A UK primary care study comparing the use of the levonorgestrel-IUS (LNG-IUS) with usual medical treatments for heavy menstrual bleeding (HMB) showed both to have very good outcomes.

Women, aged 25-50 years, who presented to their GP with HMB of at least three months’ duration were considered for entry to the study. Exclusions included: those on HRT or tamoxifen, findings suggestive of fibroids, inter-menstrual or post-coital bleeding, contraindications or a preference for either of the treatments and those who intended to become pregnant over the next five years.

Between February 2005 and July 2009, 571 women with HMB from 63 primary care centres were randomised to LNG-IUS insertion (n = 285) or a standard medical treatment (n = 286). In the latter group, 215 (75%) received mefenamic acid, tranexamic acid or the two combined. Other treatments included: norethisterone, the combined or progesterone-only contraceptive pill, or medroxy-progesterone acetate injections.

The primary outcome was improvement on the Menorrhagia Multi-Attribute Scale (MMAS), which measures the impact of HMB on six domains of the patient’s daily life, at five years’ follow-up.

The overall five-year follow-up rate was 74%. At five years 47% (95% CI: 40-52%) of those allocated to the LNG-IUS were continuing with that method. For the usual medical treatment group the continuation rate was 15% (95% CI: 11-20%).

After drop outs, 97 (43%) of 228 women randomised to usual medical treatment had changed to the LNG-IUS, and 57 (39%) of 148 had changed from the LNG-IUS to usual medical treatments.

At five years 80% of the LNG-IUS and 77% of the usual treatment group respectively had not required surgery. Overall 115 women, 54 in the LNG-IUS group and 61 in the usual medical treatment group, required surgery (endometrial ablation or hysterectomy). The difference was not statistically significant.

MMAS scores improved significantly in both groups. The mean increase was 44.9 points in the LNG-IUS group and 43.4 points in the usual medical treatments group.

Quality of life and depression (SF36 and EuroQoL) and sexual activity questionnaires were completed at recruitment and again at five years. There was highly significant and similar improvement in all physical, emotional, social, and mental domains in both groups from baseline.

Pain scores also improved significantly as did general health perception.

With the exception of the last measure there was no difference at five years between the groups. General health perception scores, however, were higher in LNG-IUS women at five years. The difference between groups increased by 4.7 points (95% CI: 0.6-8.8; P = 0.02). There was no change in sexual activity scores in either group from baseline.

NICE recommends the LNG-IUS as first-line therapy for uncomplicated HMB and the other interventions for second-line use.¹

The authors conclude: ‘This pragmatic trial shows that women affected by HMB can be effectively helped in primary care by initiating LNG-IUS or usual medical treatment, with long-term benefit, and only modest need for surgery.’

‘Women receiving usual medical treatment were no more likely to need surgical intervention than those treated with insertion of an LNG-IUS,’ they add.

Dr Chris Barclay