The effect of hysterectomy or levonorgestrel-releasing intrauterine system on lower abdominal pain and back pain among women treated for menorrhagia: a five-year randomized controlled trial.

OBJECTIVE: The purpose of this study was to evaluate the changes in lower abdominal pain and back pain among women with menorrhagia treated by hysterectomy or levonorgestrel-releasing intrauterine system (LNG-IUS). DESIGN: A randomized controlled trial. SETTING: Five university hospitals in Finland. SAMPLE: A total of 236 women, aged 35-49 years. METHODS: Women were randomly assigned to treatment by hysterectomy (n = 117) or LNG-IUS (n = 119). MAIN OUTCOME MEASURES: Frequency and intensity of lower abdominal pain and back pain were evaluated by questionnaires at baseline and after 6 months, 12 months and 5 years. RESULTS: By six months, women in both groups had less frequent back pain than before treatment (p < 0.001). Lower abdominal pain decreased only in the hysterectomy group (p = 0.02) with significant differences between the groups. Between 12 months and 5 years, frequency of lower abdominal pain (p = 0.05) and back pain (p = 0.002) decreased more in the LNG-IUS group than in the hysterectomy group. Between baseline and five years, the lower abdominal pain score (including frequency and intensity of pain) decreased in both groups (p < 0.001, p = 0.01). Back pain score decreased only in the LNG-IUS group and the difference between the groups was significant (p = 0.02). However, some women experienced more pain after both treatments than before treatment. In multivariate analyses, LNG-IUS use was associated with a decrease in lower abdominal pain and back pain. CONCLUSIONS: In the treatment of menorrhagia, both hysterectomy and LNG-IUS decrease lower abdominal pain. LNG-IUS use, but not hysterectomy, has beneficial effects on back pain.

Depressive symptoms as predictors of discontinuation of treatment of menorrhagia by levonorgestrel-releasing intrauterine system.

It has been shown that levonorgestrel-releasing intrauterine system (LNG-IUS) is an effective treatment of menorrhagia. However, the discontinuation rate of LNG-IUS treatment is high, and little is known about the actual reasons intertwining it. We tested the hypothesis that depressive symptoms is the factor responsible for deciding to have a hysterectomy during LNG-IUS treatment. The participants (119 women, ages = 35-49 years) were randomly selected over a 3-year period (1994-1997) to receive the LNG-IUS or a hysterectomy for the treatment of menorrhagia. Depressive symptoms, based on Beck's Depression Inventory measured 6 months after the beginning of the treatment, were related to discontinuation of LNG-IUS use Odds Ratio (OR) = 3.70, 95% Confidence Intervals (CI) 1.55-8.82, p = .003 during a 5-year follow-up. This association was not attenuated after adjustment for other known risk factors. Our findings suggest that diagnosing and treating depression among patients having menstrual problems may improve the continuity of LNG-IUS treatment of menorrhagia.

A randomized trial among women with heavy menstruation -- impact of a decision aid on treatment outcomes and costs.

OBJECTIVE: To evaluate the effects of a decision aid for menorrhagia on treatment outcomes and costs over a 12-month follow-up. DESIGN: Randomized trial and pre-trial prospective cohort study. SETTING AND PARTICIPANTS: Gynaecology outpatient clinics in 14 Finnish hospitals, 363 (randomized trial) plus 206 (cohort study) patients with menorrhagia. INTERVENTION: A decision aid booklet explaining menorrhagia and treatment options, mailed to patients before their first clinic appointment. MAIN OUTCOME MEASURES: Health related quality of life, psychological well-being, menstrual symptoms, satisfaction with treatment outcome, use and cost of health care services. RESULTS: All study groups experienced overall improvement in health-related quality of life, anxiety, and psychosomatic and menstrual symptoms, but not in sexual life. Treatment in the intervention group was more active than in the control group, with more frequent course of medication and less undecided treatments. However, there were no marked disparities in health outcomes, satisfaction with treatment outcome and costs. Total costs (including productivity loss) per woman because of menorrhagia over the 12-month follow-up were 2760 and 3094 in the intervention and control group, respectively (P = 0.1). The pre-trial group also had a significantly lower rate of uterus saving surgery compared with the control group, but no difference in costs because of menorrhagia treatment. CONCLUSION: Despite some differences in treatment courses, a decision aid for menorrhagia in booklet form did not increase the use of health services or treatment costs, nor had it impact on health outcomes or satisfaction with outcome of treatment.

Comparison of HPV test versus conventional and automation-assisted Pap screening as potential screening tools for preventing cervical cancer.

OBJECTIVE: To evaluate new techniques in primary cervical cancer screening programmes. DESIGN: Cross sectional pilot study. SETTING: Department of Obstetrics and Gynaecology, Helsinki University Hospital. POPULATION: Consecutive 2032 human papillomavirus (HPV) DNA and Pap smear samples were taken. Histological diagnoses were obtained from 460 patients. METHODS: We compared the validity of the high risk (HR) HPV DNA detection test to automation-assisted and conventional Pap smear screening. MAIN OUTCOME MEASURES: Specificity and sensitivity of screening methods. RESULTS: Twenty-three percent of women were HPV positive. Forty-five of 46 had high grade lesions and cancers were HR HPV DNA positive, whereas 72/93 of low grade and more severe lesions were HR HPV DNA positive. When histologically verified high grade lesions were observed, the relative sensitivity of HR Hybrid Capture 2 (HR HC2) test was 98% compared with conventional Pap smear and Papnet tests, which performed 54%versus 58%, 83%versus 86% and 93%versus 98% relative sensitivity respectively, using cytological diagnoses HSIL (high grade squamous intraepithelial lesion), LSIL (low grade squamous intraepithelial lesion) or ASCUS (atypical squamous cells of undetermined significance) as the cutoff. The specificity of HC2 test (77-79%) was comparable with the ASCUS+ (ASCUS and more severe) cytology (68-79%), but lower when compared with LSIL+ (91-95%) or especially HSIL+ (97-99%) Pap smear results. CONCLUSION: Pap smear, as a screening test, is very different from HPV DNA detecting test HR HC 2. If cutoff LSIL or more severe lesions is used, primary Pap smear is clearly more specific than HR HC2, but markedly less sensitive. Due to high relative sensitivity of the HPV, only very few histologically confirmed high grade lesions would be detected among HPV negatives using simultaneous cytology. On the other hand, using HPV DNA test alone would lead to multifold amounts of referrals for colposcopy. A posterior Pap smear assessment among HPV positives might be helpful in increasing sensitivity and specificity of screening and defining those who need an immediate referral or treatment. We plan to incorporate primary HR HPV DNA test with posterior Pap smear reading of HPV positives into our ongoing randomised prospective multiarm trial evaluating new techniques in organised screening for cervical cancer in Finland.

Clinical outcomes and costs with the levonorgestrel-releasing intrauterine system or hysterectomy for treatment of menorrhagia: randomized trial 5-year follow-up.

CONTEXT: Because menorrhagia is often a reason for seeking medical attention, it is important to consider outcomes and costs associated with alternative treatment modalities. Both the levonorgestrel-releasing intrauterine system (LNG-IUS) and hysterectomy have proven effective for treatment of menorrhagia but there are no long-term comparative studies measuring cost and quality of life. OBJECTIVE: To compare outcomes, quality-of-life issues, and costs of the LNG-IUS vs hysterectomy in the treatment of menorrhagia. DESIGN, SETTING, AND PARTICIPANTS: Randomized controlled trial conducted between October 1, 1994, and October 6, 2002, and enrolling 236 women (mean [SD] age, 43 [3.4] years) referred to 5 university hospitals in Finland for complaints of menorrhagia. INTERVENTIONS: Participants were randomly assigned to treatment with the LNG-IUS (n = 119) or hysterectomy (n = 117) and were monitored for 5 years. MAIN OUTCOME MEASURES: Health-related quality of life (HRQL) as measured by the 5-Dimensional EuroQol and the RAND 36-Item Short-Form Health Survey, other measures of psychosocial well-being (anxiety, depression, and sexual function), and costs. RESULTS: After 5 years of follow-up, 232 women (99%) were analyzed for the primary outcomes. The 2 groups did not differ substantially in terms of HRQL or psychosocial well-being. Although 50 (42%) of the women assigned to the LNG-IUS group eventually underwent hysterectomy, the discounted direct and indirect costs in the LNG-IUS group (2817 dollars [95% confidence interval, 2222 dollars-3530 dollars] per participant) remained substantially lower than in the hysterectomy group (4660 dollars [95% confidence interval, 4014 dollars-5180 dollars]). Satisfaction with treatment was similar in both groups. CONCLUSIONS: By providing improvement in HRQL at relatively low cost, the LNG-IUS may offer a wider availability of choices for the patient and may decrease costs due to interventions involving surgery.

Levonorgestrel-releasing intrauterine system or hysterectomy in the treatment of essential menorrhagia: predictors of outcome.

Levonorgestrel-releasing intrauterine system (LNG-IUS) has been advocated as an effective alternative to hysterectomy in the treatment of menorrhagia. The outcome predictors have been poorly known. In this study the amount of menstrual blood loss (MBL) turned out to be the single most important outcome predictor of these treatments. However, the treatment with LNG-IUS seemed to be an appropriate alternative to hysterectomy for all women who perceived their MBL heavy.

Factors predicting choice of treatment for menorrhagia in gynaecology outpatient clinics.

The aim of this prospective study was to investigate factors predicting choice of treatment for excessive menstrual bleeding, with special emphasis on women's pre-treatment preference. A cohort of women with heavy menstruation and their treatment process in gynaecology outpatient clinics were followed-up for 1yr. A total of 383 35-54-yr-old women attending 14 Finnish hospitals participated. They completed a questionnaire before their first outpatient clinic visit, and postal follow-ups were conducted 3 and 12 months later. Information on treatment(s) during the follow-up was taken from medical records and questionnaires. The choice between hysterectomy and conservative treatments, and fulfillment of pre-treatment preference were the main outcome measures. During the 1-yr follow-up, 51% (n=196) of the women underwent hysterectomy and nine were still awaiting it, 12% (n=44) had a minor surgical procedure, 11% (n=41) had oral medication, 9% (n=33) used a hormonal intrauterine system, and nine women changed preventive method. Forty-two women (11%) reported having had no treatment. Data on previous treatments suggested that conservative treatment modalities were under-used. Most of the treatment decisions were made within the first 3-month period. Women's pre-treatment preference was the strongest predictor of chosen treatment. Unemployment, irregular periods and anxiety decreased the probability of a decision for hysterectomy, while pelvic pain and inconvenience due to bleeding increased it. The treatment plan accorded with pre-treatment preference in 72% of the women preferring hysterectomy and in 74% of those preferring a conservative option.

Correlates of women's preferences for treatment of heavy menstrual bleeding.

This cross-sectional survey investigated factors associated with treatment preferences of women with menorrhagia. Women (n = 474) aged 35-54 years referred to gynaecology out-patient clinics for menorrhagia were mailed a self-administered questionnaire before their first clinic visit. The main outcome measure was treatment preference. Hysterectomy and conservative treatment (combined with no treatment) were favoured equally often. In a multivariate analysis, completed family size (P = 0.003), menstrual pain (P = 0.02), irregular periods (P = 0.03), and higher age (P = 0.04) predicted hysterectomy preference, as did lower education level (P = 0.001), gynaecologist consultations (P = 0.002), and unemployment (P = 0.03). The psychological factors assessed were not associated with treatment preference. In conclusion, rational considerations regarding stage of reproductive life and severity of symptoms were linked to women's treatment preferences. However, education, employment status and use of specialists' services guided women's preferences even more powerfully than menstrual symptoms and burden caused by them. Doctors should pay more attention to motivating women for a trial of conservative treatment since only half of the women reported previous treatment for their menstrual problem.

Impact of patient information booklet on treatment decision--a randomized trial among women with heavy menstruation.

OBJECTIVE: Does a patient information booklet influence treatment for menorrhagia? DESIGN: Randomized trial and a pre-trial prospective cohort study. SETTING: Gynaecology outpatient clinics in 14 Finnish hospitals. PARTICIPANTS: A total of 363 (randomized trial) plus 206 (cohort study) patients with menorrhagia. INTERVENTION: An information booklet about menorrhagia and treatment options, mailed before the first visit to the outpatient clinic. MAIN OUTCOME MEASURES: Distribution of treatment modalities, knowledge about treatment options, satisfaction with communication with personnel and anxiety. RESULTS: Treatment decision within 3 months was made more often in the intervention group than in the control group (96% and 89% respectively, P = 0.02). Oral medication was more frequently chosen, and newly introduced treatments (minor surgery, hormonal intrauterine system) were less frequently used in the intervention group (at 3-month follow-up 21% and 29%, respectively). The differences persisted at the 12-month follow-up. In the pre-trial group, new treatment methods were less frequently chosen and used than in the control group. Additional information did not increase the number of surgical procedures used, improve knowledge, or influence satisfaction or anxiety. CONCLUSIONS: Additional information led to an increase in specific treatment decisions and changed the distribution of used treatments without increasing the number of surgical procedures. The study suggests that well-informed women adopting an active role may counteract physicians' emphasis on newly introduced treatments.