Anne Lethaby

Methods of hysterectomy: systematic review and meta-analysis of randomised controlled trials

Abstract Objective To evaluate the most appropriate surgical method of hysterectomy (abdominal, vaginal, or laparoscopic) for women with benign disease. Design Systematic review and meta-analysis. Data sources Cochrane Menstrual Disorders and Subfertility Group Trials Register, Cochrane Central Register of Controlled Trials, Medline, Embase, and Biological Abstracts. Selection of studies Only randomised controlled trials were selected; participants had to have benign gynaecological disease; interventions had to comprise at least one hysterectomy method compared with another; and trials had to report primary outcomes (time taken to return to normal activities, intraoperative visceral injury, and major long term complications) or secondary outcomes (operating time, other immediate complications of surgery, short term complications, and duration of hospital stay). Results 27 trials (total of 3643 participants) were included. Return to normal activities was quicker after vaginal than after abdominal hysterectomy (weighted mean difference 9.5 (95% confidence interval 6.4 to 12.6) days) and after laparoscopic than after abdominal hysterectomy (difference 13.6 (11.8 to 15.4) days), but was not significantly different for laparoscopic versus vaginal hysterectomy (difference −1.1 (−4.2 to 2.1) days). There were more urinary tract injuries with laparoscopic than with abdominal hysterectomy (odds ratio 2.61 (95% confidence interval 1.22 to 5.60)), but no other intraoperative visceral injuries showed a significant difference between surgical approaches. Data were notably absent for many important long term patient outcome measures, where the analyses were underpowered to detect important differences, or they were simply not reported in trials. Conclusions Significantly speedier return to normal activities and other improved secondary outcomes (shorter duration of hospital stay and fewer unspecified infections or febrile episodes) suggest that vaginal hysterectomy is preferable to abdominal hysterectomy where possible. Where vaginal hysterectomy is not possible, laparoscopic hysterectomy is preferable to abdominal hysterectomy, although it brings a higher chance of bladder or ureter injury.

Overall survival from breast cancer in women pregnant or lactating at or after diagnosis

The effect of concurrent or subsequent pregnancy or lactation has been studied in women with breast cancer to determine if these variables influence prognosis. Information was collected from 382 women potentially capable of bearing children, aged less than 45 years, in the Auckland Breast Cancer Study Group data file, a consecutive series of women diagnosed with breast cancer from 1976 to 1985, with a median follow‐up of 10.2 years. The prevalence of both pregnancy at diagnosis and lactation at diagnosis was 2.6%. The incidence of pregnancy subsequent to diagnosis was 3.9%. Women pregnant at the time of breast cancer diagnosis had significantly more advanced disease than non‐pregnant patients, and there was a similar trend for women lactating at diagnosis. Overall survival in these women was poor compared with the non‐pregnant and non‐lactating groups; only 2 of 10 pregnant patients and 0 of 10 lactating patients survived more than 12 years. The adverse outcome for women lactating at diagnosis of their breast cancer persisted despite allowance for nodal status, tumour size and age. However, survival was similar between pregnant and non‐pregnant patients when these variables were taken into account. No significant differences in survival were found between those women who had pregnancies subsequent to diagnosis of breast cancer and breast cancer patients who did not become pregnant.

The GATE frame: critical appraisal with pictures

Epidemiological evidence about the accuracy of diagnostic tests, the power of prognostic markers, and the efficacy and safety of interventions is the cornerstone of evidence-based health care.1 Practitioners of evidence-based health care require critical appraisal skills to judge the validity of this evidence. The Evidence-Based Medicine (EBM) Working Group members are international leaders in teaching critical appraisal skills, and their users’ guides for appraising the validity of the healthcare literature2 have long been the basis of teaching programmes worldwide. However, we found that many of our students took a reductionist “paint by numbers” approach when using the Working Group’s guides. Students could answer individual appraisal questions correctly but would have difficulty assessing overall study quality. We believe this is due to a poor understanding of epidemiological study design. So over the past 15 years of teaching critical appraisal we have modified the EBM Working Group approach and developed the Graphic Appraisal Tool for Epidemiological studies (GATE) frame to help our students conceptualise the whole study as well as its component parts. GATE is a visual framework that illustrates the generic design of all epidemiological studies (figure 1). We now teach critical appraisal by “hanging” studies and the EBM Working Group’s appraisal questions on the GATE frame. Figure 1  The GATE frame. This editorial outlines the GATE approach to critical appraisal, illustrated throughout using the Heart and Estrogen/progestin Replacement Study (HERS), a randomised, double blind, placebo controlled trial of the effect of daily oestrogen plus progestin on coronary heart disease (CHD) death in postmenopausal women.3 A detailed critical appraisal of HERS using a GATE-based checklist is available online.4 The GATE frame incorporates a triangle, circle, square, and arrow (figure 1), labelled with the acronym PECOT (or PICOT). The triangle (figure 2) represents the population studied: “P” for population or …

A randomised trial comparing the levonorgestrel intrauterine system and thermal balloon ablation for heavy menstrual bleeding

Objective  To compare the levonorgestrel intrauterine system (LNG‐IUS) (Mirena®; Schering Co., Turku, Finland) and thermal balloon ablation (Thermachoice™; Gynecare Inc., Menlo Park, CA, USA) for the treatment of heavy menstrual bleeding.

Progesterone/progestogen releasing intrauterine systems versus either placebo or any other medication for heavy menstrual bleeding.

BACKGROUND Heavy menstrual bleeding (HMB) is an important cause of ill health in women and it accounts for 12% of all gynaecology referrals in the UK. Heavy menstrual bleeding is clinically defined as greater than, or equal to, 80mls blood loss per menstrual cycle but women may complain of excessive bleeding when their blood loss is less than 80ml. Hysterectomy is often used to treat women with this complaint but medical therapy may be a successful alternative. The intrauterine coil device was originally developed as a contraceptive but the addition of uterine relaxing hormones, or progestogens, to these devices resulted in a large reduction in menstrual blood loss. Case studies of 2 types of progesterone/progestogen releasing systems, Progestasert and Mirena, report reductions of up to 90% and dysmenorrhoea may be improved. Insertion, however, may be regarded as invasive by some women affecting its acceptability as a treatment and frequent intermenstrual bleeding and spotting is likely during the first few months. OBJECTIVES To determine the effectiveness and acceptability of progesterone/progestogen-releasing intrauterine devices in achieving a reduction in heavy menstrual bleeding. SEARCH STRATEGY All studies which might describe randomised controlled trials of progesterone/progestagen-releasing intrauterine devices for the treatment of heavy menstrual bleeding were obtained by electronic searches of the MEDLINE 1966-1999, EMBASE 1980-1999 databases and the Cochrane Library. Companies producing progestogen releasing intrauterine devices and experts in the field were contacted for information on published and unpublished trials. SELECTION CRITERIA Randomised controlled trials in women of reproductive age treated with progesterone/progestogen-releasing intrauterine devices versus no treatment, placebo, or other medical or surgical therapy for heavy menstrual bleeding within either the primary care, family planning or specialist clinic setting were eligible for inclusion. Women with postmenopausal bleeding, intermenstrual or irregular bleeding, or pathological causes of heavy menstrual bleeding were excluded. DATA COLLECTION AND ANALYSIS Potential trials were independently assessed by three reviewers and five trials met the criteria for inclusion in the review. The reviewers extracted the data independently and data were pooled where appropriate. Odds ratios for dichtomous outcomes and weighted mean differences for continuous outcomes were estimated from the data. The primary outcome was reduction in menstrual blood loss but incidence of side effects, changes in quality of life and satisfaction and acceptability measures were also assessed. MAIN RESULTS Progesterone/progestogen-releasing intrauterine systems have not been compared to placebo or no treatment. Progestasert has been compared to a number of different medical therapies in one small study but no conclusions can be made about effectiveness. The levonorgestrel-releasing intrauterine device (LNG IUS) has been compared to oral cyclical norethisterone (NET) administered on days 5-26 in one trial and was significantly more effective although there was a large reduction from baseline in both groups and these differences were not perceived by the women undergoing the treatment. Some side effects were more common in the LNG IUS group but a significantly greater proportion of women in this group were satisfied and willing to continue with their treatment. In one trial of women awaiting hysterectomy where the LNG IUS was compared with a control group taking their existing medical therapy, a higher proportion of the women in the former group cancelled their planned surgery after 6 months of treatment. The levonorgestrel-releasing intrauterine device has been compared to a surgical procedure (transcervical resection of the endometrium (TCRE)) in two trials. (ABSTRACT TRUNCATED)

Cost‐effectiveness analysis of levonorgestrel intrauterine system and thermal balloon ablation for heavy menstrual bleeding

Objective  To compare the cost‐effectiveness of levonorgestrel intrauterine system (LNG‐IUS) (Mirena®; Schering Co., Turku, Finland) and thermal balloon ablation (Thermachoice™; Gynecare Inc., Menlo Park, CA, USA) for the treatment of heavy menstrual bleeding.

Treatments for heavy menstrual bleeding.

Guidelines improve prescribing practice but may not affect hysterectomy rates Heavy menstrual bleeding is a common cause of iron deficiency anaemia and may affect a womans quality of life. Thirty per cent of women consider their menstruation to be excessive.w1 In more than half of women with menorrhagia no obvious cause for the bleeding is found, and in at least half of those who undergo hysterectomies in the United Kingdom heavy menstrual bleeding is the main presenting problem.w2 Concern has been expressed that unnecessary surgery is being performed, and treatment of this common condition is not appropriate and evidence based.1 One difficulty with the available research is that the focus has been on trying accurately to measure blood loss as a response to treatment. There are problems with this approach. Firstly, there is a large discrepancy between womens perception of their menstrual loss and accurate measurement of the blood flow. For example, only about half of women complaining of heavy menstrual bleeding have a menstrual loss greater than 80 ml per cycle, which is the cut-off for a clinical diagnosis of heavy menstrual bleeding.2 Secondly, the current gold standard for measuring menstrual blood loss is a modification of the alkaline haematin technique,3 but this …

An evidence‐based guideline for the management of uterine fibroids

Uterine fibroids (myomas or leiomyomas) are benign growths of uterine muscle that occur commonly in women of reproductive age. Symptoms often attributed to uterine fibroids are heavy menstrual bleeding and pressure symptoms. When heavy menstrual bleeding occurs in association with uterine fibroids, hysterectomy has long been considered the defmitive treatment. A fibroid uterus is one of the most common indications stated for hy~terectomp’.~.~ One in five New Zealand women will, by the age of 54, undergo hy~terectomy,~ an operation that usually requires 4-6 weeks of convalescence? Yet, while the exact proportion is unknown, many cases of uterine fibroids are asymptomatic and surgical interventions may there fore be unjustified and unnecessary. Even if the fibroids are associated with symptoms, there are new management options that may reduce the need for hysterectomy

SERUM INSULIN‐LIKE GROWTH FACTOR‐I AND INSULIN‐LIKE GROWTH FACTOR BINDING PROTEIN‐3 FOLLOWING CHEMOTHERAPY FOR ADVANCED BREAST CANCER

Background:  Insulin‐like growth factor‐I (IGF‐I) and IGF binding protein‐3 (IGFBP‐3) appear to influence the growth of breast cancer cells in vitro, and epidemiological studies suggest higher serum IGF‐I levels increase the risk of breast cancer. IGF‐I and IGFBP‐3 have therefore been measured in women with advanced breast cancer to determine if changes in serum levels predict the response to treatment by chemotherapy.

Effect of breast surgery on serum levels of insulin-like growth factors (IGF-I, IGF-II, and IGF binding protein-3) in women with benign and malignant breast lesions.

AbstractBackground: There is evidence that insulin-like growth factors play a role in the development of breast cancer. Antiestrogens reduce circulating levels of IGF-I, but the influence of other breast cancer treatments, including surgery, is unknown and is investigated in this study. Methods: Circulating serum concentrations of IGF-I, IGF-II, and IGF binding protein-3 (IGFBP-3) were measured before and after breast surgery in 31 patients with breast cancer and 12 controls with benign breast lesions. Serum albumin was measured as a marker of the nonspecific metabolic effect of surgery. Results: Serum IGF-I, IGF-II, IGFBP-3, and albumin fell 24 hours after surgery for breast cancer but largely normalized again over the next 7 days. The fall in IGF-I and IGFBP-3 was not significant when the change in serum albumin was used as a covariate, suggesting a nonspecific effect of surgery. However, the reduction in IGF-II remained significant when adjusted for albumin and was greater after lumpectomy of malignant tumors (−8 ± 2%) compared with benign disease (2 ± 2%, P = .001). The fall in IGF-II was significantly related to the size of the removed tumor. Conclusions: Breast cancer may directly influence the serum concentration of IGF-II, possibly by direct tumor production.