Primary studies included in this systematic review

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Primary study

Unclassified

Levonorgestrel-releasing intrauterine system vs. usual medical treatment for menorrhagia: an economic evaluation alongside a randomised controlled trial.

Giornale PloS one
Year 2014
Links Pubmed Health Technology Assessment (HTA) DOI PubMed Central crd.york.ac.uk

Questo articolo fa parte di 1 Systematic review Systematic reviews (1 reference)

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OBJECTIVE: To undertake an economic evaluation alongside the largest randomised controlled trial comparing Levonorgestrel-releasing intrauterine device ('LNG-IUS') and usual medical treatment for women with menorrhagia in primary care; and compare the cost-effectiveness findings using two alternative measures of quality of life. METHODS: 571 women with menorrhagia from 63 UK centres were randomised between February 2005 and July 2009. Women were randomised to having a LNG-IUS fitted, or usual medical treatment, after discussing with their general practitioner their contraceptive needs or desire to avoid hormonal treatment. The treatment was specified prior to randomisation. For the economic evaluation we developed a state transition (Markov) model with a 24 month follow-up. The model structure was informed by the trial women's pathway and clinical experts. The economic evaluation adopted a UK National Health Service perspective and was based on an outcome of incremental cost per Quality Adjusted Life Year (QALY) estimated using both EQ-5D and SF-6D. RESULTS: Using EQ-5D, LNG-IUS was the most cost-effective treatment for menorrhagia. LNG-IUS costs £100 more than usual medical treatment but generated 0.07 more QALYs. The incremental cost-effectiveness ratio for LNG-IUS compared to usual medical treatment was £1600 per additional QALY. Using SF-6D, usual medical treatment was the most cost-effective treatment. Usual medical treatment was both less costly (£100) and generated 0.002 more QALYs. CONCLUSION: Impact on quality of life is the primary indicator of treatment success in menorrhagia. However, the most cost-effective treatment differs depending on the quality of life measure used to estimate the QALY. Under UK guidelines LNG-IUS would be the recommended treatment for menorrhagia. This study demonstrates that the appropriate valuation of outcomes in menorrhagia is crucial.

Primary study

Unclassified

Five-year follow-up of levonorgestrel-releasing intrauterine system versus thermal balloon ablation for the treatment of heavy menstrual bleeding: a randomized controlled trial.

Giornale Contraception
Year 2013
Links Pubmed DOI

Questo articolo fa parte di 1 Systematic review Systematic reviews (1 reference)

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BACKGROUND: The study was conducted to compare 5-year follow-up of levonorgestrel-releasing intrauterine system (LNG-IUS) or thermal balloon ablation (TBA) for the treatment of heavy menstrual bleeding (HMB). STUDY DESIGN: A prospective, randomized controlled trial comparing LNG-IUS (n=30) and TBA (n=28) was performed. Hysterectomy rates, hemoglobin level, bleeding pattern, well-being status and satisfaction rates were assessed. Comparisons between groups were performed by χ(2) test and by unpaired and paired t tests. RESULTS: After 5 years of follow-up, women treated with a TBA had higher rates of hysterectomy (24%) compared to the LNG-IUS group (3.7%) due to treatment failure (p=.039). Use of LNG-IUS resulted in higher mean hemoglobin (±SD) levels in comparison to the TBA group (14.1±0.3 vs 12.7±0.4 g/dL, p=.009). Menstrual blood loss was significantly higher in the TBA when compared to the LNG-IUS group (45.5% vs 0.0% p<.001). The psychological general well-being index scores were similar. Patient acceptability, perceived clinical improvement and overall satisfaction rates were significantly higher in women using LNG-IUS. CONCLUSION: Five-year follow-up of HMB treatment with LNG-IUS was associated with higher efficacy and satisfaction ratings compared to TBA.

Primary study

Unclassified

Levonorgestrel sistema intrauterino versus terapia medica per menorragia.

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Giornale The New England journal of medicine
Year 2013
Links Pubmed DOI

Questo articolo fa parte di 2 Systematic reviews Systematic reviews (2 references)

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BACKGROUND: Menorragia è un problema comune, ma le prove per informare le decisioni sulla terapia è limitata. In un pragmatico, multicentrico, randomizzato, abbiamo confrontato il sistema intrauterino a rilascio di levonorgestrel (levonorgestrel-IUS) con un trattamento medico al solito in donne con menorragia che hanno presentato ai loro fornitori di cure primarie. METODI: sono stati assegnati in modo casuale 571 donne con menorragia al trattamento con levonorgestrel-IUS o trattamento usuale medico (acido tranexamico, acido mefenamico, combinata estrogeno-progesterone, o progesterone da solo). L'esito primario era rappresentato dal punteggio riferito dal paziente sul Menorrhagia Multi-Attribute Scale (MMAS) (che va da 0 a 100, con punteggi più bassi indicano una maggiore gravità), valutati in un periodo di 2 anni. Gli esiti secondari includevano la qualità della vita in generale e punteggi sessuale-attività e l'intervento chirurgico. RISULTATI: punteggi MMAS miglioramento dal basale a 6 mesi sia nel gruppo Levonorgestrel-IUS e il gruppo di solito trattamento (aumento medio, 32,7 e 21,4 punti, rispettivamente; p <0.001 per entrambi i confronti). I miglioramenti sono stati mantenuti per un periodo di 2 anni, ma erano significativamente maggiori nel gruppo Levonorgestrel-IUS che nel gruppo usuale trattamento (differenza media tra i gruppi, 13.4 punti, 95% intervallo di confidenza, 9,9-16,9; p <0.001) . Miglioramenti in tutti i domini MMAS (difficoltà pratiche, la vita sociale, la vita familiare, il lavoro e la routine quotidiana, benessere psicologico e la salute fisica) erano significativamente maggiori nel gruppo Levonorgestrel-IUS che nel gruppo usuale trattamento, e questo è stato anche vale per sette degli otto ambiti della qualità della vita. A 2 anni, più delle donne sono state ancora utilizzando il levonorgestrel-IUS che stavano subendo il trattamento usuale medico (64% vs 38%, p <0,001). Non ci sono state differenze significative tra i gruppi nei tassi di punteggi di intervento chirurgico o sessuale-attività. Non ci sono state differenze significative in eventi avversi gravi tra i gruppi. In conclusione, in donne con menorragia che hanno presentato a fornitori di cure primarie, il levonorgestrel-IUS è stato più efficace del trattamento medico usuale nel ridurre l'effetto di pesanti sanguinamento mestruale sulla qualità della vita. (Finanziato dal National Institute of Health Research Programme Health Technology Assessment,. ECLIPSE Controlled-Trials.com numero, ISRCTN86566246).

Primary study

Unclassified

Levonorgestrel-releasing intrauterine system versus laparoscopic supracervical hysterectomy for the treatment of heavy menstrual bleeding: a randomized study.

Giornale Journal of women's health (2002)
Year 2012
Links Pubmed DOI

Questo articolo fa parte di 1 Systematic review Systematic reviews (1 reference)

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BACKGROUND: The optimal treatment of heavy menstrual bleeding (HMB) remains a challenge for the physician. There is a need for further trials to compare the effectiveness and compliance between a levonorgestrel-releasing intrauterine system (LNG-IUS) and minimally invasive types of hysterectomy, for example, laparoscopic supracervical hysterectomy (LSH), in women with HMB. This article is the first to report a randomized trial aimed at comparing postoperative outcomes and effects on quality of life after LNG-IUS or LSH in women with HMB. METHODS: The trial was performed at Tor Vergata University Hospital, Rome. Seventy-two women requiring treatment for HMB were randomly allocated into two treatment arms: LNG-IUS (n=36) or LSH (n=36). The primary outcome was the comparison of the effects on menstrual bleeding (pictorial blood loss assessment chart [PBAC]) at 12 months after the two procedures. The secondary outcome measures were the quality of life, improvement in bleeding patterns, intensity of postoperative pain, and early postoperative complications. A p<0.05 was considered statistically significant. RESULTS: The PBAC score was significantly reduced in both treatment groups. The Medical Outcomes Survey Short Form 36 (SF-36) score improved in both groups. A more significant improvement in the parameters Role and Mental health was observed after LNG-IUS. CONCLUSIONS: LNG-IUS can be considered as first option for the treatment of HMB unresponsive to drug therapy, and it is particularly suitable for women who want to preserve an acceptable menstrual flow. LSH may be considered the best surgical option in women with HMB unresponsive to any medical treatment.

Primary study

Unclassified

The effect of hysterectomy or levonorgestrel-releasing intrauterine system on premenstrual symptoms in women treated for menorrhagia: secondary analysis of a randomized controlled trial.

Giornale Acta obstetricia et gynecologica Scandinavica
Year 2012
Links Pubmed DOI

Questo articolo fa parte di 1 Systematic review Systematic reviews (1 reference)

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OBJECTIVE: To study the effect of hysterectomy or levonorgestrel-releasing intrauterine system (LNG-IUS) on premenstrual symptoms in women treated for menorrhagia. DESIGN: Secondary analysis of a randomized controlled trial. SETTING: Five university hospitals in Finland. SAMPLE: A cohort of 236 women, aged 35-49 years (mean 43 years) referred for menorrhagia between 1994 and 1997. Women were not diagnosed with premenstrual syndrome. METHODS: Women were randomized to treatment by hysterectomy (n=117) or LNG-IUS (n=119). Analyses were performed using the intention-to-treat and actual treatment principles. Women using estrogen therapy and women who underwent bilateral salpingo-oophorectomy were excluded from the analyses. MAIN OUTCOME MEASURES: The occurrence of premenstrual symptoms evaluated by questionnaires at baseline and at follow-up visits six and 12 months after the treatment and five years after the randomization. RESULTS: Premenstrual symptoms decreased significantly in both groups by six months (p≤0.028) without significant differences between the groups, except that in the LNG-IUS group the decrease of breast tenderness was seen first by 12 months (p=0.048). Even though 42% of the women assigned to treatment with LNG-IUS were hysterectomized during the follow-up period, the results of intention-to-treat and actual treatment analyses were comparable. CONCLUSIONS: Both hysterectomy and LNG-IUS seem to alleviate premenstrual symptoms of women treated for menorrhagia, while the effect of these treatments on premenstrual syndrome remains unsettled.

Primary study

Unclassified

Levonorgestrel-releasing intrauterine system for heavy menstrual bleeding improves hemoglobin and ferritin levels.

Giornale Contraception
Year 2012
Links Pubmed DOI

Questo articolo fa parte di 1 Systematic review Systematic reviews (1 reference)

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BACKGROUND: We compared the effects of the levonorgestrel-releasing intrauterine system (LNG-IUS) with cyclic oral medroxyprogesterone acetate (MPA) on hemoglobin and serum ferritin levels in women with heavy menstrual bleeding (HMB). STUDY DESIGN: This was a multicenter, randomized study assessing the efficacy of the LNG-IUS and oral MPA (10 mg/day for 10 days) in women with confirmed HMB over 6 cycles of treatment. We previously reported that treatment with the LNG-IUS resulted in greater menstrual blood loss reduction than MPA. In this analysis, hemoglobin and serum ferritin levels were assessed at baseline, Cycle 3, and at Cycle 6, and the relative improvement on treatment was subjectively rated by investigators and women. RESULTS: One hundred and sixty-five women were randomized (82 LNG-IUS/83 MPA). Increases in median hemoglobin levels from baseline to Cycle 6 (7.5% vs. 1.9%; p<.001) and median serum ferritin levels (68.8% vs. 14.3%; p<.001) were greater in the LNG-IUS group than in the oral MPA group. Baseline median hemoglobin and ferritin levels were 12.4 g/dL and 19.0 mcg/L with the LNG-IUS and 12.2 g/dL and 19.0 mcg/L with oral MPA, respectively. At Cycle 6, the corresponding medians were 13.4 g/dL and 34.0 mcg/L with the LNG-IUS and 12.6 g/dL and 21.0 mcg/L with oral MPA. At Cycle 6, the proportion of women who rated their bleeding as 'improved' was higher with the LNG-IUS than with oral MPA, both according to investigator assessment (93.6% vs. 61.0%) and self-assessment (93.6% vs. 67.1%). CONCLUSIONS: Women treated with the LNG-IUS had greater increases in median hemoglobin and serum ferritin levels, and higher rates of subjective improvement than women treated with oral MPA.

Primary study

Unclassified

Un trial clinico randomizzato di un sistema intrauterino a rilascio di levonorgestrel e un basso dosaggio contraccettivo orale combinato per la menorragia fibroma-correlati.

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Giornale International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics
Year 2011
Links Pubmed DOI

Questo articolo fa parte di 5 Systematic reviews Systematic reviews (5 references)

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OBIETTIVO: Per confrontare l'efficacia di un sistema intrauterino a rilascio di levonorgestrel (LNG-IUS) con quello di una bassa dose di contraccettivo orale combinato (COC) nel ridurre la menorragia fibroma-correlati. METODI: In questo unico centro aperto studio clinico, randomizzato, 58 donne con menorragia che desideravano contraccezione sono stati randomizzati a ricevere una LNG-IUS o COC. I risultati inclusi fallimento del trattamento, definito come la necessità di un altro trattamento; perdita di sangue mestruale (MBL) con il metodo ematina alcalina e un grafico di valutazione pittorico (PBAC), i livelli di emoglobina, e "giorni perduti." RISULTATI: Il trattamento fallito in 6 donne (23,1%) nel gruppo di LNG-IUS e 11 (37,9%) nel gruppo COC, per un rapporto di rischio di 0,46 (IC 95%, 0,17-1,17, p = 0,101). Utilizzando il test ematina alcalina, la riduzione della MBL era significativamente maggiore nel gruppo LNG-IUS (90,9% ± 12,8% vs 13,4% ± 11,1%, p <0.001). Utilizzando punteggi PBAC, la riduzione è stata inoltre significativamente maggiore nel gruppo di LNG-IUS (88,0% ± 16,5% vs 53,5% ± 5 1,2%, p = 0,02). Inoltre, i livelli di emoglobina sono aumentati dal 9,7 ± 1.9g/dL a 11,7 ± 1.2g/dL (P <0.001) e di giornate perse è diminuito da 8,2 ± 3,3 giorni a 1,3 ± 1,5 giorni (p = 0,003) nel gruppo di LNG-IUS. CONCLUSIONE: Anche se il tasso di fallimento del trattamento era simile in entrambi i gruppi, il LNG-IUS è stato più efficace nel ridurre MBL del COC nelle donne con menorragia fibroma-correlati.

Primary study

Unclassified

The effect of hysterectomy or levonorgestrel-releasing intrauterine system on cardiovascular disease risk factors in menorrhagia patients: a 10-year follow-up of a randomised trial.

Giornale Maturitas
Year 2011
Links Pubmed DOI

Questo articolo fa parte di 1 Systematic review Systematic reviews (1 reference)

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OBJECTIVE: To compare, whether women with menorrhagia, treated with either hysterectomy or LNG-IUS, differ in their cardiovascular risk profile during 10-year follow-up. STUDY DESIGN: A total of 236 women were randomized to treatment by hysterectomy (n=117) or LNG-IUS (n=119). Their cardiovascular risk factors were analyzed at baseline, at 5 years, and at 10 years. As 55 originally randomized to the LNG-IUS group had hysterectomy during the follow-up, all analyzes were performed by actual treatment modality. MAIN OUTCOME MEASURES: Waist circumference, body-mass index (BMI), blood pressure, and the levels of blood lipids, serum high-sensitivity CRP (hsCRP) and tumor necrosis factor alpha (TNF-α) were measured, and the use of medication for hypertension, diabetes, hypercholesterolemia, and ischemic heart disease was analyzed. RESULTS: After 5 years, an increase in the use of diabetes medication during the follow-up was only detected in the hysterectomy group (from 1.7% to 6.7%, P=0.008 vs from 5.1% to 8.4%, P=0.08), as well as they had significantly higher serum levels of TNF-α (108.59 pg/ml vs 49.02 pg/ml, P=0.001) and hsCRP (1.55 μg/ml vs 0.78 μg/ml, P=0.038) at 5- and 10-years. There was no difference between the groups in the use of cardiovascular medication, neither was there difference in blood pressure, waist circumference, BMI, or concentrations of blood lipids. CONCLUSIONS: Hysterectomy seems to be associated with increased levels of serum inflammatory markers and increased diabetes medication, which in turn, may predispose individual to future cardiovascular events.

Primary study

Unclassified

Levonorgestrel-releasing intrauterine system compared to low dose combined oral contraceptive pills for idiopathic menorrhagia: a randomized clinical trial.

Giornale Contraception
Year 2011
Links Pubmed DOI

Questo articolo fa parte di 2 Systematic reviews Systematic reviews (2 references)

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BACKGROUND: This study compared the efficacy of the levonorgestrel-releasing intrauterine system (LNG-IUS) to low dose combined oral contraceptive pills (COC) in the management of idiopathic menorrhagia. STUDY DESIGN: A single-center, open, randomized clinical trial. One hundred twelve women complaining of excessive menstruation who desired contraception were randomized to receive LNG-IUS or COC. Treatment failure was defined as the need for medical or surgical treatment during the follow-up. Other outcomes included: menstrual blood loss (MBL) by alkaline hematin and by pictorial blood assessment chart (PBLAC), hemoglobin levels and assessment of lost days in which physical or mental health prevented participating women from performing usual activities. RESULTS: At baseline, LNG-IUS (n=56) and COC (n=56) groups were comparable in age (mean ± S.D.) (39.3 ± 6.7 vs. 38.7 ± 5.2 years, p=.637), parity (median and range) [3(1-6.4) vs.3(2-6), p=.802] and BMI (mean ± S.D.) (29.6 ± 5.9 vs. 31.1 ± 5.7 kg/m(2), p=.175). Time to treatment failure was longer in LNG compared to COC group with a total of 6 (11%) patients who had treatment failure in the LNG-IUS compared to 18 (32%) in COC group with a hazard ratio of 0.30 (95% CI, 0.15-0.73, p=.007). Using alkaline hematin, the reduction in MBL (mean ± S.D.) was significantly more in the LNG-IUS group (87.4 ± 11.3%) compared to the COC group (34.9 ± 76.9%) (p=.013). Utilizing PBLAC scores, the reduction in the LNG-IUS (86.6 ± 17.0%) group was significantly more compared to the COC group (2.5 ± 93.2%) (p<.001). In the LNG-IUS group, increase in the hemoglobin and ferritin levels (mean ± S.D.) were noted (from 10.2 ± 1.3 to 11.4 ± 1.0 g/dL; p<.001; with reduction of the number of lost days (from 6.8 ± 2.6 to 1.6 ± 2.4 days, p=.003). CONCLUSION: The LNG-IUS is a more effective therapy for idiopathic menorrhagia compared to COC.

Primary study

Unclassified

Comparison of levonorgestrel intrauterine system versus hysterectomy on efficacy and quality of life in patients with adenomyosis.

Giornale Fertility and sterility
Year 2011
Links Pubmed DOI

Questo articolo fa parte di 1 Systematic review Systematic reviews (1 reference)

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OBJECTIVE: To compare the levonorgestrel intrauterine system (LNG-IUS) with hysterectomy in patients with adenomyosis and to study the effects of both treatments on quality of life (QOL). DESIGN: Prospective randomized clinical trial. SETTING: Women's health teaching and research hospital. PATIENT(S): Eighty-six patients (43 patients for each group) were enrolled, but only 75 women continued the study. INTERVENTION(S): Women interpreted as having adenomyosis on transvaginal ultrasound and magnetic resonance imaging were assigned to receive either LNG-IUS or hysterectomy. MAIN OUTCOME MEASURE(S): Clinical measures of menstrual bleeding as number of used pads/day during menstruation, hemoglobin levels, and health-related QOL variables were assessed. Each woman was followed up for 1 year after treatment. RESULT(S): LNG-IUS increased the hemoglobin levels at the sixth month and first year of the treatment to the comparable levels with hysterectomy. When pretreatment and post-treatment QOL scores of groups were compared, three of the five mean domain scores (physical, environmental, environmental-TR) were increased in patients treated with hysterectomy, while in patients managed with LNG-IUS, all five mean domain scores were increased. CONCLUSION(S): It seems that LNG-IUS demonstrates significant and comparable improvements in hemoglobin levels to hysterectomy in treating adenomyosis-associated menorrhagia during the first year. Although both treatments lead to improvements in health-related QOL, LNG-IUS seems to have superior effects on psychological and social life. It may be a promising alternative therapy to hysterectomy.