Women treated with the levonorgestrel- releasing intrauterine system (IUS) rated their treatment more effective than those who received medical therapy in reducing the effect of heavy menstrual bleeding (HMB) on quality of life, a primary care study has found.

A cohort of 571 women with HMB from 63 UK practices was studied between February 2005 and July 2009. Initially, 285 were randomised to receive an IUS and 286 to medical treatment.

All completed a Menorrhagia Multi-Attribute Scale (MMAS) questionnaire which covers the following domains:

• Practical difficulties

• Social life

• Psychological health

• Physical health

• Work and daily routine

• Family life and relationships

Other questionnaires were used to collect data on general quality of life and sexual activity. Data were collected at baseline and at 6, 12 and 24 months.

A total of 261 women eventually had an IUS inserted and 247 returned questionnaires at 24 months. For medical treatment the figures were 280 and 231 respectively. At the end of two years those assigned to the IUS were almost twice as likely to still be using it compared with those assigned to medical treatment (64% vs 38%; P < 0.001).

Seventy nine women had their IUS removed, mainly for treatment failure or irregular bleeding. Of the 163 women who discontinued medical treatment, 80 went on to have an IUS fitted. There was no statistical difference in adverse effect reporting between the groups (IUS n=49, medical treatment n=58).

The primary end point was the MMAS score which improved in both groups at all three time points. Those with the IUS showed significantly greater improvement in all six domains surveyed and at every time point than the women receiving medical treatment. By two years the IUS group had a 13.4 point (95% CI:9.9-16.9, P < 0.001) higher (better) score than the medical treatment group. This was both statistically and clinically significant.

No differences between the groups were seen in mental health and sexual functioning, however SF-36 scores were better in the IUS group in all domains and at all time points.

There was no difference in surgical outcome rates, 6% of women in each group had a hysterectomy, and endometrial ablation was carried out in 4% of the IUS, and 6% of the medical treatment group.

The NICE guideline recommends the IUS as the first-line therapy for HMB.1 The results of this study support this recommendation and confirm previous research showing that the IUS is the most effective treatment option for women with HMB.

Dr Chris Barclay