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BJOG : An International Journal of... Mar 2008The guidance on SUI has not been rigorously assessed using GRADE system. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The guidance on SUI has not been rigorously assessed using GRADE system.
OBJECTIVE
To determine if the quality and results of existing systematic reviews on conservative treatment of stress urinary incontinence (SUI) can underpin evidence-based recommendations for practice.
STUDY DESIGN
Review of systematic reviews. Data sources Electronic search in PubMed, Medline (OVID 1966-version), CINAHL, Biomed, Psychinfo, the Cochrane library, National Library for Health, the National Research Register and hand search of reference lists.
METHODS
Two reviewers independently selected systematic review articles in which a publicly available database was searched for randomised trials on conservative treatment of SUI and assessed them for quality of methods and results (OR and 95% CIs). The extracted information was used to classify strength of evidence as per the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system.
RESULTS
There were 13 reviews of variable quality. Quality assessment of studies included in the reviews and their findings were adequately tabulated in all but four reviews. Meta-analysis of data was carried out in six reviews. Pelvic floor muscle training (PFMT) and other physical treatments, estrogens and duloxetine were better than no treatment in SUI. Based on the assessment as per GRADE system, only 2/13 (15.4%) reviews were deemed to be of high quality, 8/13 (61.5%) of moderate quality and 3/13 (23.1%) of low quality. The case for recommendation of PFMT and duloxetine was strong.
CONCLUSION
Systematic reviews of conservative treatments of SUI are not always suitable to generate robust recommendations for practice as they are weak in methodological quality or lack power to produce reliable results.
Topics: Biofeedback, Psychology; Duloxetine Hydrochloride; Electric Stimulation Therapy; Estrogens; Exercise Therapy; Humans; Randomized Controlled Trials as Topic; Review Literature as Topic; Thiophenes; Treatment Outcome; Urinary Incontinence, Stress
PubMed: 18271880
DOI: 10.1111/j.1471-0528.2007.01629.x -
The Cochrane Database of Systematic... Jul 2005To date, standard recommendations for the management of stress urinary incontinence (SUI) would be either pelvic floor muscle training (PFMT) or surgery. A new form of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
To date, standard recommendations for the management of stress urinary incontinence (SUI) would be either pelvic floor muscle training (PFMT) or surgery. A new form of drug treatment with a serotonin-noradrenaline reuptake inhibitor (SNRI), duloxetine, may now have a place in treatment of this condition.
OBJECTIVES
To determine whether a SNRI is better than placebo (or no treatment, other pharmacological and non-pharmacological therapies, or surgery) in the treatment of women with SUI, or mixed urinary incontinence that includes stress incontinence (MUI), or both and which doses should be used.
SEARCH STRATEGY
We searched the Cochrane Incontinence Group specialised register (searched 1 December 2004), (CENTRAL) (Issue 2, 2004), MEDLINE (January 1966 to September 2004), PREMEDLINE (11 March 2004), Dissertation Abstracts and the reference lists of relevant articles.
SELECTION CRITERIA
All randomised or quasi-randomised controlled trials of treatment for SUI or MUI, in which at least one management arm involved a SNRI.
DATA COLLECTION AND ANALYSIS
Two authors evaluated the trials for appropriateness for inclusion and methodological quality. Three authors performed the data extraction using predetermined criteria. Analyses were performed using the Cochrane Review Manager software, RevMan.
MAIN RESULTS
Nine randomised trials were included, involving 3327 adults with predominantly SUI, randomised to receive duloxetine or placebo. Both arms in individual trials were comparable for various baseline characteristics. Treatment duration was between three weeks and 12 weeks. Duloxetine was significantly better than placebo in terms of improving patients' quality of life (WMD 5.26, 95%CI 3.84 to 6.68. P< 0.00001) and perception of improvement. Individual studies demonstrated a significant reduction in the Incontinence Episode Frequency (IEF) by approximately 50% during treatment with duloxetine. With regard to objective cure, however, meta-analysis of stress pad test and 24 hour pad weight change failed to demonstrate a benefit for duloxetine over placebo though data were relatively few. Subjective cure favoured duloxetine, albeit with a small effect size (3%). One trial suggested that duloxetine was better than pelvic floor muscle training alone in reducing IEF (P < 0.05) based on median percentage decrease in IEF per week. Although significant side effects were commonly associated with duloxetine, they were reported as acceptable.
AUTHORS' CONCLUSIONS
The available evidence suggests that duloxetine treatment can significantly improve the quality of life of patients with stress urinary incontinence, but it is unclear whether or not benefits are sustainable. Adverse effects are common but not serious. About one in three participants allocated duloxetine reported adverse effects (most commonly nausea) related to treatment, and about one in eight allocated duloxetine stopped treatment as a consequence.
Topics: Adrenergic Uptake Inhibitors; Adult; Duloxetine Hydrochloride; Humans; Norepinephrine; Randomized Controlled Trials as Topic; Selective Serotonin Reuptake Inhibitors; Thiophenes; Urinary Incontinence, Stress
PubMed: 16034945
DOI: 10.1002/14651858.CD004742.pub2 -
The Cochrane Database of Systematic... Oct 2012Although pharmacological and psychological interventions are both effective for major depression, in primary and secondary care settings antidepressant drugs remain the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Although pharmacological and psychological interventions are both effective for major depression, in primary and secondary care settings antidepressant drugs remain the mainstay of treatment. Amongst antidepressants many different agents are available. Duloxetine hydrochloride is a dual reuptake inhibitor of serotonin and norepinephrine and has been licensed by the Food and Drug Administration in the US for major depressive disorder (MDD), generalised anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia and chronic musculoskeletal pain.
OBJECTIVES
To assess the evidence for the efficacy, acceptability and tolerability of duloxetine in comparison with all other antidepressant agents in the acute-phase treatment of major depression.
SEARCH METHODS
MEDLINE (1966 to 2012), EMBASE (1974 to 2012), the Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register and the Cochrane Central Register of Controlled Trials up to March 2012. No language restriction was applied. Reference lists of relevant papers and previous systematic reviews were hand-searched. Pharmaceutical company marketing duloxetine and experts in this field were contacted for supplemental data.
SELECTION CRITERIA
Randomised controlled trials allocating patients with major depression to duloxetine versus any other antidepressive agent.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted data and a double-entry procedure was employed. Information extracted included study characteristics, participant characteristics, intervention details and outcome measures in terms of efficacy, acceptability and tolerability.
MAIN RESULTS
A total of 16 randomised controlled trials (overall 5735 participants) were included in this systematic review. Of these, three trials were unpublished. We found 11 studies (overall 3304 participants) comparing duloxetine with one selective serotonin reuptake inhibitor (SSRI) (six studies versus paroxetine, three studies versus escitalopram and two versus fluoxetine), four studies (overall 1978 participants) comparing duloxetine with a newer antidepressants (three with venlafaxine and one with desvenlafaxine, respectively) and one study (overall 453 participants) comparing duloxetine with an antipsychotic drug which is also used as an antidepressive agent, quetiapine. No studies were found comparing duloxetine with tricyclic antidepressants. The pooled confidence intervals were rather wide and there were no statistically significant differences in efficacy when comparing duloxetine with other antidepressants. However, when compared with escitalopram or venlafaxine, there was a higher rate of drop out due to any cause in the patients randomised to duloxetine (odds ratio (OR) 1.62; 95% confidence interval (CI) 1.01 to 2.62 and OR 1.56; 95% CI 1.14 to 2.15, respectively). There was also some weak evidence suggesting that patients taking duloxetine experienced more adverse events than paroxetine (OR 1.24; 95% CI 0.99 to 1.55).
AUTHORS' CONCLUSIONS
Duloxetine did not seem to provide a significant advantage in efficacy over other antidepressive agents for the acute-phase treatment of major depression. No differences in terms of efficacy were found, even though duloxetine was worse than some SSRIs (most of all, escitalopram) and newer antidepressants (like venlafaxine) in terms of acceptability and tolerability. Unfortunately, we only found evidence comparing duloxetine with a handful of other active antidepressive agents and only a few trials per comparison were found (in some cases we retrieved just one trial). This limited the power of the review to detect moderate, but clinically meaningful differences between the drugs. As many statistical tests have been used in the review, the findings from this review are better thought of as hypothesis forming rather than hypothesis testing and it would be very comforting to see the conclusions replicated in future trials. Most of included studies were sponsored by the drug industry manufacturing duloxetine. As for all other new investigational compounds, the potential for overestimation of treatment effect due to sponsorship bias should be borne in mind. In the present review no trials reported economic outcomes. Given that several SSRIs and the great majority of antidepressants are now available as generic formulation (only escitalopram, desvenlafaxine and duloxetine are still on patent), more comprehensive economic estimates of antidepressant treatment effect should be considered to better inform healthcare policy.
Topics: Antidepressive Agents; Citalopram; Cyclohexanols; Depression; Desvenlafaxine Succinate; Dibenzothiazepines; Duloxetine Hydrochloride; Fluoxetine; Humans; Paroxetine; Quetiapine Fumarate; Randomized Controlled Trials as Topic; Thiophenes; Venlafaxine Hydrochloride
PubMed: 23076926
DOI: 10.1002/14651858.CD006533.pub2 -
Expert Opinion on Pharmacotherapy May 2010Except for generalized anxiety disorder, few reports have been published on the efficacy, safety and tolerability of duloxetine in patients with anxiety disorders... (Review)
Review
IMPORTANCE OF THE FIELD
Except for generalized anxiety disorder, few reports have been published on the efficacy, safety and tolerability of duloxetine in patients with anxiety disorders individually or in comorbidity with major depressive disorder (MDD).
AREAS COVERED IN THIS REVIEW
The literature search in Medline (dating back to 1966) and Embase (dating back to 1988) databases was conducted using the OVID interface on 9 April 2009, restricted to any article or abstract in English, per title, reporting any information on the use of duloxetine in patients with any anxiety disorder with or without concomitant MDD. A systematic review approach was taken.
WHAT THE READER WILL GAIN
The reader will gain knowledge of the current data available on the use of duloxetine to treat patients with anxiety disorders individually or in comorbidity with MDD.
TAKE HOME MESSAGE
Duloxetine could be considered an effective treatment option in the treatment of anxiety disorders individually or in comorbidity with each other, or with MDD; however, apart from the well-demonstrated efficacy, tolerability and safety of duloxetine in the treatment of MDD with or without anxiety and GAD, data on this subject are preliminary and very limited, and more research is warranted.
Topics: Animals; Antidepressive Agents; Anxiety Disorders; Clinical Trials as Topic; Depressive Disorder, Major; Duloxetine Hydrochloride; Humans; Quality of Life; Thiophenes
PubMed: 20402555
DOI: 10.1517/14656561003747441 -
Journal of Affective Disorders Nov 2016There has been a steady increase in the prescription of antidepressants for the elderly. This study comprises a systematic review of randomized, placebo-controlled... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
There has been a steady increase in the prescription of antidepressants for the elderly. This study comprises a systematic review of randomized, placebo-controlled trials of antidepressants for treatment of depressive disorder in people aged 65 years or more.
METHODS
PubMed, EMBASE, Cochrane Library, CINAL, and PsycINFO were searched until May 2016. Where appropriate, the results were synthesized in meta-analyses.
RESULTS
Twelve trials met the inclusion criteria. For patients with major depressive disorder, selective serotonin re-uptake inhibitors (SSRI) were not superior to placebo in achieving remission (OR: 0.79, 95% CI: 0.61-1.03) or response (OR=0.86, 95% CI: 0.51-1.10) after 8 weeks of treatment (three trials). However, maintenance treatment with SSRIs was superior to placebo in preventing relapse (OR: 0.22, 95% CI: 0.13-0.36; NNT=5, 95% CI: 3-6; two trials). Duloxetine was superior to placebo in achieving remission (OR: 1.78, 95% CI: 1.20-2.65; NNT=9, 95% CI: 6-20; three trials) and response (OR: 1.83, 95% CI: 1.96-4.08; two trials) in recurrent major depression after 8 weeks, but increased the risk of adverse events that can be problematic in the elderly.
LIMITATIONS
The quality of evidence was generally low or moderate, emphasizing the uncertainty of the results. Study populations only partly covered the heterogeneous population of elderly with depressed mood, limiting the generalizability.
CONCLUSION
The results underscore the importance of close monitoring of the effects of antidepressants in treatment of elderly patients with a depressive disorder. Methods for early detection of non-responders and effective treatment options for this group are needed.
Topics: Aged; Antidepressive Agents; Depressive Disorder, Major; Duloxetine Hydrochloride; Humans; Odds Ratio; Selective Serotonin Reuptake Inhibitors; Treatment Outcome
PubMed: 27389296
DOI: 10.1016/j.jad.2016.06.013 -
PloS One 2022To evaluate the efficacy and safety of different antidepressants and anticonvulsants in the treatment of central poststroke pain (CPSP) by network meta-analysis and... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To evaluate the efficacy and safety of different antidepressants and anticonvulsants in the treatment of central poststroke pain (CPSP) by network meta-analysis and provide an evidence-based foundation for clinical practice.
METHODS
PubMed, Cochrane Library, EMBASE, CNKI, APA PsycINFO, Wanfang, VIP and other databases were searched by computer to find clinical randomized controlled studies (RCTs) on drug treatment of CPSP. The retrieval time limit was from the establishment of each database to July 2022. The quality of the included RCTs was evaluated using the bias risk assessment tool recommended by Cochrane. Stata 14.0 was used for network meta-analysis.
RESULTS
A total of 13 RCTs, 1040 patients and 9 drugs were finally included. The results of the network meta-analysis showed that the effectiveness ranking as rated by the visual analog scale (VAS) was gabapentin > pregabalin > fluoxetine > lamotrigine > duloxetine > serqulin > amitriptyline > carbamazepine > vitamin B. Ranking according to the numerical rating scale (NRS) was pregabalin > gabapentin > carbamazepine. Ranking derived from the Hamilton depression scale (HAMD) was pregabalin > duloxetine > gabapentin > amitriptyline.
CONCLUSION
All nine drugs can relieve the pain of CPSP patients to different degrees; among them pregabalin and gabapentin have the most significant effect, and gabapentin and pregabalin also have the most adverse reactions. In the future, more multicenter, large sample, double-blind clinical randomized controlled trials need to be carried out to supplement and demonstrate the results of this study.
Topics: Amitriptyline; Anticonvulsants; Antidepressive Agents; Carbamazepine; Duloxetine Hydrochloride; Fluoxetine; Gabapentin; Humans; Lamotrigine; Multicenter Studies as Topic; Network Meta-Analysis; Neuralgia; Pregabalin; Randomized Controlled Trials as Topic; Vitamins
PubMed: 36227855
DOI: 10.1371/journal.pone.0276012 -
Schmerz (Berlin, Germany) Jun 2012The scheduled update to the German S3 guidelines on fibromyalgia syndrome (FMS) by the Association of the Scientific Medical Societies ("Arbeitsgemeinschaft der... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The scheduled update to the German S3 guidelines on fibromyalgia syndrome (FMS) by the Association of the Scientific Medical Societies ("Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften", AWMF; registration number 041/004) was planned starting in March 2011.
MATERIALS AND METHODS
The development of the guidelines was coordinated by the German Interdisciplinary Association for Pain Therapy ("Deutsche Interdisziplinären Vereinigung für Schmerztherapie", DIVS), 9 scientific medical societies and 2 patient self-help organizations. Eight working groups with a total of 50 members were evenly balanced in terms of gender, medical field, potential conflicts of interest and hierarchical position in the medical and scientific fields. Literature searches were performed using the Medline, PsycInfo, Scopus and Cochrane Library databases (until December 2010). The grading of the strength of the evidence followed the scheme of the Oxford Centre for Evidence-Based Medicine. The recommendations were based on level of evidence, efficacy (meta-analysis of the outcomes pain, sleep, fatigue and health-related quality of life), acceptability (total dropout rate), risks (adverse events) and applicability of treatment modalities in the German health care system. The formulation and grading of recommendations was accomplished using a multi-step, formal consensus process. The guidelines were reviewed by the boards of the participating scientific medical societies.
RESULTS AND CONCLUSION
Amitriptyline and-in case of comorbid depressive disorder or generalized anxiety disorder-duloxetine are recommended. Off-label use of duloxetine and pregabalin can be considered in case of no comorbid mental disorder. Strong opioids are not recommended. The English full-text version of this article is available at SpringerLink (under "Supplemental").
Topics: Amitriptyline; Analgesics; Analgesics, Opioid; Antidepressive Agents; Anxiety Disorders; Combined Modality Therapy; Comorbidity; Cooperative Behavior; Depressive Disorder, Major; Duloxetine Hydrochloride; Fibromyalgia; Germany; Humans; Interdisciplinary Communication; Off-Label Use; Patient Care Team; Pregabalin; Somatoform Disorders; Thiophenes; gamma-Aminobutyric Acid
PubMed: 22760463
DOI: 10.1007/s00482-012-1172-2 -
Annals of Internal Medicine Mar 2008Urinary incontinence in women is a common problem that adversely affects quality of life. (Review)
Review
BACKGROUND
Urinary incontinence in women is a common problem that adversely affects quality of life.
PURPOSE
To synthesize evidence of management of urinary incontinence in women.
DATA SOURCES
MEDLINE, CINAHL, and the Cochrane Library.
STUDY SELECTION
96 randomized, controlled trials (RCTs) and 3 systematic reviews published in English from 1990 through May 2007.
DATA EXTRACTION
Using standardized protocols, reviewers abstracted cases of continence, improvement of urinary incontinence, and prevalence of urinary incontinence to calculate risk difference.
DATA SYNTHESIS
Compared with regular care, pelvic floor muscle training plus bladder training resolved urinary incontinence (pooled risk difference, 0.13 [95% CI, 0.07 to 0.20]). Pelvic floor muscle training alone resolved or improved urinary incontinence compared with regular care, although the effect size was inconsistent across studies. Different injectable bulking agents and medical devices were associated with similar continence and improvement rates. Electrical stimulation failed to resolve urinary incontinence. Oral hormone administration increased rates of urinary incontinence compared with placebo in most RCTs (1243 women). Transdermal or vaginal estrogen resulted in inconsistent improvement of urinary incontinence. Adrenergic drugs did not resolve or improve urinary incontinence. Oxybutynin or tolterodine resolved urinary incontinence compared with placebo (pooled risk difference, 0.18 [CI, 0.13 to 0.22]). Duloxetine compared with placebo improved (pooled risk difference, 0.11 [CI, 0.07 to 0.14]) but did not resolve urinary incontinence, with no significant dose-response association.
LIMITATIONS
Inconsistent measurements of outcomes limited the findings. Predictors of better effect have not been identified in RCTs.
CONCLUSION
Moderate levels of evidence suggest that pelvic floor muscle training and bladder training resolved urinary incontinence in women. Anticholinergic drugs resolved urinary incontinence, with similar effects from oxybutynin or tolterodine. Duloxetine improved but did not resolve urinary incontinence. The effects of electrostimulation, medical devices, injectable bulking agents, and local estrogen therapy were inconsistent.
Topics: Benzhydryl Compounds; Cholinergic Antagonists; Collagen; Cresols; Duloxetine Hydrochloride; Electric Stimulation Therapy; Estrogen Replacement Therapy; Exercise Therapy; Female; Humans; Magnetics; Mandelic Acids; Pelvic Floor; Pessaries; Phenylpropanolamine; Randomized Controlled Trials as Topic; Thiophenes; Tolterodine Tartrate; Urinary Incontinence
PubMed: 18268288
DOI: 10.7326/0003-4819-148-6-200803180-00211 -
The Cochrane Database of Systematic... Mar 2021Seasonal affective disorder (SAD) is a seasonal pattern of recurrent depressive episodes that is often treated with second-generation antidepressants (SGAs), light... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Seasonal affective disorder (SAD) is a seasonal pattern of recurrent depressive episodes that is often treated with second-generation antidepressants (SGAs), light therapy, or psychotherapy.
OBJECTIVES
To assess the efficacy and safety of second-generation antidepressants (SGAs) for the treatment of seasonal affective disorder (SAD) in adults in comparison with placebo, light therapy, other SGAs, or psychotherapy.
SEARCH METHODS
This is an update of an earlier review first published in 2011. We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 1) in the Cochrane Library (all years), Ovid MEDLINE, Embase, and PsycINFO (2011 to January 2020), together with the Cochrane Common Mental Disorders Controlled Trials Register (CCMDCTR) (all available years), for reports of randomised controlled trials (RCTs). We hand searched the reference lists of all included studies and other systematic reviews. We searched ClinicalTrials.gov for unpublished/ongoing trials. We ran a separate update search for reports of adverse events in the Ovid databases. SELECTION CRITERIA: For efficacy we included RCTs of SGAs compared with other SGAs, placebo, light therapy, or psychotherapy in adult participants with SAD. For adverse events we also included non-randomised studies.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened abstracts and full-text publications against the inclusion criteria. Data extraction and 'Risk of bias' assessment were conducted individually. We pooled data for meta-analysis where the participant groups were similar, and the studies assessed the same treatments with the same comparator and had similar definitions of outcome measures over a similar duration of treatment.
MAIN RESULTS
In this update we identified no new RCT on the effectiveness of SGAs in SAD patients. We included 2 additional single-arm observational studies that reported on adverse events of SGAs. For efficacy we included three RCTs of between five and eight weeks' duration with a total of 204 participants. For adverse events we included two RCTs and five observational (non-randomised) studies of five to eight weeks' duration with a total of 249 participants. All participants met the DSM (Diagnostic and Statistical Manual of Mental Disorders) criteria for SAD. The average age ranged from 34 to 42 years, and the majority of participants were female (66% to 100%). Results from one trial with 68 participants showed that fluoxetine (20/36) was numerically superior to placebo (11/32) in achieving clinical response; however, the confidence interval (CI) included both a potential benefit as well as no benefit of fluoxetine (risk ratio (RR) 1.62, 95% CI 0.92 to 2.83, very low-certainty evidence). The number of adverse events was similar in both groups (very low-certainty evidence). Two trials involving a total of 136 participants compared fluoxetine versus light therapy. Meta-analysis showed fluoxetine and light therapy to be approximately equal in treating seasonal depression: RR of response 0.98 (95% CI 0.77 to 1.24, low-certainty evidence), RR of remission 0.81 (95% CI 0.39 to 1.71, very low-certainty evidence). The number of adverse events was similar in both groups (low-certainty evidence). We did not identify any eligible study comparing SGA with another SGA or with psychotherapy. Two RCTs and five non-randomised studies reported adverse event data on a total of 249 participants who received bupropion, fluoxetine, escitalopram, duloxetine, nefazodone, reboxetine, light therapy, or placebo. We were only able to obtain crude rates of adverse events, therefore caution is advised regarding interpretation of this information. Between 0% and 100% of participants who received an SGA suffered an adverse event, and between 0% and 25% of participants withdrew from the study due to adverse events.
AUTHORS' CONCLUSIONS
Evidence for the effectiveness of SGAs is limited to one small trial of fluoxetine compared with placebo showing a non-significant effect in favour of fluoxetine, and two small trials comparing fluoxetine against light therapy suggesting equivalence between the two interventions. The lack of available evidence precluded us from drawing any overall conclusions on the use of SGAs for SAD. Further, larger RCTs are required to expand and strengthen the evidence base on this topic, and should also include comparisons with psychotherapy and other SGAs. Data on adverse events were sparse, and a comparative analysis was not possible. The data we obtained on adverse events is therefore not robust, and our confidence in the data is limited. Overall, up to 25% of participants treated with SGAs for SAD withdrew from the study early due to adverse events.
Topics: Adult; Antidepressive Agents, Second-Generation; Bias; Citalopram; Duloxetine Hydrochloride; Female; Fluoxetine; Humans; Male; Morpholines; Observational Studies as Topic; Phototherapy; Placebos; Quality of Life; Randomized Controlled Trials as Topic; Reboxetine; Seasonal Affective Disorder; Thiophenes; Treatment Outcome
PubMed: 33661528
DOI: 10.1002/14651858.CD008591.pub3 -
The Cochrane Database of Systematic... Dec 2011Seasonal affective disorder (SAD) is a seasonal pattern of recurrent depressive episodes that is often treated with second-generation antidepressants (SGAs), light... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Seasonal affective disorder (SAD) is a seasonal pattern of recurrent depressive episodes that is often treated with second-generation antidepressants (SGAs), light therapy or psychotherapy.
OBJECTIVES
To assess the efficacy and safety of SGAs for the treatment of SAD in adults in comparison with placebo, light therapy, other SGAs or psychotherapy.
SEARCH METHODS
We searched the Cochrane Depression, Anxiety and Neuorosis Review Group's specialised register (CCDANCTR) on the 26 August 2011. The CCDANCTR contains reports of relevant randomised controlled trials from The Cochrane Library (all years), EMBASE (1974 to date), MEDLINE (1950 to date) and PsycINFO (1967 to date). In addition, we searched pharmaceutical industry trials registers via the Internet to identify unpublished trial data. Furthermore, we searched OVID MEDLINE, MEDLINE In-process, EMBASE and PsycINFO to 27July 2011 for publications on adverse effects (including non-randomised studies).
SELECTION CRITERIA
For efficacy we included randomised trials of SGAs compared with other SGAs, placebo, light therapy or psychotherapy in adult participants with SAD. For adverse effects we also included non-randomised studies.
DATA COLLECTION AND ANALYSIS
Two review authors screened abstracts and full-text publications against the inclusion criteria. Data abstraction and risk of bias assessment were conducted by one reviewer and checked for accuracy and completeness by a second. We pooled data for meta-analysis where the participant groups were similar and the studies assessed the same treatments with the same comparator and had similar definitions of outcome measures over a similar duration of treatment.
MAIN RESULTS
For efficacy we included three randomised trials of between five and eight weeks duration with a total of 204 participants. For adverse effects we included two randomised trials and three observational (non-randomised) studies of five to eight weeks duration with a total of 225 participants. Overall, the randomised trials had low-to-moderate risk of bias, and the observational studies had a high risk of bias (due to small size and high attrition). The participants in the studies all met DSM (Diagnostic and Statistics Manual of Mental Disorders) criteria for SAD. The average age was approximately 40 years and 70% of the participants were female.Results from one trial with 68 participants showed that fluoxetine was not significantly more effective than placebo in achieving clinical response (risk ratio (RR) 1.62, 95% confidence interval (CI) 0.92 to 2.83). The number of adverse effects were similar between the two groups.We located two trials that contained a total of 136 participants for the comparison fluoxetine versus light therapy. Our meta-analysis of the results of the two trials showed fluoxetine and light therapy to be approximately equal in treating seasonal depression: RR of response 0.98 (95% CI 0.77 to 1.24), RR of remission 0.81 (95% CI 0.39 to 1.71). The number of adverse effects was similar in both groups.Two of the three randomised trials and three non-randomised studies contained adverse effect data on 225 participants who received fluoxetine, escitalopram, duloxetine, reboxetine, light therapy or placebo. We were only able to obtain crude rates of adverse effects, so any interpretation of this needs to be undertaken with caution. Between 22% and 100% of participants who received a SGA suffered an adverse effect and between 15% and 27% of participants withdrew from the studies because of adverse effects.
AUTHORS' CONCLUSIONS
Evidence for the effectiveness of SGAs is limited to one small trial of fluoxetine compared with placebo, which shows a non-significant effect in favour of fluoxetine, and two small trials comparing fluoxetine against light therapy, which suggest equivalence between the two interventions. The lack of available evidence precludes the ability to draw any overall conclusions on the use of SGAs for SAD. Further larger RCTs are required to expand and strengthen the evidence base on this topic, and should also include comparisons with psychotherapy and other SGAs.Data on adverse events were sparse, and a comparative analysis was not possible. Therefore the data we obtained on adverse effects is not robust and our confidence in the data is limited. Overall, up to 27% of participants treated with SGAs for SAD withdrew from the studies early due to adverse effects. The overall quality of evidence in this review is very low.
Topics: Adult; Antidepressive Agents, Second-Generation; Citalopram; Duloxetine Hydrochloride; Female; Fluoxetine; Humans; Male; Morpholines; Phototherapy; Randomized Controlled Trials as Topic; Reboxetine; Seasonal Affective Disorder; Thiophenes
PubMed: 22161433
DOI: 10.1002/14651858.CD008591.pub2