among perimenopausal and postmenopausal women with VMS. One RCT reported menopause-specific quality-of-life and found significantly lower sleep problems at 6-month follow-up for women in the exercise group; the other trial found moderate benefit from structured exercise on health-related quality-of-life at end of treatment and 12 weeks later.

Meditation, Mindfulness, Hypnosis, and Relaxation

• In one good-quality systematic review that included four RCTs, no significant differences were found between any type of relaxation or mindfulness interventions compared with control groups for the primary outcomes of VMS frequency or quality of life.
• Six new RCTs that were not included in existing systematic reviews were identified, and three examined the effect of paced respiration on VMS. A new meta-analysis compared paced respiration with a control group and found that it was not associated with a statistically significant decrease in hot flash frequency.
• Secondary outcomes of interest – sleep quality, depression, anxiety, and adverse effects – were rarely reported in systematic reviews addressing relaxation, and the results were mixed when they were reported.

Future Research
For some interventions such as acupuncture and yoga, there is evidence of benefit. However, the strength of evidence is low to moderate, so larger high-quality trials are needed. Comparative effectiveness trials would be more likely to inform policy and clinical decision-making rather than sham- or placebo-controlled effectiveness trials. This may be especially true in the search for alternatives to pharmacologic approaches to managing menopausal symptoms, where clinical effectiveness outcomes may need to be counter-balanced by other outcomes of importance to women, healthcare providers, and policymakers, such as potential harm, cost, overall utility, and women's preferences.

Further, none of the RCTs included in this review specifically involved Veterans. Additional research is needed to evaluate the acceptability, feasibility, and comparative effectiveness of non-pharmacologic approaches to managing menopausal symptoms for women Veterans in VA primary care clinics, as well as other settings and patient populations such as medically underserved populations.

A cyberseminar session titled "Nonpharmacologic Treatments for Menopause-associated Vasomotor Symptoms" will be held on December 19, 2016 from 1:00pm to 2:00pm (ET). To register, go to the HSR&D Cyberseminar web page.

Reference
Goldstein KM, Coeytaux RR, Williams Jr JW, Shepherd-Banigan M, Goode AP, McDuffie JR, Befus D, Adam S, Masilamani V, Van Noord MG. Non-pharmacologic Treatments for Menopause-Associated Vasomotor Symptoms. VA ESP Project #09-009; 2016.

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