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.
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.
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).
OBIETTIVO: Per esaminare i fattori associati con sintomi depressivi, prima e dopo l'intervento chirurgico nelle donne che si sottopongono a isterectomia elettiva.
DESIGN: Un'analisi secondaria dei dati longitudinali da uno studio di coorte prospettico progettato per comprendere il dolore post-chirurgico cronica nelle donne.
IMPOSTAZIONE: Un ospedale per acuti nel sud-est, Ontario, nel corso di un periodo di 4 anni (2006-2010).
PARTECIPANTI: donne Trecento ottantaquattro (384) di lingua inglese, età 18 anni o più anziani, che hanno presentato per isterectomia elettiva.
METODI: I dati sono stati raccolti prima dell'intervento nel centro di ammissione stessa giornata e sei mesi dopo l'intervento utilizzando questionari basati su web o mail convalidati.
RISULTATI: Trentasei per cento (36%) dei partecipanti hanno riferito sintomi depressivi prima dell'intervento chirurgico, il 22% sintomi riferiti in seguito, il 15% hanno riferito sintomi in entrambi i punti di tempo, e il 6% sviluppato nuovi sintomi depressivi insorgenza dopo l'intervento. Giovane (odds ratio [OR] = 2,5, IC 95% [CI], [1.7, 5.0]) donne, quelli con livelli più elevati di ansia (stato: OR = 8.6, 95% CI [5.2, 14.0]), o che ha conosciuto il dolore che interferiva con il loro funzionamento quotidiano (OR = 2.8, 95% CI [1.7, 4.7]) sono stati più propensi a riferire sintomi depressivi prima isterectomia. Dolore preoperatoria (OR = 2.0, 95% CI [1.1, 3.6]), ansia di tratto (OR = 2.4, 95% CI [1.2, 4.6]), e sintomi depressivi (OR = 3.9, 95% CI [2.1, 7.5] ) ha aumentato il rischio di sintomi depressivi sei mesi dopo l'intervento.
CONCLUSIONE: Giovani donne che presentano alti livelli di ansia e di dolore e che necessitano di un intervento di isterectomia sono a rischio di sperimentare disagio psicologico prima e dopo il loro intervento.
OBIETTIVO: Per valutare se i sintomi dell'umore sono aumentati di più per le donne negli anni dopo isterectomia con o senza ovariectomia bilaterale rispetto alla menopausa naturale.
METODI: utilizzando i dati dello studio di salute delle donne in tutta la nazione (n = 1.970), depressione e ansia sintomi sono stati valutati ogni anno per un massimo di 10 anni con il Centro di Epidemiological Studies Depression Index e quattro domande di ansia, rispettivamente. Modelli di crescita gerarchici a tratti sono stati usati per relazionarsi menopausa naturale, isterectomia con conservazione ovarica, e isterectomia con ooforectomia bilaterale di traiettorie di disturbi dell'umore, prima e dopo il periodo mestruale finale o un intervento chirurgico. Covariate incluso il livello di istruzione, razza, stato di menopausa, di età l'anno prima del periodo mestruale o la chirurgia, e l'indice di massa corporea, salute percepita, terapia ormonale, e l'uso di antidepressivi variabili nel tempo.
RISULTATI: Con la visita annuale decimo, 1.793 (90,9%) donne hanno raggiunto la menopausa naturale, 76 (3,9%) hanno riportato isterectomia con conservazione ovarica, e 101 (5,2%) hanno riportato isterectomia con ooforectomia bilaterale. Per tutte le donne, i sintomi depressivi e di ansia sono diminuiti negli anni dopo il periodo mestruale finale o un intervento chirurgico. Queste traiettorie non differivano significativamente per isterectomia o stato ovariectomia. Il Centro per i mezzi Epidemiological Studies Depression indice fosse 0,72 deviazioni standard inferiori ed i sintomi di ansia were 0,67 deviazioni standard inferiore a 5 anni dalla periodo mestruale finale o un intervento chirurgico.
In conclusione, in questo studio, i sintomi dell'umore continuato a migliorare dopo il periodo mestruale o isterectomia per tutte le donne. Le donne che si sottopongono a un intervento di isterectomia con o senza ooforectomia bilaterale nella mezza età non avvertono sintomi dell'umore più negativi negli anni dopo l'intervento chirurgico.
LIVELLO DI EVIDENZA: II.
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.
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.
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.
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.
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.
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.
