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PubMed1997

Plasticity, political economy, and physical growth status of Guatemala Maya children living in the United States.

Migration of Maya refugees to the United States since the late 1970s affords the opportunity to study the consequences of life in a new environment on the growth of Maya children. The children of this study live in Indiantown, Florida, and Los Angeles, California. Maya children between 4 and 14 years old (n = 240) were measured for height, weight, fatness, and muscularity. Overall, compared with reference data for the United States, the Maya children are, on average, healthy and well nourished. They are taller and heavier and carry more fat and muscle mass than Maya children living in a village in Guatemala. However, they are shorter, on average, than children of black, Mexican-American, and white ethnicity living in Indiantown. Children of Maya immigrants born in the United States tend to be taller than immigrant children born in Guatemala or Mexico. Families that invest economic and social resources in their children have taller children. More economic successful families have taller children. Migration theory and political economy theory from the social sciences are combined with plasticity theory and life history theory (parental investment) from biology to interpret these data.

Black or African American↗
PubMed1998

An alternative method for assessing early mortality in contemporary populations.

Biological anthropologists are interested in a population's early mortality rates for a variety of reasons. Early mortality (infant or juvenile) is of obvious importance to those interested in demography, but early mortality statistics are useful for life history analysis, paleodemography, and human adaptability studies, among others. In general, the form of mortality statistics is derived from demography, where chronological age is the gold standard for statistical calculation and comparison. However, there are numerous problems associated with the collection, analysis, and interpretation of early mortality statistics based on age, particularly for anthropological research, which is often conducted in small or non-calendrical-age numerate populations. The infant mortality rate (IMR), for example, is notoriously difficult to determine in populations where accurate accounting of age is not routine, and yet it is widely used in demography, public health, medicine, and social science research. Here we offer an alternative to age-based early mortality statistics that makes use of human biologists' interest in, and skill at, assessing human growth and development. Our proposal is to use developmental stages of juveniles instead of relying exclusively on age as the basis for mortality statistics. Death or survival according to a developmental stage (such as crawling or weaning) may provide more accurate data that are also more closely related to the cause of death. Developmental stages have the added advantage of putting infants and children back at the center of the discussion of early mortality by focusing on their activities in relation to their environment. A case study from the Turkana population of Kenya illustrates the use of developmental stages in describing early mortality.

Cause of Death↗
PubMed1996

Meta-analysis: current issues in research synthesis.

Recent concern about the effectiveness of alternative treatments in medicine and health, in education, in psychology, and in the social sciences has led to a consideration of how to combine or synthesize the results of independent studies. Historically, integration of independent results focused on how to combine p-values. More recently the emphasis has been on estimating effect sizes, which in turn has motivated a variety of alternative models depending on the experimental conditions. We here review the development of the field with an emphasis of diagnostics and future research.

Bias↗
PubMed1997

Clinical evaluations for transfer of juveniles to criminal court: current practices and future research.

Completing clinical evaluations of juveniles considered for transfer to criminal court requires specialized expertise. However, there is little empirical foundation upon which they can be based. Within each of the three major evaluation domains (amenability to treatment, risk for future violence, and sophistication/maturity), we ask the following questions: a) Can forensic examiners properly assess this area, and if so using what tools?; b) How can social science research clarify the transfer evaluation, particularly as it is impacted by systems issues?; and c) How should the evaluation be structured? In doing so, we review clinical suggestions for completing these evaluations and identify pertinent research directions. A number of general issues specific to these evaluations are also discussed.

Adolescent↗
PubMedDate not supplied

Multilevel models and health economics.

Multilevel analyses have become an accepted statistical technique in the field of education where over the past decade or so the methods have been developed to explore the relationships between pupil characteristics and the characteristics of the schools they attend. More recently, widespread use has extended to other social sciences and health research. However, to date, little use has been made of these techniques within the health economics literature. This paper presents an introductory account of multilevel models and describes some of the areas of health economics research that may benefit from their use.

Adult↗
PubMed2000

The Harvard study of values: mirror for postwar anthropology.

In 1949, social scientists at Harvard University began a long-range, multidisciplinary research project called the Comparative Study of Values in Five Cultures. The topic of values had been hotly debated since the 1920s, a debate that was renewed with vigor in the postwar period. When Clyde Kluckhohn, an anthropologist well known for his work among the Navajos, designed the Values Study research, he thus focused on a topic of much interest. This essay describes how this little-known project had roots in the debate on values and cut a trajectory through a quickly changing intellectual environment.

Anthropology, Cultural↗
PubMed1991

Progress and challenges in psychosocial and behavioral research in cancer in the twentieth century.

Research in the psychosocial and behavioral aspects of cancer has shown steady growth since the 1950s, and its course of development has paralleled the history of medical techniques in treating cancer. Table 1 outlines this parallel evolution from the 1850s to the 1960s. The roles of the American Cancer Society and the National Cancer Institute (NCI) in spearheading and nurturing research in this area are documented. Interest in psychooncologic questions can be traced back for centuries to the search for etiologic factors and psychologic variables that would explain individual vulnerability to cancer. The first psychologic studies of cancer patients were reported in 1951 and 1952 from the Massachusetts General Hospital and Memorial Sloan-Kettering Cancer Center, respectively. The 1970s saw new interest in psychosocial and behavioral research with many issues being addressed for the first time: better care of the terminally ill through more humanistic approaches including better means of pain control; ethical concerns related to patient rights and their status as subjects in experimental protocols; trying to measure quality of life for cancer patients on protocols; seeing the need for multidisciplinary collaborative groups to make up for the absence of formal training in this area; and the need to design valid, accurate measuring scales specific to the symptomology of patients with cancer. Table 4 outlines how the 1980s gave increasing recognition and support to the psychosocial dimensions of cancer. This period produced a series of key conferences that examined a broad research and education perspective and produced recommendations that remain a benchmark in regard to instrumentation, conceptual models, pitfalls of psychosocial research, training, and education, and the organization of research efforts. New precision has been added to the field in the past 6 years: studies measuring concurrent psychologic, endocrine, and immune function; use of statistical modeling to incorporate quality of life data as a correction factor in survival data (TWiST and QALY); and broadened definitions of medical outcome to include functional status, thus allowing advances in psychiatric measurements to help answer questions in cancer. The challenges for the 1990s are identified in a summary in Table 9. Especially noteworthy is the observation that the comprehensive research needed today cannot be carried out by any one discipline alone. New approaches call for areas of the social sciences formerly inactive in cancer research (e.g., anthropology) to contribute the tools and expertise required to address the problems.

Adult↗
PubMed1991

Behavioral and psychosocial cancer research. Building on the past, preparing for the future.

This report identifies five general conclusions that emerged from the Second Workshop on Methodology in Behavioral and Psychosocial Cancer Research. These conclusions address diverse topics, including a focus on areas other than methodology; an emphasis on the transfer of technology and knowledge to applied settings; a recognition of the role of basic behavioral research in answering clinical questions; the need to recognize and strengthen ties between the field of behavioral and psychosocial oncology and the basic behavioral and social science fields from which it emerged; and the importance of additional research on minorities and other special populations. It is suggested that meeting the challenges posed in each of these five areas is critical to continued progress in the field.

Attitude to Health↗
PubMed2000

Therapeutic jurisprudence in the courts.

Therapeutic jurisprudence is an emerging field of law and social science inquiry that explores the role of the law in fostering therapeutic or antitherapeutic outcomes. This article considers the relationship between therapeutic jurisprudence and court performance goals, examines applications of therapeutic jurisprudence in court settings, discusses the steps involved in incorporating therapeutic jurisprudence principles into the work of courts, outlines the pros and cons associated with practicing therapeutic jurisprudence primarily in specialized courts, and offers suggestions for fostering continued experimentation by courts.

Cognitive Behavioral Therapy↗
PubMedDate not supplied

Race, region and the territorial politics of immigration in the US.

Zelinsky and Lee recently unveiled a model of the sociospatial process of immigrant settlement designed to augment and possibly supplant the well-known theories of assimilation and pluralism. Although in some ways new, their work continues a tradition in social science that treats the settlement geography of immigrants as a measure of their more general fit into American society. The authors question the prevailing assumption that immigrant settlement patterns represent a barometer of their adaptation, or lack thereof, to a host society. This critique of the concepts of assimilation, pluralism and Zelinsky and Lee's alternative "heterolocal" model of immigrant settlement pivots around the issues of spatial scale and race. The authors argue that the contestations over immigration and how well immigrants fit into society are increasingly constructed at the regional scale. The authors also assert that questions race infuse almost all aspects of these debates. The transformation of America's largest city-regions into places of non-White immigrants, and the shifting political balance of power to states like California through immigration-driven reapportionment, are touchstones for anti-immigration initiatives and associated local and national debate. Fear of racial regional changes underpins an increasingly powerful response to immigration. The reactions elicited by these settlement geographies fall under the heading the authors call the "territorial politics of immigration".

Acculturation↗
PubMed2000

Discharge planning from hospital to home.

BACKGROUND: Discharge planning is the development of an individualised discharge plan for the patient prior to leaving hospital for home, with the aim of containing costs and improving patient outcomes. It has been suggested that discharge planning can reduce unplanned readmission to hospital. OBJECTIVES: To assess the effects of discharge planning for patients moving from hospital to home. SEARCH STRATEGY: We searched the Cochrane Effective Practice and Organisation of Care Group specialised register, the Cochrane Controlled Trials Register, MEDLINE (1966 to 1996), EMBASE (1980 to 1996), Sigle (1980 to 1996), Bioethics (1985 to 1996), Health Plan (all available years), PsycLit (1974 to 1996), Cinahl (1982 to 1996), EconLit (1969 to 1996), Social Science Citation Index (1992 to 1996), and reference lists of articles. SELECTION CRITERIA: Randomised trials and controlled trials comparing discharge planning with routine discharge for hospital patients. The outcomes were mortality, clinical complications, hospital length of stay, readmissions, discharge destination, general and disease specific health status, functional status, psychological well-being, patient satisfaction, carer satisfaction, carer burden, cost to the health service, patient and family, general practice, and community services. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed study quality. MAIN RESULTS: Eight studies were included involving 4837 patients. Four studies recruited patients with a medical condition; four recruited patients with a mix of medical and surgical conditions, and one of these recruited medical and surgical patients as separate groups. There was a small reduction in hospital length of stay for elderly medical patients allocated to discharge planning (weighted mean difference -1.01, 95% CI -2.06 to 0.05). The effects of discharge planning on readmission rates were mixed. No statistically significant differences were detected for patient health outcomes. Patients with medical conditions allocated to discharge planning reported increased satisfaction compared with those receiving routine discharge. No statistically significant differences were reported for overall health care costs, although one study reported a significant reduction in readmission costs for medical patients allocated to discharge planning. REVIEWER'S CONCLUSIONS: The studies showed mixed results, which may reflect the different study populations and the different ways the intervention was implemented. There is some evidence that discharge planning may lead to reduced hospital length of stay, and in some cases reduced readmission to hospital. There is also some evidence that discharge planning increased patient satisfaction. There was no evidence that discharge planning reduced health care costs; however few studies conducted a formal economic analysis.

Controlled Clinical Trials as Topic↗
PubMed2004

Discharge planning from hospital to home.

BACKGROUND: Discharge planning is a routine feature of health systems in many countries. The aim is to reduce hospital length of stay and unplanned readmission to hospital, and improve the co ordination of services following discharge from hospital thereby bridging the gap between hospital and place of discharge. Sometimes discharge planning is offered as part of an integrated package of care, which may cover both the hospital and community. The focus of this review is discharge planning that occurs while a patient is in hospital; we exclude studies that evaluate discharge planning with follow up care. OBJECTIVES: To determine the effectiveness of planning the discharge of patients moving from hospital. SEARCH STRATEGY: Relevant studies were identified using Medline, Embase, SIGLE database for grey literature, Bioethics database, Health Plan, Psych. Lit, Sociofile, CINAHL, Cochrane Library, Econ Lit, Social Science Citation Index, EPOC register. The review was updated using the EPOC trials register in August 2002. SELECTION CRITERIA STUDY DESIGN: randomised controlled trials (RCTs) that compare discharge planning (the development of an individualised discharge plan) with routine discharge care. PARTICIPANTS: all patients in hospital. INTERVENTION: the development of an individualised discharge plan. DATA COLLECTION AND ANALYSIS: Data analysis and quality assessment was undertaken independently by two reviewers using a data checklist. Studies are grouped according to patient group (elderly medical patients, surgical patients, and those with a mix of conditions), and by outcome. MAIN RESULTS: Three new studies were included in this update. In total we included eleven RCTS: 6 trials recruited patients with a medical condition (2,368 patients), and four recruited patients with a mix of medical and surgical conditions (2,983 patients), one of these four recruited medical and surgical patients as separate groups, and the final trial recruited 97 patients in a psychiatric hospital and from a general hospital. We failed to detect a difference between groups in mortality for elderly patients with a medical condition (OR 1.44 95% CI 0.82 to 2.51), hospital length of stay (weighted mean difference -0.86, 95% CI -1.9 to 0.18), readmission rates (OR 0.91 95% CI 0.67 to 1.23) and being discharged from hospital to home (OR 1.15 95% CI 0.72 to 1.82). This was also the case for trials recruiting patients recovering from surgery and those recruiting patients with a mix of medical and surgical conditions. One trial comparing a structured care pathway for patients recovering from a stroke with multidisciplinary care reported a significant rate of improvement in functional ability and quality of life for the control group (median change in Barthel score between 4 to 12 weeks of 2 points for the treatment group, versus 6 for the control group, p<0.01); (Euroqol scores at 6 months 63 for the treatment group, vs. 72 for the control group, p<0.005). Two trials reported that patients with medical conditions allocated to discharge planning reported increased satisfaction compared with those who received routine discharge. No statistically significant differences were reported for overall health care costs. REVIEWER'S CONCLUSIONS: The impact of discharge planning on readmission rates, hospital length of stay, health outcomes and cost is uncertain. This reflects a lack of power as the degree to which we could pool data was restricted by the different reported measures of outcome. It is possible that even a small reduction in length of stay, or readmission rate, could have an impact on the timeliness of subsequent admissions in a system where there is an shortage of acute hospital beds.

Controlled Clinical Trials as Topic↗
PubMed2000

Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding.

BACKGROUND: Heavy menstrual bleeding (HMB) or menorrhagia is an important cause of ill health in women. Surgical treatment of HMB often follows failed or ineffective medical therapy and the definitive treatment is hysterectomy but this is a major surgical procedure with significant physical and emotional complications and social and economic costs. A number of less invasive surgical techniques (e.g. endometrial resection and laser ablation) have been developed with the purpose of removing the entire thickness of the endometrium. The benefits claimed for these therapies are reduced trauma and post-operative complications to the woman, reduced need for a general anaesthetic, direct cost savings to the health service due largely to a shift from inpatient to day case treatment and indirect cost savings to society as women return more quickly to their usual activities. However, endometrial hysteroscopic techniques are not always completely successful and additional surgical treatment is required in a proportion of cases. Although initially the resource and patient costs of these techniques are much cheaper than the cost of hysterectomy, the need for re treatment at a later stage may reduce the cost differential. Thus, the effectiveness of these techniques to improve a woman's perception of her own wellbeing long term has yet to be confirmed. OBJECTIVES: The objective of this review is to compare endometrial destruction techniques with hysterectomy by any means for the treatment of heavy menstrual bleeding (HMB). SEARCH STRATEGY: Electronic searches for relevant randomised controlled trials of the Cochrane Menstrual Disorders and Sub fertility Group Register of Trials, MEDLINE, EMBASE, PsychLIT, Current Contents, Biological Abstracts, Social Sciences Index and CINAHL were performed. Attempts were also made to identify trials from citation lists of review articles and hand searching. In most cases, the first or corresponding author of each included trial was contacted for additional information. SELECTION CRITERIA: The inclusion criteria were randomised comparisons of endometrial destruction techniques with hysterectomy by any means for the treatment of heavy menstrual bleeding in premenopausal women. DATA COLLECTION AND ANALYSIS: Five RCTs were identified that fulfilled the inclusion criteria for this review. For two trials, a number of publications were identified which assessed different outcomes and different follow up time points for the same patients. The reviewers extracted the data independently and odds ratios for dichotomous outcomes and weighted mean differences for continuous outcomes were estimated from the data. Outcomes analysed included improvement in menstrual blood loss, satisfaction, change in quality of life, duration of surgery and hospital stay, time to return to work, adverse events and requirement for repeat surgery because of failure of the initial surgical treatment. MAIN RESULTS: There was a significant advantage in favour of hysterectomy in the improvement in HMB and satisfaction rates (up to 4 years post surgery) compared with endometrial destruction techniques. Although many quality of life scales reported no differences between surgery groups, there was some evidence of a greater improvement in general health for hysterectomy patients. Duration of surgery, hospital stay and recovery time were all shorter following endometrial destruction. Most adverse events, both major and minor, were significantly more likely after hysterectomy and before discharge from hospital. After discharge from hospital, the only difference that was reported for this group was a higher rate of infection. Repeat surgery because of failure of the initial treatment, either endometrial ablation or hysterectomy, was more likely after endometrial destruction than hysterectomy. (ABSTRACT TRUNCATED)

Endometrium↗
PubMed2000

Interventions for preventing falls in the elderly.

BACKGROUND: Fractures in the elderly often result from a simple fall. OBJECTIVES: To assess the effects of programmes designed to reduce the incidence of falls in community dwelling, institutionalised, or hospitalised elderly people. SEARCH STRATEGY: We searched MEDLINE, EMBASE, CINAHL, PsycLIT, Social Science Citation Index, Dissertation Abstracts, Index to UK Theses, the Cochrane Register of Controlled Trials, and bibliographies of identified studies. We contacted known workers in the field. Trials were also obtained from the Cochrane Musculoskeletal Injuries Group trials register. Date of the most recent search: May 1997. SELECTION CRITERIA: Randomised trials of interventions designed to minimise the effect of, or prevent exposure to, any putative risk factor for falling in elderly individuals living in the community, in institutional care, or in hospital. The main outcomes of interest were number of fallers or falls, or the number sustaining a fall resulting in injury. Trials that focused on intermediate outcomes such as improved balance or did not report fall outcomes, were excluded. DATA COLLECTION AND ANALYSIS: Two reviewers selected trials for inclusion. For each included trial, quality assessment and data extraction was carried out independently by two reviewers. Results of trials of similar design were pooled. MAIN RESULTS: Eighteen trials and one pre-planned meta-analysis were included. The analysis of four trials which studied the effect of exercise alone did not establish protection against falling (Peto odds ratio 1.05; 95% confidence interval 0.74 to 1.48). Based on one trial, there was no evidence to support exercise in conjunction with health education classes (Peto odds ratio 1.72; 95% confidence interval 0.78 to 3.75), or of health education classes alone (Peto odds ratio 1.25; 95% confidence interval 0.51 to 3.03) for the prevention of falls. However, significant protection against falling was apparent from interventions which targeted multiple, identified, risk factors in individual patients (Peto odds ratio 0.77; 95% confidence interval 0. 64 to 0.91), and from interventions which focused on behavioural interventions targeting environmental hazards plus other risk factors (Peto odds ratio 0.81; 95% confidence interval 0.71 to 0.93). REVIEWER'S CONCLUSIONS: Health care purchasers and providers contemplating fall prevention programmes should consider health screening of at risk elderly people, followed by interventions which are targeted at both intrinsic and environmental risk factors of individual patients. There is inadequate evidence for the effectiveness of single interventions such as exercise alone or health education classes for the prevention of falls.

Accidental Falls↗
PubMed2005

Hospital at home versus in-patient hospital care.

BACKGROUND: Hospital at home is defined as a service that provides active treatment by health care professionals, in the patient's home, of a condition that otherwise would require acute hospital in-patient care, always for a limited period. OBJECTIVES: To assess the effects of hospital at home compared with in-patient hospital care. SEARCH STRATEGY: We searched the Cochrane Effective Practice and Organisation of Care Group (EPOC) specialised register (November 2004), MEDLINE (1966 to 1996), EMBASE (1980 to 1995), Social Science Citation Index (1992 to 1995), Cinahl (1982 to 1996), EconLit (1969 to 1996), PsycLit (1987 to 1996), Sigle (1980 to 1995) and the Medical Care supplement on economic literature (1970 to 1990). SELECTION CRITERIA: Randomised trials of hospital at home care compared with acute hospital in-patient care. The participants were patients aged 18 years and over. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed study quality. MAIN RESULTS: Twenty two trials are included in this update of the review. Among trials evaluating early discharge hospital at home schemes we found an odds ratio (OR) for mortality of 1.79 95% CI 0.85 to 3.76 for elderly medical patients (age 65 years and over) (n = 3 trials); OR 0.58; 95% CI 0.29 to 1.17 for patients with chronic obstructive pulmonary disease (COPD) (n = 5 trials); and OR 0.78; 95%CI 0.52 to 1.19 for patients recovering from a stroke (n = 4 trials). Two trials evaluating the early discharge of patients recovering from surgery reported an OR 0.43 (95% CI 0.02 to 10.89) for patients recovering from a hip replacement and an OR 1.01 (95% CI 0.37 to 2.81) for patients with a mix of conditions at three months follow-up. For readmission to hospital we found an OR 1.76; 95% CI 0.78 to 3.99 at 3 months follow-up for elderly medical patients (n = 2 trials); OR 0.81; 95% CI 0.55 to 1.19 for patients with COPD (n = 5 trials); and OR 0.96; 95% CI 0.63 to 1.45 for patients recovering from a stroke (n = 3 trials). No significant heterogeneity was observed. One trial recruiting patients following surgery for hernia or varicose veins reported 0/117 versus 2/121 patients were re admitted (Ruckley 1978); another that 2/37 (5%) versus 1/49 (2%) (difference 3%, 95% CI -5% to 12%) of patients recovering from a hip replacement, 4/47 (9%) versus 1/39 (3%) (difference 6%, 95% CI -3% to 15%) of patients recovering from a knee replacement, and 7/114 (6%) versus 13/124 (10%) (difference -4% 95% CI -11% to 3%) of patients recovering from a hysterectomy were readmitted. A third trial analysing surgical and medical patients together reported that 42/159 versus 17/81 patients were readmitted at 3 months (OR 1.34 95% CI 0.66 to 2.20). Allocation to hospital at home resulted in a small reduction in hospital length of stay, but hospital at home increased overall length of care. Patients allocated to hospital at home expressed greater satisfaction with care than those in hospital, while the view of carers was mixed. AUTHORS' CONCLUSIONS: Despite increasing interest in the potential of hospital at home services as a cheaper alternative to in-patient care, this review provides insufficient objective evidence of economic benefit. Early discharge schemes for patients recovering from elective surgery and elderly patients with a medical condition may have a place in reducing the pressure on acute hospital beds, providing the views of the carers are taken into account. For these clinical groups hospital length of stay is reduced, although this is offset by the provision of hospital at home. Future primary research should focus on rigorous evaluations of admission avoidance schemes and standards for original research should aim at assisting future meta-analyses of individual patient data from these and future trials.

Adult↗
PubMed2000

Nonsteroidal anti-inflammatory drugs for heavy menstrual bleeding.

BACKGROUND: Heavy menstrual bleeding is an important cause of ill health in premenopausal women. Although surgery is often used as a treatment, a range of medical therapies are also available. Nonsteroidal anti-inflammatory drugs or prostaglandin synthetase inhibitors reduce prostaglandin levels which are elevated in women with excessive menstrual bleeding and also may have a beneficial effect on dysmenorrhoea. OBJECTIVES: The primary objective of this review was to investigate the effectiveness of non-steroidal anti-inflammatory drugs (NSAIDs) in achieving a reduction in menstrual blood loss in women of reproductive years with heavy menstrual bleeding (HMB). SEARCH STRATEGY: Electronic searches for relevant randomised controlled trials of the Cochrane Menstrual Disorders and Subfertility Group Register of Trials, MEDLINE, EMBASE, PsychLIT, Current Contents, Biological Abstracts, Social Sciences Index and CINAHL were performed. Attempts were also made to identify trials from citation lists of review articles and drug companies were approached for unpublished data. In most cases, the first author of each included trial was contacted for additional information. SELECTION CRITERIA: The inclusion criteria were randomised comparisons of individual NSAIDs with either each other, placebo or other medical treatments in women of reproductive years with regular heavy periods measured either objectively or subjectively and with no pathological or iatrogenic (treatment induced) causes for their heavy menstrual blood loss. DATA COLLECTION AND ANALYSIS: Sixteen RCTs were identified that fulfilled the inclusion criteria for this review. The reviewers extracted the data independently and odds ratios for dichotomous outcomes and weighted mean differences for continuous outcomes were estimated from the data of nine trials. The remaining seven trials were of crossover design with data unsuitable for pooling and their individual results were described in text form. MAIN RESULTS: As a group, NSAIDs were more effective than placebo at reducing heavy menstrual bleeding but less effective than either tranexamic acid or danazol. Treatment with danazol caused a shorter duration of menstruation and more adverse events than NSAIDs but this did not appear to affect the acceptability of treatment. There was a non significant trend towards greater efficacy of NSAIDs compared to oral progestogen (luteal phase) and ethamsylate but no differences were demonstrated between NSAIDs and the progesterone releasing intra-uterine system (IUS) and the oral contraceptive pill, although these results were based on very small studies. There was no evidence of a difference between the individual NSAIDs (naproxen and mefenamic acid) in reducing HMB. REVIEWER'S CONCLUSIONS: NSAIDs reduce heavy menstrual bleeding when compared with placebo but are less effective than either tranexamic acid or danazol. However, adverse events are more severe with danazol therapy. In the limited number of small scale studies suitable for evaluation, no significant difference in efficacy was demonstrated between NSAIDs and other medical treatments such as oral progestogen given in the luteal phase, ethamsylate, oral contraceptive pill and the progesterone releasing IUS.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed2000

Hormone replacement therapy in postmenopausal women: endometrial hyperplasia and irregular bleeding.

BACKGROUND: The decline in circulating oestrogen around the time of the menopause often induces unacceptable symptoms that affect the health and well being of women. Hormone replacement therapy (both unopposed oestrogen and oestrogen and progestogen combinations) is an effective treatment for these symptoms. In women with an intact uterus, unopposed oestrogen may induce endometrial stimulation and increase the risk of endometrial hyperplasia and carcinoma. The addition of progestogen reduces this risk but may cause unacceptable symptoms, bleeding and spotting which can affect adherence to therapy. OBJECTIVES: The objective of this review is to assess which hormone replacement therapy regimens provide effective protection against the development of endometrial hyperplasia and/or carcinoma with a low rate of abnormal vaginal bleeding. SEARCH STRATEGY: Electronic searches for relevant randomised controlled trials of the Cochrane Menstrual Disorders and Subfertility Group Register of Trials, MEDLINE, EMBASE, PsychLIT, Current Contents, Biological Abstracts, Social Sciences Index and CINAHL were performed. Attempts were also made to identify trials from citation lists of review articles and drug companies were contacted for unpublished data. In most cases, the corresponding author of each included trial was contacted for additional information. SELECTION CRITERIA: The inclusion criteria were randomised comparisons of unopposed oestrogen therapy, combined continuous oestrogen-progestogen therapy and sequential oestrogen-progestogen therapy with each other and placebo administered over a minimum treatment period of six months. Trials had to assess which regimen was the most protective against the development of endometrial hyperplasia/carcinoma and/or caused the lowest rate of irregular bleeding. DATA COLLECTION AND ANALYSIS: Twenty three RCTs were identified and five were excluded. The reviewers assessed the eighteen included studies for quality, extracted the data independently and odds ratios for dichotomous outcomes were estimated. Outcomes analysed included frequency of endometrial hyperplasia or carcinoma, frequency of irregular bleeding and unscheduled biopsies or dilation and curettage, and adherence to therapy. MAIN RESULTS: Unopposed moderate or high dose oestrogen therapy was associated with a significant increase in rates of endometrial hyperplasia with increasing rates at longer duration of treatment and follow up. Odds ratios ranged from 5.4 (1. 4-20.9) for 6 months of treatment to 16.0 (9.3-27.5) for 36 months of treatment with moderate dose oestrogen (in the PEPI trial, 62% of those who took moderate dose oestrogen had some form of hyperplasia at 36 months compared to 2% of those who took placebo). Irregular bleeding and non adherence to treatment were also significantly more likely under these unopposed oestrogen regimens with greater effects with higher dose therapy. There was no evidence of increased hyperplasia rates, however, with low dose oestrogen. The addition of progestogens, either in continuous combined or sequential regimens, helped to prevent the development of endometrial hyperplasia and improved adherence to therapy (odds ratios of 3.7 for sequential therapy and 6.0 for continuous therapy). Irregular bleeding, however, was more likely under a continuous than a sequential oestrogen-progestogen regimen (OR = 2.3, 95% CI 2.1-2.5) but at longer duration of treatment, continuous therapy was more protective than sequential therapy in preventing endometrial hyperplasia (OR = 0.3, 95% CI 0.1-0.97). There was evidence of a higher incidence of hyperplasia under long cycle sequential therapy (progestogen given every 3 months) compared to monthly sequential therapy (progestogen given every month). No increase in endometrial cancer was seen in any of the treatment groups during the limited duration (maximum of 3 years) of these trials. (ABSTRACT TRUNCATED)

Endometrial Hyperplasia↗
PubMed2004

Hormone replacement therapy in postmenopausal women: endometrial hyperplasia and irregular bleeding.

BACKGROUND: The decline in circulating oestrogen around the time of the menopause often induces unacceptable symptoms that affect the health and well being of women. Hormone replacement therapy (both unopposed oestrogen and oestrogen and progestogen combinations) is an effective treatment for these symptoms. In women with an intact uterus, unopposed oestrogen may induce endometrial stimulation and increase the risk of endometrial hyperplasia and carcinoma. The addition of progestogen reduces this risk but may cause unacceptable symptoms, bleeding and spotting which can affect adherence to therapy. OBJECTIVES: The objective of this review is to assess which hormone replacement therapy regimens provide effective protection against the development of endometrial hyperplasia and/or carcinoma with a low rate of abnormal vaginal bleeding. SEARCH STRATEGY: We searched the Cochrane Menstrual Disorders and Subfertility Group trials register (searched January 2003), The Cochrane Library (Issue 2, 2003), MEDLINE (1966 to January 2003), EMBASE (1980 to January 2003), Current Contents (1993 to January 2003), Biological Abstracts (1969 to 2002), Social Sciences Index (1980 to January 2003), PsycINFO (1972 to February 2003) and CINAHL (1982 to January 2003). The search strategy was developed by the Cochrane Menstrual Disorder and Subfertility Group. Attempts were also made to identify trials from citation lists of review articles and drug companies were contacted for unpublished data. In most cases, the corresponding author of each included trial was contacted for additional information. SELECTION CRITERIA: The inclusion criteria were randomised comparisons of unopposed oestrogen therapy, combined continuous oestrogen-progestogen therapy and sequential oestrogen-progestogen therapy with each other and placebo administered over a minimum treatment period of six months. Trials had to assess which regimen was the most protective against the development of endometrial hyperplasia/carcinoma and/or caused the lowest rate of irregular bleeding. DATA COLLECTION AND ANALYSIS: Sixty RCTs were identified. Of these 23 were excluded and seven remain awaiting assessment. The reviewers assessed the thirty included studies for quality, extracted the data independently and odds ratios for dichotomous outcomes were estimated. Outcomes analysed included frequency of endometrial hyperplasia or carcinoma, frequency of irregular bleeding and unscheduled biopsies or dilation and curettage, and adherence to therapy. MAIN RESULTS: Unopposed moderate or high dose oestrogen therapy when compared to placebo was associated with a significant increase in rates of endometrial hyperplasia with increasing rates at longer duration of treatment and follow up. Odds ratios ranged from (1 RCT; OR 5.4, 95% CI 1.4 to 20.9) for 6 months of treatment to (4 RCTs; OR 9.6, 95% CI 5.9 to 15.5) for 24 months treatment and (1 RCT; OR 15.0, 95% CI 9.3 to 27.5) for 36 months of treatment with moderate dose oestrogen (in the PEPI trial, 62% of those who took moderate dose oestrogen had some form of hyperplasia at 36 months compared to 2% of those who took placebo). Irregular bleeding and non adherence to treatment were also significantly more likely under these unopposed oestrogen regimens that increased bleeding with higher dose therapy. Although not statistically significant, there was a 3% incidence (2 RCTs) of hyperplasia in women who took low dose oestrogen compared to no incidence of hyperplasia in the placebo group. The addition of progestogens, either in continuous combined or sequential regimens, helped to reduce the risk of endometrial hyperplasia and improved adherence to therapy. At longer duration of treatment, continuous therapy was more effective than sequential therapy in reducing the risk of endometrial hyperplasia. There was evidence of a higher incidence of hyperplasia under long cycle sequential therapy (progestogen given every three months) compared to monthly sequential therapy (progestogen given every month). No increase in endometrial cancer was seen in any of t in any of the treatment groups during the duration (maximum of six years) of these trials. During the first year of therapy irregular bleeding and spotting was more likely in continuous combined therapy than sequential therapy. However, during the second year of therapy bleeding and spotting was more likely under sequential regimens. REVIEWERS' CONCLUSIONS: There is strong and consistent evidence in this review that unopposed oestrogen therapy, at moderate and high doses, is associated with increased rates of endometrial hyperplasia, irregular bleeding and consequent non adherence to therapy. The addition of oral progestogens administered either sequentially or continuously is associated with reduced rates of hyperplasia and improved adherence to therapy. Irregular bleeding is less likely under sequential than continuous therapy during the first year of therapy but there is a suggestion that continuous therapy over long duration is more protective than sequential therapy in the prevention of endometrial hyperplasia. Hyperplasia is more likely when progestogen is given every three months in a sequential regimen compared to a monthly progestogen sequential regimen.

Endometrial Hyperplasia↗