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1.
Cannabinoids for control of chemotherapy induced nausea and vomiting: quantitative systematic review
Martin R Tramèr Dawn Carroll Fiona A Campbell D John M Reynolds R Andrew Moore Henry J McQuay 《BMJ (Clinical research ed.)》2001,323(7303):16
ObjectiveTo quantify the antiemetic efficacy and adverse effects of cannabis used for sickness induced by chemotherapy.DesignSystematic review.Studies30 randomised comparisons of cannabis with placebo or antiemetics from which dichotomous data on efficacy and harm were available (1366 patients). Oral nabilone, oral dronabinol (tetrahydrocannabinol), and intramuscular levonantradol were tested. No cannabis was smoked. Follow up lasted 24 hours.ResultsCannabinoids were more effective antiemetics than prochlorperazine, metoclopramide, chlorpromazine, thiethylperazine, haloperidol, domperidone, or alizapride: relative risk 1.38 (95% confidence interval 1.18 to 1.62), number needed to treat 6 for complete control of nausea; 1.28 (1.08 to 1.51), NNT 8 for complete control of vomiting. Cannabinoids were not more effective in patients receiving very low or very high emetogenic chemotherapy. In crossover trials, patients preferred cannabinoids for future chemotherapy cycles: 2.39 (2.05 to 2.78), NNT 3. Some potentially beneficial side effects occurred more often with cannabinoids: “high” 10.6 (6.86 to 16.5), NNT 3; sedation or drowsiness 1.66 (1.46 to 1.89), NNT 5; euphoria 12.5 (3.00 to 52.1), NNT 7. Harmful side effects also occurred more often with cannabinoids: dizziness 2.97 (2.31 to 3.83), NNT 3; dysphoria or depression 8.06 (3.38 to 19.2), NNT 8; hallucinations 6.10 (2.41 to 15.4), NNT 17; paranoia 8.58 (6.38 to 11.5), NNT 20; and arterial hypotension 2.23 (1.75 to 2.83), NNT 7. Patients given cannabinoids were more likely to withdraw due to side effects 4.67 (3.07 to 7.09), NNT 11.ConclusionsIn selected patients, the cannabinoids tested in these trials may be useful as mood enhancing adjuvants for controlling chemotherapy related sickness. Potentially serious adverse effects, even when taken short term orally or intramuscularly, are likely to limit their widespread use.
What is already known on this topic
Requests have been made for legalisation of cannabis (marijuana) for medical useLong term smoking of cannabis can have physical and neuropsychiatric adverse effectsCannabis may be useful in the control of chemotherapy related sicknessWhat this study adds
Oral nabilone and dronabinol and intramuscular levonantradol are superior to conventional antiemetics (such as prochlorperazine or metoclopramide) in chemotherapySide effects are common with cannabinoids, and although some may be potentially beneficial (euphoria, “high,” sedation), others are harmful (dysphoria, depression, hallucinations)Many patients have a strong preference for cannabinoids 相似文献2.
Brett D. Thombs Michelle Roseman James C. Coyne Peter de Jonge Vanessa C. Delisle Erin Arthurs Brooke Levis Roy C. Ziegelstein 《PloS one》2013,8(1)
Objectives
To systematically review evidence on depression screening in coronary heart disease (CHD) by assessing the (1) accuracy of screening tools; (2) effectiveness of treatment; and (3) effect of screening on depression outcomes.Background
A 2008 American Heart Association (AHA) Science Advisory recommended routine depression screening in CHD.Methods
CINAHL, Cochrane, EMBASE, ISI, MEDLINE, PsycINFO and SCOPUS databases searched through December 2, 2011; manual journal searches; reference lists; citation tracking; trial registries. Included articles (1) compared a depression screening instrument to a depression diagnosis; (2) compared depression treatment to placebo or usual care in a randomized controlled trial (RCT); or (3) assessed the effect of screening on depression outcomes in a RCT.Results
There were few examples of screening tools with good sensitivity and specificity using a priori-defined cutoffs in more than one patient sample among 15 screening accuracy studies. Depression treatment with antidepressants or psychotherapy generated modest symptom reductions among post-myocardial infarction (post-MI) and stable CHD patients (N = 6; effect size = 0.20–0.38), but antidepressants did not improve symptoms more than placebo in 2 heart failure (HF) trials. Depression treatment did not improve cardiac outcomes. No RCTs investigated the effects of screening on depression outcomes.Conclusions
There is evidence that treatment of depression results in modest improvement in depressive symptoms in post-MI and stable CHD patients, although not in HF patients. There is still no evidence that routine screening for depression improves depression or cardiac outcomes. The AHA Science Advisory on depression screening should be revised to reflect this lack of evidence. 相似文献3.
ObjectivesTo assess the efficacy and safety of hypericum extract (STEI 300, Steiner Arzneimittel, Berlin) compared with imipramine and placebo in patients in primary care with a current episode of moderate depression.DesignRandomised, double blind, multicentre, parallel group trial for 8 weeks.SettingTrained panel of 18 general practitioners from four German states: Bavaria, Berlin, Rhineland Palatinate, and Saxony.Participants263 patients (66 men, 197 women) with moderate depression according to ICD-10 (international classification of diseases, 10th revision) codes F32.1 and F33.1.Interventions1050 mg hypericum extract (350 mg three times daily), 100 mg imipramine (50 mg, 25 mg, and 25 mg daily), or placebo three times daily.ResultsHypericum extract was more effective at reducing Hamilton depression scores than placebo and as effective as imipramine (mean −15.4 (SD 8.1), −12.1 (7.4), and –14.2 (7.3) respectively). Comparable results were found for Hamilton anxiety and clinical global impressions scales and were most pronounced for the Zung self rating depression scale. Quality of life was more improved in the standardised mental component scale of the SF-36 with both active treatments than with placebo but in the physical component scale was improved only by hypericum extract compared with placebo. The rate of adverse events with hypericum extract was in the range of the placebo group but lower than that of the imipramine group (0.5, 0.6, and 1.2 events per patient respectively).ConclusionsAt an average dose of 350 mg three times daily hypericum extract was more effective than placebo and at least as effective as 100 mg imipramine daily in the treatment of moderate depression. Treatment with hypericum extract is safe and improves quality of life.
Key messages
- Hypericum extract (STEI 300) was effective after 4, 6, and 8 weeks of treatment in patients with moderate depression
- Simultaneous analysis confirmed hypericum extract to be at least as efficacious as imipramine 100 mg daily after eight weeks of treatment
- Besides better antidepressive efficacy both hypericum extract and imipramine improved quality of life
- Patients tolerate hypericum extracts much better than they do tricyclics and therefore by improving patients'' compliance hypericum extracts are promising drugs for long term treatment
4.
Zelda Di Blasi Ted J Kaptchuk John Weinman Jos Kleijnen 《BMJ (Clinical research ed.)》2002,325(7376):1329
ObjectivesTo assess whether and how investigators of placebo controlled randomised trials inform participants of their treatment allocation at trial closure and to assess barriers to feedback.DesignPostal survey with a semistructured questionnaire.ParticipantsAll investigators who published a placebo controlled randomised trial in 2000 in five leading medical journals, and a random sample of 120 trials listed in the national research register database.Results45% of investigators informed either all or most participants of their treatment allocation, and 55% did not inform any participant or only informed those who asked. The main reasons for not informing participants were that the investigators never considered this option (40%) or to avoid biasing results at study follow up (24%).ConclusionFurther research is required to examine sensitive ways to communicate treatment information to trial participants.
What is already known on this topic
Information is poor on the nature, extent, and effect of informing participants of placebo controlled randomised trials about their treatment allocation at trial closureLess than 50% of participants receiving placebo are informed about their treatment allocationWhat this study adds
No standard procedure is available for informing patients of their treatment arm or of study results at the end of a trialEffective and sensitive ways of communicating treatment allocation to participants are required, as is information on the effects on placebo responders 相似文献5.
ObjectivesTo determine the association between inhibition of serotonin reuptake by antidepressants and upper gastrointestinal bleeding.DesignRetrospective cohort study from population based databases.SettingOntario, Canada.Participants317 824 elderly people observed for more than 130 000 person years. The patients started taking an antidepressant between 1992 and 1998 and were grouped by how much the drug inhibited serotonin reuptake. Patients were observed until they stopped the drug, had an upper gastrointestinal bleed, or died or the study ended.ResultsOverall, 974 bleeds were observed, with an overall bleeding rate of 7.3 per 1000 person years. After controlling for age or previous gastrointestinal bleeding, the risk of bleeding significantly increased by 10.7% and 9.8%, respectively, with increasing inhibition of serotonin reuptake. Absolute differences in bleeding between antidepressant groups were greatest for octogenarians (low inhibition of serotonin reuptake, 10.6 bleeds/1000 person years v high inhibition of serotonin reuptake, 14.7 bleeds/1000 person years; number needed to harm 244) and those with previous upper gastrointestinal bleeding (low, 28.6 bleeds/1000 person years v high, 40.3 bleeds/1000 person years; number needed to harm 85).ConclusionsAfter age or previous upper gastrointestinal bleeding were controlled for, antidepressants with high inhibition of serotonin reuptake increased the risk of upper gastrointestinal bleeding. These increases are clinically important for elderly patients and those with previous gastrointestinal bleeding.
What is already known on this topic
A case-control study found that the risk of upper gastrointestinal bleeding increases with intake of antidepressants that extensively inhibit serotonin reuptakeThe study''s validity was questioned because antidepressants were not specifically classified by the extent that they inhibit serotonin reuptake, and absolute differences in bleeding rates between antidepressants were unavailableWhat this study adds
The risk of upper gastrointestinal bleeding in elderly and depressed patients increases with antidepressants having the greatest extent of inhibition of serotonin reuptakeThis increased risk of bleeding is clinically important for patients with a high risk of bleeding—namely, octogenarians and those with previous upper gastrointestinal bleedingThe extent that an antidepressant inhibits serotonin reuptake should be considered when drugs are required for depression in high risk patients 相似文献6.
ObjectiveTo evaluate the efficacy of emotional support and counselling combined with placebo or antidepressants with single or dual mechanism of action in the treatment of depression in primary care.DesignRandomised double blind study.SettingSeveral locations in Norway.Subjects372 patients with depression.Results Intention to treat analyses showed 47% remission in patients randomised to placebo compared with 61% remission in patients randomised to sertraline (odds ratio 0.56, 95% confidence interval 0.33 to 0.96) and 54% in patients randomised to mianserin (0.75, 0.44 to 1.27). Women responded better than men (1.86, 1.17 to 2.96). Subgroup analyses showed that subjects with recurrent depression (n=273) responded more frequently to sertraline than to placebo (0.43, 0.23 to 0.82) than those having their first episode of depression (1.18, 0.39 to 3.61). Statistically significant interactions between type of drug treatment and history of depression were not shown by logistic regression.Conclusion The combination of active drug and simple psychological treatment (counselling, emotional support, and close follow up over a 24 week period) was more effective than simple psychological treatment alone, in particular for those with recurrent depression. Overall, women may benefit more than men. If confirmed in future studies, the findings should lead to more differentiated treatment guidelines for depression in primary care.
Key messages
- The effectiveness of simple psychological treatment and active drug provided by general practitioners is comparable to treatment results reported by psychiatrists and clinical psychologists
- Treatment benefits women more than men
- There may be differences in response to treatment depending on the nature of depression
- A 6 month treatment period is necessary to evaluate effectiveness of treatments for depression in general practice
- The development of more differentiated treatment guidelines for depression in primary care is needed
7.
Eva Haastrup Katrine Grau Jesper Eugen-Olsen Christian Thorball Lars Vedel Kessing Henrik Ullum 《PloS one》2014,9(10)
Objectives
Inflammation is involved in the pathogenesis of depression. A few cross-sectional population-based studies have found that depression is associated with increased levels of inflammatory markers. Soluble urokinase plasminogen activation receptor (suPAR) is known to be a stable marker for inflammation. We investigated the bidirectional association between suPAR levels and use of antidepressants.Methods
suPAR level was measured in 9305 blood donors and analysed in relation to 5-years follow-up data on purchase of antidepressants and hospital diagnoses of depression from a nationwide Danish register.Results
For men and women without prior use of antidepressants we found a significantly higher risk for incident use of antidepressants with higher suPAR values. For men, the risk of first use of antidepressants increased by 72% from the 1st to the 4th quartile (HR = 1.72, 95% CI: 1.11–2.69). For women, it increased by 108% from the 1st to the 4th quartile (HR = 2.08, 95% CI: 1.45–2.98). Previous use of antidepressants was also significantly associated with higher suPAR levels (p = 0.002).Conclusions
High suPAR levels are associated with an increased risk for both previous and future use of antidepressants in healthy men and women. High suPAR are also associated with increased risk for a hospital diagnosis of depression. 相似文献8.
D J P Barker T Forsén A Uutela C Osmond J G Eriksson 《BMJ (Clinical research ed.)》2001,323(7324):1273
ObjectiveTo determine whether men who grew slowly in utero or during infancy are more vulnerable to the later effects of poor living conditions on coronary heart disease.DesignFollow up study of men for whom there were data on body size at birth and growth and social class during childhood, educational level, and social class and income in adult life.SettingHelsinki, Finland.Participants3676 men who were born during 1934-44, attended child welfare clinics in Helsinki, were still resident in Finland in 1971, and for whom data from the 1980 census were available.ResultsMen who had low social class or low household income in adult life had increased rates of coronary heart disease. The hazard ratio among men with the lowest annual income (<£8400) was 1.71 (95% confidence interval 1.18 to 2.48) compared with 1.00 in men with incomes above £15 700. These effects were stronger in men who were thin at birth (ponderal index <26 kg/m3): hazard ratio 2.58 (1.45 to 4.60) for men with lowest annual income. Among the men who were thin at birth the effects of low social class were greater in those who had accelerated weight gain between ages 1 and 12 years. Low social class in childhood further increased risk of disease, partly because it was associated with poor growth during infancy. Low educational attainment was associated with increased risk, and low income had no effect once this was taken into account.ConclusionMen who grow slowly in utero remain biologically different to other men. They are more vulnerable to the effects of low socioeconomic status and low income on coronary heart disease.
What is already known on this topic
People who grow slowly in utero and during infancy remain biologically different through their livesSuch people are at increased risk of coronary heart diseaseWhat this study adds
Among men who were thin at birth the risk of coronary heart disease is further increased if they have poor living standards in adult lifeOther men tend to be resilient to the adverse effects of poor living standards 相似文献9.
Hugh R Taylor Gabriella Tikellis Luba D Robman Catherine A McCarty John J McNeil 《BMJ (Clinical research ed.)》2002,325(7354):11
ObjectiveTo determine whether vitamin E supplementation influences the incidence or rate of progression of age related maculopathy (AMD).DesignProspective randomised placebo controlled clinical trial.SettingAn urban study centre in a residential area supervised by university research staff.Participants1193 healthy volunteers aged between 55 and 80 years; 73% completed the trial on full protocol.InterventionsVitamin E 500 IU or placebo daily for four years.ResultsThe incidence of early age related macular degeneration (early AMD 3) was 8.6% in those receiving vitamin E versus 8.1% in those on placebo (relative risk 1.05, 95% confidence interval 0.69 to 1.61). For late disease the incidence was 0.8% versus 0.6% (1.36, 0.67 to 2.77). Further analysis showed no consistent differences in secondary outcomes.ConclusionDaily supplement with vitamin E supplement does not prevent the development or progression of early or later stages of age related macular degeneration.
What is already known on this topic
Age related macular degeneration is the leading cause of loss of vision and blindness in elderly people; for people aged ⩾90 years, two out of every three will be affected and one in four will become blindCurrently, there are no methods of prevention or treatment in most cases, though a third of cases are due to cigarette smokingAntioxidant vitamins have been suggested as a possible preventionWhat this study adds
Daily supplementation with 500 mg vitamin E for four years did not alter the incidence or progression of AMD 相似文献10.
Background
Previous meta-analyses of published and unpublished trials indicate that antidepressants provide modest benefits compared to placebo in the treatment of depression; some have argued that these benefits are not clinically significant. However, these meta-analyses were based only on trials submitted for the initial FDA approval of the medication and were limited to those aimed at treating depression. Here, for the first time, we assess the efficacy of a selective serotonin reuptake inhibitor (SSRI) in the treatment of both anxiety and depression, using a complete data set of all published and unpublished trials sponsored by the manufacturer.Methods and Findings
GlaxoSmithKline has been required to post the results for all sponsored clinical trials online, providing an opportunity to assess the efficacy of an SSRI (paroxetine) with a complete data set of all trials conducted. We examined the data from all placebo-controlled, double-blind trials of paroxetine that included change scores on the Hamilton Rating Scale for Anxiety (HRSA) and/or the Hamilton Rating Scale for Depression (HRSD). For the treatment of anxiety (k = 12), the efficacy difference between paroxetine and placebo was modest (d = 0.27), and independent of baseline severity of anxiety. Overall change in placebo-treated individuals replicated 79% of the magnitude of paroxetine response. Efficacy was superior for the treatment of panic disorder (d = 0.36) than for generalized anxiety disorder (d = 0.20). Published trials showed significantly larger drug-placebo differences than unpublished trials (d’s = 0.32 and 0.17, respectively). In depression trials (k = 27), the benefit of paroxetine over placebo was consistent with previous meta-analyses of antidepressant efficacy (d = 0.32).Conclusions
The available empirical evidence indicates that paroxetine provides only a modest advantage over placebo in treatment of anxiety and depression. Treatment implications are discussed. 相似文献11.
Michael King Oliver Davidson Fiona Taylor Andrew Haines Deborah Sharp Rebecca Turner 《BMJ (Clinical research ed.)》2002,324(7343):947
ObjectiveTo assess the effectiveness of teaching general practitioners skills in brief cognitive behaviour therapy.DesignParallel group, cluster randomised, controlled trial of an educational package on cognitive behaviour therapy.SettingGeneral practices in north London.Participants84 general practitioner principals and 272 patients attending their practices who scored above the threshold for psychological distress on the hospital anxiety and depression scale.InterventionA training package of four half days on brief cognitive behaviour therapy.ResultsDoctors'' knowledge of depression and attitudes towards its treatment showed no major difference between intervention and control groups after 6 months. The training had no discernible impact on patients'' outcomes.ConclusionGeneral practitioners may require more training and support than a basic educational package on brief cognitive behaviour therapy to acquire skills to help patients with depression.
What is already known on this topic
Trained professionals can deliver effective cognitive behaviour therapy to depressed patients presenting to general practitionersLimited evidence shows that cognitive behaviour therapy is effective when delivered by general practitioners who have received extensive instructionMost doctors do not have the time or inclination to carry out such comprehensive trainingWhat this study adds
Basic training in brief cognitive behaviour therapy has little effect on general practitioners'' attitudes to the identification and treatment of depression or the outcome of their patients with emotional problemsGeneral practitioners may require more extensive training and support if they are to acquire skills in brief cognitive behaviour therapy that will have a positive impact on their patients 相似文献12.
Background
Meta-analyses of antidepressant medications have reported only modest benefits over placebo treatment, and when unpublished trial data are included, the benefit falls below accepted criteria for clinical significance. Yet, the efficacy of the antidepressants may also depend on the severity of initial depression scores. The purpose of this analysis is to establish the relation of baseline severity and antidepressant efficacy using a relevant dataset of published and unpublished clinical trials.Methods and Findings
We obtained data on all clinical trials submitted to the US Food and Drug Administration (FDA) for the licensing of the four new-generation antidepressants for which full datasets were available. We then used meta-analytic techniques to assess linear and quadratic effects of initial severity on improvement scores for drug and placebo groups and on drug–placebo difference scores. Drug–placebo differences increased as a function of initial severity, rising from virtually no difference at moderate levels of initial depression to a relatively small difference for patients with very severe depression, reaching conventional criteria for clinical significance only for patients at the upper end of the very severely depressed category. Meta-regression analyses indicated that the relation of baseline severity and improvement was curvilinear in drug groups and showed a strong, negative linear component in placebo groups.Conclusions
Drug–placebo differences in antidepressant efficacy increase as a function of baseline severity, but are relatively small even for severely depressed patients. The relationship between initial severity and antidepressant efficacy is attributable to decreased responsiveness to placebo among very severely depressed patients, rather than to increased responsiveness to medication. 相似文献13.
David G. Bruce Wendy A. Davis Violetta Cetrullo Sergio E. Starkstein Timothy M. E. Davis 《PloS one》2013,8(12)
Background
The clinical features of type 2 diabetes may differ depending on whether first depression episode precedes or follows the diagnosis of diabetes.Methods
Type 2 patients from the observational community-based Fremantle Diabetes Study Phase II underwent assessment of lifetime depression using the Brief Lifetime Depression Scale (developed and validated for this study) supplemented by information on current depression symptoms (Patient Health Questionnaire, 9-item version) and use of antidepressants. Patients were categorized as never depressed (Group 1), having had depression before diabetes diagnosis (Group 2), diagnosed with depression and diabetes within 2 years of each other (Group 3) and having depression after diabetes diagnosis (Group 4).Results
Of 1391 patients, 20.8% were assigned to Group 2, 6.0% to Group 3 and 14.5% to Group 4. In Group 2, depression occurred a median 15.6 years before diabetes onset at age 37.2±14.7 years. These patients had similar clinical characteristics to never depressed patients except for reduced self-care behaviours and having more symptomatic peripheral arterial disease. In Group 4, depression occurred a median 9.9 years after diabetes onset at age 59.8±13.0 years. These patients had long duration diabetes, poor glycaemic control, more intensive management and more diabetic complications. Group 4 patients had more current depression than Group 2 but were less likely to be receiving antidepressants.Conclusions/Interpretation
The clinical features of depression and type 2 diabetes are heterogeneous depending on their temporal relationship. There may be corresponding differences in the pathogenesis of depression in diabetes that have implications for diagnosis and management. 相似文献14.
《Phytomedicine》2015,22(2):231-237
Aimto evaluate the efficacy of Berberis aristata/Silybum marianum (Berberol®) in a sample of dyslipidemic patients intolerant to statins at high dosages in a randomized, double blind, placebo-controlled clinical trial.Methodswe enrolled 175 euglycemic, dyslipidemic subjects, intolerant to statins at high dosages. During the run-in period, statins were stopped for 1 month, then they were re-introduced at the half of the previously taken dose. After that, patients were randomized to placebo or Berberol®, 1 tablet during the lunch and 1 tablet during the dinner, for 6 months. Anthropometric, metabolic and inflammatory parameters were assessed at randomization, at 3 and 6 months.Resultsfasting plasma glucose, insulin, and HOMA-index levels were reduced by Berberol®, but not by placebo; moreover they were lower than the ones recorded with placebo. Total cholesterol, LDL-C, triglycerides, and myeloperoxidase did not change after 6 months since the reduction of statin dosage and the introduction of Berberol®, while they increased in the placebo group, and were higher compared to the ones obtained with active treatment. No patients had serious adverse events in both groups.Conclusionsour study displays the rationale of the combination of Berberol® and a reduced dosage of statin for the treatment of hyperlipidemia in patients intolerant to statins at high dosage. 相似文献
15.
K. Linde G. Ramirez C. D. Mulrow A. Pauls W. Weidenhammer D. Melchart 《BMJ (Clinical research ed.)》1996,313(7052):253-258
OBJECTIVE--To investigate if extracts of Hypericum perforatum (St John''s wort) are more effective than placebo in the treatment of depression, are as effective as standard antidepressive treatment, and have fewer side effects than standard antidepressant drugs. DESIGN--Systematic review and meta-analysis of trials revealed by searches. TRIALS--23 randomised trials including a total of 1757 outpatients with mainly mild or moderately severe depressive disorders: 15 (14 testing single preparations and one a combination with other plant extracts) were placebo controlled, and eight (six testing single preparations and two combinations) compared hypericum with another drug treatment. MAIN OUTCOME MEASURES--A pooled estimate of the responder rate ratio (responder rate in treatment group/responder rate in control group), and numbers of patients reporting and dropping out for side effects. RESULTS--Hypericum extracts were significantly superior to placebo (ratio = 2.67; 95% confidence interval 1.78 to 4.01) and similarly effective as standard antidepressants (single preparations 1.10; 0.93 to 1.31, combinations 1.52; 0.78 to 2.94). There were two (0.8%) drop outs for side effects with hypericum and seven (3.0%) with standard antidepressant drugs. Side effects occurred in 50 (19.8%) patients on hypericum and 84 (52.8%) patients on standard antidepressants. CONCLUSION--There is evidence that extracts of hypericum are more effective than placebo for the treatment of mild to moderately severe depressive disorders. Further studies comparing extracts with standard antidepressants in well defined groups of patients and comparing different extracts and doses are needed. 相似文献
16.
Background
Antidepressants are effective in treating interferon-α/ribavirin (IFN-α/RBV)-associated depression during or after treatment of chronic hepatitis C (CHC). Whether antidepressant prophylaxis is necessary in this population remains under debate.Methods
Comprehensive searches were performed in Medline, Embase, Cochrane Controlled Trials Register and PubMed. Reference lists were searched manually. The methodology was in accordance with the 2009 PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) Statement.Results
We identified six randomized, double-blind, placebo-controlled trials involving 522 CHC patients treated with pegylated (PEG)-IFN-α plus RBV. The antidepressants used were escitalopram, citalopram, and paroxetine, which are selective serotonin reuptake inhibitors (SSRIs). The rates of depression (17.9% vs. 31.0%, P = 0.0005), and rescue therapy (27.4% vs. 42.7%, P<0.0001) in the SSRI group were significantly lower than those in the placebo group. The rate of sustained virological response (SVR) (56.8% vs. 50.0%, P = 0.60) and drug discontinuation (18.7% vs. 21.1%, P = 0.63) in the SSRI group did not differ significantly to those in the placebo group. In terms of safety, the incidence of muscle and joint pain (40.8% vs. 52.4%, P = 0.03) and respiratory problems (29.3% vs. 40.1%, P = 0.03) were lower, but the incidence of dizziness was significantly higher (22.3% vs. 10.2%, P = 0.001) in the SSRI group.Conclusion
Prophylactic SSRI antidepressants can significantly reduce the incidence of PEG-IFN-α/RBV-associated depression in patients with CHC, with good safety and tolerability, without reduction of SVR. 相似文献17.
Dorian Deshauer David Moher Dean Fergusson Ester Moher Margaret Sampson Jeremy Grimshaw 《CMAJ》2008,178(10):1293-1301
Background
Selective serotonin reuptake inhibitors are increasingly used in the long-term treatment of depression. Much of the supporting evidence about the effects of these drugs comes from discontinuation trials, a variant of randomized controlled trials whose design is problematic to interpret. We conducted a systematic review to examine the efficacy and acceptability of long-term therapy with selective serotonin reuptake inhibitors relative to placebo in the treatment of unipolar depression.Methods
We identified placebo-controlled randomized trials with a treatment duration of at least 6 months by searching MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials to update a recently published systematic review. Efficacy was defined in terms of response to treatment (50% improvement in depression score relative to baseline) and remission (score of 7 or below on the Hamilton rating scale for depression). Key secondary outcomes included quality of life, return to work, need for additional treatment and self-harm. Overall acceptability was defined in terms of dropouts for any reason over a course of treatment.Results
Of the 2693 records identified initially, we included 6 randomized controlled trials that met our eligibility criteria. These studies had a moderate risk of bias, had assigned a total of 1299 participants with depression to either treatment or placebo and had followed both groups for 6–8 months. We observed statistically significant improvements in response to treatment (odds ratio [OR] 1.66, 95% confidence interval [CI] 1.12–2.48), but not in remission (OR 1.46, 95% CI 0.92–2.32) or acceptability (OR 0.87, 95% CI 0.67–1.14). The effects appeared greater among patients without comorbidities.Interpretation
There is a lack of classic randomized controlled trials of serotonin reuptake inhibitors lasting more than 1 year for the treatment of depression. The results of our systematic review support current recommendations for 6–8 months of antidepressant treatment following initial recovery but provide no guidance for longer treatment.Over the past decade, the use of selective serotonin reuptake inhibitors for the management of depression has increased dramatically, and preliminary evidence suggests that long-term use, for more than 1 or 2 years, accounts for much of this rise.1–3 Clinical practice guidelines generally recommend a 6- to 9-month course following initial recovery after a first episode of depression and longer, sometimes indefinite, therapy after subsequent episodes, to prevent relapse.4–10Long-term randomized controlled trials of antidepressants have typically used 1 of 2 possible designs, each answering different questions (Figure 1).11 The most widely used design is called the “discontinuation trial,” a 2-phase study in which all participants are initially treated with an open (unblinded) course of drug therapy. Participants attaining a certain response during the open-treatment phase enter the second phase, during which they are randomly assigned to continue active drug treatment or to receive placebo.12–14 Discontinuation trials are believed to minimize the number of participants with depression who must be exposed to placebo. This advantage comes at a cost, since the results apply only to patients with a response to the medication, not to those who experience spontaneous recovery; furthermore, withdrawal symptoms may lead to an overestimate of the true effect of the medication. When this design is used to test long-term therapy with selective serotonin reuptake inhibitors for the treatment of depression, the results are difficult to interpret with confidence because rates of spontaneous recovery in depression are potentially high and because withdrawal effects can mimic depression.13–15Open in a separate windowFigure 1: Two designs of randomized controlled trials used to investigate long-term antidepressant therapy.The second type of randomized trial used to test long-term therapy with selective serotonin reuptake inhibitors is a 2-arm parallel randomized controlled trial, hereafter referred to as a classic randomized controlled trial (Figure 1).16 In this type of trial, participants with acute depression are assigned to receive either placebo or active drug, and all those achieving a certain response, either to the drug or to the placebo, are followed. The advantage of classic randomized controlled trials is that data from all participants contribute to our understanding of the drug''s real-world effectiveness. Their main drawback is that a greater number of acutely ill people may have to receive placebo than in a discontinuation trial.13 Most classic trials of antidepressants are short-term studies. Fergusson and colleagues,17 in a systematic review examining selective serotonin reuptake inhibitors and suicide, identified 702 classic trials involving a total of 18 413 participants, the majority of which (93%) lasted less than 6 months.A recent systematic review based mainly on studies with discontinuation designs showed that, in a subgroup of patients who experienced recovery while taking medications, long-term therapy with selective serotonin reuptake inhibitors reduced the chances of relapse by up to 70% for up to 36 months, relative to patients whose therapy was discontinued earlier.6 However, there has been no systematic review of classic randomized trials of long-term therapy with this drug class to determine the potential benefits in all patients with depression, including those with spontaneous recovery.We sought to examine the efficacy and acceptability of long-term therapy with selective serotonin reuptake inhibitors relative to placebo in the treatment of moderate to severe depression, including subgroups of patients with major chronic health conditions. We also examined a number of key indicators of the quality of evidence and its clinical importance. 相似文献18.
19.
Background
Although previous meta-analyses have examined effects of antidepressants, psychotherapy, and alternative therapies for depression, the efficacy of these treatments alone and in combination has not been systematically compared. We hypothesized that the differences between approved depression treatments and controls would be small.Methods and Findings
The authors first reviewed data from Food and Drug Administration Summary Basis of Approval reports of 62 pivotal antidepressant trials consisting of data from 13,802 depressed patients. This was followed by a systematic review of data from 115 published trials evaluating efficacy of psychotherapies and alternative therapies for depression. The published depression trials consisted of 10,310 depressed patients. We assessed the percentage symptom reduction experienced by the patients based on treatment assignment. Overall, antidepressants led to greater symptom reduction compared to placebo among both unpublished FDA data and published trials (F = 38.5, df = 239, p<0.001). In the published trials we noted that the magnitude of symptom reduction with active depression treatments compared to controls was significantly larger when raters evaluating treatment effects were un-blinded compared to the trials with blinded raters (F = 2.17, df = 313, p<0.05). In the blinded trials, the combination of antidepressants and psychotherapy provided a slight advantage over antidepressants (p = 0.027) and psychotherapy (p = 0.022) alone. The magnitude of symptom reduction was greater with psychotherapies compared to placebo (p = 0.019), treatment-as-usual (p = 0.012) and waiting-list (p<0.001). Differences were not seen with psychotherapy compared to antidepressants, alternative therapies or active intervention controls.Conclusions
In conclusion, the combination of psychotherapy and antidepressants for depression may provide a slight advantage whereas antidepressants alone and psychotherapy alone are not significantly different from alternative therapies or active intervention controls. These data suggest that type of treatment offered is less important than getting depressed patients involved in an active therapeutic program. Future research should consider whether certain patient profiles might justify a specific treatment modality. 相似文献20.