Efficacy of selective serotonin reuptake inhibitors and adverse events: meta-regression and mediation analysis of placebo-controlled trials.

BACKGROUND: It has been suggested that the efficacy of antidepressants has been overestimated in clinical trials owing to unblinding of drug treatments by adverse events. AIMS: To investigate the association between adverse events and the efficacy of selective serotonin reuptake inhibitors (SSRIs). METHOD: The literature was searched to identify randomised, double-blind, placebo-controlled trials of SSRIs in the treatment of major depression. Efficacy outcomes were response to treatment and change in depressive symptoms. Reporting of adverse events was used as an indicator of tolerability. Random effects meta-analyses were used to calculate pooled estimates. Meta-regression analyses were performed to investigate the association between adverse events and efficacy. Potential mediation was investigated with the Baron & Kenny approach. RESULTS: A total of 68 trials (n = 17 646) were included in the analyses. In meta-analysis SSRIs were superior to placebo in terms of efficacy (odds ratio, OR = 1.62, 95% CI 1.51-1.72). More patients allocated to SSRIs reported adverse events than did patients receiving placebo (OR = 1.73, 95% CI 1.58-1.89). Meta-regression analyses did not find an association between adverse events and efficacy (P = 0.439). There was no indication of adverse events mediating the effect of SSRI treatment. CONCLUSIONS: Our results do not support, but also do not unequivocally disprove, the hypothesis that adverse events lead to an overestimation of the effect of SSRIs over placebo.

The MOBI-Kids Study Protocol: Challenges in Assessing Childhood and Adolescent Exposure to Electromagnetic Fields from Wireless Telecommunication Technologies and Possible Association with Brain Tumor Risk.

The rapid increase in mobile phone use in young people has generated concern about possible health effects of exposure to radiofrequency (RF) and extremely low frequency (ELF) electromagnetic fields (EMF). MOBI-Kids, a multinational case-control study, investigates the potential effects of childhood and adolescent exposure to EMF from mobile communications technologies on brain tumor risk in 14 countries. The study, which aims to include approximately 1,000 brain tumor cases aged 10-24 years and two individually matched controls for each case, follows a common protocol and builds upon the methodological experience of the INTERPHONE study. The design and conduct of a study on EMF exposure and brain tumor risk in young people in a large number of countries is complex and poses methodological challenges. This manuscript discusses the design of MOBI-Kids and describes the challenges and approaches chosen to address them, including: (1) the choice of controls operated for suspected appendicitis, to reduce potential selection bias related to low response rates among population controls; (2) investigating a young study population spanning a relatively wide age range; (3) conducting a large, multinational epidemiological study, while adhering to increasingly stricter ethics requirements; (4) investigating a rare and potentially fatal disease; and (5) assessing exposure to EMF from communication technologies. Our experience in thus far developing and implementing the study protocol indicates that MOBI-Kids is feasible and will generate results that will contribute to the understanding of potential brain tumor risks associated with use of mobile phones and other wireless communications technologies among young people.

Determinants of inadequate parental sun protection behaviour in their children--results of a cross-sectional study in Germany.

OBJECTIVE: Unprotected sun exposure especially during childhood is a risk factor for skin cancer. A combined use of sun protection measures is recommended to protect children. However, the prevalence and determinants for combined use have been scarcely studied in children. The objective of this study was to identify determinants of parental sun protection behaviour. METHODS: A cross-sectional survey was performed in five regions in Bavaria (Germany) during school entrance health examination (2010/2011). Parents of 4579 children (47% female, aged 5-6 years) completed a self-administered questionnaire (response 61%). RESULTS: Most children were regularly protected with single measures (shade (69%), clothes (80%), hat (83%), sunscreen (89%), sunglasses (20%)). However, regarding regular and combined use, >50% of children were inadequately protected. Larger family size, lower household equivalent income, darker skin and sunburn history were associated with inadequate use of different sun protection measures. The less frequent use of one sun protection measure was associated with less frequent use of the others. Child's sex, migration background, parental education and sun exposure showed inconsistent results regarding the different sun protection outcomes. CONCLUSION: Based on our results a regular, combined and correct use of multiple sun protection for children should be promoted independent of sociodemographic characteristics. Priority of shade, clothes and hat before sunscreen should be clarified.