Controversial and unproven treatments for menopause

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Posted 03 August 2015

500,000 Australian women use alternative menopause therapy – study

The Guardian
Melissa Davey Sunday 2 August 2015 15.01

http://www.theguardian.com/society/2015/aug/03/500000-australian-women-use-alternative-menopause-therapy-study

Study published in Medical Journal of Australia finds women still shun hormone replacement therapy and turn to herbal and complementary treatments

Controversial and unproven treatments for menopause are being used by almost half a million Australian women aged between 40 and 65, and are often recommended by their doctors, a study published on Monday in the Medical Journal of Australia has found.

Experts have responded to the finding by calling for stronger education about the benefits of conventional treatment through hormone replacement therapy, which they say has received a bad rap despite its overall safety and effectiveness.

Researchers from Melbourne’s Monash university surveyed 2020 women recruited from a large, nationally representative database derived from the Australian electoral roll, and who were aged between 40 and 65.  

Of these, 13.2%, or 267 women, reported having used at least one complementary or alternative therapy to treat vasomotor symptoms of menopause, which include night sweats, hot flashes, vaginal dryness and flushes. The most commonly used treatments were phytoestrogens (6.29%, derived from plant compounds, usually soy), evening primrose oil (3.91%) and ginseng (1.73%).

Overall 8.33% of women, or 168, had seen a complementary or alternative practitioner, such as a chiropractor or naturopath.

Phytoestrogens have not been shown to be effective for treating vasomotor symptoms of menopause, and ginseng, black cohosh and evening primrose oil are no more effective than a placebo, studies, including from Cochrane, have found.

“The effects are not always desirable, with the known side-effects of ginseng including hypertension, diarrhoea, sleeplessness, skin eruptions and vaginal bleeding,” the Monash study said.

“A national survey found that about a third of Australian general practitioners self-identified as practising complementary therapy. It is a cause for concern that a sizeable portion of Australian practitioners are recommending ineffective therapies.”

Menopause occurs when women cease menstruation and oestrogen levels drop, and can result in crippling symptoms which continue in some women for several years.  

Dr Ken Harvey, a medicinal drug policy expert with Medreach, said many women had shunned hormone replacement therapy – despite it being safe and effective for 80% of menopause patients – because of a 2002 study which found use of the treatments increased cancer risk.

“The study found the relative risk of invasive breast cancer increased by 26%, which triggered widespread panic and many women ceased hormone replacement therapy,” Harvey said.

“In fact, the risk only increased by 8 cases per 10,000 person years, and absolute risk increased by 0.08%. The reporting of this study, from 2002, was a classic example of the ability of the media and researchers to misrepresent results to make them sound impressive.”

Since then, many additional studies and reviews into the safety of hormone replacement therapy, such as the use of oestrogen and progesterone, have been carried out and have found the benefits outweighed the risks in healthy women who used the therapy short-term.

It was regrettable the manufacturers of herbal remedies and other complementary treatments could make false advertising claims about their products with few repercussions, Harvey said.

An author of the study, Dr Roisin Worsley, agreed with Harvey that women were still fearful about the risks, though minimal, of taking hormone replacement therapy, despite being overweight being associated with a higher cancer risk.

“There are risks associated but they’re not as frightening as what we thought, and more recent studies and recommendations suggest that for typical women in their early 50s the benefits outweigh the harms,” she said.

“I think there does need to be a re-education campaign, not just for women but also for doctors.”

However, Worsley said she did not blame women for turning to complementary and alternative therapies. It could be hard to find doctors who specialised in treatments for menopause, and the symptoms of menopause could severely hamper quality of life. Many women also were unaware there were several types of hormone replacement therapies they could try.

“We really just need to get out there and empower women by giving them more information,” she said.

The study was the first to look at the use of complementary and alternative therapy treatment and practitioner use among Australian women for the treatment of menopausal symptoms.

https://www.mja.com.au/journal/2015/203/3/use-complementary-and-alternative-medicines-menopausal-symptoms-australian-women

Use of complementary and alternative medicines for menopausal symptoms in Australian women aged 40-65 years

Pragya Gartoulla, Susan R Davis, Roisin Worsley, Robin J Bell

Med J Aust 2015; 203 (3): 146.

doi: 10.5694/mja14.01723

Abstract

Objective: To document the prevalence of, and factors associated with, the use of complementary and alternative medicines (CAMs) for vasomotor symptoms (VMS) and other symptoms of menopause in Australian women aged 40-65 years.

Design, setting and participants: Cross-sectional questionnaire-based study of Australian women aged 40-65 years living independently in the community. Women able to complete a questionnaire in English were recruited by telephone between October 2013 and March 2014 from a large, representative, national, continually refreshed database derived from the electoral roll.

Main outcome measures: Use of CAMs for VMS and other menopausal symptoms (eg, arthralgia, depression and sleep disturbance), assessed using the Menopause-Specific Quality of Life questionnaire.

Results: Of 5850 women contacted, 2911 agreed to participate, and 2020 eligible women returned completed questionnaires (response rate, 34.53%). Most of the women were postmenopausal (54.90%), resided in metropolitan areas (62.70%) and were born in Australia (80.43%). The prevalence of use of CAMs for VMS was 13.22%. Phytoestrogens were most commonly used for VMS (6.29%), followed by evening primrose oil (3.91%) and ginseng (1.73%). Compared with premenopausal women, perimenopausal women (odds ratio [OR], 2.09; 95% CI, 1.42-3.06) and early postmenopausal women (OR, 1.83, 95% CI, 1.21-2.76) were more likely to use any CAM for VMS. The prevalence of use of CAMs for other symptoms was 32.23%; being postmenopausal and older were the factors associated with this use.

Conclusions: Australian women at midlife are using CAMs that are known to be ineffective for managing VMS. Health care providers need to be more involved in guiding women in the treatment of VMS and other menopausal symptoms. More judicious use of supplements such as fish oil and glucosamine, particularly by older women, is needed until their efficacy and safety profiles are better understood.

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http://www.cochrane.org/CD007244/MENSTR_black-cohosh-cimicifuga-spp.-for-menopausal-symptoms

Black cohosh (Cimicifuga spp.) for menopausal symptoms

Published: 17 October 2012

Authors: Leach MJ, Moore V

Primary Review Group: Menstrual Disorders and Subfertility Group

Menopause is the period of time in a woman’s life when menstruation ceases. These changes in menstruation are often accompanied by troublesome symptoms, including hot flushes, vaginal dryness and night sweats. Interventions that decrease the severity and frequency of these menopausal symptoms are likely to improve a person’s well-being and quality of life. The herb black cohosh was traditionally used by Native Americans to treat menstrual irregularity, with many experimental studies indicating a possible use for black cohosh in menopause. This review set out to evaluate the effectiveness of black cohosh for controlling the symptoms of menopause. The review of 16 studies (involving 2027 women) found insufficient evidence to support the use of black cohosh for menopausal symptoms. Given the uncertain quality of most studies included in the review, further research investigating the effectiveness of black cohosh for menopausal symptoms is warranted. Such trials need to give greater consideration to the use of other important outcomes (such as quality of life, bone health, night sweats and cost-effectiveness), stringent study design and the quality reporting of study methods.

Authors’ conclusions: There is currently insufficient evidence to support the use of black cohosh for menopausal symptoms. However, there is adequate justification for conducting further studies in this area. The uncertain quality of identified trials highlights the need for improved reporting of study methods, particularly with regards to allocation concealment and the handling of incomplete outcome data. The effect of black cohosh on other important outcomes, such as health-related quality of life, sexuality, bone health, night sweats and cost-effectiveness also warrants further investigation.

Background: Menopause can be a distressing and disruptive time for many women, with many experiencing hot flushes, night sweats, vaginal atrophy and dryness. Postmenopausal women are also at increased risk of osteoporosis. Interventions that decrease the severity and frequency of these menopausal symptoms are likely to improve a woman’s well-being and quality of life. Hormone therapy has been shown to be effective in controlling the symptoms of menopause; however, many potentially serious adverse effects have been associated with this treatment. Evidence from experimental studies suggests that black cohosh may be a biologically plausible alternative treatment for menopause; even so, findings from studies investigating the clinical effectiveness of black cohosh have, to date, been inconsistent.

Objectives: To evaluate the clinical effectiveness and safety of black cohosh (Cimicifuga racemosa or Actaea racemosa) for treating menopausal symptoms in perimenopausal and postmenopausal women.

Search strategy: Relevant studies were identified through AARP Ageline, AMED, AMI, BioMed Central gateway, CAM on PubMed, CINAHL, CENTRAL, EMBASE, Health Source Nursing/Academic edition, International Pharmaceutical Abstracts, MEDLINE, Natural medicines comprehensive database, PsycINFO, TRIP database, clinical trial registers and the reference lists of included trials; up to March 2012. Content experts and manufacturers of black cohosh extracts were also contacted.

Selection criteria: All randomised controlled trials comparing orally administered monopreparations of black cohosh to placebo or active medication in perimenopausal and postmenopausal women.

Data collection and analysis: Two review authors independently selected trials, extracted data and completed the ‘Risk of bias’ assessment. Study authors were contacted for missing information.

Main results: Sixteen randomised controlled trials, recruiting a total of 2027 perimenopausal or postmenopausal women, were identified. All studies used oral monopreparations of black cohosh at a median daily dose of 40 mg, for a mean duration of 23 weeks. Comparator interventions included placebo, hormone therapy, red clover and fluoxetine. Reported outcomes included vasomotor symptoms, vulvovaginal symptoms, menopausal symptom scores and adverse effects. There was no significant difference between black cohosh and placebo in the frequency of hot flushes (mean difference (MD) 0.07 flushes per day; 95% confidence interval (CI) -0.43 to 0.56 flushes per day; P=0.79; 393 women; three trials; moderate heterogeneity: I2 = 47%) or in menopausal symptom scores (standardised mean difference (SMD) -0.10; 95% CI -0.32 to 0.11; P = 0.34; 357 women; four trials; low heterogeneity: I2 = 21%). Compared to black cohosh, hormone therapy significantly reduced daily hot flush frequency (three trials; data not pooled) and menopausal symptom scores (SMD 0.32; 95% CI 0.13 to 0.51; P=0.0009; 468 women; five trials; substantial heterogeneity: I2 = 69%). These findings should be interpreted with caution given the heterogeneity between studies. Comparisons of the effectiveness of black cohosh and other interventions were either inconclusive (because of considerable heterogeneity or an insufficient number of studies) or not statistically significant. Similarly, evidence on the safety of black cohosh was inconclusive, owing to poor reporting. There were insufficient data to pool results for health-related quality of life, sexuality, bone health, vulvovaginal atrophic symptoms and night sweats. No trials reported cost-effectiveness data. The quality of included trials was generally unclear, owing to inadequate reporting.

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