scholarly journals Clinical trials of antidepressant medications are producing meaningless results

2003 ◽  
Vol 183 (2) ◽  
pp. 102-104 ◽  
Author(s):  
Gordon Parker ◽  
Ian M. Anderson ◽  
Peter Haddad
Keyword(s):  
Clinical Trials ◽  
Antidepressant Treatment ◽  
Meta Analysis ◽  
Antidepressant Medication ◽  
Unipolar Depression ◽  
Controlled Trials ◽  
Antidepressant Medications ◽  
Treatment Of Depression ◽  
Randomised Controlled ◽  
The Uk

A recent alert from the UK Committee on Safety of Medicines stated that the dangers of treatment of depression with paroxetine outweigh the benefits in those under 18. Such a warning should focus our minds on the evidence on which clinical practice is based. Antidepressant treatment of depression in the under-18s has been thought to be justified because clinical trials show that it works so well in over-18s. But is that a reasonable assessment of the evidence? Kirsch et al (2002) use the analogy of ‘The Emperor's New Clothes' to describe the findings from their meta-analysis of randomised placebo-controlled trials of antidepressants. They conclude that antidepressant medication appears to have only a small effect on outcome over and above placebo. In this analogy psychiatry is the emperor, drug trials are the fraudsters and the deception is being revealed by a growing body of critical opinion proposing that, once methodological problems with clinical trials are taken into account, antidepressants either do not work at all or have an effect that is so small as to be clinically unimportant (Andrews, 2001; Moncrieff, 2002). A large number of randomised placebo-controlled trials of antidepressants have been carried out over the past decades, mostly funded by the pharmaceutical industry, and it is now recognised that about 50% of negative trials go unpublished (Thase, 1999). Meanwhile, unipolar depression has jumped into the top five of the world's total burden of disease, and there is an imperative need for effective and safe treatments. Do we need more randomised controlled trials (RCTs) of antidepressant medications, or has that research paradigm outlived its usefulness? In this month's debate, Professor Gordon Parker, University of New South Wales and Black Dog Institute, Australia, and Drs Ian Anderson and Peter Haddad from the University of Manchester discuss whether clinical trials for antidepressant medication produce meaningless results.

scholarly journals What are the chances for personalised treatment with antidepressants? Detection of patient-by-treatment interaction with a variance ratio meta-analysis

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e034816 ◽  
Author(s):  
Martin Plöderl ◽  
Michael Pascal Hengartner
Keyword(s):  
Treatment Outcome ◽  
Randomised Controlled Trials ◽  
Simulation Analysis ◽  
Antidepressant Treatment ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Variance Ratios ◽  
Treatment Interaction ◽  
Personalised Treatment ◽  
Randomised Controlled

ObjectivesTo investigate if the treatment effect of antidepressants in patients with depression substantially varies in each patient (patient-by-treatment interaction or treatment heterogeneity), a necessary but largely unexplored prerequisite of personalised antidepressant treatment.DesignMeta-analytic variance comparison of treatment outcome between drug arms and placebo arms of clinical trials, based on the assumption that patient-by-treatment interaction should lead to larger variances in drug arms than placebo arms. To put the results into context, we run simple simulations, assuming different definitions and rates of those who respond especially well to antidepressants.Data sources163 randomised, placebo-controlled trials (51 396 patients) with complete results for pre–post differences, selected from a recently published systematic review.AnalysisVariance ratios (VRs) and coefficients of variance ratios (CVRs) of individual trials were meta-analytically combined. The analysis was repeated for classes of antidepressants and specific antidepressants.ResultsVRs (VR=1.01, CI 0.99 to 1.02) and CVRs (CVR=0.82, CI 0.80 to 0.84) of the antidepressant-treatment arms were comparable or smaller than in placebo arms. Similar results were observed for classes of antidepressants and for specific antidepressants. Our simulation analysis confirmed that equal VRs can only be obtained if they are not more than a few patients who respond slightly above average.ConclusionsThe lack of increased treatment-outcome variance in the antidepressants versus placebo groups in randomised controlled trials indicates that no or only very small subgroups of patients respond particularly well to antidepressants. Thus, the scope for personalised treatment with antidepressants seems to be limited.

scholarly journals Interventions for oropharyngeal dysphagia in acute and critical care: a protocol for a systematic review and meta-analysis

2019 ◽  
Vol 8 (1) ◽  
Author(s):  
Sallyanne Duncan ◽  
Jennifer Mc Gaughey ◽  
Richard Fallis ◽  
Daniel F. McAuley ◽  
Margaret Walshe ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Critical Care ◽  
Acute Care ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Oropharyngeal Dysphagia ◽  
Length Of Hospital Stay ◽  
Controlled Trials ◽  
Randomised Controlled

Abstract Background Oropharyngeal dysphagia or swallowing difficulties are common in acute care and critical care, affecting 47% of hospitalised frail elderly, 50% of acute stroke patients and approximately 62% of critically ill patients who have been intubated and mechanically ventilated for prolonged periods. Complications of dysphagia include aspiration leading to chest infection and pneumonia, malnutrition, increased length of hospital stay and re-admission to hospital. To date, most dysphagia interventions in acute care have been tested with acute stroke populations. While intervention studies in critical care have been emerging since 2015, they are limited and so there is much to learn about the type, the delivery and the intensity of treatments in this setting to inform future clinical trials. The aim of this systematic review is to summarise the evidence regarding the relationship between dysphagia interventions and clinically important patient outcomes in acute and critical care settings. Methods We will search MEDLINE, EMBASE, CENTRAL, Web of Science, CINAHL and clinical trial registries from inception to the present. We will include studies conducted with adults in acute care settings such as acute hospital wards or units or intensive care units and critical care settings. Studies will be restricted to randomised controlled trials and quasi-randomised controlled trials comparing a new dysphagia intervention with usual care or another intervention. The main outcomes that will be collected include length of time taken to return to oral intake, change in incidence of aspiration and pneumonia, nutritional status, length of hospital stay and quality of life. Key intervention components such as delivery, intensity, acceptability, fidelity and adverse events associated with such interventions will be collected to inform future clinical trials. Two independent reviewers will assess articles for eligibility, data extraction and quality appraisal. A meta-analysis will be conducted as appropriate. Discussion No systematic review has attempted to summarise the evidence for oropharyngeal dysphagia interventions in acute and critical care. Results of the proposed systematic review will inform practice and the design of future clinical trials. Systematic review registration PROSPERO CRD 42018116849 (http://www.crd.york.ac.uk/PROSPERO/)

Pharmacological Treatments for Unipolar Depression

2007 ◽  
pp. 271-288 ◽  
Author(s):  
Charles B. Nemeroff ◽  
Alan F. Schatzberg
Keyword(s):  
Major Depression ◽  
Selective Serotonin Reuptake Inhibitors ◽  
Rating Scale ◽  
Antidepressant Treatment ◽  
Safety Margin ◽  
Antidepressant Medication ◽  
Unipolar Depression ◽  
Controlled Trials ◽  
Adverse Side Effect ◽  
Drug Induced

The treatment of unipolar major depression with antidepressant medication is well established on the basis of scores of randomized placebo-controlled trials involving thousands of patients. Tricyclic antidepressants (TCAs) were the first to be studied extensively; meta-analyses of placebo-controlled trials show them to be consistently and significantly more efficacious than a placebo. Because of a narrow safety margin and significant drug-induced adverse side effect problems, TCAs have now largely been replaced as the first-line treatment of depression by selective serotonin reuptake inhibitors (SSRIs)—fluoxetine, sertraline, paroxetine, citalopram, and escitalopram; serotonin norepinephrine reuptake inhibitors (SNRIs)—venlafaxine and duloxetine; as well as other compounds, including, for example, bupropion and mirtazapine. Each of these agents has been shown to be superior to a placebo and as effective as comparator TCAs or SSRIs in controlled trials. Clinical trials consistently show them to be better tolerated than TCAs, and they clearly have a wider margin of safety. However, there is a controversy concerning whether TCAs are more effective than SSRIs for the treatment of the most severely ill depressed patients. Monoamine oxidase inhibitors (MAOIs), while also more effective than placebo, have generally been reserved for treatment-refractory patients; however, a recently released transdermally delivered selegiline may be used in less refractory patients. It is now generally recognized that patients with recurrent major depression benefit from continued antidepressant treatment, and there is evidence that TCAs, SSRIs, SNRIs, and so forth are all effective for the long-term management of recurrent major depression. An important issue in evaluating the antidepressant literature is to distinguish between response rated as a reduction in the level of symptoms on a rating scale and response rated as true remission from illness.

scholarly journals 470 Could Covid-19 Change the Way We Do Clinics for The Better? A Comparison of Remote Versus Outpatient Clinic Follow-Up for Surgical Patients: A Meta-Analysis of Randomised Controlled Trials

2021 ◽  
Vol 108 (Supplement_2) ◽  
Author(s):  
Emily Oates ◽  
Grace Hui Chin Lim ◽  
Edward J Nevins ◽  
Venkatesh Kanakala
Keyword(s):  
Outpatient Clinic ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Surgical Patients ◽  
Surgical Patient ◽  
Controlled Trials ◽  
Randomised Controlled ◽  
The Uk ◽  
The Way

Abstract Introduction As the Covid-19 pandemic hit the UK, the way the NHS operates changed overnight. One change was the move to remote appointments (RA) by video or telephone. This meta-analysis (MA) of randomised controlled trials (RCTs) looks at existing evidence on RA and aims to discover if surgical patients are satisfied with them. Method A literature search of RCTs of surgical patient satisfaction of RA versus conventional outpatient clinic (OPC) was performed. The PubMed, EMBASE and Google Scholar databases were searched to include articles from January 2000 to 2020. A random effects MA model was used to compare outcomes. Results All 5 RCTs showed that patients were as satisfied with RA as OPC (RR = 1.00, [0.97-1.03] p = 0.96). Furthermore, both patient cohorts would prefer RA for future follow-up (RR = 2.28 [1.85-2.82] p < 0.00001). 1 RCT performed a cost analysis and found the cost to institutions was less in the RA group ($19.05 vs $52.76). All other RCTs suggested cost to patients and institutions would be less for RA. Conclusions Surgical patients are satisfied with RA and in fact would prefer them, thus indicating that out with the Covid-19 pandemic RAs could be continued, and in doing so may well save money for patients and the NHS.

scholarly journals The “NICE Guideline” on the treatment of depression

2006 ◽  
Vol 15 (1) ◽  
pp. 11-15 ◽  
Author(s):  
David Goldberg
Keyword(s):  
Randomised Controlled Trials ◽  
Clinical Excellence ◽  
Stepped Care ◽  
Controlled Trials ◽  
Nice Guideline ◽  
Hierarchy Of Evidence ◽  
Treatment Of Depression ◽  
Randomised Controlled ◽  
The Uk ◽  
Meta Analyses

AbstractThe National Institute of Clinical Excellence (NICE) in the UK is responsible for producing evidence based guidelines for the treatment of most common illnesses, both physical and psychological. NICE uses a hierarchy of evidence, ranging from data from meta-analyses of randomised controlled trials (RCT's) at the apex, to the opinions of acknowledged experts at the bottom. The task of preparing guideline for depression involved us in performing clean meta-analyses of around 8,000 published RCTs of the treatment of this disorder. Where drug treatments were concerned we used three indicators of efficacy, as well as considering toxicity, tolerability and cost. We also distinguished between studies carried out in primary care, and studies in patients treated by the mental health services. We found it helpful to arrange our report in terms of a “stepped care” model, addressing the indications for patients being referred on for more specialised, and expensive, treatments. In the full guideline we included our doubts that depression was a homogenous clinical entity, and our awareness of the limitations of relying on randomised controlled trials (RCT's) as the only source of evidence. This Editorial summarises the content of the guideline on the treatment of depression and discusses how it was received and also what it did not say.

scholarly journals Patient adherence in the treatment of depression

2002 ◽  
Vol 180 (2) ◽  
pp. 104-109 ◽  
Author(s):  
S. Pampallona ◽  
P. Bollini ◽  
G. Tibaldi ◽  
B. Kupelnick ◽  
C. Munizza
Keyword(s):  
Response Rate ◽  
Patient Adherence ◽  
Antidepressant Treatment ◽  
Meta Analysis ◽  
Unipolar Depression ◽  
Quantitative Evidence ◽  
Quantitative Studies ◽  
Treatment Of Depression ◽  
Review Criteria ◽  
Combined Interventions

BackgroundNon-adherence with antidepressant treatment is very common. Increasing adherence to pharmacological treatment may affect response rate.AimsTo review and summarise quantitative evidence on factors associated with adherence and of adherence-enhancing interventions.MethodA systematic review of computerised databases was carried out to identify quantitative studies of adherence in depression. Papers retained addressed unipolar depression and considered adherence as the primary end-point.ResultsOf studies published between 1973 and 1999, 32 met the review criteria: epidemiological descriptive studies (n=14): non-random comparisons of control and intervention groups (n=3); randomised interventions (n=14); and meta-analysis (n=1). Patient education and medication clinics were the interventions most commonly tested, combined with a variety of other interventions.ConclusionsThe studies did not give consistent indications of which interventions may be effective. Carefully designed clinical trials are needed to clarify the effect of single and combined interventions.

scholarly journals Comparison between binocular therapy and patching for treatment of amblyopia: a meta-analysis of randomised controlled trials

2021 ◽  
Vol 6 (1) ◽  
pp. e000625
Author(s):  
Chun-Wen Chen ◽  
Qin Zhu ◽  
Yu-Bing Duan ◽  
Jing-Yan Yao
Keyword(s):  
Clinical Trials ◽  
Visual Acuity ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Corrected Visual Acuity ◽  
Supplementary Method ◽  
Randomised Controlled ◽  
Best Corrected Visual Acuity

Several studies have compared binocular therapy and patching for the treatment of amblyopia. However, most of them involved a small number of cases and reported controversial results. Thus, the benefit of binocular therapy remains to be confirmed. We conducted a meta-analysis to evaluate the efficacy of binocular therapy versus patching and to testify whether binocular therapy could become supplementary method in children with amblyopia. Randomised controlled trials that evaluated the efficacy of binocular therapy for amblyopia versus patching were identified using PubMed, Embase, Cochrane Library, Ovid, Web of Science, ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform. Data screening, extraction and quality assessment were performed independently by two researchers. Six trials were identified and analysed to compare binocular therapy (708 eyes) with patching (664 eyes) for change in best-corrected visual acuity and stereoacuity. Efficacy estimates were evaluated by standard mean difference (SMD) and 95% CI. The best-corrected visual acuity in binocular group was better than that of in patching group (SMD=−0.21 logarithm of the minimum angle of resolution (log MAR), 95% CI of −0.50 to 0.08 log MAR, p=0.003). The results showed statistically significant difference in the change of best-corrected visual acuity between the groups, but not in stereoacuity. Binocular therapy may be a promising treatment of conditions affecting visual acuity, and could be applied as a supplementary method to patching for amblyopia in clinical practice. The present analysis showed that some children with amblyopia may benefit from binocular therapy. Nevertheless, larger randomised controlled clinical trials are required to confirm these findings.

scholarly journals Systematic Review and Meta-Analysis of the Use of Hyaluronic Acid Injections to Restore Interproximal Papillae

2021 ◽  
Vol 11 (22) ◽  
pp. 10572
Author(s):  
Arturo Sanchez-Perez ◽  
Tania Rosa Vela-García ◽  
Bibiana Mateos-Moreno ◽  
Alfonso Jornet-García ◽  
Carlos Navarro-Cuellar
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Hyaluronic Acid ◽  
Social Relationships ◽  
Treatment Strategy ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Interdental Papilla ◽  
Randomised Controlled

The absence of interdental papillae leads to the appearance of black triangles. For most patients, the appearance of these triangles is an important reason for concern and affects their social relationships. Multiple reconstruction techniques have been developed with different degrees of success and predictability. The main aim of this study was to evaluate the efficiency of hyaluronic acid (HA) injected into interproximal papillae 6 months after injection and to perform a systematic review and meta-analysis. After a systematic review, seven articles were selected: two clinical randomised controlled trials and five clinical trials. In total, 127 patients with a deficiency in upper papillae in the front of the maxilla and jaw were included in the study. The height variable was evaluated (mm) 6 months after HA injection. In total, 166 interproximal papillae were studied. Four articles showed an important difference in favour of intervention. The total result regarding in the injection of HA was favourable with an approximate average filling of 0.47 mm in the height of the interdental papilla. The injection of HA for the reconstruction of deficient papillae in the region of the upper and lower maxilla was a possible option treatment strategy in mild black triangles.

The Effectiveness of Acupuncture for Depression – a Systematic Review of Randomised Controlled Trials

2005 ◽  
Vol 23 (2) ◽  
pp. 70-76 ◽  
Author(s):  
Yoshito Mukaino ◽  
Jongbae Park ◽  
Adrian White ◽  
Edzard Ernst
Keyword(s):  
Weighted Mean Difference ◽  
Meta Analysis ◽  
Antidepressant Drugs ◽  
Antidepressant Medication ◽  
Controlled Trials ◽  
Control Procedure ◽  
Manual Acupuncture ◽  
Weighted Mean ◽  
Randomised Controlled ◽  
Comparative Trials

Objective To summarise the existing evidence on acupuncture as a therapy for depression. Methods RCTs were included, in which either manual acupuncture or electroacupuncture was compared with any control procedure in subjects with depression. Data were extracted independently by two authors. The methodological quality was assessed. Pre and post means and SDs for depression specific measures were extracted, when available, for meta-analysis. Results Seven randomised comparative trials involving 509 patients were included. The evidence is inconsistent on whether manual acupuncture is superior to sham, and suggests that acupuncture was not superior to waiting list. Evidence suggests that the effect of electroacupuncture may not be significantly different from antidepressant medication, weighted mean difference −0.43(95% CI −5.61 to 4.76). There is inconclusive evidence on whether acupuncture has an additive effect when given as an adjunct to antidepressant drugs. Conclusion The evidence from controlled trials is insufficient to conclude whether acupuncture is an effective treatment for depression, but justifies further trials of electroacupuncture.

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