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Traction for low back pain with or without sciatica: an updated systematic review within the framework of the Cochrane collaboration.

STUDY DESIGN: Systematic review. OBJECTIVE: To determine if traction is more effective than reference treatments, placebo/sham traction, or no treatment for low back pain (LBP). SUMMARY OF BACKGROUND DATA: Various types of traction are used in the treatment of LBP, often in conjunction with other treatments. METHODS: We searched MEDLINE, EMBASE, and CINAHL to November 2004, and screened the latest issue of the Cochrane Library (2004, issue 4) and references in relevant reviews and our personal files. We selected randomized controlled trials (RCTs) involving any type of traction for the treatment of acute (less than 4 weeks duration), subacute (4-12 weeks), or chronic (more than 12 weeks) nonspecific LBP with or without sciatica. Sets of 2 reviewers independently performed study selection, methodological quality assessment, and data extraction. Because available studies did not provide sufficient data for statistical pooling, we performed a qualitative "levels of evidence" analysis, systematically estimating the strength of the cumulative evidence on the difference/lack of difference observed in trial outcomes. RESULTS: A total of 24 RCTs (2177 patients) were included. There were 5 trials considered high quality. For mixed groups of patients with LBP with and without sciatica, we found: (1) strong evidence that there is no statistically significant difference in short or long-term outcomes between traction as a single treatment, (continuous or intermittent) and placebo, sham, or no treatment; (2) moderate evidence that traction as a single treatment is no more effective than other treatments; and (3) limited evidence that adding traction to a standard physiotherapy program does not result in significantly different outcomes. For LBP with sciatica, we found conflicting evidence in several of the comparisons: autotraction compared to placebo, sham, or no treatment; other forms of traction compared to other treatments; and different forms of traction. In the remaining comparisons, there were no statistically significant differences; level of evidence is moderate regarding continuous or intermittent traction compared to placebo, sham, or no treatment, and is limited regarding different forms of traction. CONCLUSION: Based on the current evidence, intermittent or continuous traction as a single treatment for LBP cannot be recommended for mixed groups of patients with LBP with and without sciatica. Neither can traction be recommended for patients with sciatica because of inconsistent results and methodological problems in most of the studies involved. However, because high-quality studies within the field are scarce, because many are underpowered, and because traction often is supplied in combination with other treatment modalities, the literature allows no firm negative conclusion that traction, in a generalized sense, is not an effective treatment for patients with LBP.

Humans↗

"Flower remedies": a systematic review of the clinical evidence.

BACKGROUND: Flower remedies (also called "Bach" flower remedies) are used by an increasing number of individuals, and many health claims have been made for them. No systematic review of flower remedies has so far been published. AIM: The aim of this systematic review is to summarise and critically analyse the data from all available controlled clinical trials of flower remedies. METHODS: Six databases were searched to identify all controlled clinical trials of flower remedies in humans for any medical condition. No language restrictions were applied. Key data were validated and extracted into table format according to pre-defined criteria. Statistical pooling was not possible, and results were evaluated in narrative form. RESULTS: Four studies met the inclusion/exclusion criteria. Two trials suggested a positive outcome. Those studies that controlled for placebo-effects and minimised selection bias through randomisation failed to demonstrate effects beyond a placebo response. CONCLUSION: The hypothesis that flower remedies are associated with effects beyond a placebo response is not supported by data from rigorous clinical trials.

Adult↗

Corticosteroids in acute traumatic brain injury: systematic review of randomised controlled trials.

OBJECTIVE: To quantify the effectiveness and safety of corticosteroids in the treatment of acute traumatic brain injury. DESIGN: Systematic review of randomised controlled trials of corticosteroids in acute traumatic brain injury. Summary odds ratios were estimated as an inverse variance weighted average of the odds ratios for each study. SETTING: Randomised trials available by March 1996. SUBJECTS: The included trials with outcome data comprised 2073 randomised participants. RESULTS: The effect of corticosteroids on the risk of death was reported in 13 included trials. The pooled odds ratio for the 13 trials was 0.91 (95% confidence interval 0.74 to 1.12). Pooled absolute risk reduction was 1.8% (-2.5% to 5.7%). For the 10 trials that reported death or disability the pooled odds ratio was 0.90 (0.72 to 1.11). For infections of any type the pooled odds ratio was 0.92 (0.69 to 1.23) and for the seven trials reporting gastrointestinal bleeding it was 1.05 (0.44 to 2.52). With only those trials with the best quality of concealment of allocation, the pooled odds ratio estimates for death and death or disability became closer to unity. CONCLUSIONS: This systematic review of randomised controlled trials of corticosteroids in acute traumatic brain injury shows that there remains considerable uncertainty over their effects. Neither moderate benefits nor moderate harmful effects can be excluded. The widely practicable nature of the drugs and the importance of the health problem suggest that large simple trials are feasible and worth while to establish whether there are any benefits from use of corticosteroids in this setting.

Acute Disease↗

A systematic review and critical evaluation of the immunology of chronic fatigue syndrome.

OBJECTIVE: Immune dysfunction in patients with chronic fatigue syndrome (CFS) has been widely but inconsistently reported. Traditional reviews of the literature have produced a variety of conclusions. We present the results of the first systematic review of the subject. METHODS: EMBASE, MEDLINE and PSYCHINFO databases were searched, and leading researchers in the field were contacted. Inclusion criteria were applied, and studies were then divided into groups based on the quality of their methodology. Study results were collated and described. RESULTS: Studies ranged widely in quality. There was an inverse association between study quality and finding low levels of natural killer cells, suggesting that the association may be related to study methodology. On the other hand, reports of abnormalities in T cells and cytokine levels were not related to study quality. CONCLUSIONS: The conclusions of this systematic review differ from a recent traditional narrative review of the immunology of CFS. No consistent pattern of immunological abnormalities is identified.

Cytokines↗

Adenosine deaminase and tuberculous pericarditis--a systematic review with meta-analysis.

BACKGROUND: Adenosine deaminase (ADA) activity in pericardial fluid is a valuable aid in the diagnosis of tuberculous pericarditis (TP), but there is no systematic review performed to evaluate the benefits of ADA activity as an adjunctive test for TP diagnosis. The objective of this systematic review was to evaluate the utility of ADA activity as a diagnostic marker of TP on patients presenting with pericardial effusion. METHODS: MEDLINE, LILACS and Cochrane Library databases (1980-2005) searches to identify articles related to adenosine deaminase activity on TP diagnosis. Articles with patients with at least one TP diagnostic criteria were included. The controls were patients with other pericardial diseases with moderate or large pericardial effusion. To calculate the sensitivity, specificity, as well as positive and negative likelihood ratios we extracted the total number of confirmed TP cases over all patients with pericardial effusion as well as the number of cases with ADA activity values of 40 U/L and over. RESULTS: Thirty one studies met our initial inclusion criteria and five articles were selected. The heterogeneity limited the specificity analysis (p=0.004). The method yielded a sensitivity and specificity of 88% and 83%, respectively. The SROC curve presented an area with a tendency towards 1 (value of 0.9539) and corroborates the diagnostic value of ADA activity. CONCLUSIONS: The present study confirms the clinical value of ADA activity as adjunctive diagnostic marker of TP among other causes of pericardial effusion.

Adenosine Deaminase↗

A systematic review describing the prognosis of chronic fatigue syndrome.

AIM: To perform a systematic review of studies describing the prognosis of chronic fatigue (CF) and chronic fatigue syndrome (CFS) and to identify occupational outcomes from such studies. METHOD: A literature search was used to identify all studies describing the clinical follow-up of patients following a diagnosis of CF or CFS. The prognosis is described in terms of the proportion of individuals improved during the period of follow-up. Return to work, other medical illnesses and death as outcomes are also considered, as are variables which may influence prognosis. RESULTS: Twenty-eight articles met the inclusion criteria and, for the 14 studies of subjects meeting operational criteria for CFS, the median full recovery rate was 5% (range 0-31%) and the median proportion of patients who improved during follow-up was 39.5% (range 8-63%). Less fatigue severity at baseline, a sense of control over symptoms and not attributing illness to a physical cause were all associated with a good outcome. Return to work at follow-up ranged from 8 to 30% in the three studies that considered this outcome. CONCLUSIONS: Full recovery from untreated CFS is rare. The prognosis for an improvement in symptoms is less gloomy. This review looks at the course of CF/CFS without systematic intervention. However, there is increasing evidence for the effectiveness of cognitive behavioural and graded exercise therapies. Medical retirement should be postponed until a trial of such treatment has been given.

Fatigue↗

Central nervous system injuries in sport and recreation: a systematic review.

Many sports have been associated with a variety of neurological injuries affecting the central nervous system (CNS), with some injuries specific to that sport. A systematic review of sport-specific CNS injuries has not been attempted previously, and could assist in the understanding of morbidity and mortality associated with particular sporting activities, either professional or amateur. A systematic review of the literature was performed using PubMed (1965-2003) examining all known sports and a range of possible CNS injuries attributable to that sport. Numerous sporting activities (45) have associated CNS injuries as reported within the literature. The sports most commonly associated with CNS injuries are: football, boxing, hockey, use of a trampoline, and various winter activities. A number of sporting activities are associated with unique CNS injuries or injury-related diseases such as heat stroke in auto racing, vertebral artery dissection in the martial arts, and dementia pugilistica in boxing. Neurological injuries of the CNS due to sport comprise a wide collection of maladies that are important for the neurologist, neurosurgeon, orthopaedic surgeon, physiatrist, sports medicine doctor, athletic trainer and general physician to recognise.

Adolescent↗

Nasal and paranasal sinus carcinoma: are we making progress? A series of 220 patients and a systematic review.

BACKGROUND: The authors reviewed treatment results in patients with nasal and paranasal sinus carcinoma from a large retrospective cohort and conducted a systematic literature review. METHODS: Two hundred twenty patients who were treated between 1975 and 1994 with a minimum follow-up of 4 years were reviewed retrospectively. A systematic review of published articles on patients with malignancies of the nasal and paranasal sinuses during the preceding 40 years was performed. RESULTS: The 5-year survival rate was 40%, and the local control rate was 59%. The 5-year actuarial survival rate was 63%, and the local control rate was 57%. Factors that were associated statistically with a worse prognosis, with results expressed as 5-year actuarial specific survival rates, included the following: 1) histology, with rates of 79% for patients with glandular carcinoma, 78% for patients with adenocarcinoma, 60% for patients with squamous cell carcinoma, and 40% for patients with undifferentiated carcinoma; 2) T classification, with rates of 91%, 64%, 72%, and 49% for patients with T1, T2, T3, and T4 tumors, respectively; 3) localization, with rates of 77% for patients with tumors of the nasal cavity, 62% for patients with tumors of the maxillary sinus, and 48% for patients with tumors of the ethmoid sinus; 4) treatment, with rates of 79% for patients who underwent surgery alone, 66% for patients who were treated with a combination of surgery and radiation, and 57% for patients who were treated exclusively with radiotherapy. Local extension factors that were associated with a worse prognosis included extension to the pterygomaxillary fossa, extension to the frontal and sphenoid sinuses, the erosion of the cribriform plate, and invasion of the dura. In the presence of an intraorbital invasion, enucleation was associated with better survival. In multivariate analysis, tumor histology, extension to the pterygomaxillary fossa, and invasion of the dura remained significant. Systematic review data demonstrated a progressive improvement of results for patients with squamous cell and glandular carcinoma, maxillary and ethmoid sinus primary tumors, and most treatment modalities. CONCLUSIONS: Progress in outcome for patients with nasal and paranasal carcinoma has been made during the last 40 years. These data may be used to make baseline comparisons for evaluating newer treatment strategies.

Adolescent↗

Privacy, security, and reliability risks of artificial intelligence in healthcare: a systematic review of empirical evidence.

BACKGROUND: Artificial intelligence (AI) is increasingly integrated into healthcare information systems, supporting clinical decision-making, imaging analysis, and predictive modeling. While these applications offer operational and clinical benefits, they also introduce emerging risks to patient privacy, data security, and system reliability. OBJECTIVE: To systematically review empirical evidence on privacy breaches, security vulnerabilities, and misuse associated with AI applications in healthcare settings. METHODS: PubMed, Embase, Web of Science, Scopus, IEEE Xplore, and ACM Digital Library were searched for empirical studies published between January 2015 and November 2025 that evaluated AI use or misuse in clinical diagnosis, treatment, or decision-making. Two reviewers independently screened studies and extracted data using a standardized form. Findings were synthesized narratively due to heterogeneity in study designs, AI methods, and reported outcomes. RESULTS: Of 7,285 records identified through database searches and 205 through citation screening, 22 empirical studies met the inclusion criteria, spanning multiple clinical domains and data modalities, predominantly medical imaging applications. Five recurring threat categories were identified: patient re-identification, membership inference, unauthorized access and adversarial exploitation, input manipulation, and misuse or overinterpretation of AI outputs. Across studies, AI models were shown to encode latent biometric signals across diverse data types, limiting the effectiveness of traditional anonymization and synthetic data approaches. Adversarial attacks and input manipulation were also shown to compromise diagnostic performance and system integrity. CONCLUSION: This systematic review provides empirical evidence suggesting that contemporary AI systems in healthcare introduce privacy and security risks that may challenge traditional assumptions about data protection. These findings underscore the need for privacy- and security-by-design approaches and governance frameworks that address risks across the AI lifecycle.

Humans↗

A systematic review of the history and physical examination to diagnose influenza.

BACKGROUND: Although influenza is a commonly encountered condition in primary care, and diagnosis is increasingly important given the availability of new treatments, there has been no systematic review of the evidence on clinical diagnosis. METHODS: This was a systematic review of the literature with meta-analysis where appropriate. We included cohort studies and randomized trials that compared the history and physical examination with a reference laboratory test for the diagnosis of influenza A and/or B. The primary outcomes were the sensitivity, specificity, likelihood ratios, and area under the receiver-operating characteristic (ROC) curve. RESULTS: Seven studies reported the sensitivity and specificity for a total of 59 variables. We combined studies of influenza A or B alone with those of influenza A and B. Rigors [likelihood ratio (LR) +7.2], the combination of fever and presenting within 3 days of the onset of illness (LR +4.0), and sweating (LR +3.0) were best at ruling-in influenza when present. When absent, the following decreased the likelihood of influenza: any systemic symptoms (LR -0.36), coughing (LR -0.38), not being able to cope with daily activities (LR -0.39), and being confined to bed (LR -0.50). Cough, nasal congestion, and fever (subjective or objective) had the highest calculable areas under the ROC curve. CONCLUSIONS: Individual signs and symptoms are of limited value for the diagnosis of influenza. Development of clinical decision rules that systematically combine symptoms may be a more useful strategy.

Cohort Studies↗

A systematic review of the effectiveness of interventions to help older people adhere to medication regimes.

BACKGROUND: Non-adherence is a common cause of treatment failure. The causes and context of non-adherence may differ amongst older people and reviews of interventions to improve adherence have tended to focus on the younger adult population. OBJECTIVE: To conduct a systematic review of interventions to aid adherence to medication for older people over the age of 65. METHOD: Relevant papers identified by searching the Cochrane Database of Systematic Reviews and the Database of Abstracts of Review of Effectiveness (Cochrane Library), Medline 1966-October 2002, Embase 1980-October 2002, Best Evidence, PsychINFO 1887-October 2002 and CINAHL 1982-October 2002. These were then hand-searched. The papers that fitted our inclusion criteria were selected. Two independent reviewers using an established tool assessed the studies for methodological quality. A non-statistical narrative approach was then taken to analyse the studies due to the heterogeneity of the outcome measures. RESULTS: 7 studies were identified. They used a variety of approaches involving external cognitive supports and/or educational interventions. Most studies were of poor methodological quality. Statistically significant effects, where present, tended to have small effects clinically. CONCLUSIONS: Currently there is no strong evidence to support the use of any one intervention type. Future research should use combinations of approaches, as there is some evidence that these are more likely to be successful.

Aged↗

Improving adherence to antidepressants: a systematic review of interventions.

BACKGROUND: Effectiveness of antidepressant medication is reduced by patients' nonadherence. Several interventions to improve adherence in patients diagnosed with unipolar depression have been tested. OBJECTIVE: To systematically review the effectiveness of interventions that aimed to improve adherence to antidepressant medication in patients with unipolar depression. METHOD: Systematic review of English-language articles of randomized controlled trials obtained by a computerized literature search of MEDLINE (1966-January 2002) using the terms patient compliance, patient dropout, treatment refusal, patient education, adherence, clinical trial, randomized controlled trial, controlled trial, depressive disorder, and depression; PSYCINFO (1984-January 2002) using the terms random, clinical, control, trial, adherence, compliance, noncompliance, dropouts, patient education, depression, major depression, affective disorders, and dysthymic disorder; EMBASE (1980-January 2002) using the terms patient compliance, patient dropouts, illness behavior, treatment refusal, patient education, clinical trial, controlled study, randomized controlled trial, and depression; and the Cochrane Controlled Trials Register (no restrictions) using the terms random*, complian*, adheren*, pharmacotherapy, regimen*, educat*, medicat*, depression, and depressive disorder. RESULTS: Educational interventions to enhance adherence failed to demonstrate a clear benefit on adherence and depression outcome. However, collaborative care interventions tested in primary care demonstrated significant improvements in adherence during the acute and continuation phase of treatment and were associated with clinical benefit, especially in patients suffering from major depression who were prescribed adequate dosages of antidepressant medication. CONCLUSION: We found evidence to support the introduction of interventions to enhance adherence with antidepressant medication in primary care, not only because of better adherence but also because of better treatment results. Because collaborative care interventions require additional resources, a better understanding of the mode of action of different programs is needed to reduce avoidable costs. The effectiveness of educational interventions needs more evidence.

Antidepressive Agents↗

Advancing nursing education through social and emotional learning: A systematic review guided by the Collaborative for Academic, Social, and Emotional Learning framework.

BACKGROUND: With Generation Z entering the nursing workforce in growing numbers, strengthening social and emotional learning is critical for academic success, professional adaptation, and safe practice. However, the existing evidence remains fragmented because of varied interventions and inconsistent approaches. OBJECTIVES: This systematic review examined (1) the social and emotional learning essential for nursing students and nurses within the Collaborative for Academic, Social, and Emotional Learning framework, (2) their impact on educational and clinical outcomes, and (3) implications for advancing nursing education and practice. METHODS: Following Joanna Briggs Institute methodology and Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, five international (PubMed, EMBASE, CINAHL, PsycINFO, Cochrane) and three Korean (RISS, KoreaMed, KMBASE) databases were searched up to June 2025. Eighteen studies involving 2,952 participants met the inclusion criteria, including quasi-experimental quantitative studies, descriptive quantitative studies, qualitative studies, and mixed-methods studies. The methodological quality of the included studies was appraised using the Mixed Methods Appraisal Tool. RESULTS: Within the Collaborative for Academic, Social, and Emotional Learning framework, relationship skills and self-management were the most frequently studied competencies, emphasizing teamwork, communication, and stress regulation. Self-awareness and social awareness were underexplored, despite their importance in empathy, resilience, and reflective practice. Responsible decision-making was the least studied competency, despite its importance in ethical reasoning. Social and emotional learning was consistently associated with enhanced adaptation, communication, leadership, relationships, and clinical performance. Effective strategies included blended learning, simulation, reflective activities, and mentorship, which are aligned with Generation Z's learning preferences. CONCLUSION: Although social and emotional learning integration is associated with improvements in educational and clinical outcomes in nursing, current research has largely centered on relational and stress-related competencies while underrepresenting responsible decision-making. To cultivate reflective, empathetic, and ethically grounded nurses, curricula should integrate social and emotional learning through a balanced and structured approach. REGISTRATION: This study was registered on PROSPERO (ID: CRD420251005683).

Humans↗

Serological assessment of type I collagen burden in scleroderma spectrum disorders: a systematic review.

RATIONALE: The aim of the study was to evaluate the validity of collagen type I metabolites as markers of disease activity in scleroderma (SSc), through a systematic review of the literature and by validating the results by measuring collagen type I metabolites in well characterized patients with scleroderma spectrum disorders and in Raynaud's phenomenon. METHODS: A systematic review was performed of studies of collagen type I metabolites in scleroderma spectrum disorders published from 1980 to 2003. The collected results from the literature were compared with our own measurements of collagen type I metabolites (PINP and ICTP) in a small number of well characterized patients within the scleroderma spectrum and in patients with primary and "autoimmune" Raynaud's phenomenon. Peptide concentrations from all sources, including the present study, were compared. Reported correlations between peptide concentrations and clinical variables were also analysed. RESULTS: Of 19 papers identified by an extensive Medline search, 12 were eligible for systematic analysis. There was a considerable heterogeneity in the results with a wide range of metabolite concentrations. Values from disease groups and healthy controls overlapped. These findings were confirmed by our study where, similarly, there was a large range of values in all groups, but particularly in the diffuse SSc subset. When the correlation between peptide levels and clinical variables was assessed, large discordance between the studies was observed. CONCLUSIONS: We have not found sufficient evidence to support the use of serum markers of collagen turnover in the assessment of scleroderma activity and severity, in view of their low specificity and the heterogeneity of the results of various studies. Lack of standardized routine evaluation of SSc patients in clinical studies might have accounted for the variability of the findings. However, due to the small sizes of most published studies, demonstration of no effect should come from large-scale randomised trials. Longitudinal serial analysis of these molecules in individual patients may play a future role in the evaluation of the response to fibroblast-targeting therapeutic strategies in scleroderma patients.

Biomarkers↗

[Systematic review about the usefulness and prognostic value of the p53 oncoprotein and proliferation marker Ki-67 for upper urinary tract transitional cell carcinoma].

OBJECTIVES: To perform a systematic review on the expression and prognostic value of the p 53 oncoprotein and Ki 67 proliferation marker in transitional cell carcinoma of the upper urinary tract. METHODS: A systematic review of cohort, prospective and retrospective studies from 1/1/1990 to 11/24/2003 has been undertaken, performing a bibliographic search both manual and electronic in the main databases. 632 works were found using the keywords "ureter, renal and pelvis tumor", and 14 with "ureter, renal and pelvis tumor, and immunohistochemical". RESULTS: 509 patients were studied; they were selected from 7 retrospective studies about the usefulness of p53 and Ki 67 in transitional cell carcinoma of the upper urinary tract published between 1995 and 2002 (three Spanish studies, three Japanese and one North American). Each one analyzes between 37 and 121 cases, with a mean age of 66.8 years (range 63.0-74.7) and a predominance of male sex in 100% of the studies. The pyelocalyceal site was the most frequent in these series. Treatment is another issue taken into consideration in this papers, being nephroureterectomy the most frequently found. The p53 and Ki 67 percentage expression in various studies has been related to clinical and histological factors. Only 5 studies performed a multivariate analysis using Cox regression models. Three of them deal with Ki 67 and two with p53, although one of the p53 studies associates cyclin E determinations. Only two out of three studies about Ki 67 were considered evaluable, because multivariate analysis was not performed in the other one. CONCLUSIONS: 1) There are a few studies and they are very heterogeneous in terms of design, selection criteria, follow-up, and use of prognostic variables. 2) The analyzed studies establish that oncoprotein p53 and proliferation marker Ki 67 are prognostic factors for transitional cell carcinoma of the upper urinary tract, and 3) To perform a meta-analysis was deemed not indicated because of the heterogeneicity of the studies found in our search.

Biomarkers, Tumor↗

Rapid infancy weight gain and subsequent obesity: systematic reviews and hopeful suggestions.

UNLABELLED: In a systematic review, we identified 21 separate studies with data on the association between rapid infancy weight gain, up to age 2 y, and subsequent obesity risk. Uniformly all studies reported significant positive associations. We transformed the reported effect sizes to a standard infancy weight gain exposure, and found that further differences in study design accounted for much of the variation in risk. An accompanying paper by Melinda Yeung reminds us that there are benefits of postnatal catch-up growth in certain populations, and suggests that genetic and nutritional factors could moderate the unhealthy translation of rapid infancy weight gain to visceral fat and insulin resistance. Further evidence is needed, and we will need to rigorously test the benefits and risks of any interventions. However, the concept of "healthy" rapid catch-up infancy growth is an attractive prospect. CONCLUSION: Rapid infancy weight gain is consistently associated with increased subsequent obesity risk, but the predictive ability of different weight gain cut-offs needs to be tested.

Humans↗

Systematic reviews--triumph of form over substance?

Cochrane systematic reviews are conducted to identify level 1a evidence. So far the ENT group have published 24 reviews, while around 70 titles are in various stages of the review process. Only one review has been able to produce Ia evidence and the rest recommended further trials. The majority of otorhinolaryngology reviews are unable to identify level 1a evidence due to the paucity of high quality randomised control trials. This presents a challenge, therefore - to identify and discuss alternate methods of evidence gathering for future research?

Evidence-Based Medicine↗

Association between suicide attempts and selective serotonin reuptake inhibitors: systematic review of randomised controlled trials.

OBJECTIVE: To establish whether an association exists between use of selective serotonin reuptake inhibitors (SSRIs) and suicide attempts. DESIGN: Systematic review of randomised controlled trials. DATA SOURCES: Medline and the Cochrane Collaboration's register of controlled trials (November 2004) for trials produced by the Cochrane depression, anxiety, and neurosis group. SELECTION OF STUDIES: Studies had to be randomised controlled trials comparing an SSRI with either placebo or an active non-SSRI control. We included clinical trials that evaluated SSRIs for any clinical condition. We excluded abstracts, crossover trials, and all trials whose follow up was less than one week. RESULTS: Seven hundred and two trials met our inclusion criteria. A significant increase in the odds of suicide attempts (odds ratio 2.28, 95% confidence 1.14 to 4.55, number needed to treat to harm 684) was observed for patients receiving SSRIs compared with placebo. An increase in the odds ratio of suicide attempts was also observed in comparing SSRIs with therapeutic interventions other than tricyclic antidepressants (1.94, 1.06 to 3.57, 239). In the pooled analysis of SSRIs versus tricyclic antidepressants, we did not detect a difference in the odds ratio of suicide attempts (0.88, 0.54 to 1.42). DISCUSSION: Our systematic review, which included a total of 87 650 patients, documented an association between suicide attempts and the use of SSRIs. We also observed several major methodological limitations in the published trials. A more accurate estimation of risks of suicide could be garnered from investigators fully disclosing all events.

Adult↗