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.

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.

The effect of hysterectomy or levonorgestrel-releasing intrauterine system on lower urinary tract symptoms: a 10-year follow-up study of a randomised trial.

OBJECTIVE: To evaluate the effect of hysterectomy and levonorgestrel-releasing intrauterine system (LNG-IUS) on lower urinary tract symptoms (LUTS) among women treated for menorrhagia. DESIGN: Randomised controlled trial analysed by actual treatment. SETTING: Five university hospitals in Finland. SAMPLE: A cohort of 236 women, aged 35-49 years, referred for menorrhagia between 1994 and 1997. METHODS: Women were randomly assigned to treatment by hysterectomy (n = 117) or LNG-IUS (n = 119). MAIN OUTCOME MEASURES: Lower urinary tract symptoms were evaluated by questionnaires at baseline, and after 6, 12 months, 5, and 10 years. Medications and operations for urinary incontinence were confirmed from medical records and national registries. RESULTS: Overall, 221 (94%) women took part in the 10-year follow-up evaluation. As 55 (46%) women originally randomised to the LNG-IUS group underwent hysterectomy, the results were analysed by actual treatment. Women treated by hysterectomy used more medication for urinary incontinence than LNG-IUS users (12% versus 1%) (OR 9.45, 95% CI 1.24-71.87, P = 0.006). Three hysterectomised women and one LNG-IUS user underwent surgery for stress urinary incontinence (SUI). Women treated by hysterectomy had more urinary tract infections (UTIs) than LNG-IUS users (OR 3.20, 95% CI 1.47-6.96, P = 0.002). Feeling of incomplete emptying (OR 3.00, 95% CI 1.00-9.05, P = 0.04) and SUI (OR 1.83, 95% CI 1.01-3.32, P = 0.04) were more common among women treated by hysterectomy. No differences between the study arms were noted in urge urinary incontinence or by the Urinary Incontinence Severity Score. A multivariate model showed that UTIs were associated with hysterectomy (P = 0.004). CONCLUSIONS: Hysterectomy increases the risks for incomplete emptying, lower UTIs and SUI.

The effect of hysterectomy or levonorgestrel-releasing intrauterine system on sexual functioning among women with menorrhagia: a 5-year randomised controlled trial.

OBJECTIVE: To compare among women with menorrhagia the effect of hysterectomy or levonorgestrel-releasing intrauterine system (LNG-IUS) on sexual functioning. DESIGN: A randomised controlled trial. SETTING: Five university hospitals in Finland. SAMPLE: A total of 236 women, aged 35-49 years. METHODS: Of the women, 117 were treated by hysterectomy and 119 by LNG-IUS. MAIN OUTCOME MEASURES: Sexual functioning was evaluated by modified McCoy sexual scale at baseline and at 6 months, 12 months, and 5 years after initiation of treatment (hysterectomy or application of LNG-IUS). RESULTS: Among women treated by hysterectomy, sexual satisfaction increased and sexual problems decreased. Among LNG-IUS users, satisfaction with partner decreased. In addition to treatment modality (P = 0.02), estrogen therapy (P = 0.01), smoking (P = 0.001), night sweats (P = 0.03), vaginal dryness (P = 0.04), hot flushes (P = 0.01), and having someone to ask for advice (P = 0.03) and to share worries (P = 0.01) explained changes in sexual functioning. CONCLUSIONS: Among women with menorrhagia, hysterectomy improves sexual functioning, whereas LNG-IUS does not have such a positive effect.

A randomized controlled trial of hysterectomy or levonorgestrel-releasing intrauterine system in the treatment of menorrhagia-effect on FSH levels and menopausal symptoms.

BACKGROUND: The purpose of this study was to compare the effects of hysterectomy and a levonorgestrel-releasing intrauterine system (LNG-IUS) on serum FSH levels and menopausal symptoms. METHODS: A total of 236 women referred for menorrhagia to five university hospitals were randomly assigned to treatment with hysterectomy (n = 117) or LNG-IUS (n = 119). Menopausal symptoms were characterized by the Kupperman menopausal distress test. Serum FSH and estradiol levels were measured at baseline and 6 and 12 months after hysterectomy or application of LNG-IUS. Analyses were by intention to treat. RESULTS: After 6 months, there was no difference between the groups, but 12 months after follow-up hysterectomized women had higher FSH levels than women with LNG-IUS (P = 0.005). There was a significant association between FSH levels and treatment modality (P = 0.020). Hot flushes increased significantly in the hysterectomy group (P = 0.02). There was a significant association between hot flushes and both treatment modality and age (P = 0.02 and P = 0.01, respectively). CONCLUSION: Hysterectomy may impair ovarian function shown by rising serum FSH levels and hot flushes. However, these results should be interpreted with caution, and longer follow-up is needed.

Comparison of ovarian cyst formation in women using the levonorgestrel-releasing intrauterine system vs. hysterectomy.

OBJECTIVE: To analyze the effect of the levonorgestrel-releasing intrauterine system (LNG-IUS) on ovarian cyst formation, endometrial thickness and the size of uterus and uterine fibroids by ultrasonography. SUBJECTS AND METHODS: This was a prospective, randomized trial comparing the LNG-IUS and hysterectomy in 236 women (age range 35-49 years) referred for menorrhagia. Transvaginal ultrasound examination was used to study the presence of ovarian cysts, uterine size, endometrial thickness, and the size of the uterus and uterine fibroids during a 12-month follow-up period. RESULTS: At baseline examination, 12 ovarian cysts were detected, eight in the LNG-IUS group and four in the hysterectomy group. During the follow-up period, 14 new cysts had emerged at 6 months and 14 new cysts had emerged at 12 months in the LNG-IUS group, whereas the corresponding figures in the hysterectomy group were three and eight, respectively. All but one of the 14 new cysts (94.1%) detected at 6 months in the LNG-IUS group resolved spontaneously, whereas two out of the eight cysts detected at the baseline examination persisted for 12 months. Three cysts were removed at operation. The relative risk of the occurrence of ovarian cysts was significantly higher in women with LNG-IUS, compared with women who underwent hysterectomy. LNG-IUS did not affect the size of the uterus or uterine fibroids, but it was associated with a decrease in endometrial thickness. The occurrence of cysts did not correlate with age or follicle stimulating hormone levels, but a weak positive correlation between the occurrence of cysts and the presence of irregular bleeding was observed. CONCLUSIONS: LNG-IUS use in the treatment of menorrhagia was associated with the development of ovarian cysts, but these were symptomless and showed a high rate of spontaneous resolution. LNG-IUS did not affect the size of the uterus or the size of uterine fibroids, but decreased the thickness of the endometrium.

Psychosocial and other characteristics of women complaining of menorrhagia, with and without actual increased menstrual blood loss.

OBJECTIVE: To discover whether psychosocial factors can explain why many women with normal menstrual blood loss seek care for menorrhagia. DESIGN: Cross-sectional comparative study of women referred for menorrhagia. SETTING: Gynaecology departments of all five university teaching hospitals in Finland. SAMPLE: Two hundred and twenty-six women aged 35-49 years complaining of menorrhagia. MAIN OUTCOME MEASURES: Several psychosocial factors, seeking medical attention, menstrual blood loss. RESULTS: Twenty-nine percent of the women had their menstrual blood loss in the normal range (menstrual blood loss <60 mL). By univariate analysis, unemployment, anxiety, perceived inconvenience, abdominal pain, haemoglobin level and serum ferritin concentration distinguished this group of women from those with true menorrhagia. Unemployment, perceived inconvenience, abdominal pain and serum ferritin remained significant variables by multivariate analysis. CONCLUSIONS: A significant proportion of women with complaints of menorrhagia have their measured menstrual blood loss within the normal range. Psychosocial factors can have an impact on their seeking health care. Better understanding of the factors, which explain complaints of menorrhagia in women with normal bleeding could improve both medical outcomes and reduce the cost of treatment for menorrhagia.

Quality of life and cost-effectiveness of levonorgestrel-releasing intrauterine system versus hysterectomy for treatment of menorrhagia: a randomised trial.

BACKGROUND: Heavy menstrual blood loss is a common reason for women to seek medical care. The levonorgestrel-releasing intrauterine system (IUS) is an effective medical treatment for menorrhagia. We report a randomised comparison of this approach with hysterectomy in terms of the quality of life of women with menorrhagia and cost-effectiveness. METHODS: Of 598 women referred with menorrhagia to five university hospitals in Finland, 236 were eligible and agreed to take part. They were randomly assigned treatment with the levonorgestrel-releasing IUS (n=119) or hysterectomy (n=117). The amount of menstrual blood loss was objectively measured. The primary outcome measure was health-related quality of life at 12-month follow-up. Analyses were by intention to treat. FINDINGS: In the group assigned the levonorgestrel-releasing IUS, 24 (20%) women had had hysterectomy and 81 (68%) continued to use the system at 12 months. Of the women assigned to the hysterectomy group, 107 underwent the operation. Health-related quality of life improved significantly in both the IUS and hysterectomy groups (change 0.10 [95% CI 0.06-0.14] in both groups) as did other indices of psychological wellbeing. There were no significant differences between the treatment groups except that women with hysterectomy suffered less pain. Overall costs were about three times higher for the hysterectomy group than for the IUS group. INTERPRETATION: The significant improvement in health-related quality of life highlights the importance of treating menorrhagia. During the first year the levonorgestrel-releasing IUS was a cost-effective alternative to hysterectomy in treatment of this disorder.

Expression of sex steroid receptors and Ki-67 in the endometria of menorrhagic women: effects of intrauterine levonorgestrel.

The levonorgestrel-releasing intrauterine system (LNG-IUS) has proven to be the most effective medical treatment in reducing the amount of menstrual blood loss. However, the molecular mechanisms underlying menorrhagia and/or accounting for the therapeutic effect of the LNG-IUS are still obscure. In this study, we used immunohistochemistry to compare the distribution of sex steroid receptors and the proliferation marker Ki-67 in the endometria of women with and without menorrhagia before and after 6 and 12 months of treatment with an LNG-IUS. The study sample included 67 women (aged 35-49 years) who had spontaneous ovulatory cycles. In women with menorrhagia, secretory phase endometrium exhibited more proliferative activity than in women without menorrhagia. No significant differences were found in the immunoreactivity of the oestrogen or progesterone receptors in women either with or without menorrhagia suggesting that, in addition to endocrine hormones, other factors are involved in the regulation of endometrial proliferation and menstrual blood loss. A total of 35 women were treated with LNG-IUS. After 6 months use of an LNG-IUS, the immunoreactivity of both epithelial and stromal progesterone receptors, as well as those of epithelial Ki-67 declined, and no differences were detectable between the women in the menorrhagia and control groups. Breakthrough bleeding remained a problem for nine (26%) LNG-IUS users, with no association with the pre-treatment amount of bleeding. No significant differences were found in the parameters studied between the women with and without breakthrough bleeding 6 months after insertion of an LNG-IUS.

Regional equity in childhood health--register-based follow-up of the Finnish 1987 birth cohort.

Our objective was to investigate regional health differences among Finnish children using a population-based longitudinal register data. All live births born in 1987 were included in the study (N=59,546) and followed-up until the age of seven years. Statistically significant regional variation was found for all health indicators but diabetes. Background variables, such as maternal age and social class, explained only the difference in mortality. Various indicators gave different geographical patterns. Regional equity in childhood health has not been achieved in Finland. Existing health registers were feasible in studying regional variation in health, but a set of comprehensive morbidity indicators - preferably derived from different data sources - should be developed to monitor equity in health.

Menorrhagia and uterine artery blood flow.

Menorrhagia is a significant problem in women of reproductive age. In half of the cases no specific aetiology is known. Vascular factors play a role but remain poorly understood. We chose to study whether any association exists between the flow impedance of uterine arteries and the amount of menstrual blood loss. The study population consisted of 60 spontaneously menstruating 35- to 49-year-old women without endometrial hyperplasia, polyps, or submucous fibroids. The pulsatility index (PI) from uterine arteries, arcuate arteries, and radial arteries was measured by transvaginal colour Doppler. Menstrual blood loss was measured by the alkaline haematin method. A significant inverse correlation was found between uterine artery PI and the amount of menstrual blood loss, suggesting that women with lower uterine flow impedance bleed more. A regression model confirmed that this association was specific and not explained by uterine size, fibroids or any other of the 11 potential confounders included in the model. The correlation between uterine artery PI and amount of menstrual blood loss suggests that vascular factors may be involved in the pathogenesis of menorrhagia.

Hysterectomy trends in Finland in 1987-1995--a register based analysis.

BACKGROUND: The study objective was to identify trends in the use of hysterectomy by nationwide register based analysis in Finland. METHODS: All women (n=89,069) undergoing hysterectomy in 1987-1995 according to the Finnish Hospital Discharge Register were the numerator. The annual denominator data were obtained from the population database of Statistics Finland. RESULTS: From 1987 to 1992 the hysterectomy rate increased by 22%, from 340 to 414 per 100,000 females, almost half of this being attributable to the changing age structure. From 1993 on, ambiguity in coding laparoscopically assisted vaginal hysterectomies prohibited detailed analyses. However, the overall trend continued at least among women 50 years and over until 1995. The age-adjusted 12% increase from 1987 to 1992 coincided with a rapid increase in operation rates in postmenopausal groups (60% or more among women aged 55 59 and 70-79 years). Among women aged 55-64 years, operations for fibroids and uterine bleeding more than doubled, suggesting an influence of increased use of estrogen replacement therapy. Among all women, operations due to bleeding disorders and genital prolapse showed the largest increase (41% and 42% respectively). Bilateral oophorectomy became more common in all age groups over 46 years. CONCLUSIONS: There was a modest increase in the overall hysterectomy rate. However, the operation became far more common in postmenopausal women, possibly due to the growing use of estrogen replacement therapy. Register data can be used for describing changes in clinical practice, but other methods are needed to confirm the causal relationships underlying the changes.

Combined laboratory and diary method for objective assessment of menstrual blood loss.

BACKGROUND: To develop an objective measurement system for menstrual blood loss applicable in clinical practice. METHODS: One hundred and fifty-six patients were enrolled in a randomized trial of the treatment of menorrhagia in all five gynecology departments of the university teaching hospitals in Finland. Correlation between venous blood hemoglobin concentration (Hb) and absorbance at 564 nm (A564) was investigated in experiments with blood samples. Amount of collected menstrual blood and menstrual diary data were analyzed. RESULT: Hb concentration and A564 of the blood were linearly correlated (r=0.99). One hundred and fifty-four women (99%) returned used sanitary protection and menstrual diaries. On average, 12% (range 0-57%) of menstrual blood was lost during collection. The median amount of blood recovered from sanitary protection was 89 ml (range 14-724 ml), with 58% (n=90) of the women exceeding 80 ml per cycle. When the spilled blood was taken into account, the corresponding figures were 104 ml (range 15-724 ml) and 66% (n= 101). CONCLUSIONS: The spectrophotometric measurement of venous blood in the conventional alkaline hematin method can be replaced by measurement of Hb concentration. All blood incompletely collected should be recorded. Objective measurement of menstrual blood loss can be applied in routine clinical practice.

Data quality after restructuring a national medical registry.

The validity of the 1991 Finnish Medical Birth Registry data was assessed, with special emphasis on the effects of changes made to the data collection form in 1990. Data abstracted from medical records for all births occurring in 49 hospitals during a five-day sample period (n = 865) were compared to the register information. Good or satisfactory validity was found for 32 of 33 variables, when minor error was tolerated in variables with continuous scales. For diagnoses and procedures, recorded in check-box format, satisfactory validity was found for 10 of 45 variables. Validity could not be assessed for 18 variables because of insufficient number of cases (13 items) or definition problems (5 items). When the results were compared to a 1987 data quality study, many of the variables that had been changed to the check-box format showed improvement in validity. In addition, in some cases a small change in question alternatives or instructions caused a noticeable change in validity.

Impact of induced abortions and statistical definitions on perinatal mortality figures.

Two problems originating from the advanced use of medical technology in screening for malformations and in the care of preterm and low birthweight infants are presented: the impact of the increasing number of induced medical abortions and the differences in statistical definitions on perinatal mortality (PNM) figures. Data on 186,562 births registered in the Finnish Medical Birth Registry between 1987 and 1989 were studied, and 65,554 medical abortions (of which 1647 were performed after the sixteenth week of gestation) registered in the Abortion Registry between 1985 and 1990. A 115% increase in abortions for medical reasons in the period 1985-1990 was found. It was estimated that the trend accounted for up to one-third of the decline in PNM rate during that time. The perinatal mortality rate was strongly influenced by very small infants. The application of the Finnish version of the International Classification of Diseases, Ninth Revision (ICD-9) (including all livebirths and using both birthweight of 500 g and gestational age of 22 weeks as the criteria) resulted in PNM rates which were about 5% higher than according to ICD-9. We suggest that the impact of medical abortions on perinatal statistics has reduced the value of the perinatal mortality rate as an indicator of the standard of care.

PIP: Criteria vary for determining which newborns should be included in perinatal statistics. Identical criteria are also applied in different ways, while registration laws and data collection recommendations may also differ from one another. This situation is problematic, especially for international comparisons of perinatal mortality (PNM) rates. International efforts made to develop and unify these definitions have not, however, proved successful. In Europe, for example, there are at least five different definitions of stillbirth. The care of premature infants has developed rapidly, increasing the survival rate of very small newborns. On the other hand, more efficient methods have been introduced for screening malformations and other fetal diseases. The authors considered the effect of induced abortions for medical reasons upon the PNM rate as well as the impact of departures from the International Classification of Diseases, Ninth Revision (ICD-9), recommendations for calculating perinatal statistics currently used in Finland. Data were studied on 186,562 births registered in the Finnish Medical Birth Registry during 1987-89, as well as for 65,554 medical abortions registered in the Abortion Registry during 1985-90. There was a 115% increase in abortions for medical reasons during 1985-90. It is estimated that the trend accounted for up to one-third of the decline in PNM rate during that time. The PNM rate was strongly influenced by very small infants. The application of the Finnish version of the ICD-9 resulted in PNM rates approximately 5% higher than according to ICD-9. The impact of medical abortions upon perinatal statistics reduced the value of the PNM rate as an indicator of the standard of care.

Regional variation in surgical procedure rates in Finland.

The aim was to describe the regional variation of population based surgery rates in Finland with special reference to the comparison of surgical activities in individual hospitals. Data on 11 common procedures covering all Finnish hospitals were obtained from the Finnish Hospital Discharge Register and the Finnish Medical Birth Register of the years 1987 and 1988. The variations of age and sex standardized procedure rates were studied across the procedure specific hospital service areas. The variation was estimated by three methods: extremal quotient, coefficient of variation, and systematic component of variation. The statistical significance of the variation measures was tested with a computerized simulation model. The variation was small for mastectomy, inguinal hernia repair, and hip replacement due to fracture, and large for lumbar disc operations, haemorrhoidectomies, and uterus operations. The results are similar to those of comparable studies elsewhere. The results indicate that there are clear differences in surgical activities between Finnish hospitals.

Reporting of malformations in routine health registers.

The utility of three national registers--the malformation, birth, and hospital in-patient discharge registers--in identification of malformations among 60,255 children born in 1987 in Finland was compared. Information in the malformation register is collected by specific reporting of physicians; information on the malformed children in the other two registers in 1987 through 1990 was routinely collected and identified by ICD 9-codes (740-759, 7886A). From October 1990 on, the ICD-9 codes were omitted from the birth register and malformation data were asked only in a yes-no question. In 1987, the malformation register included 1,032, the birth register 3,084 and the in-patient register 2,003 malformed infants identified up to the age of 1 year. There was underrepresentation of almost all malformation diagnoses in the malformation register. Individual linkage of the three registers showed that the malformation register revealed very few cases not recorded in the birth and the in-patient registers. With the adoption of the new recording method in the birth register beginning in October 1990, reports of malformation declined by 75%. Our analyses showed that data sources based on diagnoses collected routinely and not requiring an explicit decision on whether or not a problem is a malformation, can be more useful for routine surveillance of occurrence of malformations.

Multi method approach to the assessment of data quality in the Finnish Medical Birth Registry.

OBJECTIVE: To assess comprehensively the validity of the data in the Finnish Medical Birth Registry (MBR) by the combined use of several controls and internal analysis of the data. DESIGN: The MBR data were individually linked to a medical record sample (n = 775) and to all perinatal death certificates in 1987. The data were also compared with annual hospital statistics. The distributions of birth weights and gestational ages were examined. SUBJECTS: All stillborn and liveborn babies registered in the MBR in 1987 (n = 59,370). SETTING: The nationwide MBR data were compared with medical records from one third of the Finnish hospitals, with statistics for all hospitals, and with nationwide cause of death registry data. MEASUREMENTS AND MAIN RESULTS: With regard to most variables, the data quality was good or satisfactory (agreement with medical records 95% or more). Allowing for minor deviations in variables with continuous scales improved the agreement rates further. Explanations could be deduced for items with poor agreement values. For most variables, the amount of missing data was less than 1%. With the exception of caesarean sections, medical procedures were registered in only 30 to 72% of the cases, and the proportion varied strongly between the hospitals. Common diagnoses (32 to 86%) and primary causes of death (59 to 78%) were also poorly recorded. CONCLUSIONS: Combined use of several control materials and internal analyses was successful in investigating the whole data content. The data in the MBR were generally valid but diagnoses and most data on medical procedures were not of sufficiently good quality.

Mother's education and perinatal problems in Finland.

This study using nationwide data expands a previous study from one area in Finland. The purpose was to study how perinatal problems (mortality, short gestation, low birthweight and low Apgar scores) vary by mother's social class, which is measured by level of education. Outcomes of all births in the 1987 Medical Birth Register were linked to the 1988 National Education Register with gives the estimated number of years of completed education. In unadjusted analyses, the lowest educational groups (less than 9 years) had the worst results for outcomes other than neonatal mortality. Results in the two highest educational groups (greater than or equal to 13 and 12 years of education) were similar and if anything, better in the second highest group. Excluding twins and adjusting for confounding variables (age, parity, county, urbanization of residence) by logistic regression analysis did not alter the results much. Adjustment for possible mechanisms correlated with social class (marital status, smoking, time of first antenatal visit) decreased the higher occurrence of low birthweight infants in the low educational groups. Reported previous miscarriages were more common in the higher educational groups. Based on the available background characteristics one would expect to have found the usual social gradient in perinatal problems to have persisted between the two highest educational groups. Further studies on factors causing the plateau in the gradient between these groups might be useful.