PURPOSE: Primary dysmenorrhea, which refers to painful, spasmodic cramping in the lower abdomen just before/or during menstruation, is the most common gynecological complaint in women of reproductive age. Non-steroidal anti-inflammatory drugs have been prescribed as the first-line therapy for pain relief from dysmenorrhea. We aimed to investigate the efficacy of the daily recommended dose (150 mg) of diclofenac potassium, administered at set intervals across the first 24 h of menstruation, in treating severe menstrual pain in 24 women with severe primary dysmenorrhea.
METHODS: In a randomized, placebo-controlled, double-blind cross-over study, women rated their menstrual pain intensity on a 100-mm visual analog scale across set time intervals over a 24-h period.
RESULTS: Menstrual pain intensity was significantly reduced after taking the first capsule of diclofenac, and remained consistently lower (P < 0.0001), compared with initial pain intensity, in the morning (before treatment), throughout the day, evening, and into the next morning. Also, women rated their pain intensity as significantly lower (P < 0.001) at each time point across the 24-h time interval of the cycle when receiving diclofenac compared with the cycle when they received placebo. No woman required rescue medication when taking diclofenac potassium compared with six women taking rescue medications during the placebo trial. When taking only placebo, women rated their menstrual pain intensity as persistently severe across the first 24 h of menstruation.
CONCLUSION: These results show that the recommended daily dose of diclofenac potassium, in three 50 mg doses across the day and evening, offers effective menstrual pain relief across 24 h, compared with placebo, in women with severe primary dysmenorrhea.
BACKGROUND: Dysmenorrhea has negative effects on women's life. Due to side-effects of chemical drugs, there is growing trend toward herbal medicine. The aim of this study was to assess the effect of Dill compared to mefenamic acid on primary dysmenorrhea.
MATERIALS AND METHODS: This double-blind, randomized, clinical trial study was conducted on 75 single female students between 18 and 28 years old educating in Nursing and Midwifery School and Paramedical Faculty of Qom University of Medical Sciences of Iran in 2011. They were allocated randomly into one of the three groups: In Dill group, they took 1000 mg of Dill powder q12h for 5 days from 2 days before the beginning of menstruation for two cycles. Other groups received 250 mg mefenamic acid or 500 mg starch capsule as placebo, respectively. Dysmenorrhea severity was determined by a verbal multidimensional scoring system and a visual analog scale (VAS). Students with mild dysmenorrhea were excluded. Data were analyzed by SPSS using the descriptive statistic, paired-samples t-test, Wilcoxon signed-rank test, Mann-Whitney test, and Kruskal-Wallis test.
RESULTS: There were no significant differences between three groups for demographic or descriptive variables. Comprising the VAS showed that the participants of Dill and mefenamic acid groups had lower significant pain in the 1(st) and the 2(nd) months after treatment, whereas in the placebo group this was only significant in the 2(nd) month (P < 0.05).
CONCLUSION: Dill was as effective as mefenamic acid in reducing the pain severity in primary dysmenorrhea. Further studies regarding side-effects of Dill and its interactivity are recommended.
BACKGROUND: Dysmenorrhea is one of the most common medical problems in gynecology causing several problems in the personal and social life of women. This study was conducted to compare the effect of thymus vulgaris and ibuprofen on the treatment of primary dysmenorrhea Methods: This clinical study was conducted on 84 students of Babol University of Medical Sciences with primary dysmenorrhea. The students were randomly assigned to three groups receiving thymus vulgaris, ibuprofen and placebo. In all three groups, with the beginning of pain, 200 mg capsules and 25 drops of essential oil were given every 6 hours for two consecutive cycles. Pain intensity used the visual scale before and one hour after each dose for 48 hour after starting medication. The data were collected and analyzed. This study was registered in the Iranian Registry of Clinical Trial (www.irct.ir) with registration number ID: IRCT201101245683N1 RESULTS: The mean age of participants was 20.5±1.8 years. Both thymus vulgaris and ibuprofen were effective to reduce the pain severity of dysmenorrhea. Before treatment, the mean pain intensity in thymus vulgaris, ibuprofen and placebo groups were 6.57±2.02, 5.30±2.23 and 6.18±1.78, respectively and after treatment decreased to 1.21±1.06, 1.48±1.62 and 3.54±2.26, respectively. Reduction of pain severity was not statistically significant between the two medications, however it was significant for each drug compared with placebo (p<0.001).
CONCLUSION: The results suggest that thymus vulgaris as well as ibuprofen can be effective in reducing the severity of pain and spasm in primary dysmenorrhea.
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).
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.
Primary dysmenorrhea, which refers to painful, spasmodic cramping in the lower abdomen just before/or during menstruation, is the most common gynecological complaint in women of reproductive age. Non-steroidal anti-inflammatory drugs have been prescribed as the first-line therapy for pain relief from dysmenorrhea. We aimed to investigate the efficacy of the daily recommended dose (150 mg) of diclofenac potassium, administered at set intervals across the first 24 h of menstruation, in treating severe menstrual pain in 24 women with severe primary dysmenorrhea.
METHODS:
In a randomized, placebo-controlled, double-blind cross-over study, women rated their menstrual pain intensity on a 100-mm visual analog scale across set time intervals over a 24-h period.
RESULTS:
Menstrual pain intensity was significantly reduced after taking the first capsule of diclofenac, and remained consistently lower (P < 0.0001), compared with initial pain intensity, in the morning (before treatment), throughout the day, evening, and into the next morning. Also, women rated their pain intensity as significantly lower (P < 0.001) at each time point across the 24-h time interval of the cycle when receiving diclofenac compared with the cycle when they received placebo. No woman required rescue medication when taking diclofenac potassium compared with six women taking rescue medications during the placebo trial. When taking only placebo, women rated their menstrual pain intensity as persistently severe across the first 24 h of menstruation.
CONCLUSION:
These results show that the recommended daily dose of diclofenac potassium, in three 50 mg doses across the day and evening, offers effective menstrual pain relief across 24 h, compared with placebo, in women with severe primary dysmenorrhea.
