Statement on results from WHI study

Comments from researchers at the Jean Hailes Foundation for Women's Health - September 21, 2009

Study summary

Research based on the original Women's Health Initiative (WHI) study has just been published in the Lancet 2009; September 20, entitled "Oestrogen plus progestin and lung cancer in postmenopausal women (Women's Health Initiative trial): a post-hoc analysis of a randomised controlled trial. This research has noted that among women aged 60 years and over, there is a small increased risk of death from one type of lung cancer, (5 additional deaths per 10,000 women over 60 started on HRT per year) but no increased risk of death overall for women taking HRT compared to those not on HRT. The study did not show an increased number or rate of lung cancers. Importantly, these observations were not noted in women 50-59 years of age who make up the large majority of women starting HRT for menopausal symptom relief in Australia.  In women over 60 years who are at high risk of lung cancer (ex or current smokers), this should be taken into account when weighing up the risks and benefits of beginning HRT, an uncommon practice in that age group.

The International Menopause Society, at their latest Congress, confirmed that for women aged 50 to 59, HRT remains the first line and most effective treatment for menopausal symptoms. For women in this age group there is no significant increase in risk in using HRT - in fact the benefits outweigh the risks. This recent study data does not influence that conclusion with no observed impact on women aged 50-59 years.

Introduction

The Foundation strongly advocates that women and health professionals take a balanced, evidence-based and informed approach to health. All risks and benefits should be taken into perspective when considering the use of HRT for menopausal symptom relief.

The context of the study

For the majority of women who experience menopause, as a natural transition in life, education, explanation by trusted GP or health professional, lifestyle change and simple interventions are all that are needed. But for those women where menopause causes significant symptoms and impacts on quality of life, HRT has been used for many decades to effectively relieve those menopausal symptoms. The choice a woman faces with respect to HRT needs to be made in the setting of well balanced information of risks and benefits in their individual circumstance and needs to be well informed. Hence the following statement is provided to assist women and their health professionals to make informed choices.

The data presented in the most recent issue of the Lancet, is a post hoc or retrospective look at the data from the large Women's Health Initiative study in the United States which was ceased in 2002. It is from the oestrogen (conjugated oestrogen or Premarin) and progestin (Provera) arm of the study (where women were randomised to either HRT or placebo) and involved 16, 608 women of mean age 63 years.

In this most recent analysis, the WHI study did not demonstrate a significant increase in lung cancer cases in HRT users. However, the paper does show a small increase in lung cancer deaths in older women taking HRT. However, importantly, the paper finds that, in the age group 50-59 years, the numbers of deaths from lung cancers were almost was almost identical for the HRT and placebo groups. The current advice from the International Menopause Society in the wake of this recent data is that "HRT is safe for healthy young women in the 50-59-year age group, but that older women should be dealt with individually and take greater care. The findings of this paper support this advice. Like all clinicians, we would urge women of any age not to smoke."

Current guidelines

Current guidelines recommend that women who take HRT for menopausal symptoms take the lowest effective dose for the shortest time period to alleviate symptoms.  HRT can be stopped at any time with the guidance of your medical practitioner. The Foundation recommends that each woman discuss her decision about taking HRT with her health practitioner regularly or whenever she has any concerns. 

Frequently asked questions

What does this study mean for women?

It is of no significance for healthy women taking HRT in their 50s at the time of menopause for 2-5 years for the relief of menopausal symptoms. For women over 60 years on longer term treatment, who have a higher risk of lung cancer (current or ex-smokers), the findings need to be included in the risk to benefit considerations when regularly reviewing the advisability of HRT continuation or not.

Do I need to stop taking HRT?

There is no indication from this study for stopping HRT used for symptom relief in younger healthy women in their 50s.

What is the risk of lung cancer relating to HRT?

For otherwise healthy women under 60 years of age taking combined oestrogen and progestin therapy there is no evidence of increased lung cancer risk or of increased death from lung cancer. Even in those older than 60 there was no evidence or proof of increased risk, only a suggestion more cases occurred in HRT users. For those over 60 years this inconclusive data suggests that there is a 3 in 10,000 increased risk of lung cancer per year in HRT users compared to nonusers. There is a small increased risk of dying from lung cancer in those on HRT compared to non HRT users of around 5 per 10,000 per year.

What other risk factors can affect my chance of getting lung cancer?

Cigarette smoking, past, current or passive smoking (inhaling smoke from others smoking around you) is the most potent risk factor for lung cancer.

How often do I need to see my doctor to review my use of HRT?

Best practice guidelines for treatment of the menopausal woman indicate an annual review. However, if concerns exist, a more regular review is reasonable.

What else can I take to relieve my symptoms?

For women who experience menopausal symptoms and have their quality of life impacted on or compromised, there are a number of approaches to manage their symptoms. These include education and awareness of symptoms, management of stress, regular physical activity and a healthy diet , support and interaction with a trusted health professional - resources are available on these options online at www.jeanhailes.org.au or by calling the Jean Hailes Foundation for Women's Health tollfree on 1800 151 441.

Many women find that simple measures, such as wearing lighter clothing or keeping room temperatures low at night, can make a big difference. These changes won't eliminate all symptoms, but can make them manageable. Some women may find complementary therapies helpful, although only black cohosh or remifemin has been proven in some, but not all studies, to be more effective than placebo. Diets high in plant based phytoestrogens have health benefits but need to be taken in diet rather than tablet or supplement form to attain these benefits. 

If hot flushes continue to make your life miserable, talk to your health practitioner about the different types of hormone therapy currently available - many of which come in much lower doses and in forms more similar to what the ovary makes in women, than the medication used in the WHI study.

Where do I go for further information?

The Jean Hailes Foundation has a variety of up to date information and free health resources to help you make informed health choices about menopause and other health issues.

www.managingmenopause.org.au

Reference

Chlebowski RT, Schwartz AG, Wakelee H, et al. for the Women's Health Initiative Investigators. Oestrogen plus progestin and lung cancer in postmenopausal women (Women's Health Initiative trial): a post-hoc analysis of a randomised controlled trial. Lancet 2009; September 20, 2009. E-pub ahead of print

Other information

See also IMS comment on Lancet HRT and lung cancer

Content Updated September 21, 2009