Placebos without Deception: A Randomized Controlled Trial in Irritable Bowel Syndrome
Publication Date
December 22, 2010
Journal
PLOS ONE
Authors
Ted J. Kaptchuk, Elizabeth Friedlander, John M. Kelley, M. Norma Sanchez, et al
Volume
5
Issue
12
Pages
e15591
DOI
http://doi.org/10.1371/journal.pone.0015591
Publisher URL
http://journals.plos.org/plosone/article?id=10.1371%2Fjournal.pone.0015591
PubMed
http://www.ncbi.nlm.nih.gov/pubmed/21203519
PubMed Central
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3008733
Europe PMC
http://europepmc.org/abstract/MED/21203519
Web of Science
000285578000036
Scopus
78650988467
Mendeley
http://www.mendeley.com/research/placebos-without-deception-randomized-controlledtrial-irritable-bowel-syndrome
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{"title"=>"Placebos without deception: A randomized controlledtrial in irritable bowel syndrome", "type"=>"journal", "authors"=>[{"first_name"=>"Ted J.", "last_name"=>"Kaptchuk", "scopus_author_id"=>"26643513100"}, {"first_name"=>"Elizabeth", "last_name"=>"Friedlander", "scopus_author_id"=>"26322966900"}, {"first_name"=>"John M.", "last_name"=>"Kelley", "scopus_author_id"=>"26642973000"}, {"first_name"=>"M. Norma", "last_name"=>"Sanchez", "scopus_author_id"=>"57198646961"}, {"first_name"=>"Efi", "last_name"=>"Kokkotou", "scopus_author_id"=>"6603579594"}, {"first_name"=>"Joyce P.", "last_name"=>"Singer", "scopus_author_id"=>"23493947900"}, {"first_name"=>"Magda", "last_name"=>"Kowalczykowski", "scopus_author_id"=>"35734171300"}, {"first_name"=>"Franklin G.", "last_name"=>"Miller", "scopus_author_id"=>"55480107500"}, {"first_name"=>"Irving", "last_name"=>"Kirsch", "scopus_author_id"=>"7102863523"}, {"first_name"=>"Anthony J.", "last_name"=>"Lembo", "scopus_author_id"=>"26426421700"}], "year"=>2010, "source"=>"PLoS ONE", "identifiers"=>{"pmid"=>"21203519", "doi"=>"10.1371/journal.pone.0015591", "sgr"=>"78650988467", "isbn"=>"0022-5282", "scopus"=>"2-s2.0-78650988467", "issn"=>"19326203", "pui"=>"361059708"}, "id"=>"452d1e38-3db1-3da4-abb5-3aa71400b10b", "abstract"=>"Background: Placebo treatment can significantly influence subjective symptoms. However, it is widely believed that response to placebo requires concealment or deception. We tested whether open-label placebo (non-deceptive and nonconcealed administration) is superior to a no-treatment control with matched patient-provider interactions in the treatment of irritable bowel syndrome (IBS). Methods: Two-group, randomized, controlled three week trial (August 2009-April 2010) conducted at a single academic center, involving 80 primarily female (70%) patients, mean age 47+/-18 with IBS diagnosed by Rome III criteria and with a score >=150 on the IBS Symptom Severity Scale (IBS-SSS). Patients were randomized to either open-label placebo pills presented as ''placebo pills made of an inert substance, like sugar pills, that have been shown in clinical studies to produce significant improvement in IBS symptoms through mind-body self-healing processes'' or no-treatment controls with the same quality of interaction with providers. The primary outcome was IBS Global Improvement Scale (IBS-GIS). Secondary measures were IBS Symptom Severity Scale (IBS-SSS), IBS Adequate Relief (IBS-AR) and IBS Quality of Life (IBS-QoL). Findings: Open-label placebo produced significantly higher mean (+/-SD) global improvement scores (IBS-GIS) at both 11- day midpoint (5.2+/-1.0 vs. 4.0+/-1.1, p", "link"=>"http://www.mendeley.com/research/placebos-without-deception-randomized-controlledtrial-irritable-bowel-syndrome", "reader_count"=>75, "reader_count_by_academic_status"=>{"Unspecified"=>4, "Professor > Associate Professor"=>2, "Researcher"=>11, "Student > Doctoral Student"=>6, "Student > Ph. D. Student"=>14, "Student > Postgraduate"=>7, "Student > Master"=>11, "Other"=>1, "Student > Bachelor"=>11, "Lecturer"=>4, "Lecturer > Senior Lecturer"=>1, "Professor"=>3}, "reader_count_by_user_role"=>{"Unspecified"=>4, "Professor > Associate Professor"=>2, "Researcher"=>11, "Student > Doctoral Student"=>6, "Student > Ph. D. Student"=>14, "Student > Postgraduate"=>7, "Student > Master"=>11, "Other"=>1, "Student > Bachelor"=>11, "Lecturer"=>4, "Lecturer > Senior Lecturer"=>1, "Professor"=>3}, "reader_count_by_subject_area"=>{"Unspecified"=>7, "Biochemistry, Genetics and Molecular Biology"=>3, "Nursing and Health Professions"=>2, "Medicine and Dentistry"=>20, "Agricultural and Biological Sciences"=>7, "Neuroscience"=>4, "Arts and Humanities"=>1, "Psychology"=>25, "Social Sciences"=>5, "Immunology and Microbiology"=>1}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>20}, "Neuroscience"=>{"Neuroscience"=>4}, "Social Sciences"=>{"Social Sciences"=>5}, "Psychology"=>{"Psychology"=>25}, "Immunology and Microbiology"=>{"Immunology and Microbiology"=>1}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>7}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>2}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>3}, "Unspecified"=>{"Unspecified"=>7}, "Arts and Humanities"=>{"Arts and Humanities"=>1}}, "reader_count_by_country"=>{"Canada"=>1, "Germany"=>1}, "group_count"=>3}

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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/810477"], "description"=>"<p>Enrollment Flowchart.</p>", "links"=>[], "tags"=>["public health and epidemiology"], "article_id"=>480840, "categories"=>["Biotechnology"], "users"=>["Ted J. Kaptchuk", "Elizabeth Friedlander", "John M. Kelley", "M. Norma Sanchez", "Efi Kokkotou", "Joyce P. Singer", "Magda Kowalczykowski", "Franklin G. Miller", "Irving Kirsch", "Anthony J. Lembo"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0015591.g001", "stats"=>{"downloads"=>3, "page_views"=>5, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Enrollment_Flowchart_/480840", "title"=>"Enrollment Flowchart.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2010-12-22 00:14:00"}
  • {"files"=>["https://ndownloader.figshare.com/files/810742"], "description"=>"<p><b>Note</b>: All values are means ±SD, unless otherwise noted. Group differences were examined using independent t-tests for continuous measures and chi square test for categorical measures.. IBS  =  irritable bowel syndrome; IBS-SSS  =  IBS Symptom Severity Scale; IBS-QOL  =  IBS Quality of Life Scale; GI  =  Gastrointestinal; GERD  =  Gastroesophageal Reflux Disease.</p>", "links"=>[], "tags"=>["baseline"], "article_id"=>481105, "categories"=>["Biotechnology"], "users"=>["Ted J. Kaptchuk", "Elizabeth Friedlander", "John M. Kelley", "M. Norma Sanchez", "Efi Kokkotou", "Joyce P. Singer", "Magda Kowalczykowski", "Franklin G. Miller", "Irving Kirsch", "Anthony J. Lembo"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0015591.t001", "stats"=>{"downloads"=>1, "page_views"=>7, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Demographics_and_Baseline_Characteristics_/481105", "title"=>"Demographics and Baseline Characteristics.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2010-12-22 00:18:25"}
  • {"files"=>["https://ndownloader.figshare.com/files/404383", "https://ndownloader.figshare.com/files/404391"], "description"=>"<div><h3>Background</h3><p>Placebo treatment can significantly influence subjective symptoms. However, it is widely believed that response to placebo requires concealment or deception. We tested whether open-label placebo (non-deceptive and non-concealed administration) is superior to a no-treatment control with matched patient-provider interactions in the treatment of irritable bowel syndrome (IBS).</p> <h3>Methods</h3><p>Two-group, randomized, controlled three week trial (August 2009-April 2010) conducted at a single academic center, involving 80 primarily female (70%) patients, mean age 47±18 with IBS diagnosed by Rome III criteria and with a score ≥150 on the IBS Symptom Severity Scale (IBS-SSS). Patients were randomized to either open-label placebo pills presented as “placebo pills made of an inert substance, like sugar pills, that have been shown in clinical studies to produce significant improvement in IBS symptoms through mind-body self-healing processes” or no-treatment controls with the same quality of interaction with providers. The primary outcome was IBS Global Improvement Scale (IBS-GIS). Secondary measures were IBS Symptom Severity Scale (IBS-SSS), IBS Adequate Relief (IBS-AR) and IBS Quality of Life (IBS-QoL).</p> <h3>Findings</h3><p>Open-label placebo produced significantly higher mean (±SD) global improvement scores (IBS-GIS) at both 11-day midpoint (5.2±1.0 vs. 4.0±1.1, <em>p</em><.001) and at 21-day endpoint (5.0±1.5 vs. 3.9±1.3, <em>p</em> = .002). Significant results were also observed at both time points for reduced symptom severity (IBS-SSS, <em>p</em> = .008 and <em>p</em> = .03) and adequate relief (IBS-AR, <em>p</em> = .02 and <em>p</em> = .03); and a trend favoring open-label placebo was observed for quality of life (IBS-QoL) at the 21-day endpoint (<em>p</em> = .08).</p> <h3>Conclusion</h3><p>Placebos administered without deception may be an effective treatment for IBS. Further research is warranted in IBS, and perhaps other conditions, to elucidate whether physicians can benefit patients using placebos consistent with informed consent.</p> <h3>Trial Registration</h3><p>ClinicalTrials.gov <a href=\"http://www.clinicaltrials.gov/ct2/show/NCT01010191\">NCT01010191</a></p> </div>", "links"=>[], "tags"=>["placebos", "randomized", "controlled", "irritable", "bowel"], "article_id"=>139914, "categories"=>["Biotechnology"], "users"=>["Ted J. Kaptchuk", "Elizabeth Friedlander", "John M. Kelley", "M. Norma Sanchez", "Efi Kokkotou", "Joyce P. Singer", "Magda Kowalczykowski", "Franklin G. Miller", "Irving Kirsch", "Anthony J. Lembo"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0015591.s001", "https://dx.doi.org/10.1371/journal.pone.0015591.s002"], "stats"=>{"downloads"=>28, "page_views"=>18, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Placebos_without_Deception_A_Randomized_Controlled_Trial_in_Irritable_Bowel_Syndrome/139914", "title"=>"Placebos without Deception: A Randomized Controlled Trial in Irritable Bowel Syndrome", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2010-12-22 02:45:14"}
  • {"files"=>["https://ndownloader.figshare.com/files/810628"], "description"=>"<p>Outcomes at the 21-Day Endpoint by Treatment Group.</p>", "links"=>[], "tags"=>["21-day", "endpoint"], "article_id"=>480987, "categories"=>["Biotechnology"], "users"=>["Ted J. Kaptchuk", "Elizabeth Friedlander", "John M. Kelley", "M. Norma Sanchez", "Efi Kokkotou", "Joyce P. Singer", "Magda Kowalczykowski", "Franklin G. Miller", "Irving Kirsch", "Anthony J. Lembo"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0015591.g002", "stats"=>{"downloads"=>2, "page_views"=>7, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Outcomes_at_the_21_Day_Endpoint_by_Treatment_Group_/480987", "title"=>"Outcomes at the 21-Day Endpoint by Treatment Group.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2010-12-22 00:16:27"}
  • {"files"=>["https://ndownloader.figshare.com/files/810699"], "description"=>"<p><b>Note</b>: All values are means ±SD except where noted. IBS  =  irritable bowel syndrome; IBS-GIS  =  IBS Global Improvement Scale; IBS-AR  =  IBS Adequate Relief; IBS-SSS  =  IBS Symptom Severity Scale; IBS-QoL  =  IBS Quality of Life Scale.</p>", "links"=>[], "tags"=>["public health and epidemiology"], "article_id"=>481068, "categories"=>["Biotechnology"], "users"=>["Ted J. Kaptchuk", "Elizabeth Friedlander", "John M. Kelley", "M. Norma Sanchez", "Efi Kokkotou", "Joyce P. Singer", "Magda Kowalczykowski", "Franklin G. Miller", "Irving Kirsch", "Anthony J. Lembo"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0015591.t002", "stats"=>{"downloads"=>1, "page_views"=>10, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Treatment_Outcomes_/481068", "title"=>"Treatment Outcomes.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2010-12-22 00:17:48"}

PMC Usage Stats | Further Information

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Relative Metric

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