Medical treatment for menorrhagia may only delay hysterectomy
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《英国医生杂志》
Some women with abnormal uterine bleeding may be able to avoid hysterectomy by making the best use of available medical options. But the results of two new studies show that despite aggressive medical management most women with menorrhagia unrelated to pregnancy or malignancy will eventually need surgery and will undergo additional suffering by forestalling more definitive treatment (JAMA 2004;291:1447-55,1456-63).
The two studies contained some conflicting conclusions and differed with respect to the controls. The first study used "expanded medical therapy" with sex steroid hormones or prostaglandin synthetase inhibitors, or both. The other study used an intrauterine administration of a continuous release progestational hormone that is only available for this indication in Europe (marketed as Mirena by Schering Health).
The first study, led by Dr Miriam Kuppermann of the obstetrics and gynaecology department at the University of California, San Francisco, studied 63 premenopausal women aged 30 to 50 years who had had abnormal uterine bleeding for a median of 4 years and who were dissatisfied with their current medical treatments. The women were randomised to one of five arms: hysterectomy alone; oestrogen alone; oestrogen and progesterone; oestrogen, progesterone, and a prostaglandin synthetase inhibitor; or oestrogen and a prostaglandin synthetase inhibitor. The participants, who were patients at US gynaecology clinics between 1997 and 2000, were followed for two years.
The primary outcome was mental health measured by the mental component summary (MCS), a quality of life measurement. Secondary outcomes included measures of symptom reduction and satisfaction, body image, and sexual functioning.
At six months, women in the hysterectomy group had higher MCS than women in the other three groups combined (the medical treatment group) (8 v 2, P=0.04). They also had better resolution of, and satisfaction with, symptoms and reported that their symptoms interfered less with sexual activities. By the end of the study 17 (53%) of the women in the medical treatment group had requested and had a hysterectomy.
In the second study, researchers led by Dr Ritva Hurskainen of the obstetrics and gynaecology department at the University of Helsinki, Finland, found that treatment with a levonorgestrel releasing intrauterine system may offer patients a wider availability of choices and may decrease costs arising from interventions involving surgery.
In this study, 236 women were randomly assigned to treatment with a levonorgestrel releasing intrauterine system (n=119) or hysterectomy (n=117) and were monitored for five years. Health related quality of life was measured by the five dimensional EuroQol and the RAND 36-item short form health survey.
After five years of follow up, the two groups did not differ substantially in terms of health related quality of life or psychosocial wellbeing. Although 50 (42%) of the women assigned to the levonorgestrel group eventually had a hysterectomy, the discounted direct and indirect costs for that group ($2817 (?526; �2284) per participant, 95% confidence interval $2222 to $3530) remained substantially lower than in the hysterectomy group ($4660; $40140 to $5180). Satisfaction with treatment was similar in both groups.
The findings present a "familiar conundrum of whether a glass is half-empty or half-full," wrote Drs Roy Pitkin and James Scott in a related editorial published in the same issue (p 1503-4) "Does it mean surgery will likely be necessary eventually anyway, so perhaps better sooner than later, sparing the woman continued symptoms? Or does it mean there is a 50% chance of avoiding hysterectomy and these odds are worth taking to avoid a major operation?" they asked.
The authors said that additional randomised trials with longer follow up are needed to determine the long term benefits of more conservative treatments over hysterectomy.(New York Scott Gottlieb)
The two studies contained some conflicting conclusions and differed with respect to the controls. The first study used "expanded medical therapy" with sex steroid hormones or prostaglandin synthetase inhibitors, or both. The other study used an intrauterine administration of a continuous release progestational hormone that is only available for this indication in Europe (marketed as Mirena by Schering Health).
The first study, led by Dr Miriam Kuppermann of the obstetrics and gynaecology department at the University of California, San Francisco, studied 63 premenopausal women aged 30 to 50 years who had had abnormal uterine bleeding for a median of 4 years and who were dissatisfied with their current medical treatments. The women were randomised to one of five arms: hysterectomy alone; oestrogen alone; oestrogen and progesterone; oestrogen, progesterone, and a prostaglandin synthetase inhibitor; or oestrogen and a prostaglandin synthetase inhibitor. The participants, who were patients at US gynaecology clinics between 1997 and 2000, were followed for two years.
The primary outcome was mental health measured by the mental component summary (MCS), a quality of life measurement. Secondary outcomes included measures of symptom reduction and satisfaction, body image, and sexual functioning.
At six months, women in the hysterectomy group had higher MCS than women in the other three groups combined (the medical treatment group) (8 v 2, P=0.04). They also had better resolution of, and satisfaction with, symptoms and reported that their symptoms interfered less with sexual activities. By the end of the study 17 (53%) of the women in the medical treatment group had requested and had a hysterectomy.
In the second study, researchers led by Dr Ritva Hurskainen of the obstetrics and gynaecology department at the University of Helsinki, Finland, found that treatment with a levonorgestrel releasing intrauterine system may offer patients a wider availability of choices and may decrease costs arising from interventions involving surgery.
In this study, 236 women were randomly assigned to treatment with a levonorgestrel releasing intrauterine system (n=119) or hysterectomy (n=117) and were monitored for five years. Health related quality of life was measured by the five dimensional EuroQol and the RAND 36-item short form health survey.
After five years of follow up, the two groups did not differ substantially in terms of health related quality of life or psychosocial wellbeing. Although 50 (42%) of the women assigned to the levonorgestrel group eventually had a hysterectomy, the discounted direct and indirect costs for that group ($2817 (?526; �2284) per participant, 95% confidence interval $2222 to $3530) remained substantially lower than in the hysterectomy group ($4660; $40140 to $5180). Satisfaction with treatment was similar in both groups.
The findings present a "familiar conundrum of whether a glass is half-empty or half-full," wrote Drs Roy Pitkin and James Scott in a related editorial published in the same issue (p 1503-4) "Does it mean surgery will likely be necessary eventually anyway, so perhaps better sooner than later, sparing the woman continued symptoms? Or does it mean there is a 50% chance of avoiding hysterectomy and these odds are worth taking to avoid a major operation?" they asked.
The authors said that additional randomised trials with longer follow up are needed to determine the long term benefits of more conservative treatments over hysterectomy.(New York Scott Gottlieb)