Randomised, double-blind, placebo-controlled trials of non-individualised homeopathic treatment: systematic review and meta-analysis

Background: A rigorous systematic review and meta-analysis focused on randomised controlled trials (RCTs) of non-individualised homeopathic treatment has not previously been reported. We tested the null hypothesis that the main outcome of treatment using a non-individualised (standardised) homeopathic medicine is indistinguishable from that of placebo. An additional aim was to quantify any condition-specific effects of non-individualised homeopathic treatment. Methods: Literature search strategy, data extraction and statistical analysis all followed the methods described in a pre-published protocol. A trial comprised ‘reliable evidence’ if its risk of bias was low or it was unclear in one specified domain of assessment. ‘Effect size’ was reported as standardised mean difference (SMD), with arithmetic transformation for dichotomous data carried out as required; a negative SMD indicated an effect favouring homeopathy. Results: Forty-eight different clinical conditions were represented in 75 eligible RCTs. Forty-nine trials were classed as ‘high risk of bias’ and 23 as ‘uncertain risk of bias’; the remaining three, clinically heterogeneous, trials displayed sufficiently low risk of bias to be designated reliable evidence. Fifty-four trials had extractable data: pooled SMD was –0.33 (95% confidence interval (CI) –0.44, –0.21), which was attenuated to –0.16 (95% CI –0.31, –0.02) after adjustment for publication bias. The three trials with reliable evidence yielded a non-significant pooled SMD: –0.18 (95% CI –0.46, 0.09). There was no single clinical condition for which meta-analysis included reliable evidence. Conclusions: The quality of the body of evidence is low. A meta-analysis of all extractable data leads to rejection of our null hypothesis, but analysis of a small sub-group of reliable evidence does not support that rejection. Reliable evidence is lacking in condition-specific meta-analyses, precluding relevant conclusions. Better designed and more rigorous RCTs are needed in order to develop an evidence base that can decisively provide reliable effect estimates of non-individualised homeopathic treatment

Ein Interview zur Erfassung sozialer Ängste unter Einbeziehung von Körpersymptomen

Die Brief Social Phobia Scale – German version (BSPS-G) ist ein Kurzinterview zum Screening sozialer Ängste. Dabei werden Schwere oder Verlauf einer bereits diagnostizierten sozialen Angststörung erfasst. Im Folgenden wird der Hintergrund dargelegt und eine Kurzbeschreibung des englischsprachigen Originals (BSPS) gegeben: Die soziale Phobie ist gekennzeichnet durch ausgeprägte und anhaltende Angst, sich in sozialen oder Leistungssituationen peinlich zu verhalten, gedemütigt zu werden oder bestimmte Körpersymptome zu zeigen (Diagnostisches und Statistisches Manual psychischer Störungen, DSM-IV-TR [Saß et al., 2003]). Die Prävalenzraten liegen zwischen 6,7% [Fehm et al., 2005] und 12,1% [Kessler et al., 2005] und bei bis zu 25% für subklinische Ängste, die in Schwere und Beeinträchtigung häufig dem Vollbild ähnlich sind [Beesdo et al., 2007; Knappe et al., 2009]. Zur diagnostischen Erfassung der sozialen Phobie liegen zahlreiche Selbsteinschätzungsverfahren vor, aber kaum Fremdbeurteilungsverfahren [Mitte et al., 2007]. Als Interviewverfahren hat sich die Liebowitz Skala (Liebowitz Soziale Angst Skala, LSAS) [Stangier und Heidenreich, 2005] etabliert. Die BSPS hat demgegenüber die Vorteile, dass sie viel ökonomischer ist und explizit typische Körpersymptome erfasst, die soziale Ängste sowohl begleiten als auch auslösen können. Die Validierung der englischsprachigen Originalversion der BSPS zeigte sehr gute Kennwerte für die Test-Retest-Reliabilität (rtt = 0,91) und die interne Konsistenz (Cronbachs α = 0,82) sowie gute konvergente und diskriminante Validität und Änderungssensitivität. Als Cut-Off-Wert wurde ein Summenwert von 20 Punkten bestimmt [Davidson et al., 1997].Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG-geförderten) Allianz- bzw. Nationallizenz frei zugänglich

Association of Anxiety and Depression With All‐Cause Mortality in Individuals With Coronary Heart Disease

BACKGROUND: Depression has been related to mortality in coronary heart disease (CHD) patients, but few studies have evaluated the role of anxiety or the role of the co‐occurrence of depression and anxiety. We examined whether anxiety is associated with increased risk of mortality after accounting for depression in individuals with established CHD. METHODS AND RESULTS: The cohort was composed of 934 men and women with confirmed CHD (mean age, 62±11 years) who completed the Hospital Anxiety and Depression scale (HADS) during hospitalization for coronary angiography. Over the 3‐year follow‐up period, there were 133 deaths. Elevated scores on the HADS anxiety subscale (HADS‐A≥8) were associated with increased risk of mortality after accounting for established risk factors including age, congestive heart failure, left ventricular ejection fraction, 3‐vessel disease, and renal disease (hazard ratio [HR], 2.27; 95% CI, 1.55 to 3.33; P<0.001). Elevated scores on the HADS depression subscale (HADS‐D≥8) were also associated with increased risk of mortality (HR, 2.18; 95% CI, 1.47 to 3.22; P<0.001). When both psychosocial factors were included in the model, each maintained an association with mortality (anxiety, HR, 1.83; 95% CI, 1.18 to 2.83; P=0.006; depression, HR, 1.66; 95% CI, 1.06 to 2.58; P=0.025). Estimation of the HR for patients with both anxiety and depression versus those with neither revealed a larger HR than for patients with either factor alone (HR, 3.10; 95% CI, 1.95 to 4.94; P<0.001). CONCLUSIONS: Anxiety is associated with increased risk of mortality in CHD patients, particularly when comorbid with depression. Future studies should focus on the co‐occurrence of these psychosocial factors as markers of increased mortality risk

Duloxetine treatment for relapse prevention in adults with generalized anxiety disorder: A double-blind placebo-controlled trial

The objective was to examine duloxetine 60–120mg/day treatment for relapse prevention in adults with generalized anxiety disorder (GAD). Adult patients (N=887; mean age=43.3 years; 61.0% female) with DSM-IV-TR-defined GAD diagnosis were treated with duloxetine for 26 weeks. Patients who completed open-label phase and were treatment responders (≥50% reduction in Hamilton Anxiety Rating Scale total score to ≤11 and “much”/“very much improved” ratings for the last 2 visits of open-label phase) were randomly assigned to receive duloxetine or placebo for a 26-week double-blind continuation phase. Relapse was defined as ≥2-point increase in illness severity ratings or by discontinuation due to lack of efficacy. During the double-blind phase, placebo-treated patients (N=201) relapsed more frequently (41.8%) than duloxetine-treated patients (13.7%, N=204, P≤0.001) and worsened on each outcome measure (P≤0.001, all comparisons). Duloxetine 60–120 mg/day treatment was efficacious and reduced risk of relapse in patients with GAD

Fluoxetine, comprehensive cognitive behavioral therapy, and placebo in generalized social phobia

Background: Generalized social phobia is common, persistent, and disabling and is often treated with selective serotonin reuptake inhibitor drugs or cognitive behavioral therapy. Objective: We compared fluoxetine (FLU), comprehensive cognitive behavioral group therapy (CCBT), placebo (PBO), and the combinations of CCBT/FLU and CCBT/PBO. Design: Randomized, double-blind, placebo-controlled trial. Setting: Two academic outpatient psychiatric centers. Patients: Subjects meeting a primary diagnosis of generalized social phobia were recruited via advertisement. Seven hundred twenty-two were screened, and 295 were randomized and available for inclusion in an intention-to-treat efficacy analysis; 156 (52.9%) were male, 226 (76.3%) were white, and mean age was 37.1 years. Interventions: Treatment lasted for 14 weeks. Fluoxetine and PBO were administered at doses from 10 mg/d to 60 mg/d (or equivalent). Group comprehensive cognitive behavioral therapy was administered weekly for 14 sessions. Main Outcome Measures: An independent blinded evaluator assessed response with the Brief Social Phobia Scale and Clinical Global Impressions scales as primary outcomes. A videotaped behavioral assessment served as a secondary outcome, using the Subjective Units of Distress Scale. Adverse effects were measured by self-rating. Each treatment was compared by means of 2 tests and piecewise linear mixed-effects models. Results: Clinical Global Impressions scales response rates in the intention-to-treat sample were 29 (50.9%) (FLU), 31 (51.7%) (CCBT), 32 (54.2%) (CCBT/FLU), 30 (50.8%) (CCBT/PBO), and 19 (31.7%) (PBO), with all treatments being significantly better than PBO. On the Brief Social Phobia Scale, all active treatments were superior to PBO. In the linear mixed-effects models analysis, FLU was more effective than CCBT/FLU, CCBT/PBO, and PBO at week 4; CCBT was also more effective than CCBT/FLU and CCBT/PBO. By the final visit, all active treatments were superior to PBO but did not differ from each other. Site effects were found for the Subjective Units of Distress Scale assessment, with FLU and CCBT/FLU superior to PBO at Duke University Medical Center, Durham, NC. Treatments were well tolerated. Conclusions: All active treatments were superior to PBO on primary outcomes. Combined treatment did not yield any further advantage. Notwithstanding the benefits of treatment, many patients remained symptomatic after 14 weeks. <br/

Moclobemide in Social Phobia: A Controlled Dose-Response Trial

Although the monoamine oxidase inhibitor phenelzine has proven efficacious in social phobia, the risk of hypertensive crises has reduced its acceptability. The reversible monoamine oxidase inhibitor moclobemide has less potential for such reactions, but; its efficacy in this disorder remains unproven. A double-blind, placebo-controlled study was undertaken to assess the efficacy and safety of fixed doses of moclobemide. After a 1-week placebo run-in, subjects with social phobia were randomly assigned to placebo or one of five doses (75 mg, 150 mg, 300 mg, 600 mg, or 900 mg daily) of moclobemide for 12 weeks. Although a trend toward greater efficacy of higher doses of moclobemide was observed at 8 weeks, no differences in response to various doses of the drug and placebo were observed at 12 weeks. At 12 weeks, 35% of subjects on 900 mg of moclobemide and 33% of those on placebo were at least much improved. Moclobemide was well tolerated, insomnia being the only dose-related adverse event observed with the drug. In this dose-response trial, moclobemide did not demonstrate efficacy at; 12 weeks. Some other controlled studies have found moclobemide and brofaromine, another reversible monoamine oxidase inhibitor, efficacious in social phobia. Possible reasons for inconsistent findings are discussed

Modifizierung wasserverduennbarer organischer Beschichtungsstoffe durch Korrosioninhibitoren und experimenteller Nachweis ihrer Wirksamkeit Abschlussbericht

SIGLEAvailable from TIB Hannover: F95B47+a / FIZ - Fachinformationszzentrum Karlsruhe / TIB - Technische InformationsbibliothekBundesministerium fuer Forschung und Technologie (BMFT), Bonn (Germany)DEGerman