WOMEN’S HEALTH Examining the

AUTHOR:

Denise Doherty

DO COMPLEMENTARY AND ALTERNATIVE THERAPIES HAVE A PLACE IN THE MANAGEMENT OF MENOPAUSE?

EXPLORING THE SYMPTOMS OF MENOPAUSE AND WHETHER ALTERNATIVE TREATMENT MODALITIES COULD AND SHOULD PLAY A ROLE IN THEIR MANAGEMENT

Menopause is a significant stage in every woman’s lifecycle. It occurs 12 months after the last period, but women may experience various symptoms in the years leading up to, during, and for many years after the transition.1 Menopause and its associated symptoms are gaining increasing awareness and support across Ireland because the overwhelming evidence would suggest that it is not well managed, talked about, or understood here. Less than 20 per cent of women currently experiencing menopause and perimenopause describe it as a positive experience, and 82 per cent agree that it is not openly discussed enough.2 Women want more information, education, and understanding of the complex challenges and changes menopause brings physically, psychologically, emotionally, and socioeconomically.

In October 2022, Minister for Health Stephen Donnelly launched a national campaign to encourage everyone to talk about menopause and support those experiencing it. The campaign was launched in response to findings from The Radical Listening Exercise that was commissioned by the Women's Health Taskforce to improve women’s health outcomes and gauge their experiences of the healthcare system.2 Prior to the launch, research was carried out on behalf of the Department of Health (DoH) to quantify the  Three-quarters of women over the age of 35 have either entered perimenopause (19 per cent), are in menopause (18 per cent), or have completed menopause (37 per cent).

 While going through menopause, more than half describe their experience as being mainly negative.

 A third of women have almost constant symptoms.

 One-in-seven women describe their symptoms as severe.

 Only a quarter of women have minimal or no symptoms.

 Main symptoms experienced are related to temperature regulation, fatigue, insomnia, menstrual changes, and brain fog.

 Most commonly, people are comfortable to talk to their GP, partner or spouse, or a close friend.

TABLE 1: Highlights from research on behalf of the DoH (October 2022)3 perceptions around menopause in Ireland.3 The major findings are outlined in Table 1, and highlight the urgent need for better menopause management.

Alongside the campaign, several innovations have been implemented and achieved to enhance menopause care in Ireland, including:  Five specialist menopause clinics (in the National Maternity Hospital; Nenagh

Hospital; the Rotunda; the Coombe; and

University Hospital Galway) have opened to-date, with a further clinic in Cork planned to open later this year.  The Irish College of General

Practitioners (ICGP) has recently published its Quick Reference Guide on the Diagnosis and Management of

Menopause in General Practice.  Budget 2023 saw the removal of

VAT from hormone replacement therapy (HRT).

Menopause symptom management

Data released in 2021 from Mental Health Ireland’s Menopause Report4 is similar to the findings published by the DoH, and reinforces the need for improved symptom management strategies. Results published in the report include:  78 per cent of women report that menopausal symptoms interfere sometimes or often in their daily activities.

 59 per cent of symptomatic postmenopausal women experience 13 or more symptoms, with vasomotor symptoms (VMS) being the most common.  The most commonly reported symptoms are hot flushes (92 per cent of women), low sex drive (89 per cent of women), and night sweats (87 per cent of women).  80 per cent of women experience weight changes during the menopause transition, with almost half of women finding weight management challenging.

Less than one-third of women are using HRT in Ireland.4 Forty per cent of women have never considered HRT, 13 per cent are unsuitable candidates, 25 per cent do not wish to take hormones, and 12.5 per cent use other remedies for symptom alleviation.4 Only 29 per cent of women have never tried other remedies during menopause, meaning that more than twothirds have sought symptom relief from complementary and alternative medicine (CAM) treatments at some point during the menopause trajectory.4 The most commonly used CAM treatments are outlined in Table 2, along with their perceived effectiveness in symptom management.

Observational and anecdotal evidence, combined with the longevity and popularity of many CAM therapies, would suggest that they may provide effective adjuvant or stand-alone methods to alleviate symptoms associated with menopause. However, many CAM therapies are poorly regulated, expensive, and lack a sound body of empirical data supporting their efficacy. The HSE does cite several of these treatments among its alternatives to HRT, with an acknowledgement of the lack of evidence supporting their use.5 Validated clinical research examining their role in the management of menopause symptoms is indeed scarce, but does gradually continue to emerge. Because menopause is primarily treated in general practice, general practice nurses (GPNs) are often a major support to this population of women. Therefore, examining the existing evidence supporting CAM therapies in menopause will help in the education, empowerment, and conversations these patients are calling for.

CAM therapies: The available evidence

In 2019, a critical review of the existing literature on the CAM treatments most commonly used for menopausal symptoms was published in the Journal of Evidence-Based Integrative Medicine.

5 It included RCTs with a sample size of at least 10, including randomised pilot studies and systematic reviews. Observational, uncontrolled, nonrandomised data, and case studies did not meet the inclusion criteria. The major findings of this review are outlined and discussed in relation to a wide range of popular CAM therapies.

Hypnosis

Hypnotherapy, an induced state of deep relaxation and altered awareness, was shown in the review to be associated with statistically significant improvements in menopause symptoms. Two randomised trials among breast cancer survivors showed a clinically significant reduction in hot flush severity and frequency that was comparable to drug therapy. The review also uncovered a separate study that found hypnosis to be as effective as venlafaxine 75mg in reducing both hot flush frequency and associated interference. Other data demonstrated associations between hypnotherapy and improved sleep quality and sexual function. No negative effects were reported and the reviewers concluded that hypnotherapy may act as standalone or adjuvant therapy in menopause, but that more investigation is required to validate the hypothesis.

Cognitive behavioural therapy (CBT)

The evidence supporting the talking therapy CBT as a therapeutic intervention for menopause is also inconclusive, but generally positive.

CAM THERAPY BLACK COHOSH BREATHING TECHNIQUES SLEEP AIDS MINDFULNESS MIND-BODY RELAXATION TECHNIQUES CHIROPRACTOR/ SPINAL MANIPULATION

Use (%) 38 26.1 21.6 24.1 34.3

Very effective (%)

Somewhat effective (%)

Not at all effective (%)

36.1 20.7

36.1 61.1

8.6 18.2 36.4 25.6

52.7 64.7

11.0 9.7 25.9

60.3

13.8

TABLE 2: CAM therapy use and perceived effectiveness for menopause symptom management in Ireland4 7.1

60.6

30.6

8.8

No RCTs reported clinically significant improvements in hot flush frequency, but several did demonstrate that the treatment may be beneficial in reducing hot flush distress and interference, as well as other psychological symptoms, such as depression and anxiety, that are associated with menopause. The HSE cites CBT as a potential treatment for low mood, anxiety, hot flushes, and sleep disturbances in menopause.7 Research in the field is still ongoing.

Biofeedback and relaxation techniques

Biofeedback uses a device to monitor autonomic bodily functions and provides ‘feedback’ about relaxation techniques to the patient. Some of the relaxation techniques examined in the reviewed RCTs included muscle relaxation, relaxation combined with thermal control biofeedback training, paced respiration, at-home relaxation audiotapes, guided imagery, and applied relaxation. Five trials indicated that relaxation techniques may reduce the frequency of hot flushes and improve psychological symptoms of menopause. However, these studies were considered low quality, with small sample sizes. Other studies also concluded that relaxation techniques may have a positive benefit on VMS, psychological issues, and stress, yet due to low-quality evidence and inconsistent findings, more evidence is needed to draw conclusions. Preliminary reports indicate these therapies may benefit some women.

Mindfulness-based stress reduction (MBSR)

Mindfulness utilises the principles of non-judgemental awareness in the present moment and has been studied in a wide range of disorders. Research on its efficacy in menopause symptoms is, however, scarce. Only one RCT examining the effects of MBSR for menopause symptoms in 110 women was examined in the review. Hot flush frequency, distress, and intensity failed to show statistically significant improvements. However, there was a clinically meaningful improvement in overall menopause-related quality-oflife and sleep quality. Perceived stress and anxiety also significantly improved in the MBSR group following treatment. More research is warranted before conclusions can be drawn, but initial indications are positive.

Yoga

There is high variability among yoga studies, which makes accurate datagathering and analysis difficult. This is likely in view of the multiple branches, methods, and styles of yoga, that range from physical body postures, to breath manipulation, and spiritual practices. The reviewers concluded that despite these challenges, there does appear to be moderate evidence supporting the short-term effects of yoga on psychological symptoms and fatigue in menopause, but no evidence was uncovered to support its application in the management of physical symptoms. Yoga is one of the relaxation techniques recommended by the HSE and may be beneficial for some women.8

Aromatherapy

Aromatherapy involves the use of various essential oils in the promotion of healing. Again, drawing conclusions is difficult due to a lack of clinical trials, the vast selection and combinations of oils that may be used, and the frequent implementation of aromatherapy into other therapies. However, the limited available evidence is generally positive. RCTs included in the review reported that 12 weeks of lavender essential oil inhalation improved self-reported sleep quality compared with health education control, and reduced hot flush frequency by 50 per cent compared to a less than 1 per cent reduction in the control group. When combined with massage, aromatherapy was reportedly more beneficial than massage alone in improving both physiological and psychological symptoms. Again, more clinical research is required to draw conclusions and make solid recommendations. Some women may experience benefits of aromatherapy alone, or combined with other CAM treatments.

Reflexology

Reflexology is a specific type of massage performed on the feet, hands, and other zones of the body that are believed to stimulate and regulate corresponding glands and organs. Again, valid and reliable data is scarce regarding its benefits in menopause, and the available literature is conflicting. Only two RCTs examining the use of reflexology for menopausal symptoms were included in the review. The earlier of the two found no significant differences between non-specific foot massage and reflexology on anxiety, depression, and VMS. A more recent RCT of 120 women did, however, find that 12 twice-weekly reflexology sessions significantly enhanced sexual dysfunction and improved hot flush frequency by 56 per cent compared to simple foot massage. In a separate investigation, the National Institute for Health and Care Excellence (NICE) has found that foot reflexology was more effective than control aromatherapy for hot flushes, sweats, and night sweats, but does state that a larger body of evidence is required to consider changing current guidelines.9

Homeopathy

Homeopathy operates on the principles of hormesis, or ‘like-cures-like’, whereby patients are given micro-doses of natural substances that would be harmful in higher amounts to treat a disorder. The review uncovered only one study that found homeopathy to be beneficial in reducing distress in

menopause. Overall, researchers have concluded that there is no convincing evidence for the efficacy of homeopathy in menopause symptom management.

Acupuncture

Acupuncture is a popular form of traditional Chinese medicine (TCM) that involves light needle insertion into various points of the body, called acupoints. To-date, empirical data is conflicting regarding its role in menopause. Four trials included in the review found no statistical difference between acupuncture and placebo of superficially placed needles or needling at non-acupoints. However, six trials did report significant improvements in VMS, sleep, and other symptoms compared sleep problems. Reviewers concluded that more precise trials are required to explore the reported benefits to-date and the various treatment combinations.

Chinese herbs

Chinese herbs come in a variety of combinations, preparations, and doses. It is, therefore, difficult to source accurate and comparable data, and again, available data was conflicting in the review. VMS, psychological symptoms, sleep quality, sexual functioning, and quality-of-life significantly improved with Chinese herbs when compared to placebo in several of the trials reviewed, while other RCTs reported no significant differences between treatment and placebo groups. Chinese herbs were not found to be

THE EVIDENCE SUPPORTING CAM THERAPIES IS INCONCLUSIVE TO-DATE, BUT THE EVIDENCE SUPPORTING EMPOWERMENT, INFORMATION SHARING, AND AWARENESS IN MENOPAUSE MANAGEMENT IS DEFINITIVE

to placebo. Like several other CAM therapies, acupuncture is sometimes combined with other techniques. The review included one study that found no benefit to acupuncture plus auricular acupressure in managing VMS over hormone replacement. Two studies investigating the effects of electroacupuncture (which involves the passing of a small electrical current between the acupuncture needles) found no significant differences between it and placebo. One study did report clinically significant improvements after electroacupuncture, but in mood only. An RCT using acupuncture in tandem with diet therapy and Tuina self-massage found that the combination significantly improved hot flush frequency, irritability, and superior when compared to HRT in reducing VMS, anxiety, or depression. The drug Paroxetine was also shown to be more effective than Japanese herbs in a similar trial. More clinical trials are needed to draw conclusions.

Black cohosh

Black cohosh is a popular herbal remedy for menopause symptoms and multiple RCTs have been conducted to determine its efficacy. Of 16 RCTs that measured the effects of oral preparations on menopausal symptoms (that included VMS, sexual dysfunction, vulvovaginal symptoms, bone health, and quality-oflife), there was insufficient evidence to support its use, but enough evidence to warrant further investigation. Findings did become significant when black cohosh was combined with St John’s wort and examined against a placebo. In a study of 301 women, scores on the Menopause Rating Scale decreased by 50 per cent in the treatment group compared to 19 per cent in the control group. Depression also significantly decreased in the treatment group. A second RCT included in the review exhibited similar findings, making it difficult to conclude if black cohosh is beneficial by itself, or only in combination with other herbs. Sideeffects of black cohosh may include gastrointestinal problems, rash, and acute hepatitis. Both black cohosh and St John’s wort are cited by the HSE as potentially beneficial, but without sufficient supporting evidence.5 Women may experience benefits, but should be aware of the potential side-effects and lack of empirical data.

Dong quai

(Angelica sinensis)

As with black cohosh, Dong quai appears to be more effective when combined with other agents than individually. As a single treatment, the herb failed to show superiority over placebo for menopausal symptoms among 71 women in one of the reviewed RCTs. However, a combined preparation of Dong quai and Matricaria chamomilla in another trial demonstrated over 90 per cent improvements in the frequency and intensity of hot flushes, compared with less than 20 per cent in the placebo group. Combining Dong quai with other herbs, including black cohosh, milk thistle, red clover, American ginseng, and chastetree berry, also demonstrated improvements in hot flushes, night sweats, and sleep quality. In view of the safety concerns regarding Dong quai and its interactions with other medications and herbs (that include photosensitisation, anticoagulation, and possible carcinogenicity), the reviewers advocate for further trials before conclusions are reached.

Wild yam (Diascorea)

Only a small number of studies were uncovered by the authors, who also highlight that insufficient information exists regarding the long-term safety of wild yam use. The review did include an RCT of 50 women consuming 12mg of yam extract twice daily, who reported significant improvements in psychological symptoms compared with the placebo group. Topically, wild yam cream was no better than placebo in reducing menopause symptoms, or improving levels of oestrogen or progesterone. Again, more definitive data is required.

Evening primrose oil

No statistically meaningful benefit was associated with evening primrose oil at various doses, although symptoms did somewhat improve in one trial. When combined with marine fish oil and calcium, trials showed a 1 per cent increase in bone mineral density, which was not superior to calcium alone. The authors conclude that insufficient evidence exists to support the use of evening primrose oil in menopause at this time.

Phytoestrogens

Phytoestrogens are plant-derived compounds that are thought to mimic the effects of oestrogen in the body. The compounds are naturally found in soy, red clover, flaxseed, and hops. Fortythree RCTs, including one unpublished trial, were considered for the review. They demonstrated conflicting and inconclusive results that were difficult to evaluate. Only five trials investigating the effects of red clover extract on VMS were suitable for the meta-analysis. They did not demonstrate significant findings and the authors concluded that current evidence does not support the use of phytoestrogens to reduce the frequency or severity of VMS in menopause, but it does warrant further investigation.

Vitamin E

Vitamin E is poorly studied, but a popular choice for many women, according to the review. The authors uncovered a small number of clinical trials that found small, but clinically insignificant benefits of supplementation. They concluded that there is insufficient evidence to support the efficacy of vitamin E supplementation for menopausal symptoms at present.

Conclusion

Menopause is a challenging transition for many women. It can and does impact many or all aspects of their health and wellbeing, sometimes for a substantial period of time. It is also a deeply personal and individual experience, which necessitates and individualised and personal approach. The evidence supporting CAM therapies is inconclusive to-date, but the evidence supporting empowerment, information sharing, and awareness in menopause management is definitive.

Women want education, understanding, and support throughout the decisionmaking processes menopause brings. Some CAM therapies do appear to help alleviate many of the symptoms these women are experiencing. Others are not accumulating the same positive results in clinical trials. According to NICE, clinical guidelines regarding the use of these therapies are unlikely to change until more valid and reliable data emerges.9 However, their potential benefits and side-effects continue to be observed in ongoing trials. Sharing what we know so far is key to helping women find the right approach that meets their individual needs. l

REFERENCES

1. Currie H, Hamoda H, Fenton B. BMJ best practice: Menopause. 2015. [Updated 2021] Available at: https://bestpractice.bmj.com/topics/ en-us/194/pdf/194/Menopause.pdf. 2. Department of Health. Menopause. 2022. Available at: www.gov.ie/en/campaigns/ menopause/. 3. Department of Health. Understanding menopause: Highlights of Department of Health research carried out by B&A. Oct 2022. Available at: www.gov.ie/en/ campaigns/menopause/. 4. Lillis C, McNamara M, Wheelan J, McManus M, Murphy M B, et al. Experiences and health behaviours of menopausal women in Ireland. 2021. Available at: www. mentalhealthireland.ie/wp-content/ uploads/2021/10/MenopauseReport-2021_Final.pdf?external=1. 5. Health Service Executive. Alternatives to HRT. 2022. Available at: www2.hse.ie/ conditions/hrt/alternatives/. 6. Johnson A, Roberts L, Elkins G. Complementary and alternative medicine for menopause. J Evid Based Integr Med. 2019 JanDec;24:2515690X19829380. doi: 10.1177/2515690X19829380. 7. Health Service Executive. Treatment: Menopause. 2022. Available at: www2.hse.ie/conditions/ menopause/menopause-treatment/. 8. Health Service Executive. Menopause: Things you can do. 2022. Available at: www2.hse.ie/ conditions/menopause/thingsyou-can-do/. 9. National Institute for Health and Care Excellence. Summary of evidence for 2019 surveillance of menopause (2015) NICE guideline NG23. 2019. Available at: www.nice.org.uk/ consultations/672/10/managingshort-term-menopausal-symptoms.