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PubMed2000

A comparison of drugs versus placebo for the treatment of dysthymia.

OBJECTIVES: Dysthymia is a depressive disorder of chronic nature but of less severity than major depression, which depressive symptoms are more or less continuous for at least two years. The aim of this review was to conduct a systematic review of all RCTs comparing drugs and placebo for dysthymia. SEARCH STRATEGY: Electronic searches of Cochrane Library, EMBASE, MEDLINE, PsycLIT, Biological Abstracts and LILACS; reference searching; personal communication; conference abstracts; unpublished trials from the pharmaceutical industry; book chapters on the treatment of depression. SELECTION CRITERIA: The inclusion criteria for all randomised controlled trials were that they should focus on the use of drugs versus placebo for dysthymic patients. Exclusion criteria were: non randomised, mixed major depression/ dysthymia (trials not providing separate data) and depression secondary to other disorders (e.g. substance abuse). DATA COLLECTION AND ANALYSIS: The reviewers extracted the data independently. In order to achieve an intention-to-treat analysis, when trials failed to report it was assumed that people who died or dropped out had no improvement. Authors of relevant trials were contacted for additional and missing data. Absence of treatment response as defined by authors was the main measure of outcome used. Relative Risks (RR) and 95% confidence intervals (CI) of dichotomous data were calculated with the Random Effects Model. Where possible, number needed to treat (NNT) and number needed to harm (NNH) were estimated, taking the reciprocal of the absolute risk reduction. MAIN RESULTS: Currently the review includes 15 trials. Similar results were obtained in terms of efficacy for different groups of drugs, such as tricyclic (TCA), selective serotonin reuptake inhibitors (SSRI), monoamine oxidase inhibitors (MAOI) and other drugs (sulpiride, amineptine, and ritanserin). The pooled RR for absence of treatment response was 0. 68 (95% CI 0.59-0.78) for TCA and the NNT was 4.3 (95% CI 3.2-6.5). SSRIs showed similar RR for this outcome: 0.64 (95% CI 0.55-0.74), the NNT being 4.7 (95% CI 3.5-6.9). Concerning MAOIs, the RR was 0. 59 (95% CI 0.48-0.71) and the NNT was 2.9 (95% CI 2.2-4.3). Other drugs (amisulpride, amineptine and ritanserin) showed similar results in terms of absence of treatment response. Using more stringent criteria for improvement - full remission - the results were unchanged. Patients treated on TCA were more likely to report adverse events, compared with placebo. REVIEWER'S CONCLUSIONS: Drugs are effective in the treatment of dysthymia with no differences between and within class of drugs. Tricyclic antidepressants are more likely to cause adverse events and dropouts. As dysthymia is a chronic condition, there remains little information on quality of life and medium or long-term outcome.

Antidepressive Agents↗
PubMed2006

Prison suicides and self-harming behaviours in Italy, 1990-2002.

Data on suicides, attempted suicides and other self-harming behaviours that occurred in Italian prisons from 1990 to 2002 was studied on official records, as documented by the Ministry of Justice. Over the study interval, completed suicide rates in Italian prisons were constantly about ten times higher than among the general population, but over time they did not increase significantly despite nearly a doubling in the absolute number of inmates. The rate of completed suicides in overcrowded prisons was about ten times higher than in non-overcrowded ones. Attempted suicides were about ten times higher than completed suicides, with females being significantly more likely to attempt to take their own lives and males being more likely to complete suicide. Self-injuring acts without the intent to die involve about one in every ten individuals, with foreigners (non-EU citizens mostly) being twice as likely to self-harm than residents. A better identification of the people suffering from mental disorders and a reduction in prison overcrowding are two key issues that need to be implemented to reduce the impact of suicide and self-harming behaviours among convicts.

Adolescent↗
PubMed2003

Associations of weight-based teasing and emotional well-being among adolescents.

BACKGROUND: Verbal harassment, such as bullying and hate speech, has received considerable attention recently, but less is known about weight-based teasing and its potential harmful effects on young people's psychosocial well-being. OBJECTIVE: To determine the associations of weight-based teasing and body satisfaction, self-esteem, depressive symptoms, and suicidal ideation and suicide attempts using a large sample of adolescents. DESIGN: Secondary analysis of survey and anthropometric data. SETTING: Ethnically and socioeconomically diverse communities in the urban and suburban school districts of the Minneapolis/St Paul metropolitan area. PARTICIPANTS: A school-based sample of 4746 adolescents in grades 7 to 12 at 31 public middle schools and high schools. MAIN OUTCOME MEASURES: Weight-based teasing from peers or family members, body satisfaction, self-esteem, depressive symptoms, and suicidal ideation and suicide attempts. RESULTS: Of the eligible students, 81.5% participated; 30.0% of adolescent girls and 24.7% of adolescent boys were teased by peers, and 28.7% of adolescent girls and 16.1% of adolescent boys were teased by family members. Approximately 14.6% of adolescent girls and 9.6% of adolescent boys reported teasing from both of these sources. Teasing about body weight was consistently associated with low body satisfaction, low self-esteem, high depressive symptoms, and thinking about and attempting suicide, even after controlling for actual body weight. These associations held for adolescent boys and girls, across racial, ethnic, and weight groups. Furthermore, teasing from 2 sources was associated with a higher prevalence of emotional health problems than either teasing from a single source or no teasing. CONCLUSIONS: Physicians and other health care providers should recognize the importance of weight-based teasing for young patients. Policy, programs, and education should focus on increasing awareness of what constitutes weight-based teasing, its potentially harmful effects on adolescents' emotional well-being, and reduction of this behavior.

Adolescent↗
PubMed2007

Benzo[d]isothiazol-3-yl-benzamidines: a class of protective agents on culture of human cartilage and chondrocytes stimulated by IL-1beta.

New derivatives of N-benzo[d]isothiazol-3-yl-benzamidine 6 a were synthesized as nonacidic anti-inflammatory/antidegenerative agents. We investigated the influence of the amidines 6 a-j on the production of NO, PGE(2), MMP-3, COX-2, ROS, and GAGs, key molecules involved in cartilage destruction in osteoarthritic diseases. The antidegenerative properties of the novel designed derivatives 6 b-j were improved with respect to N-benzo[d]isothiazol-3-yl-benzamidine 6 a. All of the compounds 6 a-j promoted the reduction of most of the IL-1beta-induced harmful effects. Derivatives 6 d, 6 h, and 6 j were the most potent of all the tested compounds, particularly in the human chondrocyte culture model.

Amidines↗
PubMed2002

Detrimental effect of protracted hyperglycaemia on beta-cell neogenesis in a mouse murine model of diabetes.

AIMS/HYPOTHESIS: Previous studies have shown that new beta cells differentiate from intra-islet precursors in pancreatic islets of mice in which diabetes is induced by injecting a high dose of the beta-cell toxin streptozotocin. Moreover, the re-establishment of euglycaemia by insulin therapy 1 day after streptozotocin treatment improved the process of regeneration. We sought to assess whether a 1-week delay in the restoration of euglycaemia would affect beta-cell regeneration. METHODS: Adult CD-1 mice were injected with 200 mg/kg of streptozotocin. One group of mice remained hyperglycaemic throughout the experiment while a second group became normoglycaemic following the administration of insulin therapy 1 week after the injection of streptozotocin. Pancreata removed at different times after treatment were processed for visualization ofbeta precursor-cell markers and insulin by confocal microscopy. RESULTS: New beta cells appeared in islets of streptozotocin-treated mice after restoration of normoglycaemia. Like islets of streptozotocin mice in which blood glucose concentrations were rapidly restored, islets of mice that became normoglycaemic 1 week after streptozotocin treatment also had two potential insulin precursor cell types. Protracted hyperglycaemia however, had several harmful effects on insulin cell neogenesis, such as a reduction in the number of euglycaemic mice with successful beta-cell regeneration and a decrease in the number and survival of the newly differentiated insulin-containing cells. CONCLUSION/INTERPRETATION: These results indicate that islets gradually lose their regenerative potential when they are exposed to high circulating glucose concentrations for an extended period of time.

Animals↗
PubMed2000

Clinical trials of mediator-directed therapy in sepsis: what have we learned?

Almost 60 randomized controlled clinical trials have been undertaken, testing the hypothesis that modulation of the endogenous host inflammatory response can improve survival for patients with a clinical diagnosis of sepsis. The results have been tantalizing, but frustrating, and no new agent has been introduced into clinical practice. Analysis of pooled data from studies of the use of an neutralizing antibody to tumor necrosis factor, or recombinant interleukin 1 receptor antagonist, show that these two approaches yield a statistically significant, but small improvement in 28 day all-cause mortality. However variability in results from one study to the next, the small absolute mortality reduction, the emerging evidence of a substantial potential for harm, and the predicted costs of recombinant biologic agents has engendered a climate of caution and pessimism. The challenge is to find methods of refining investigative approaches to maximize benefit and minimize harm. This paper reviews the recent history of sepsis clinical trials, focussing on emerging insights into the limitations of study entry criteria and measures of biologic activity and clinical benefit that may inform and direct future investigations. The biologic complexity of systemic inflammation, and the multiple interactions between clinical biology and the process of care suggest that future success in clinical research in sepsis will occur through the conduct of highly focussed investigations in a small number of dedicated centres of excellence.

Antibodies, Monoclonal↗
PubMed2003

Incidence and severity of intravenous drug errors in a German hospital.

OBJECTIVE: To determine the incidence of errors in preparing and administering intravenous (i.v.) drugs, identify the stages in the process at which errors occurred and evaluate their clinical importance. METHODS: A prospective ethnographic study using disguised observation was carried out on two wards in one German non-university hospital. RESULTS: We observed 22 nurses administering 122 i.v. drug preparations and administrations. One or more errors occurred in the preparation and administration of 58 of 122 i.v. drug doses (error rate 48%, 95% confidence interval 39-57%). In total, 65 errors were identified. Of doses, 4 had potentially severe errors (3%), 38 (31%) potentially moderate errors and 16 (13%) potentially minor errors. Common errors included multiple step preparations and the co-administration of potentially incompatible drugs as intermittent infusions. CONCLUSION: A high incidence of i.v. drug errors was found in the study hospital. Effective strategies to reduce potentially harmful errors are urgently needed. Measures could include a reduction in the number of ward-based i.v. drug preparations, improvement of staff training and the introduction of ward-based clinical pharmacy services.

Drug Compounding↗
PubMed2005

Vitrified metal finishing wastes I. Composition, density and chemical durability.

Durable phosphate glasses were formed by vitrifying waste filter cakes from two metal finishing operations. Some melts formed crystalline components during cooling. Compositional analysis of dried, heat treated and vitrified samples was made using energy-dispersive X-ray spectroscopy, X-ray fluorescence spectroscopy, inductively-coupled plasma spectroscopy and Leco induction furnace combustion analysis. Hydrolytic dissolution, measured by an adapted product consistency test, was reduced by up to 3 orders of magnitude upon heat treatment or vitrification, surpassing the performance of borosilicate glass in some cases. This was attributed to the high levels of iron and zinc in the wastes, which greatly improve the durability of phosphate glasses. One of the wastes arose from a metal phosphating process and was particularly suitable for vitrification due to its high P2O5 content and favourable melting behaviour. The other waste, which arose from a number of processes, was less suitable as it had a low P2O5 content and during heating it emitted harmful corrosive gases and underwent violent reactions. Substantial volume reductions were obtained by heat treatment and vitrification of both wastes. Compositions and performances of some vitrified wastes were comparable with those of glasses which are under consideration for the immobilisation of toxic and nuclear wastes.

Crystallization↗
PubMed1996

Prevalence and correlates of the injection of methadone syrup in Sydney, Australia.

A sample of 312 heroin users was interviewed on their injection of methadone syrup. Methadone injecting was widespread, with 52% of subjects having injected methadone syrup, 29% in the preceding six months. Males and females were equally likely to report methadone injecting. Forty per cent of current methadone injectors reported weekly or more frequent methadone injecting over the preceding six months. A history of methadone injecting was associated with abscesses and infections in injection sites, having been diagnosed with a venous thrombosis and a history of heroin overdose. Current methadone injectors were in poorer general health, had more injection-related symptoms, higher levels of psychological distress, were more likely to have recently passed on used injecting equipment and to have recently committed criminal acts. Implications for the reduction in the prevalence of methadone injecting and associated harm are discussed.

Adolescent↗
PubMed1997

Reduced calcium dialysate in CAPD patients: efficacy and limitations.

BACKGROUND: The increasing use of 'reduced calcium' dialysate in CAPD patients treated with calcium-based phosphate binders has raised concerns that this could lead to negative calcium balance, worsening hyperparathyroidism, and osteopenia. METHODS: The present study was conducted to examine the possibilities (a) that 1.25 mM calcium dialysate leads to negative calcium balance and worsening hyperparathyroidism, and (b) that conversely 1.25 mM calcium dialysate is still too high for some patients. We studied 22 patients who, after a 2-month run in using 1.75 mM calcium dialysate and aluminium hydroxide binders, entered a 3-month phase of 1.25 mM calcium dialysate with continuation of aluminium hydroxide as the sole phosphate binder. The patients then entered a final 9-month phase in which dialysate calcium remained at 1.25 mM and calcium carbonate was substituted for aluminium hydroxide and progressively titrated to achieve optimum phosphate control. RESULTS: During the initial 3-month period, parathyroid hormone increased from 259, range 11-1149 to 405, range 16-1318 pg/ml (P = 0.0001) and ionized calcium decreased from 1.17 +/- 0.06 to 1.11 +/- 0.08 mM (P = 0.0004). The subsequent 9-month phase was associated with return of parathyroid hormone to baseline levels. Further dialysate calcium reduction to 0.6 mM was implemented in the four patients who became hypercalcaemic. CONCLUSION: This study has clearly shown that reduction of dialysate calcium to 1.25 mM can be harmful to CAPD patients if oral calcium availability is inadequate. It has also shown that dialysate calcium at 1.25 mM is a compromise, with increased risk of hyperparathyroidism if calcium intake is too low and, conversely, risk of hypercalcaemia and unacceptable increases of the Ca x Pi product in a minority of patients. At these extremes there is a need for a high-calcium dialysate (1.75 mM) and a very low-calcium dialysate (0.6 mM or less), to optimize management.

Adult↗
PubMed2003

Abdominal aortic aneurysms: elective endovascular repair versus conventional surgery--evaluation with evidence-based medicine techniques.

PURPOSE: To use evidence-based techniques to compare elective open surgical repair of abdominal aortic aneurysms with endovascular repair by means of stent placement. MATERIALS AND METHODS: A focused clinical question formed the basis of a literature search. Evidence-based criteria were used to appraise and assign a "level of evidence" to retrieved articles. The following data were determined from the best studies: systemic, local, and/or vascular complications; graft failure rates; blood loss; mortality; length of intensive care and/or hospital stay; mid- and long-term outcomes; cost of endovascular repair versus that of surgery; and eligibility for endovascular repair. Absolute risk reductions and/or increases and numbers needed to treat or harm were calculated. RESULTS: The best current evidence came from 22 studies, which showed that there is slight, if any, difference between mortality rates of endovascular repair and surgery. Hospital and/or intensive care stay is shorter, blood loss less, and systemic complications fewer (numbers needed to treat, two to 12) with endovascular repair. Some authors reported a significant increase in local and/or vascular complications with endovascular repair (numbers needed to harm, two to six). Graft failure is significantly more common with endovascular repair (numbers needed to harm, four), and substantive adjunctive interventions are needed. Endovascular repair is more expensive than surgery. CONCLUSION: Elective endovascular repair has short-term benefits compared with surgery. There is slight, if any, difference in mortality. Endovascular repair costs more than surgery. At follow-up, surgical grafts performed better.

Aortic Aneurysm, Abdominal↗
PubMed1987

Changing ideas in the treatment of heart failure--an overview.

Patients with heart failure should stop smoking, maintain an optimal weight and limit their intake of salt. Alcohol abuse should be avoided. The detection and early treatment of hypertension appears to have had a major impact in preventing heart failure. Diuretics revolutionized the treatment of congestive heart failure and their proper and appropriate use can alleviate peripheral and pulmonary oedema. Diuretics should not be overused and care should be taken to avoid hypokalaemia. Controversy surrounds the use of digoxin in patients in sinus rhythm; the drug should be used in patients in atrial fibrillation. The use of an inotropic drug may be harmful in the presence of coronary artery disease. A reduction in the current use of digoxin might be of benefit to many patients with heart failure. When the drug is prescribed it should be used in a therapeutic and not homeopathic dose. Recent interest has been directed toward the use of vasodilators and the angiotensin-converting enzyme inhibitors in patients with heart failure. In my opinion, these drugs should be used after patients have been treated with thiazide and loop diuretics. Vasodilators are particularly beneficial in acute heart failure or in patients with chronic heart failure when the symptoms are related to fluid overload and volume expansion. The cause of symptoms in patients with chronic heart failure optimally treated with diuretics is controversial. Shortness of breath may not be simply related to the left atrial pressure.(ABSTRACT TRUNCATED AT 250 WORDS)

Combined Modality Therapy↗
PubMed1994

[Arterial hypertension in the acute phase of cerebral infarction. Survey on the current practice in a university hospital].

PURPOSE: Evaluate current practice in a university hospital on management of high blood-pressure in patients in the acute phase of brain infarction (BI). METHODS: A case report of a lucid patient admitted 8 hours after onset of a BI with normal CT and high blood pressure (BP = 186/110 mmHg) was presented to staff members and resident physicians (departments of neurology and neurosurgery excluded). Responders were asked to decide as to the best therapeutic option: no treatment/reduction/elevation of BP. RESULTS: 27 of 44 responders (61%) considered BP reduction as the best treatment option. The same trend was observed among residents (16/27: 60%) and staff members (11/17: 65%); among surgeons (6/12: 50%) and clinicians (20/30: 67%). CONCLUSIONS: BP reduction in the hyperacute phase of BI may be harmful. This basic concept of BI management has not been adequately assimilated by physicians of our university hospital, including those recently graduated. The results of this study signal to the urgent need of a wide diffusion of current concepts on pathophysiology and treatment of BI. Organization of stroke units may contribute to better patient management, medical education and research.

Cerebral Infarction↗
PubMed1999

[Climatic changes in Scandinavia--consequences for public health].

Atmospheric composition and climate conditions are of great importance for health. Increasing consumption of fossil fuels ever since the industrial revolution has resulted in higher contents of greenhouse gases in the atmosphere. Primarily, this will increase the global temperature. Secondarily, it may change the patterns of precipitation and droughts. Higher extreme temperatures will have a negative effect on health. Climate changes can also change the living conditions of undesirable insects and microbes. The ozone gas in the atmosphere acts as a shield against the harmful ultraviolet radiation from the sun. Chlorofluorocarbons contribute to reduction of the ozone layer and increase ultraviolet radiation. Increased exposure of the skin to this radiation may cause damage such as sunburn and skin cancer. In order to avoid damage, it is of importance to wear protective clothing or use effective sunshades.

Air Pollutants↗
PubMed2005

Antiplatelet therapy and anticoagulation in patients with hypertension.

BACKGROUND: Elevated systemic blood pressure results in high intravascular pressure. The main complications, coronary heart disease, ischemic strokes, and peripheral vascular disease, are related to thrombosis rather than hemorrhage. Some complications related to elevated blood pressure, heart failure, and atrial fibrillation are associated with stroke and thromboembolism. It seems plausible that antithrombotic therapy may be particularly useful in preventing thrombosis-related complications of elevated blood pressure. OBJECTIVES: To conduct a systematic review of the role of antiplatelet therapy and anticoagulation in patients with hypertension, including those with elevations in systolic and diastolic blood pressure and those with isolated elevations of systolic or diastolic blood pressure. The following hypotheses were addressed: (1) antiplatelet agents reduce total deaths and major thrombotic events compared with other active treatment or placebo; and (2) oral anticoagulants reduce total deaths and major thromboembolic events compared with other active treatment or placebo. SEARCH STRATEGY: The authors' studied reference lists of articles found by searching electronic databases (MEDLINE, EMBASE, DARE) and abstracts from national and international cardiovascular meetings. Relevant authors of these studies were contacted to obtain further data. SELECTION CRITERIA: Randomized controlled trials (RCTs) in patients with elevated blood pressure were included if they were of at least three months' duration and compared antithrombotic therapy with other active treatment or placebo. DATA COLLECTION AND ANALYSIS: Data were independently collected and verified by two reviewers. Data from different trials were pooled when appropriate. PRIMARY RESULTS: The Antiplatelet Trialists' Collaboration meta-analysis of antiplatelet therapy for secondary prevention in patients with elevated blood pressure reported a 4.1 percent absolute reduction in vascular events compared with placebo. Data on the patients with elevated blood pressure from the 29 individual trials were requested but could not be obtained. Three additional trials met the inclusion criteria and were included. Acetylsalicylic acid (ASA) did not reduce stroke or "all cardiovascular events" compared with placebo in primary prevention patients with elevated blood pressure and no prior cardiovascular disease. In one large trial (the Hypertension Optimal Treatment trial), ASA taken for five years reduced rates of myocardial infarction (MI) (absolute risk reduction, 0.5 percent; number needed to treat [NNT], 200 for five years), increased rates of major hemorrhage (absolute risk increase, 0.7 percent; NNT, 154), and did not reduce all-cause mortality or cardiovascular mortality. In the Clopidogrel vs. Aspirin in Patients at Risk of Ischemic Events trial, there was no significant difference between ASA and clopidogrel for the composite end point of stroke, MI, or vascular death. In two small trials, warfarin alone or in combination with ASA did not reduce rates of stroke or coronary events. REVIEWERS' CONCLUSIONS: Antiplatelet therapy with ASA cannot be recommended for primary prevention of vascular events in patients with elevated blood pressure, because the magnitude of benefit--a reduction in rates of MI--is negated by a harm of similar magnitude, an increase in rates of major hemorrhage. Antiplatelet therapy is recommended for secondary prevention in patients with elevated blood pressure because the magnitude of the absolute benefit is many times greater. Warfarin therapy alone or in combination with aspirin in patients with elevated blood pressure cannot be recommended because of lack of demonstrated benefit. Glycoprotein IIb/IIIa inhibitors, as well as ticlopidine and clopidogrel, have not been evaluated sufficiently in patients with elevated blood pressure. Further trials of antithrombotic therapy with complete documentation of all benefits and harms are needed in patients with elevated blood pressure.

Anticoagulants↗
PubMed1994

Periodic health examination, 1994 update: 3. Primary and secondary prevention of neural tube defects. Canadian Task Force on the Periodic Health Examination.

OBJECTIVE: To make recommendations on nutritional interventions and screening manoeuvres to prevent the birth of infants with neural tube defects (NTDs). OPTIONS: Folic acid consumption through diet or supplementation in women at low risk and at high risk of having a fetus with an NTD, and maternal serum alpha-fetoprotein (MSAFP) screening in low-risk pregnancies. OUTCOMES: A reduction in the incidence rate of NTDs and potentially harmful effects of false-positive results of screening tests (i.e., abortion of a normal fetus). EVIDENCE: A MEDLINE search with the use of medical subject headings "neural tube defects," "prenatal diagnosis" and "prevention and control" identified 103 original articles published between January 1979 and March 1993. Two reviewers extracted the data by applying the rules of evidence developed by the Canadian Task Force on the Periodic Health Examination. VALUES: The task force's evidence-based methods and values were used; high value was placed on prevention of NTDs and on limitation of the harmful effects of a pregnancy involving a fetus with an NTD. BENEFITS, HARMS AND COSTS: Evidence suggests that folic acid supplementation can decrease the incidence rate of NTDs in low-risk pregnancies by 40% to 60% with no adverse effects. MSAFP screening between the 16th and 18th weeks of gestation can reach a sensitivity of 83% and a specificity of 98% when it is used as part of an organized program. The effect of screening on the incidence rate of NTDs depends on whether affected fetuses are aborted. RECOMMENDATIONS: All women of childbearing age should be advised to increase their consumption of folic acid through diet or supplementation to 0.4 mg/d beginning 1 month before pregnancy and ending at the start of the second trimester. MSAFP screening is recommended in low-risk pregnancies only when it is part of a screening program that includes access to all necessary diagnostic services. High-risk women should be referred to genetic counselling before they plan a pregnancy. VALIDATION: These recommendations are comparable to the current recommendations of the US Centers for Disease Control and Prevention, the Society of Obstetricians and Gynaecologists of Canada, the Canadian Laboratory Centre for Disease Control and the Canadian College of Medical Geneticists, and they were validated through external review. SPONSOR: These guidelines were developed and endorsed by the Canadian task force, which funded by Health Canada.

Canada↗
PubMed2001

Antidepressants versus psychological treatments and their combination for bulimia nervosa.

BACKGROUND: Psychotherapeutic approaches, mainly cognitive behavior therapy, and antidepressant medication are the two treatment modalities that have received most support in controlled outcome studies of bulimia nervosa. OBJECTIVES: The primary objective was to conduct a systematic review of all RCTs comparing antidepressants with psychological approaches or comparing their combination with each single approach for the treatment of bulimia nervosa. SEARCH STRATEGY: (1) electronic searches of MEDLINE (1966 to December 2000), EMBASE (1980-December 2000), PsycLIT (to December 2000), LILACS & SCISEARCH (to 1999) (2) the Cochrane Register of Controlled Trials and the Cochrane Depression, Anxiety and Neurosis Group Register - ongoing (3) handsearches of the references of all identified trials (4) contact with the pharmaceutical companies and the principal investigator of each included trial (5) handsearch of the International Journal of Eating Disorders - ongoing SELECTION CRITERIA INCLUSION CRITERIA: every randomized controlled trial in which antidepressants were compared with psychological treatments or the combination of antidepressants with psychological approaches was compared to each treatment alone, to reduce the symptoms of bulimia nervosa in patients of any age or gender. Quality criteria: reports were considered adequate if they were classified as A or B according to the Cochrane Manual. DATA COLLECTION AND ANALYSIS: Data were extracted independently by two reviewers for each included trial. The main outcome for efficacy was full remission of bulimic symptoms, defined as 100% reduction in binge or purge episodes from baseline to endpoint. Dichotomous data was evaluated by the relative risks and 95% confidence intervals around this measure, based on the random effects model; continuous data was evaluated by the average difference and the 95% confidence interval. Number needed to treat (NNT) and number needed to harm (NNH) were calculated using the inverse of the absolute risk reduction. MAIN RESULTS: Five trials were included in comparison one (antidepressants versus psychological treatments), five in comparison two (antidepressants versus the combination) and seven in comparison three (psychological treatments versus the combination). Remission rates were 20% for single antidepressants compared to 39% for single psychotherapy (DerSimonian-Laird Relative Risk = 1.28; 95% Confidence Interval = 0.98;1.67). Dropout rates were higher for antidepressants than for psychotherapy (DerSimonian-Laird Relative Risk = 2.18; 95% Confidence Interval = 1.09;4.35). The NNH for a mean treatment duration of 17.5 weeks was 4 (95% confidence interval = 3;11). Comparison two found remission rates of 42% for the combination versus 23% for antidepressants (DerSimonian-Laird Relative Risk = 1.38; 95% Confidence Interval = 0.98;1.93). Comparison three showed a 36% pooled remission rate for psychological approaches compared to 49% for the combination (DerSimonian-Laird Relative Risk = 1.21; 95% Confidence Interval = 1.02;1.45). The NNT for a mean treatment duration of 15 weeks was 8 (95% Confidence Interval = 4;320). Dropout rates were higher for the combination compared to single psychological treatments (DerSimonian-Laird Relative Risk = 0.57; 95% Confidence Interval = 0.38;0.88). The NNH was 7 (95% Confidence Interval = 4;21). REVIEWER'S CONCLUSIONS: Using a more conservative statistical approach, combination treatments were superior to single psychotherapy. This was the only statistically significant difference between treatments. The number of trials might be insufficient to show the statistical significance of a 19% absolute risk reduction in efficacy favouring psychotherapy or combination treatments over single antidepressants. Psychotherapy appeared to be more acceptable to subjects. When antidepressants were combined to psychological treatments, acceptability of the latter was significantly reduced.

Antidepressive Agents↗
PubMed2006

Reanalysis of systematic reviews: the case of invasive strategies for acute coronary syndromes.

OBJECTIVES: The objective of this study was to collect all systematic reviews on invasive strategies for acute coronary syndromes (ACS) and reanalyze the data in these reviews to reach combined estimates, as well as to make predictions on the effectiveness and risk of harm so as to facilitate relevant decision making in health care. METHODS: The data sources used were the following electronic databases, searched from 1994 to September 2004: Cochrane Database of Systematic Reviews; Cochrane Central Register of Controlled Trials; DARE, HTA, EED (NHS CRD); MEDLINE In-Process, Other Non-Indexed Citations, MEDLINE, and PubMed (2000 to 2004). References to the identified systematic reviews were checked. An ancillary search to identify recent randomized controlled trials (RCTs) covering the period from January 2003 to January 2006 was done in MEDLINE(R). We included systematic reviews of RCTs on patients with ACS. In unstable angina and non-ST-elevation myocardial infarction (UA/NSTEMI), eligible reviews had to compare early routine invasive strategy with early selective invasive strategy. In ST-elevation myocardial infarction (STEMI), a comparison between primary percutaneous coronary intervention (PCI) and thrombolytic therapy was required. The methodological quality of the reviews was assessed, and a standardized data extraction form was used. Results for the main outcomes of the RCTs in the reviews were reanalyzed. An additional search of those RCTs not included in the meta-analyses was performed for UA/NSTEMI and short-term morality data on STEMI. Bayesian models were constructed to estimate the uncertainty about a possible treatment effect and to make predictions and probability statements. Main results are based on these analyses. Mortality was considered as the primary outcome measure. RESULTS: One systematic review on invasive strategies was identified for UA/NSTEMI and nine on invasive strategies for STEMI. Five reviews of the latter that were published after the year 2000 were included for the final analysis. The median quality score was 10.5 (range, 7-13; n = 6) on a scale from 0 to 18 points. An updated literature search identified one further RCT on UA/NSTEMI. Regarding NSTEMI and mortality, the average risk difference favoring an early invasive treatment strategy compared with early conservative strategy was .6 percent (95 percent credible interval [CrI], -2.1 to 1.0). Predicted risk (relative risk/risk difference scales) of doing harm was 26.7/26.6 percent. Regarding STEMI and mortality, the absolute risk reduction in favor of primary PCI over thrombolysis was 4.1 percent (95 percent CrI, -7.1 to -1.1) when PCI was compared with streptokinase and 1.2 percent (95 percent CrI, -2.7 to .2) when compared with fibrin-specific thrombolytics. Predicted risk of harm was 8.9/5.3 percent and 8.0/13.3 percent, respectively. CONCLUSIONS: There seems to be at present no solid evidence for survival benefit on early invasive strategy for UA/NSTEMI as a broad diagnostic group, and the risk of doing harm should be considered. Also, the evidence for PCI to decrease early mortality after STEMI is scanty. Estimations of predicted harm may further aid decisions on whether to implement the new treatment over the old one. It may also give an additional dimension for interpreting the results of any meta-analysis.

Angioplasty, Balloon, Coronary↗