The Efficacy of Paroxetine and Placebo in Treating Anxiety and Depression: A Meta-Analysis of Change on the Hamilton Rating Scales
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{"title"=>"The efficacy of paroxetine and placebo in treating anxiety and depression: A meta-analysis of change on the Hamilton Rating Scales", "type"=>"journal", "authors"=>[{"first_name"=>"Michael A.", "last_name"=>"Sugarman", "scopus_author_id"=>"53878577600"}, {"first_name"=>"Amy M.", "last_name"=>"Loree", "scopus_author_id"=>"26423789000"}, {"first_name"=>"Boris B.", "last_name"=>"Baltes", "scopus_author_id"=>"6603946465"}, {"first_name"=>"Emily R.", "last_name"=>"Grekin", "scopus_author_id"=>"6508043733"}, {"first_name"=>"Irving", "last_name"=>"Kirsch", "scopus_author_id"=>"7102863523"}], "year"=>2014, "source"=>"PLoS ONE", "identifiers"=>{"pui"=>"373852543", "sgr"=>"84929344180", "issn"=>"19326203", "pmid"=>"25162656", "scopus"=>"2-s2.0-84929344180", "doi"=>"10.1371/journal.pone.0106337", "isbn"=>"1932-6203 (Electronic)\\r1932-6203 (Linking)"}, "id"=>"c7ac1f69-a432-3073-8cc3-5d0ad2a9de69", "abstract"=>"BACKGROUND: Previous meta-analyses of published and unpublished trials indicate that antidepressants provide modest benefits compared to placebo in the treatment of depression; some have argued that these benefits are not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inhibitor (SSRI) in the treatment of both anxiety and depression, using a complete data set of all published and unpublished trials sponsored by the manufacturer.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.", "link"=>"http://www.mendeley.com/research/efficacy-paroxetine-placebo-treating-anxiety-depression-metaanalysis-change-hamilton-rating-scales", "reader_count"=>73, "reader_count_by_academic_status"=>{"Professor > Associate Professor"=>3, "Librarian"=>1, "Researcher"=>10, "Student > Doctoral Student"=>5, "Student > Ph. D. Student"=>6, "Student > Postgraduate"=>6, "Other"=>11, "Student > Master"=>18, "Student > Bachelor"=>10, "Lecturer"=>2, "Professor"=>1}, "reader_count_by_user_role"=>{"Professor > Associate Professor"=>3, "Librarian"=>1, "Researcher"=>10, "Student > Doctoral Student"=>5, "Student > Ph. D. Student"=>6, "Student > Postgraduate"=>6, "Other"=>11, "Student > Master"=>18, "Student > Bachelor"=>10, "Lecturer"=>2, "Professor"=>1}, "reader_count_by_subject_area"=>{"Unspecified"=>2, "Nursing and Health Professions"=>2, "Biochemistry, Genetics and Molecular Biology"=>1, "Mathematics"=>1, "Medicine and Dentistry"=>28, "Agricultural and Biological Sciences"=>5, "Neuroscience"=>4, "Arts and Humanities"=>2, "Pharmacology, Toxicology and Pharmaceutical Science"=>3, "Psychology"=>21, "Social Sciences"=>3, "Economics, Econometrics and Finance"=>1}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>28}, "Neuroscience"=>{"Neuroscience"=>4}, "Social Sciences"=>{"Social Sciences"=>3}, "Psychology"=>{"Psychology"=>21}, "Economics, Econometrics and Finance"=>{"Economics, Econometrics and Finance"=>1}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>5}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>2}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>1}, "Mathematics"=>{"Mathematics"=>1}, "Unspecified"=>{"Unspecified"=>2}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>3}, "Arts and Humanities"=>{"Arts and Humanities"=>2}}, "reader_count_by_country"=>{"Sweden"=>1, "Mexico"=>1, "Spain"=>1}, "group_count"=>3}

Scopus | Further Information

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  • {"files"=>["https://ndownloader.figshare.com/files/1652170"], "description"=>"<p>GSK = GlaxoSmithKline, HRSA = Hamilton Rating Scale for Anxiety, HRSD = Hamilton Rating Scale for Depression. Please refer to the text for more specific information regarding specific exclusion criteria.</p>", "links"=>[], "tags"=>["serotonin reuptake inhibitor", "treatment implications", "ssri", "baseline severity", "Hamilton Rating Scale", "paroxetine response", "anxiety disorder", "FDA Approval", "change scores", "efficacy difference", "panic disorder", "HRSA", "antidepressant efficacy", "HRSD", "placebo", "depression trials"], "article_id"=>1153250, "categories"=>["Biological Sciences"], "users"=>["Michael A. Sugarman", "Amy M. Loree", "Boris B. Baltes", "Emily R. Grekin", "Irving Kirsch"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0106337.g001", "stats"=>{"downloads"=>21, "page_views"=>15, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Trial_selection_Flow_chart_/1153250", "title"=>"Trial selection Flow chart.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-08-27 03:01:01"}
  • {"files"=>["https://ndownloader.figshare.com/files/1652183"], "description"=>"<p>The size of the marker reflects the relative weight of the study in the meta-analysis.</p>", "links"=>[], "tags"=>["serotonin reuptake inhibitor", "treatment implications", "ssri", "baseline severity", "Hamilton Rating Scale", "paroxetine response", "anxiety disorder", "FDA Approval", "change scores", "efficacy difference", "panic disorder", "HRSA", "antidepressant efficacy", "HRSD", "placebo", "depression trials"], "article_id"=>1153263, "categories"=>["Biological Sciences"], "users"=>["Michael A. Sugarman", "Amy M. Loree", "Boris B. Baltes", "Emily R. Grekin", "Irving Kirsch"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0106337.g004", "stats"=>{"downloads"=>3, "page_views"=>31, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Trial_duration_in_weeks_and_the_mean_change_on_the_Hamilton_Rating_Scale_for_Depression_HRSD_/1153263", "title"=>"Trial duration (in weeks) and the mean change on the Hamilton Rating Scale for Depression (HRSD).", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-08-27 03:01:01"}
  • {"files"=>["https://ndownloader.figshare.com/files/1652184"], "description"=>"<p>HRSA = Hamilton Rating Scale for Anxiety. HRSD = Hamilton Rating Scale for Depression. Year: when data collection was initiated. Trials conducted prior to 1991 were submitted for the original FDA approval of the medication. Length: study duration in weeks. GAD = generalized anxiety disorder.</p><p>List of studies.</p>", "links"=>[], "tags"=>["serotonin reuptake inhibitor", "treatment implications", "ssri", "baseline severity", "Hamilton Rating Scale", "paroxetine response", "anxiety disorder", "FDA Approval", "change scores", "efficacy difference", "panic disorder", "HRSA", "antidepressant efficacy", "HRSD", "placebo", "depression trials"], "article_id"=>1153264, "categories"=>["Biological Sciences"], "users"=>["Michael A. Sugarman", "Amy M. Loree", "Boris B. Baltes", "Emily R. Grekin", "Irving Kirsch"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0106337.t001", "stats"=>{"downloads"=>1, "page_views"=>11, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_List_of_studies_/1153264", "title"=>"List of studies.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-08-27 03:01:01"}
  • {"files"=>["https://ndownloader.figshare.com/files/1652193"], "description"=>"<p>Pre-approval and Post-approval refer to whether the trial was included as part of the original approval submission to the FDA (<i>k</i> = 16) or whether it was conducted following FDA approval in 1991 or later (<i>k</i> = 11).</p><p>Moderator effects in trials examining change on the Hamilton Rating Scale for Depression.</p>", "links"=>[], "tags"=>["serotonin reuptake inhibitor", "treatment implications", "ssri", "baseline severity", "Hamilton Rating Scale", "paroxetine response", "anxiety disorder", "FDA Approval", "change scores", "efficacy difference", "panic disorder", "HRSA", "antidepressant efficacy", "HRSD", "placebo", "depression trials"], "article_id"=>1153273, "categories"=>["Biological Sciences"], "users"=>["Michael A. Sugarman", "Amy M. Loree", "Boris B. Baltes", "Emily R. Grekin", "Irving Kirsch"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0106337.t005", "stats"=>{"downloads"=>2, "page_views"=>11, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Moderator_effects_in_trials_examining_change_on_the_Hamilton_Rating_Scale_for_Depression_/1153273", "title"=>"Moderator effects in trials examining change on the Hamilton Rating Scale for Depression.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-08-27 03:01:01"}
  • {"files"=>["https://ndownloader.figshare.com/files/1652192"], "description"=>"<p>“Approval” column designates whether the study was submitted as part of the original approval submission to the FDA or whether it was conducted following FDA approval in 1991 or later. Drug benefit denotes the effect size for paroxetine compared to placebo.</p><p>Baseline scores, mean change, standardized mean change, and sample sizes for all studies reporting change on the Hamilton Rating Scale for Depression.</p>", "links"=>[], "tags"=>["serotonin reuptake inhibitor", "treatment implications", "ssri", "baseline severity", "Hamilton Rating Scale", "paroxetine response", "anxiety disorder", "FDA Approval", "change scores", "efficacy difference", "panic disorder", "HRSA", "antidepressant efficacy", "HRSD", "placebo", "depression trials"], "article_id"=>1153272, "categories"=>["Biological Sciences"], "users"=>["Michael A. Sugarman", "Amy M. Loree", "Boris B. Baltes", "Emily R. Grekin", "Irving Kirsch"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0106337.t004", "stats"=>{"downloads"=>6, "page_views"=>18, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Baseline_scores_mean_change_standardized_mean_change_and_sample_sizes_for_all_studies_reporting_change_on_the_Hamilton_Rating_Scale_for_Depression_/1153272", "title"=>"Baseline scores, mean change, standardized mean change, and sample sizes for all studies reporting change on the Hamilton Rating Scale for Depression.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-08-27 03:01:01"}
  • {"files"=>["https://ndownloader.figshare.com/files/1652279", "https://ndownloader.figshare.com/files/1652281", "https://ndownloader.figshare.com/files/1652282", "https://ndownloader.figshare.com/files/1652283", "https://ndownloader.figshare.com/files/1652286"], "description"=>"<div><p>Background</p><p>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.</p><p>Methods and Findings</p><p>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 (<i>k</i> = 12), the efficacy difference between paroxetine and placebo was modest (<i>d</i> = 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 (<i>d</i> = 0.36) than for generalized anxiety disorder (<i>d</i> = 0.20). Published trials showed significantly larger drug-placebo differences than unpublished trials (<i>d</i>’s = 0.32 and 0.17, respectively). In depression trials (<i>k</i> = 27), the benefit of paroxetine over placebo was consistent with previous meta-analyses of antidepressant efficacy (<i>d</i> = 0.32).</p><p>Conclusions</p><p>The available empirical evidence indicates that paroxetine provides only a modest advantage over placebo in treatment of anxiety and depression. Treatment implications are discussed.</p></div>", "links"=>[], "tags"=>["serotonin reuptake inhibitor", "treatment implications", "ssri", "baseline severity", "Hamilton Rating Scale", "paroxetine response", "anxiety disorder", "FDA Approval", "change scores", "efficacy difference", "panic disorder", "HRSA", "antidepressant efficacy", "HRSD", "placebo", "depression trials"], "article_id"=>1153350, "categories"=>["Biological Sciences"], "users"=>["Michael A. Sugarman", "Amy M. Loree", "Boris B. Baltes", "Emily R. Grekin", "Irving Kirsch"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0106337.s001", "https://dx.doi.org/10.1371/journal.pone.0106337.s002", "https://dx.doi.org/10.1371/journal.pone.0106337.s003", "https://dx.doi.org/10.1371/journal.pone.0106337.s004", "https://dx.doi.org/10.1371/journal.pone.0106337.s005"], "stats"=>{"downloads"=>13, "page_views"=>15, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_The_Efficacy_of_Paroxetine_and_Placebo_in_Treating_Anxiety_and_Depression_A_Meta_Analysis_of_Change_on_the_Hamilton_Rating_Scales_/1153350", "title"=>"The Efficacy of Paroxetine and Placebo in Treating Anxiety and Depression: A Meta-Analysis of Change on the Hamilton Rating Scales", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2014-08-27 03:01:01"}
  • {"files"=>["https://ndownloader.figshare.com/files/1652186"], "description"=>"<p>GAD = generalized anxiety disorder. Drug benefit denotes the effect size for paroxetine compared to placebo.</p><p>Baseline scores, mean change, standardized mean change, and sample sizes for all studies reporting change on the Hamilton Rating Scale for Anxiety.</p>", "links"=>[], "tags"=>["serotonin reuptake inhibitor", "treatment implications", "ssri", "baseline severity", "Hamilton Rating Scale", "paroxetine response", "anxiety disorder", "FDA Approval", "change scores", "efficacy difference", "panic disorder", "HRSA", "antidepressant efficacy", "HRSD", "placebo", "depression trials"], "article_id"=>1153266, "categories"=>["Biological Sciences"], "users"=>["Michael A. Sugarman", "Amy M. Loree", "Boris B. Baltes", "Emily R. Grekin", "Irving Kirsch"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0106337.t002", "stats"=>{"downloads"=>1, "page_views"=>5, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Baseline_scores_mean_change_standardized_mean_change_and_sample_sizes_for_all_studies_reporting_change_on_the_Hamilton_Rating_Scale_for_Anxiety_/1153266", "title"=>"Baseline scores, mean change, standardized mean change, and sample sizes for all studies reporting change on the Hamilton Rating Scale for Anxiety.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-08-27 03:01:01"}

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Relative Metric

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