Acupuncture for Menopausal Hot Flushes

By Judith L. Balk, MD, MPH, FACOG. Dr. Balk is Associate Professor, Magee-Women's Hospital, University of Pittsburgh; she reports no financial relationship to this field of study.

Menopausal hormone therapy has both risks and benefits. the conclusion of the Women's Health Initiative (WHI) study was that for many women, the risks of menopausal hormone therapy outweigh the benefits.1 Since that time, many providers and patients have been looking for alternatives to hormone therapy to treat menopausal hot flushes. In 2001, prior to the publication of the WHI study, roughly 70% of women seeking care at a tertiary menopause clinic had used some type of integrative approach to treat their menopausal symptoms, and overall were satisfied with this approach.2 It is likely that the usage of integrative approaches is even higher today, in the post-WHI era.

Physicians and health care providers, however, may not be adequately educated on integrative approaches to treat menopausal symptoms. An anonymous survey asked family medicine residents and faculty to note whether they were most likely to encourage use, discourage use, or to give no advice on different integrative modalities for various menopausal issues.3 The majority were most likely to give no advice on acupuncture for vasomotor symptoms, the remainder encouraging (13.4%) or discouraging its use (13.9%) with essentially equal frequency. The authors suggest that physicians are not clear on the advantages or disadvantages of integrative modalities such as acupuncture, bodywork, herbal approaches, and behavioral therapies.

Some of the alternatives to hormone therapy include prescription medications such as venlafaxine, gabapentin, and clonidine. Non-pharmaceutical options that have been studied include Vitamin E, black cohosh, relaxation training, and acupuncture. Acupuncture has been fairly well-studied for menopausal symptoms, although it is one of the modalities that is extremely difficult to study using the gold standard double-blind, placebo-controlled, randomized trial. No one has yet succeeded in either blinding the acupuncturist, or in finding a control that is both valid and inert. That said, acupuncture trials comparing true acupuncture to sham acupuncture must be thought of as not likely having an inert control intervention.4,5 A therapeutic effect of the sham intervention would make it harder to demonstrate a difference between real and sham acupuncture.4

Mechanism of Action of Acupuncture

What mechanism could explain acupuncture's effects on hot flushes? The exact cause of hot flushes is not known, although thermoregulatory dysfunction is likely involved. Acupuncture, which increases beta-endorphin levels, may affect the sympathetic nervous system via mechanisms at the hypothalamic and brainstem levels.6 Opioids in the brain seem to stabilize the thermoregulatory center from which hot flushes are initiated.7 Keeping in mind that the prescription medications used to treat hot flushes each affect the brain, one could postulate that one of the mechanisms of action of acupuncture also might be related to neurotransmitters. In fact, in an animal model, both dopaminergic and serotonergic pathways appear to be activated with electroacupuncture and moxibustion.8

Acupuncture Theory of Hot Flushes

Acupuncture for menopausal symptoms aims to correct a condition known as "deficient heat."9 Yin energy is thought to be deficient in menopause, causing night- sweats and a general mental agitation. Acupuncture points often used in the management of menopausal symptoms balance the kidney chi by subduing kidney yang. Points that nourish the heart and quiet the spirit also are used.9

Clinical Trials

The largest controlled clinical trial of acupuncture for menopausal hot flushes is the ACUFLASH study,10 a multicenter, pragmatic, randomized, controlled trial enrolling symptomatic postmenopausal women. The acupuncture group received 10 acupuncture treatment sessions and advice on self-care, while the control group received advice on self-care only. The primary endpoint was change in mean hot flash frequency from baseline to 12 weeks, and the secondary endpoint was change in health-related quality of life. This study found that hot flush frequency decreased by 5.8 per 24 hours in the acupuncture group (n = 134) and 3.7 per 24 hours in the control group (n = 133), a difference of 2.1, which was statistically significant (P < 0.001). Hot flash intensity also decreased significantly. Regarding quality of life, the acupuncture group experienced statistically significant improvements in vasomotor, sleep, and somatic symptoms compared to the control group (P < 0.001, P = 0.002, and P = 0.011, respectively). This study did not have a placebo control, but taken as an effectiveness trial, the results are valid. The observational follow-on study did not show a significant difference between groups at 6 and 12 months,11 and the authors concluded that acupuncture can contribute to a more rapid reduction in vasomotor symptoms and improvement in health-related quality of life, but that it probably has no long-term effects.

Smaller clinical trials have found similar results. A recent randomized, single-blind study compared shallow needle sham acupuncture (n = 24) to traditional Chinese medicine (TCM) acupuncture (n = 27) in postmenopausal women experiencing hot flushes.12 Both groups had significant improvements over the 12 weeks of the study, but there were no differences between groups. The investigators note that shallow needling may have therapeutic effects, thus reducing its utility as a "placebo" control.

One study of hot flushes in perimenopausal and postmenopausal women compared three groups: TCM acupuncture, shallow needling, and usual care.13 All three groups showed an improvement in the frequency of hot flushes across the eight weeks of the study intervention (P = 0.01), but the differences between groups were nonsignificant. However, the two acupuncture groups showed a significantly greater decrease in hot flushes than the usual care group (P < 0.05), but results in the two acupuncture groups did not differ from each other. Because both acupuncture groups were better than usual care, the authors conclude that either there is a strong placebo effect, or that both sham and true acupuncture have clinical effects with respect to reducing hot flush frequency.

In a randomized study, Cohen et al compared menopause-specific acupuncture to general wellness acupuncture in a pilot study.9 Both were active groups, but the outcome variables included hot flushes, sleep disturbances, and mood changes, all of which were more likely to change with the menopause-specific acupuncture. Hot flush severity and sleep disturbance decreased in the experimental group (P < 0.05), but not in the wellness group over the treatment period. Mood changes decreased in both acupuncture groups, which was not surprising (P = 0.05). The findings support the use of acupuncture in treating symptoms of menopause in particular, and overall well-being and mood, in general.

Estrogen is known to be effective for hot flushes; thus, it is a reasonable active control group. Forty-five postmenopausal women with vasomotor symptoms were randomized to electro-acupuncture, superficial needle insertion or oral estradiol treatment for 12 weeks, with 6 months' follow-up.14 The number and severity of flushes were registered daily and the Kupperman index, which is a validated measurement of menopausal symptoms, and a general estimate of climacteric symptoms were completed before, during, and after therapy. In the electro-acupuncture group, the mean number of flushes per 24 hours decreased from 7.3 to 3.5, (P < 0.001). Eleven of the 15 women had at least a 50% decrease in number of flushes (with a mean decrease of 82%). Superficial needle insertion decreased the number of flushes per 24 hours from 8.1 to 3.8, also statistically significant (P < 0.001). In seven out of 13 women, the number of flushes decreased by at least 50% (mean decrease 83%). In the estrogen group, the number of flushes decreased from 8.4 to 0.8 (P < 0.001). The decrease in number of flushes persisted during the 24-week follow-up period in all treatment groups. The investigators conclude that acupuncture is a viable alternative treatment of vasomotor symptoms in postmenopausal women, and that they cannot recommend superficial needle insertion as an inactive control treatment. While estrogen was the most effective treatment, it carries with it risks that some patients will find unacceptable.

Mind-body approaches such as paced respiration and relaxation training also can improve hot flushes; thus, these would be appropriate active controls also. Hormone therapy is contraindicated for women with a history of breast cancer. Breast cancer patients with vasomotor symptoms were randomized to either electroacupuncture or to "applied relaxation," a progressive muscle relaxation technique.7 Menopausal symptoms and mood were assessed at baseline, during the 12 weeks of therapy, and at 3 and 6 months follow up. In both groups, hot flushes (P < 0.0001) and menopausal symptoms (P < 0.0001) decreased significantly throughout the course of the study, improvements appearing after 12 weeks of treatment and continuing to the six-month follow-up. Well-being also improved in both groups, but mood improved only in the acupuncture group (P < 0.05). The investigators propose that both applied relaxation and electroacupuncture modulate central neurotransmitters, such as beta- endorphin, with secondary positive effects on psychological well-being. A non-controlled pilot study also found that anxiety, depression, somatic, and vasomotor symptoms were improved by acupuncture in breast cancer patients on tamoxifen.15

Safety

Acupuncture is safe when it is performed by experienced and well-trained practitioners, using sterile, single-use needles.4 However, all interventions carry some risk, and acupuncture is no exception. Of 97,733 patients receiving acupuncture, six cases of potentially serious adverse events were reported including exacerbation of depression, asthma attack, hypertensive crisis, vasovagal reaction, and pneumothorax, as noted in a review article.4 Minor adverse events from acupuncture include bruising, local external bleeding, and needle pain.

Conclusion

The majority of women treated with acupuncture have some reduction in their hot flushes. However, the majority of women treated with sham acupuncture also have a significant reduction in their hot flushes. When compared with other active controls, like estrogen or relaxation techniques, acupuncture shows effectiveness in reducing hot flushes. When compared with self-care, which is likely not an active control group, acupuncture is statistically better. The questions yet to be adequately answered are whether true acupuncture offers more than a placebo effect, and whether sham acupuncture is an active control group. Hot flushes have a high placebo response rate to hormone therapy; placebo treatment caused more than 50% reduction in hot flushes in the clinical trials evaluating oral hormone therapy4; it is not surprising that such a placebo response also might be seen in studies of other modalities, including acupuncture.

Acupuncture is generally considered to be a safe procedure, and when comparing it with the known risks of hormone therapy and antidepressants, the risks of adverse effects with acupuncture are lower. Is it worth a try? This review of the literature suggests there is little to lose by trying acupuncture in the setting of menopausal hot flushes, and potentially much to gain.

References

1. The Writing Group from the Womens Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: Principal results from the Women's Health Initiative randomized controlled trial. JAMA 2002;288:321-333.

2. Vashisht A, Domoney C, Cronje W, Studd J. Prevalence of and satisfaction with complementary therapies and hormone replacement therapy in a specialist menopause clinic. Climacteric 2001;4:250-256.

3. Grant K, Burg M, Fraser K, et al. Family medicine physicians' advice about use of nonconventional modalities for menopausal symptom management. J Womens Health 2007;16:517-525.

4. Alfhaily F, Ewies A. Acupuncture in managing menopausal symptoms: Hope or mirage? Climacteric 2007;10:371-380.

5. Balk J, Horn B. Why we should change the course of acupuncture research. J Chinese Med 2008;78:54-59.

6. Andersson S, Lundeberg T. Acupuncture—from empiricism to science: Functional background to acupuncture effects in pain and disease. Medical Hypotheses 1995;45:271-281.

7. Nedstrand E, Wyon Y, Hammar M, Wijma K. Psychological well-being improves in women with breast cancer after treatment with applied relaxation or electro- acupuncture for vasomotor symptom. J Psychosom Obstet Gynecol 2006;27:193-199.

8. Yano T, Kato B, Fukuda F, et al. Alterations in the function of cerebral dopaminergic and serotonergic systems following electroacupuncture and moxibustion applications: Possible correlates with their antistress and psychosomatic actions. Neurochemical Research 2004;29:283-293.

9. Cohen S, Rousseau M, Carey B. Can acupuncture ease the symptoms of menopause? Holist Nurs Pract 2003;17:295–299.

10. Borud E, Alraek T, White A, et al. The Acupuncture on Hot Flushes Among Menopausal Women (ACUFLASH) study, a randomized controlled trial. Menopause 2009;16:484-493.

11. Borud E, Alraek T, White A, Grimsgaard S. The Acupuncture on Hot Flashes Among Menopausal Women study: Observational follow-up results at 6 and 12 months. Menopause 2010;17:262-268.

12. Venzke L, Calvert JR, Gilbertson B. A randomized trial of acupuncture for vasomotor symptoms in post- menopausal women. Compl Therap in Medicine 2010;18:59-66.

13. Avis N, Legault C, Coeytaux R, et al. A randomized, controlled pilot study of acupuncture treatment for menopausal hot flashes. Menopause 2008;15:1070-1080.

14. Wyon Y, Wijma K, Nedstrand E, Hammar M. A comparison of acupuncture and oral estradiol treatment of vasomotor symptoms in postmenopausal women. Climacteric 2004;7:153-164.

15. Porzio G, Trapasso T, Martelli S, et al. Acupuncture in the treatment of menopause-related symptoms in women taking tamoxifen. Tumori 2002;88:128-130.