Hysterectomy and levonorgestrel-releasing intrauterine system in the treatment of menorrhagia : a 10-year randomized comparative trial

Satu Heliövaara‐Peippo
2012 · W1549678833
article OA: green CC0
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A 10-year trial found the levonorgestrel-releasing intrauterine system (LNG-IUS) to be a safe, cost-effective alternative to hysterectomy for menorrhagia, with similar quality of life but fewer long-term urinary and cardiovascular risks.

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Abstract

Menorrhagia significantly impairs the quality of life of many women and causes major health care costs. Hysterectomy has been the standard treatment for menorrhagia. Levonorgestrel-releasing intrauterine system (LNG-IUS) has been advocated as an alternative to surgery. \n\nThe VuoKKo trial set out to compare the LNG-IUS and hysterectomy in the treatment of menorrhagia, and it consisted of 236 women, aged 35 49 years, referred for menorrhagia to the five university hospitals in Finland between 1994 and 1997. Of these women, 117 were randomized to treatment with hysterectomy and 119 to treatment with LNG-IUS. The follow-up visits took place at 6 and 12 months after treatment and again 5 and 10 years after randomization. The objective of this study was to compare the cost-effectiveness and effects on health-related quality of life (HRQoL), pain, lower urinary tract symptoms (LUTS) and cardiovascular disease (CVD) risk factors of these two treatment modalities during a 10-year follow-up. The continuation rate at 10 years was 94%. Of the 119 women assigned to LNG-IUS, 55 (46%) subsequently underwent hysterectomy over the 10-year period. \n\nHRQoL and psychosocial well-being improved during the first 5 years, but diminished between 5 and 10 years, presumably due to ageing. No significant differences emerged between the groups, but the overall costs per participant were lower in the LNG-IUS group ($3423) than in the hysterectomy group ($4937). \n\nBoth hysterectomy and LNG-IUS decreased pain substantially. The occurrence of pain decreased most during the first 6 months and monthly frequent pain decreased most of all. Lower abdominal pain score (occurrence and intensity) decreased in both groups, but back pain score decreased only in the LNG-IUS group. \n\nWomen treated by hysterectomy used more medication for urinary incontinence than women treated by LNG-IUS (12% vs. 1%, p=0.006). Urinary tract infections (34% vs. 14%, p=0.002), feeling of incomplete emptying (19% vs. 9%, p=0.04) and stress urinary incontinence (48% vs. 34%, p=0.04) were more common in women with hysterectomy than in LNG-IUS users. \n\nThe CVD risk profile showed that women treated by hysterectomy had higher levels of inflammatory cytocines, TNF-α at 5 years (median 108.59 vs. 49.02 pg/ml) and hsCRP at 10 years (median 1.55 vs. 0.78 mg/ml) than women treated by LNG-IUS. Women treated by hysterectomy used more often estrogen therapy than women treated by LNG-IUS (56% vs. 27%, p PIENEMPI 0.001) 10 years after the treatment. \n\nLNG-IUS is a safe and cost-effective alternative to hysterectomy in the treatment of menorrhagia. The overall costs were approximately 31% lower in the LNG-IUS group than in the hysterectomy group. Both treatments have a favourable effect on HRQoL, but hysterectomy seems to predispose women more to CVD risk factors and LUTS over the long run.
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