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• W2995347293 abstract "Based on their randomised trial, Gemma Lewis and colleagues1Lewis G Duffy L Ades A et al.The clinical effectiveness of sertraline in primary care and the role of depression severity and duration (PANDA): a pragmatic, double-blind, placebo-controlled randomised trial.Lancet Psychiatry. 2019; 6: 903-914Summary Full Text Full Text PDF PubMed Scopus (55) Google Scholar suggested that SSRIs should be prescribed to a wider group of patients than previously thought, including patients with mild symptoms who do not meet diagnostic criteria for depression or generalised anxiety disorder.1Lewis G Duffy L Ades A et al.The clinical effectiveness of sertraline in primary care and the role of depression severity and duration (PANDA): a pragmatic, double-blind, placebo-controlled randomised trial.Lancet Psychiatry. 2019; 6: 903-914Summary Full Text Full Text PDF PubMed Scopus (55) Google Scholar We are concerned with their interpretation given the trial's methods. First, Lewis and colleagues found no evidence that sertraline reduced depressive symptoms as measured by the Patient Health Questionnaire, 9-item version (PHQ-9) after 6 weeks, which was the trial's primary outcome. They did find statistically significant effects of sertraline on the secondary outcomes of remission from depression, anxiety symptoms, mental health-related quality of life, and self-reported mental health improvements.1Lewis G Duffy L Ades A et al.The clinical effectiveness of sertraline in primary care and the role of depression severity and duration (PANDA): a pragmatic, double-blind, placebo-controlled randomised trial.Lancet Psychiatry. 2019; 6: 903-914Summary Full Text Full Text PDF PubMed Scopus (55) Google Scholar However, these effects were small and might not be clinically important: the adjusted difference between placebo and sertraline was 0·77 points on the Generalised Anxiety Disorder Assessment 7-item version (range 0–21 points) and 2·85 points on the mental health component of the 12-item Short-Form Health Survey after 12 weeks, below a minimum clinically important difference estimated in patients with low back pain.2Díaz-Arribas MJ Fernández-Serrano M Royuela A et al.Minimal clinically important difference in quality of life for patients with low back pain.Spine (Phila Pa 1976). 2017; 42: 1908-1916Crossref PubMed Scopus (78) Google Scholar The outcome of self-reported improvements in mental health was not specified in the trial protocol but added after the study started,1Lewis G Duffy L Ades A et al.The clinical effectiveness of sertraline in primary care and the role of depression severity and duration (PANDA): a pragmatic, double-blind, placebo-controlled randomised trial.Lancet Psychiatry. 2019; 6: 903-914Summary Full Text Full Text PDF PubMed Scopus (55) Google Scholar, 3Salaminios G Duffy L Ades A et al.A randomised controlled trial assessing the severity and duration of depressive symptoms associated with a clinically significant response to sertraline versus placebo, in people presenting to primary care with depression (PANDA trial): study protocol for a randomised controlled trial.Trials. 2017; 18: 496PubMed Google Scholar and the outcome of remission, defined by PHQ-9 scores of 10 or lower, after 12 weeks is problematic given issues with dichotomising continuous scales.4Altman DG Royston P The cost of dichotomising continuous variables.BMJ. 2006; 3321080Crossref PubMed Google Scholar All outcomes were self-reported and susceptible to bias because of unblinding due to well known side-effects of sertraline. This fact can be seen through the finding that more patients on sertraline thought they were taking sertraline than those in the placebo group. Second, Lewis and colleagues reported seven adverse events among the 655 participants in the trial.1Lewis G Duffy L Ades A et al.The clinical effectiveness of sertraline in primary care and the role of depression severity and duration (PANDA): a pragmatic, double-blind, placebo-controlled randomised trial.Lancet Psychiatry. 2019; 6: 903-914Summary Full Text Full Text PDF PubMed Scopus (55) Google Scholar In the trial protocol it was stated that known adverse events were not communicated to the principal investigator and that only adverse events of special interest were recorded in the case report forms.3Salaminios G Duffy L Ades A et al.A randomised controlled trial assessing the severity and duration of depressive symptoms associated with a clinically significant response to sertraline versus placebo, in people presenting to primary care with depression (PANDA trial): study protocol for a randomised controlled trial.Trials. 2017; 18: 496PubMed Google Scholar It is unclear what were considered known adverse events and adverse events of special interest, but we assume that the adverse events reported in the trial publication were those not already known to be associated with sertraline. However, this information was not made available in the trial publication. This way of recording and reporting adverse events gave the impression that adverse events associated with sertraline treatment were rare. However, adverse events with sertraline are common, although there is a paucity of longer-term evidence. We know of only two trials of sertraline for depression that lasted more than 8 weeks, randomly assigning only seven and 19 patients to sertraline, respectively.5Buchsbaum MS Wu J Siegel BV et al.Effect of sertraline on regional metabolic rate in patients with affective disorder.Biol Psychiatry. 1997; 41: 15-22Summary Full Text PDF PubMed Scopus (283) Google Scholar, 6Mao JJ Xie SX Zee J et al.Rhodiola rosea versus sertraline for major depressive disorder: a randomized placebo-controlled trial.Phytomedicine. 2015; 22: 394-399Summary Full Text Full Text PDF PubMed Scopus (67) Google Scholar The PANDA trial, a large and relatively long publicly funded trial, could potentially have provided important evidence about harms associated with sertraline treatment. Considering that the PANDA trial tested sertraline in a novel patient group and the small benefit that could be expected when treating a less ill population, the decision to not investigate harms is surprising—this precludes balancing harms against benefits of sertraline therapy in this study population. We declare no competing interests. The clinical effectiveness of sertraline in primary care and the role of depression severity and duration (PANDA): a pragmatic, double-blind, placebo-controlled randomised trialSertraline is unlikely to reduce depressive symptoms within 6 weeks in primary care but we observed improvements in anxiety, quality of life, and self-rated mental health, which are likely to be clinically important. Our findings support the prescription of SSRI antidepressants in a wider group of participants than previously thought, including those with mild to moderate symptoms who do not meet diagnostic criteria for depression or generalised anxiety disorder. Full-Text PDF Open AccessSertraline in primary care: comments on the PANDA trialGemma Lewis and colleagues1 should be congratulated for conducting the PANDA trial, the largest drug trial of primary care patients with low mood. More importantly, they used the Patient Health Questionnaire, 9-item version (PHQ-9) and Generalised Anxiety Disorder Assessment 7-item version (GAD-7) measures of low mood and anxiety, which can be easily administered in primary care and are commonly used in New Zealand to assess baseline severity to qualify for funding for extended consultations. Therefore, the results of this study are immediately generalisable to a primary care population. Full-Text PDF Sertraline in primary care: comments on the PANDA trial – Authors' replyMichael Hengartner and colleagues and Asger Sand Paludan-Müller and Klaus Munkholm suggest that the effects of sertraline on anxiety and general mental health were too small to be of clinical benefit to patients.1 The figure of 0·77 points quoted by Paludan-Müller and Munkholm is a proportional difference, not a mean difference, and indicates that Generalised Anxiety Disorder Assessment 7-item version (GAD-7) scores were 23% lower at follow-up in those on sertraline compared with placebo. Full-Text PDF Sertraline in primary care: comments on the PANDA trialThe placebo-controlled PANDA trial was negative regarding the effects of sertraline on the primary outcome of depressive symptoms at week 6 (effect size 0·09) and there was only a marginal effect at week 12 (effect size 0·18).1 There was no interaction between sertraline and baseline severity, indicating that sertraline did not lead to a clinically meaningful reduction in depressive symptoms in patients with mild and severe depression. Gemma Lewis and colleagues1 acknowledge this in the discussion: “Many people in our sample had very severe depression, suggesting that there is uncertainty about prescription of antidepressants in primary care at all levels of severity.” Full-Text PDF COVID-19 and mental healthWhile the effects of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on the nervous system remain unclear, there is no doubt that the COVID-19 pandemic is bad for mental health. To alleviate the impact of both the virus and the measures taken to control its spread, we need high quality information about their immediate and long-term effects, and which countermeasures are most effective. The good news is that by October, 2020, mental health was top of the charts in terms of published papers and preprints on the effects of COVID-19. Full-Text PDF" @default.
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• W2995347293 title "Sertraline in primary care: comments on the PANDA trial" @default.
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