Can fertility acupuncture help with depression? It may sound like a strange idea, but the two may be more connected than you think. Let’s have a closer look.

Relax and it will happen, they say. Does your stress contribute to infertility or does the emotional rollercoaster of not being able to conceive lead to stress and depression? Stress and infertility – a classic Catch-22?

Many couples dealing with infertility experience increased levels of anxiety and depression, which can put a strain on their relationship and even affect their ability to conceive. Dealing with infertility causes significant distress.

Unmanaged depression can have a negative effect on a couple’s relationship.  It can affect the libido in both partners, and it even has a toll on sperm quality.  No surprise that men diagnosed with major depression are less likely to conceive a child. And women with severe symptoms have 38 per cent fewer conceptions each month.

So what can you do to address this? Are there any safe treatment options?

Many studies have explored and showed the negative effects of antidepressants on pregnancy and on health of a developing baby. We are not yet certain how these drugs affect fertility.

For instance, women undergoing medical treatment for depression are more likely to miscarry. The same study links the use of antidepressants and male infertility.  If you are in a position to choose, discuss non-pharmaceutical treatment with your doctor. For those looking for a safe and effective alternative, fertility acupuncture may be worth considering.

How to overcome your depression naturally when trying for a baby

There are a few effective non-drug interventions. We recommend a combination of

Read more

Stress affects your fertility. We can’t ignore this fact any longer.

Furthermore, long-term stress can reduce your IVF success. UK scientists measured cortisol levels in women undergoing IVF. They took samples of hair and saliva. Hair sampling allows analysis of cortisol over the preceding 3–6 months. While saliva sample shows immediate stress levels. Results were eye-opening. Women exposed to chronic stress were 27% less likely to conceive with IVF.

How many acupuncture sessions do you need to have a significant impact on stress?

Is it realistic to think that a single acupuncture session can reduce the cumulative effects of stress that has happened over a longer period, say 3-6 months?

A recent study led by Dr Sutton explored this question. They compared a month of regular acupuncture with one session on the day of embryo transfer. Acupuncture on the day of embryo transfer is often recommended by reproductive endocrinologists.

To no surprise women who had several acupuncture sessions felt more relaxed. Unfortunately, researchers didn’t further explore if acupuncture dose has an impact on pregnancy rates.

Read more

stress-acupuncture-reproduction

Too much stress is a serious factor affecting your fertility. The study, published in the Journal of Human Reproduction found that stress can lead to a two-fold increase in infertility among women trying to conceive for one year. Are you trying to conceive and are stressed? Perhaps it’s a good idea to consider acupuncture. It interferes with the very mechanism of stress.

Preconception stress increases the risk of infertility: results from a couple-based prospective cohort study—the LIFE study
C.D. Lynch1,*, R. Sundaram2, J.M. Maisog2, A.M. Sweeney3 and G.M. Buck Louis2
+ Author Affiliations Read more

The Effect of Acupuncture on Psychosocial Outcomes for Women Experiencing Infertility: A Pilot Randomized Controlled Trial

Caroline A. Smith, PhD, Jane M. Ussher, PhD, Janette Perz, PhD, Bridget Carmady, and Sheryl de Lacey, PhD

Abstract

Objectives:

The study objectives were to examine the effectiveness of acupuncture for reducing infertility-related stress.

Design:

The study design was a randomized controlled trial of acupuncture compared with a wait-list control.

Setting:

The study was conducted at The University of Western Sydney.

Subjects:

Thirty-two (32) women aged 20–45 years, with a diagnosis of infertility, or a history of unsuccessfully trying to conceive for 12 months or more, were the subjects of the study.

Interventions:

Women received six sessions of acupuncture for over 8 weeks.

Outcome measures:

The primary outcomes were infertility self-efficacy, anxiety, and infertility-related stress. The women’s experience of infertility and acupuncture is also reported.

Results:

At the end of the 8-week intervention, women in the acupuncture group reported significant changes on two domains on the Fertility Problem Inventory with less social concern (mean difference [MD] ?3.75, 95% confidence interval [CI] ?7.58 to 0.84, p=0.05), and less relationship concern (MD ?3.66, 95% CI ?6.80 to ?0.052, p=0.02). There were also trends toward a reduction of infertility stress on other domains, and a trend toward improved self-efficacy (MD 11.9, 95% CI ? 2.20 to 26.0, p=0.09) and less anxiety (MD ? 2.54, 95% CI ? 5.95 to 0.86, p=0.08) in the acupuncture group compared with the wait-list control. Women described the experience and impact of acupuncture as positive relating to a sense of relaxation and time out, the engagement with the practitioner, and intervention that had very few negative side-effects. Changes were also perceived after treatment with women describing a physical and psychologic sense of relaxation and calmness, and a changed perspective in relation to coping.

Conclusions:

Acupuncture may be a useful intervention to assist with the reduction of infertility-related stress. Further research is justified.

IVF is stressful. And Acupuncture offsets the effects of stress on some reproductive hormones during the in vitro fertilisation.

Stress and reproductive failure: past notions, present insights and future directions Journal Journal of Assisted Reproduction and Genetics
Publisher Springer Netherlands
ISSN 1058-0468 (Print) 1573-7330 (Online)
Issue Volume 25, Numbers 2-3 / March, 2008
Category REPRODUCTIVE IMMUNOLOGY
DOI 10.1007/s10815-008-9206-5
Pages 47-62
Subject Collection Medicine
SpringerLink Date Friday, February 15, 2008

Katrina Nakamura1 , Sam Sheps2, 3 and Petra Clara Arck4, 5(1) Interdisciplinary Studies Graduate Program, University of British Columbia, 6201 Cecil Green Park Road, Vancouver, BC, V6T 1Z1, Canada
(2) Department of Health Care and Epidemiology, University of British Columbia, Vancouver, Canada
(3) Western Regional Training Center for Health and Policy Research, University of British Columbia, Vancouver, Canada
(4) Charité University Medicine, Berlin, Germany
(5) Brain Body Institute, McMaster University, Hamilton, Canada

Received: 24 January 2008 Accepted: 25 January 2008 Published online: 15 February 2008
Abstract
Problem Maternal stress perception is frequently alleged as a cause of infertility, miscarriages, late pregnancy complications or impaired fetal development. The purpose of the present review is to critically assess the biological and epidemiological evidence that considers the plausibility of a stress link to human reproductive failure.
Methods All epidemiological studies published between 1980 and 2007 that tested the link between stress exposure and impaired reproductive success in humans were identified. Study outcomes were evaluated on the basis of how associations were predicted, tested and integrated with theories of etiology arising from recent scientific developments in the basic sciences. Further, published evidence arising from basic science research has been assessed in order to provide a mechanistic concept and biological evidence for the link between stress perception and reproductive success.
Results Biological evidence points to an immune–endocrine disequilibrium in response to stress and describes a hierarchy of biological mediators involved in a stress trigger to reproductive failure. Epidemiological evidence presents positive correlations between various pregnancy failure outcomes with pre-conception negative life events and elevated daily urinary cortisol. Strikingly, a relatively new conceptual approach integrating the two strands of evidence suggests the programming of stress susceptibility in mother and fetus via a so-called pregnancy stress syndrome.

Conclusions: An increasing specificity of knowledge is available about the types and impact of biological and social pathways involved in maternal stress responses. The present evidence is sufficient to warrant a reconsideration of conventional views on the etiology of reproductive failure. Physicians and patients will benefit from the adaptation of this integrated evidence to daily clinical practice.

Read more

bmj-infertility-acupuncture1 Effects of acupuncture on rates of pregnancy and live birth among women undergoing in vitro fertilisation: systematic review and meta-analysis

Eric Manheimer, research associate1, Grant Zhang, assistant professor1, Laurence Udoff, assistant professor2, Aviad Haramati, professor3, Patricia Langenberg, professor and vice-chair4, Brian M Berman, professor1, Lex M Bouter, professor and vice chancellor (rector magnificus)5

1 Center for Integrative Medicine, University of Maryland School of Medicine, 2200 Kernan Drive, Kernan Hospital Mansion, Baltimore, MD 21207, USA, 2 Department of Obstetrics, Gynecology and Reproductive Services, University of Maryland School of Medicine, 3 Department of Physiology and Biophysics and Medicine, Georgetown University School of Medicine, Washington, DC, 4 Department of Epidemiology and Preventive Medicine, University of Maryland School of Medicine, 5 VU University Amsterdam De Boelelaan 1105, 1081 HV Amsterdam, the Netherlands

Correspondence to: E Manheimer emanheimer@compmed.umm.edu
Objective To evaluate whether acupuncture improves rates of pregnancy and live birth when used as an adjuvant treatment to embryo transfer in women undergoing in vitro fertilisation.

Design Systematic review and meta-analysis.

Data sources Medline, Cochrane Central, Embase, Chinese Biomedical Database, hand searched abstracts, and reference lists.

Review methods Eligible studies were randomised controlled trials that compared needle acupuncture administered within one day of embryo transfer with sham acupuncture or no adjuvant treatment, with reported outcomes of at least one of clinical pregnancy, ongoing pregnancy, or live birth. Two reviewers independently agreed on eligibility; assessed methodological quality; and extracted outcome data. For all trials, investigators contributed additional data not included in the original publication (such as live births). Meta-analyses included all randomised patients.

Data synthesis Seven trials with 1366 women undergoing in vitro fertilisation were included in the meta-analyses. There was little clinical heterogeneity. Trials with sham acupuncture and no adjuvant treatment as controls were pooled for the primary analysis. Complementing the embryo transfer process with acupuncture was associated with significant and clinically relevant improvements in clinical pregnancy (odds ratio 1.65, 95% confidence interval 1.27 to 2.14; number needed to treat (NNT) 10 (7 to 17); seven trials), ongoing pregnancy (1.87, 1.40 to 2.49; NNT 9 (6 to 15); five trials), and live birth (1.91, 1.39 to 2.64; NNT 9 (6 to 17); four trials). Because we were unable to obtain outcome data on live births for three of the included trials, the pooled odds ratio for clinical pregnancy more accurately represents the true combined effect from these trials rather than the odds ratio for live birth. The results were robust to sensitivity analyses on study validity variables. A prespecified subgroup analysis restricted to the three trials with the higher rates of clinical pregnancy in the control group, however, suggested a smaller non-significant benefit of acupuncture (odds ratio 1.24, 0.86 to 1.77).

Conclusions Current preliminary evidence suggests that acupuncture given with embryo transfer improves rates of pregnancy and live birth among women undergoing in vitro fertilisation.

Using acupuncture to treat premenstrual syndrome.

Habek D, Habek JC, Barbir A.

More than 60% of the women in both groups suffered from premenstrual syndrome (PMS or PMT) symptoms, such as

  • anxiety,
  • mastalgia (breast pain),
  • insomnia,
  • nausea and
  • gastrointestinal disorders

whereas a smaller number of women suffered from

  • phobic disorders,
  • premenstrual headaches
  • migraines.

There were three women from the first group and seven women from the second group who continued the medication treatment with progestins, whereas one woman from the first group and nine women from the second group continued to take fluoxetine.

In the first group, nine women stopped having PMS symptoms after two acupuncture treatments, eight women stopped having them after three treatments and one woman stopped having them after four treatments.

In four women from the first group and 16 women from the second group, PMS symptoms appeared during the following period (cycle) or continued even after four treatments, so the medication was continued. In the first group, one woman had a smaller subcutaneous hematoma after the AP acupoint Ren 6.

There was a statistical and relevant reduction in PMS symptoms with the AP treatments in the first group (P<0.001), whereas their reduction was irrelevant in the placebo AP group (P>0.05). The success rate of AP in treating PMS symptoms was 77.8%, whereas it was 5.9%. in the placebo group. The positive influence of AP in treating PMS symptoms can be ascribed to its effects on the serotoninergic and opioidergic neurotransmission that modulates various psychosomatic functions. The initial positive results of PMS symptoms with a holistic approach are encouraging and AP should be suggested to the patients as a method of treatment.

Arch Gynecol Obstet. 2002 Nov;267(1):23-6.

Electroacupuncture: mechanisms and clinical application.
Ulett GA, Han S, Han JS.

University of Missouri-Columbia, School of Medicine, St. Louis 63139, USA.

Acupuncture is an ancient Chinese method to treat diseases and relieve pain. We have conducted a series of studies to examine the mechanisms of this ancient method for pain relief. This article reviews some of our major findings. Our studies showed that acupuncture produces analgesic effect and that electroacupuncture (EA) is more effective than manual acupuncture. Furthermore, electrical stimulation via skin patch electrodes is as effective as EA. The induction and recovering profiles of acupuncture analgesia suggest the involvement of humoral factors. This notion was supported by cross-perfusion experiments in which acupuncture-induced analgesic effect was transferred from the donor rabbit to the recipient rabbit when the cerebrospinal fluid (CSF) was transferred. The prevention of EA-induced analgesia by naloxone and by antiserum against endorphins suggests that endorphins are involved. More recent work demonstrated the release of endorphins into CSF following EA. In addition, low frequency (2 Hz) and high frequency (100 Hz) of EA selectively induces the release of enkephalins and dynorphins in both experimental animals and humans. Clinical studies suggesting its effectiveness for the treatment of various types of pain, depression, anxiety, spinally induced muscle spasm, stroke, gastrointestinal disorders, and drug addiction were also discussed.

Biol Psychiatry. 1998 Jul 15;44(2):129-38.

Acupuncture increases nocturnal melatonin secretion and reduces insomnia and anxiety: a preliminary report.
Spence DW, Kayumov L, Chen A, Lowe A, Jain U, Katzman MA, Shen J, Perelman B, Shapiro CM.

Centre for Addiction and Mental Health, Toronto, Ontario, Canada.

The response to acupuncture of 18 anxious adult subjects who complained of insomnia was assessed in an open prepost clinical trial study. Five weeks of acupuncture treatment was associated with a significant (p = 0.002) nocturnal increase in endogenous melatonin secretion (as measured in urine) and significant improvements in polysomnographic measures of sleep onset latency (p = 0.003), arousal index (p = 0.001), total sleep time (p = 0.001), and sleep efficiency (p = 0.002). Significant reductions in state (p = 0.049) and trait (p = 0.004) anxiety scores were also found. These objective findings are consistent with clinical reports of acupuncture’s relaxant effects. Acupuncture treatment may be of value for some categories of anxious patients with insomnia.

J Neuropsychiatry Clin Neurosci. 2004 Winter;16(1):19-28.

Effect of acupuncture treatment on the immune function impairment found in anxious women.
Arranz L, Guayerbas N, Siboni L, De la Fuente M.

Department of Physiology (Animal Physiology II), Faculty of Biological Science, Complutense University of Madrid, Spain.

It is presently accepted that emotional disturbances lead to immune system impairment, and that therefore their treatment could restore the immune response. Thus, the aim of the present work was to study the effect of an acupuncture treatment, designed specifically to relieve the emotional symptoms stemming from anxiety, on several functions (adherence, chemotaxis, phagocytosis, basal and stimulated superoxide anion levels, lymphocyte proliferation in response to phytohemagglutinin A (PHA) and natural killer (NK) activity) of leukocytes (neutrophils and lymphocytes) from anxious women. The acupuncture protocol consisted of manual needle stimulation of 19 acupoints, with each session lasting 30 min. It was performed on 34 female 30-60 year old patients, suffering from anxiety, as determined by the Beck Anxiety Inventory (BAI). Before and 72 hours after receiving the first acupuncture session, peripheral blood samples were drawn. In 12 patients, samples were also collected immediately after the first single acupuncture session and one month after the end of the whole acupuncture treatment, which consisted of 10 sessions during a year, until the complete remission of anxiety. Twenty healthy non-anxious women in the same age range were used as controls. The results showed that the most favorable effects of acupuncture on the immune functions appear 72 hours after the single session and persist one month after the end of the complete treatment. Impaired immune functions in anxious women (chemotaxis, phagocytosis, lymphoproliferation and NK activity) were significantly improved by acupuncture, and augmented immune parameters (superoxide anion levels and lymphoproliferation of the patient subgroup whose values had been too high) were significantly diminished. Acupuncture brought the above mentioned parameters to values closer to those of healthy controls, exerting a modulatory effect on the immune system.

Am J Chin Med. 2007;35(1):35-51.

Clinical study on “jin’s three-needling” in treatment of generalized anxiety disorder
[Article in Chinese]
Luo WZ, Liu HJ, Mei SY.

College of Acupuncture and Massage, Guangzhou University of TCM, Guangzhou.

OBJECTIVE: To study the clinical effect of “Jin’s three-needling” in the treatment of generalized anxiety disorder. METHODS: Fifty-eight patients with generalized anxiety were randomly assigned to two groups equally, the medication group treated with anti-anxiety drugs and the acupuncture group with “Jin’s three-needling”. The treatment course was 6 weeks. The clinical effects were evaluated with Hamilton anxiety scale (HAMA), clinical global impression (CGI), and treatment emergent symptom scale (TESS) before treatment and at the end of 2nd, 4th, 6th week of the treatment course. The concentration of 5-hydroxytryptamine (5-HT) in platelet, and plasma levels of corticosterone (CS) and adrenocorticotropic hormone (ACTH) were measured with high performance liquid chromatography-electrochemical detection (HPLC-ED) method before and after treatment. RESULTS: The clinical effects in the two groups were equivalent, while the adverse reaction found in the acupuncture group was less than that in the medication group (P < 0.05). The platelet concentration of 5-HT and plasma ACTH level decreased significantly in both groups after treatment with insignificant difference between the group (P < 0.05). The plasma CS level had no obvious change in the two groups after treatment as compared with that before treatment respectively. CONCLUSION: "Jin's three-needling" shows similar curative effect on generalized anxiety to routine Western medicine but with less adverse reaction, which may be realized through regulating the platelet 5-HT concentration and plasma ACTH level.

Zhongguo Zhong Xi Yi Jie He Za Zhi. 2007 Mar;27(3):201-3.

Stress may increase the risk of miscarriage. And the study below shows that it may be especially harmful in early pregnancy. Acupuncture has been shown to reduce stress in early pregnancy and could be one of the therapies for miscarriage prevention.

Cortisol levels and very early pregnancy loss (miscarriage) in humans

Pablo A. Nepomnaschy , Kathleen B. Welch , Daniel S. McConnell, Bobbi S. Low, Beverly I. Strassmann , and Barry G. England

Abstract

Maternal stress is commonly cited as an important risk factor for spontaneous abortion. For humans, however, there is little physiological evidence linking miscarriage to stress. This lack of evidence may be attributable to a paucity of research on maternal stress during the earliest gestational stages. Most human studies have focused on “clinical” pregnancy (>6 weeks after the last menstrual period). The majority of miscarriages, however, occur earlier, within the first 3 weeks after conception (?5 weeks after the last menstrual period). Studies focused on clinical pregnancy thus miss the most critical period for pregnancy continuance. We examined the association between miscarriage and levels of maternal urinary cortisol during the first 3 weeks after conception. Pregnancies characterized by increased maternal cortisol during this period (within participant analyses) were more likely to result in spontaneous abortion or miscarriage (P < 0.05). This evidence links increased levels in this stress marker with a higher risk of early pregnancy loss in humans.

Read more

Comparative study of electro-acupuncture and maprotiline in treating depression
[Article in Chinese]
Han C, Li XW, Luo HC.

Acupuncture and Moxibustion School, Beijing University of Chinese Medicine, Beijing 100029.

OBJECTIVE: To compare the effect of electro-acupuncture (EA) and maprotiline (Map) in treating depression. METHODS: Thirty patients of depression were treated with EA and 31 patients with Map orally taken respectively. The therapeutic effect and side-effect were evaluated by measurement of Hamilton Depression Rating Scale (HAMD), Self-Rating Scale for Depression (SDS), Self-Rating Scale for Anxiety (SAS), Clinical Global Impression Scale (CGI) and Asberg Rating Scale for side-effects (ARS) before treatment and on the day 14, 28 and 42 of the therapeutic course. RESULTS: After treatment, the scores of HAMD and SDS lowered significantly (P < 0.01) than before treatment, and with insignificant difference between the group (P > 0.05). For patients with somatic syndrome, the HAMD score decrease rate was obviously higher in the Map group than that in the EA group. However, for the patients with anxiety somatization syndrome, the score of SAS, ARS in the EA group were significantly lower than those in the Map group (P < 0.05). Moreover, the efficacy index was higher in the EA group (P < 0.01). CONCLUSION: Both EA and Map are effective in treating depression. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2002 Jul;22(7):512-4, 521.

Auricular acupuncture: a potential treatment for anxiety.
Wang SM, Kain ZN.

Department of Anesthesiology, Yale University School of Medicine and Yale-New Haven Hospital, New Haven, Connecticut 06521, USA. shu-ming.wang@yale.edu

Acupuncture can be an effective treatment for chronic anxiety disorders. The purpose of this study was to assess the effectiveness of acupuncture in reducing anxiety in a volunteer population. If found effective, this modality could be introduced as a treatment of anxiety before surgery. Adult volunteers (n = 55), were randomized to three treatment groups: a) Shenmen group–bilateral auricular acupuncture at the “shenmen” point; b) Relaxation group-bilateral auricular acupuncture at a “relaxation” point; and c) Sham group-bilateral auricular acupuncture at a “sham” point. Press-acupuncture needles were inserted at the respective auricular areas for 48 h. State anxiety, blood pressure, heart rate, and electrodermal activity were assessed at 30 min, 24 h, and 48 h after insertion. Analyzing anxiety levels using repeated-measures analysis of variance has demonstrated a significant difference [F (2,51) =8.8, P = 0.001] between the three treatment groups. Post hoc analysis demonstrated that patients in the Relaxation group were significantly less anxious at 30 min (P = 0.007) and 24 h (P = 0.035) as compared with patients in both the Shenmen group and the Sham group, and less anxious at 48 h (P = 0.042) as compared with patients in Shenmen group. Repeated-measures analysis of variance performed for electrodermal activity, blood pressure, and heart rate demonstrated no group differences (P = ns). We conclude that auricular acupuncture at the “relaxation” point can decrease the anxiety level in a population of healthy volunteers.

Anesth Analg. 2001 Feb;92(2):548-53.

Acupuncture in patients with minor depressive episodes and generalized anxiety. Results of an experimental study
[Article in German]
Eich H, Agelink MW, Lehmann E, Lemmer W, Klieser E.

Klinik fur Psychiatrie und Psychotherapie, am Evangelischen Krankenhaus Gelsenkirchen Universitatsklinik der Ruhr-Universitat Bochum.

In a placebo-controlled, randomized, modified double-blind study we investigated the effects of body needle acupuncture (n = 10) in 43 patients with minor depression (ICD 10 F32.0, F32.1) and 13 patients with generalized anxiety disorders (ICD10 F41.1). The severity of the disease was assessed by the Clinical Global Impression Scale (CGI). Treatment response was defined as a significant improvement in CGI. An intent-to-treat analysis was performed to compare treatment responses between verum- and placebo acupuncture. After completing an total of 10 acupuncture sessions the verum acupuncture group (n = 28) showed a significantly larger clinical improvement compared to the placebo group (Mann-Whitney test, p < 0.05). There were significantly more responders in the verum-compared to the placebo group (60.7% vs. 21.4%; chi-square test, p < 0.01). In contrast, no differences in the response rates were evident just after 5 acupuncture sessions. A multivariate analysis with the independent factor acupuncture (verum vs. placebo) and the results of the results of the additional rating scales (total score of HAMA, HAMD, Bf-S, BL) as dependent variables (ANOVA, 1:54 D.F.) revealed a clear trend towards lower HAMA scores in the verum group after completing 10 acupunctures (F3.29, p = 0.075). This corresponds well to the high response rate of 85.7% in patients with generalized anxiety disorders, in whom verum acupuncture was applied. Our results indicate that needle acupuncture (Du.20, Ex.6, He.7, Pe.6, Bl.62) leads to a significant clinical improvement as well as to a remarkable reduction in anxiety symptoms in patients with minor depression or with generalized anxiety disorders. The total sum of acupuncture sessions and the specific location of acupuncture needle insertions might be important factors for bringing about therapeutic success.

Tumori. 2002 Mar-Apr;88(2):128-30.
Links
Acupuncture in the treatment of menopause-related symptoms in women taking tamoxifen.
Porzio G, Trapasso T, Martelli S, Sallusti E, Piccone C, Mattei A, Di Stanislao C, Ficorella C, Marchetti P.

Medical Oncology Unit, University of L’Aquila, Italy. porzio1@interfree.it

Fifteen patients were enrolled in a pilot study to evaluate the safety and efficacy of acupuncture for the treatment of menopausal symptoms in tamoxifen-treated patients. Patients were evaluated before treatment and after one, three and six months with the Greene Menopause Index and were treated according to the traditional Chinese medicine. Anxiety, depression, somatic and vasomotor symptoms were improved by the treatment; libido was not modified. Acupuncture seems to be safe and effective for the treatment of menopausal symptoms in women with previous breast cancer taking tamoxifen. Confirmatory studies with a larger number of patients and with a placebo-treated group are warranted.