This Cochrane systematic review of trials found that a progesterone releasing coil device (mainly Mirena®) inserted in the womb was more effective at reducing heavy periods than taking oral tablets. The coil led to more minor side effects, but improved quality of life, compared with tablets. Surgical removal of the womb, hysterectomy, was more effective than the coil, but is more invasive and costly. A second surgical option - removing the womb lining – was similar at reducing heavy bleeding and improving quality of life as the coil. The findings are in line with 2007 NICE guidance saying the coil should be the first treatment considered.
Why was this study needed?
Heavy menstrual bleeding does not necessarily mean there is anything seriously wrong, but it can affect a woman physically, emotionally and socially, and can disrupt everyday life. It is not clear how common it is in the UK, but around 1 in 10 of all gynaecology referrals includes heavy menstrual bleeding. If treatment is needed, medication is most commonly used first. If this doesn’t work surgery is a later option. This can include removal of the womb (hysterectomy), or womb lining. Both operations carry risks associated with having major surgery and hysterectomy removes the ability to have children. This Cochrane systematic review aimed to find the most effective treatments for heavy menstrual bleeding by looking at all relevant trials. It updated a 2005 review with more recent studies.
What did this study do?
The study was a systematic review of randomised controlled trials. It included 21 trials involving 2,082 women of reproductive age who had heavy menstrual bleeding that was not due to a disease. Most trials excluded women with fibroids. The review compared the progesterone-releasing coil with a placebo or taking tablets, or surgical options. Only the coil device containing the hormone levonorgestrel remain on the market, so the researchers drew conclusions based on this hormone alone. Cochrane systematic reviews follow a rigorous process so are considered reliable.
What did it find?
- The progesterone-releasing coil reduced blood loss by an average of 67ml (95% confidence interval 43 to 91ml) more than taking tablets, such as hormone treatment or mefenamic acid. This was linked to a slightly higher chance of side effects using the coil including pelvic pain, breast tenderness and benign ovarian cysts. Despite this, the coil was more effective at improving quality of life, and women were more likely to continue using the coil after two years of treatment, compared with tablets.
- However, almost half (46%) of women using the coil eventually needed surgical removal of the womb to control bleeding within 10 years.
- There were no differences in patient satisfaction for any of the treatments.
- Removing the womb was most effective at reducing heavy menstrual bleeding but was the most expensive option, even over ten years.
- The findings are consistent with the 2005 Cochrane review. But their strength has increased as 12 more trials were included with more comparisons against no treatment.
What does current guidance say on this issue?
2007 NICE guidance recommends offering the progesterone-releasing coil as the first choice treatment for women who do not have underlying disease such as large fibroids, non-cancerous growths in or around the womb. The second choice is oral medication using tranexamic acid or non-steroidal anti-inflammatory drugs, or combined oral contraceptives. This guidance is due to be updated but a specific date has not been given.
What are the implications?
The findings are in line with existing 2007 NICE guideline treatment recommendations. This review strengthens the evidence on effectiveness and acceptability of the progesterone-releasing coil and so adds further weight behind its place as the first-line treatment option, before other medication or surgery. However, research evidence was incomplete on women’s satisfaction with the full range of treatments, so services should offer women information and choice on the options.
Lethaby A, Hussain M, Rishworth JR, Rees MC. Progesterone or progestogen‐releasing intrauterine systems for heavy menstrual bleeding. Cochrane Database Syst Rev. 2015;(4):CD002126.
Clegg J, King E. Estimation of haemoglobin by the alkaline haematin method. BMJ. 1942;2(4263):329.
Higham JM. O’Brien PM, Shaw RM. Assessment of menstrual blood loss using a pictorial chart. Br J Obstet Gynaecol. 1990; 8: 734–739.
NHS Choices. Heavy periods (menorrhagia). [internet] London: NHS Choices; updated 2014.
NICE. Heavy menstrual bleeding. CG44. London: National Institute for Health and Care Excellence; 2007.
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