Why use a risky synthetic drug designed for profit when as this column repeatedly stresses, there are so many safe natural supplements that reduce all risks?
update : Jan 2010: WEIGHT GAIN ON TIBOLONE:
Hester asks about a better option HRT since she has gained 5kg in a few months on Livifem tibolone.
One cannot treat an unseen patient by email based on a one-line history.
all one can advise is, read about the serious risks and deficiencies of quick-fix heavily marketed snakepills compared to finely tuned natural products eg human hormones and other natural supplements evolved/designed over millennia rather than recently in for-profit laboratories.
There are two new illuminating papers on tibolone since the November review:
Dr Peter Kenemans writes from the Netherlands Vrije Universiteit: Tibolone revisited: ‘still a good treatment option for healthy, early postmenopausal women‘.
The Ziaei paper detailed below addressed only weight issues, and describes average results.
In the Royal Free Hospital study in London in 1995, they found that in their 300-patient experience over 8 years ie medium term – an impressive 2400 patient years- that “The major side effect was weight gain and/or a tendency to bloating and oedema which occurred in 11.28% of our women”.
This doesnt mean that tibolone increases fatness- most women inexorably get fatter and frailer once past menopause. Certainly they dont do this if they maintain good balance of human hormones- testosterone, estradiol, progesterone, thyroid and insulin- with a sensible blend of all the other other scores of useful supplements, and diet and exercise.
BEAR IN MIND THAT MANY STUDIES SHOW THAT EVEN JUST 10 YEARS OF APPROPRIATE SEXHORMONE THERAPY FROM EARLY IN MENOPAUSE HAS MAJOR LONGTERM BENEFITS ON REDUCING ALL RISKS eg FRACTURE, CARDIOVASCULAR AND DEMENTIA RISKS IN LATER LIFE – without any significant adverse effects. . There do not appear to be published any studies of tibolone or any other wannabe substitute over a mean of more than 5 years. But women now often survive more than one-third of their lifespan post menopause- that is another 35+ years. No modern designer chronic drug has been used and observed reasonably continuously to be safe for much more than 10years . The only designer drugs which have been used continuously for much longer are perhaps the old diuretics and some antihypertensives.
Tibolone is yet another designer progestin- and the Women’s Health Initiative showed that, even when started appropriately soon after menopause, progestin (medroxyprogesterone MPA) reversed the myriad benefits of premarin alone in respect of worsening fracture, breast and cardiovascular risks.
This contrasts with natural supplements like eg minerals and vitamins, the plant extracts reserpine and the prohormone metformin, and all the human hormones- thyroid, insulin, cortisone, testosterone, estradiol- which many patients have used continuously for over 40 years with nothing but benefits in appropriate doses.
So as always its up to you the patient to decide whose advice, what to try. All any doctor can do is (in a brief consultation) offer advice from his experience and ongoing update studies – which may not be up to the minute. You have to decide about shortterm benefits versus long-term possible risks. In the few months on tibolone, are you just swollen-eg needing to reduce salt?- or fatter waist with higher bodyfat, bloodpressure, insulin resistance etc?
Analysis To August 18, 2008 ·
The LIFT trial report by Steve Cummings et al (NEJM August 14, 2008 The Effects of Tibolone in over 4000 Older Postmenopausal Women -mean 68years) is another nail in the coffin of tibolone.
The LIFT trial was stopped after a median of just 34 months because Tibolone doubled strokes – up from 0.34% to 0.66% per year. .
Tibolone, unlike appropriate HRT, has no significant reported benefit on all-cause mortality, on cardiovascular disease (which increased by 37% – p0.28), on memory/ dementia and on depression , although it almost halved fractures – but it doubled the risk of stroke, trebled rate of breast discomfort and vaginal bleeding- which rose from 2.9% to 9.5%; even the incidence of cervical dysplasia rose from 3.2% to 7.6%. And it increased weight in this already overweight cohort by an excess of 0.6kg in 3years..
Breast and colon cancer rates were too low to draw conclusions about benefit. “The tibolonegroup also had a decreased risk of invasive breast cancer (relativehazard, 0.32; 95% CI, 0.13 to 0.80; P=0.02) and colon cancer(relative hazard, 0.31; 95% CI, 0.10 to 0.96; P=0.04)” – but the incidence of these and coronary artery disease were each only 2 – 3% pa on placebo..
So it finally confirms tibolone as just another synthetic progestin looking for a disease to treat, much inferior to real supplements including appropriate HRT (vitamin D and lowdose parenteral human estradiol-testosterone-progesterone) for reduction of all the major diseases of aging. There are no contraindications to, only benefits from such long term appropriate steroid hormone replacement.
Update November 2009:
In a further LIFT trial report (Ettinger & Cummings Sept 2008), Tibolone treatment for 3 years minimally increased endometrial thickness, hyperplastic polyps, and endometrial carcinoma.
In the massive 31-country 2002-4 LIBERATE trial (Feb 2009 Kenemans ea ) in over 3000 women after breast cancer, recurrent breast cancer increased 44% with tibolone over a mean of 3.1yrs. Tibolone was not different from placebo with regard to other safety outcomes, such as mortality (respectively 72 vs 63 patients), cardiovascular events (14 vs 10), or gynaecological cancers (10 vs 10).
A report in September 2009 from Health and Human Services’ Agency for Healthcare Research and Quality suggests that tamoxifen, raloxifene, and tibolone used to treat breast cancer significantly reduce invasive breast cancer in midlife and older women, but also increase the risk of adverse side effects.
Regretfully, tibolone has not fulfilled early hope that it might be the first designer drug since metformin to be another panacea, reduce all-cause morbidity and mortality even in postmenopausal women.
It appears that despite 40years use elsewhere, tibolone (not invented and marketed by a US corporate) has still not been and is unlikely to be licensed for use in USA – like SERMS (tamoxifen, raloxifene) its benefits are so limited that they are not enough to balance it’s risks. .. doubling the risk of stroke and increasing the already high general risk of breast cancer by 44% in only 3 years. Whereas all (ie multisystem) risks and frailty are reversed by the safe threescore mix of natural supplements plus appropriate balanced physiological human hormone replacement as regularly set out in this column. .