Press Release on The Risks of Hormone Therapy in Postmenopausal Women
Hong Kong College of
Obstetricians and Gynaecologists		 Obstetrical and Gynaecological
Society of Hong Kong

MEDIA STATEMENT

For immediate release July 16, 2002

The Women's Health Initiative (WHI) is a large scale study of estrogen and the combination of estrogen plus progestogen as preventive therapies for postmenopausal women. It enrolled 27,000 women between 1993 and 1998 and is scheduled to conclude in 2005. There were two arms to the study. One arm involved 16,608 predominantly healthy postmenopausal women of an average age 63 years who took a combination of oral estrogen plus progestogen or a placebo tablet (sugar pills). This part of the trial was stopped earlier than planned at an average of 5.2 years because it was thought that the risks of this treatment outweighed the benefits. Another arm of over 10,000 women who took oral estrogen alone or placebo tablets (sugar pills) is still continuing as the risk of breast cancer in this group has not increased.

The main results can be summarized as follows:
If we consider 10,000 women taking either placebo or oral estrogen plus progestogen treatment for one year, the number of health events occurring in these two groups of women would be:

Health Event Placebo Estrogen+Progestogen
Invasive Breast Cancer 30 38
Heart Attack or Coronary Events 30 37
Stroke 21 29
Blood Clots in the Lungs 16 34
Colorectal Cancers 16 10
Hip Fractures 15 10

What do these figures mean?

  1. Altogether only 2.5% of women in the treatment group had these health events. In absolute numbers, for every 10,000 women using the treatment, the increase in risk is small.

  2. These figures apply to women in this age group (average 63 years) who have taken this particular combination of hormones for an average of around 5 years. The data do not necessarily apply to younger women or those who are taking either lower doses of both hormones or on estrogen alone or a different combination of estrogen and progestogen.

  3. These figures are not relevant to women taking hormone replacement for a relatively short period of time to control menopausal symptoms.

  4. For some women, particularly those with known osteoporosis, the overall benefits may still outweigh the risks.

  5. These figures only apply to a particular drug combination, conjugated estrogen (CEE) + medroxyprogesterone acetate (MPA), given in tablet form. This may not apply to users of patches, gels or other methods of hormone delivery, nor to other forms of hormonal replacement therapy.

  6. The increased risk of breast cancer in the treatment group was 8 per 10,000 woman-years. This is in line with or even lower than that the previous reported rate of breast cancer after hormone replacement therapy. It is also important to note that in this WHI trial, women in the estrogen alone study group have not shown an increased risk of breast cancer as compared with placebo up to 5.2 years of treatment.

What should postmenopausal women do?

NO ONE SHOULD PANIC

  • Women who have been using oral estrogen plus progestogen for less than 5 years should not be unduly concerned by these findings but should have annual review of their therapy with their doctor.

  • Women who have had a hysterectomy and are taking only estrogen should not be concerned as these findings do not pertain to them, and if anything, should feel reassured as the estrogen only part of the study has not shown increased risk of breast cancer.

  • Women who have been using oral estrogen plus progestogen for approaching 5 years or more should discuss their personal benefit versus risk profile with their doctor at their next review appointment, and decide whether or not their treatment should be modified.

  • Women who have been using non-oral estrogen plus progestogen for 5 or more years should be aware that results of this study may not apply to them. Whether or not non-oral therapy carries the same risks or benefits as oral HRT awaits further investigation.

ALL WOMEN USING HRT SHOULD REVIEW ANNUALLY WITH THEIR DOCTOR WHETHER OR NOT CONTINUATION OF THERAPY IS APPROPRIATE FOR THEM AND WHETHER OR NOT THEIR TREATMENT SHOULD BE MODIFIED by either change of dose or change of formulation.

Dr L.C. Ho
President
The Hong Kong College of
Obstetricians & Gynaecologists 		Dr. Dominic Li
President
The Obstetrical & Gynaecological
Society of Hong Kong

For further information please contact: The Hong Kong College of Obstetricians and Gynaecologists (Ph: 2871-8700) or The Obstetrical & Gynaecological Society of Hong Kong (Ph: 2845-8228)

香港婦產科學院 香港婦產科學會

新聞發佈

香港 2002年7月16日------ 一項名為Women's Health Initiative的研究(WHI)於1993年開始，研究對象包括27,000名婦女，原定於2005年才完成研究。其中一個組別包括16,608名大致健康良好的更年期後婦女，平均年齡為63歲，並接受口服雌激素加黃體酮混合治療或安慰劑剛超過5年。由於有關治療被指弊大於利，所以這個組別的研究被提早終止。而另一部份超過10,000名婦女單獨使用口服雌激素或安慰劑的組別則如期進行，因為該組別至今患乳癌的機會並沒有增加。

主要研究結果概括如下：

在每10,000名婦女使用這種口服雌激素加黃體酮治療達一年，結果如下：

健康狀況 發病次數
安慰劑 雌激素+黃體酮
 
乳癌 30 38
心臟病發或冠心病 30 37
中風 21 29
肺部積血 16 34
 
結腸癌 16 10
股骨骨折 15 10

這些數據代表甚麼?

  1. 以絕對數字計算，在每10,000名接受治療的婦女當中，其實風險的增加很少。

  2. 這些數字基本上只適用於此年齡組別的健康婦女，並曾接受這種荷爾蒙組合平均5年。此數字不一定應用於年齡較輕而只服用雌激素或其他不同組合雌激素及黃體酮治療的婦女。

  3. 這些數字不適用於短期服用荷爾蒙補充劑以紓緩更年期徵狀的婦女。

  4. 對於一些婦女而言(尤其已知患有骨質疏鬆症者），治療的整體好處可能大於其風險。

  5. 這些數字只適用於某一種口服的藥物組合 ─ conjugated雌激素 (CEE) + medroxyprogesterone acetate (MPA) 香港稱為Premelle。因此結果未必適用於外貼劑、膏狀或其他荷爾蒙服用方法及補充療法的使用者。

  6. 今次的研究結果指每一萬人中患乳癌的機會增加八個。這是一個預計中的發現，其結果其實可能是比預期為低，因為以往曾有研究指乳癌的風險高達一萬人中增加二十個。

更年期後婦女應該怎樣做？

不必要恐慌

  • 使用口服雌激素加黃體酮少於5年的婦女毋需憂慮，但應該與主診醫生每年定期評估她們的治療。
  • 曾接受子宮切除手術而只服用雌激素的婦女毋需憂慮並可以放心，因為研究結果並不適用於她們，而單服雌激素治療的研究沒有顯示患乳癌的風險有所增加。
  • 使用口服雌激素加黃體酮接近5年或以上的婦女，應該在下一次定期檢查時與醫生評估治療對個人的利益與風險狀況，並決定應否參考是項研究結果更改她們的療程。
  • 使用非口服雌激素加黃體酮5年或以上的婦女應注意這些結果未必應用於她們。非口服治療與口服荷爾蒙補充療法的利與弊是否相同仍有待進一步研究。

所有服用荷爾蒙補充療法的婦女，無論繼續接受治療是適合她們與否，及療程應否作出更改劑量或處方，都應該接受主診醫生每年的例行檢查。

何樓章醫生
香港婦產科學院院長 		李福謙醫生
香港婦產科學會會長

－　完　－

查詢詳情，請聯絡 :
香港婦產科學院 電話:　2871 8700
香港婦產科學會 電話:　2845 8228


© 2014 The Obstetrical and Gynaecological Society of Hong Kong. All rights reserved.