Placebo Responses in Genetically Determined Intellectual Disability: A Meta-Analysis
Identifieur interne : 001779 ( Ncbi/Curation ); précédent : 001778; suivant : 001780Placebo Responses in Genetically Determined Intellectual Disability: A Meta-Analysis
Auteurs : Aurore Curie [États-Unis, France] ; Kathy Yang [États-Unis] ; Irving Kirsch [États-Unis, Royaume-Uni] ; Randy L. Gollub [États-Unis] ; Vincent Des Portes [France] ; Ted J. Kaptchuk [États-Unis] ; Karin B. Jensen [États-Unis, Suède]Source :
- PLoS ONE [ 1932-6203 ] ; 2015.
Abstract
Genetically determined Intellectual Disability (ID) is an intractable condition that involves severe impairment of mental abilities such as learning, reasoning and predicting the future. As of today, little is known about the placebo response in patients with ID.
To determine if placebo response exists in patients with genetically determined ID.
We searched Medline/PubMed, EMBASE, CENTRAL and PsycINFO to find all placebo-controlled double-blind randomized clinical trials (RCTs) in patients with genetically determined ID, published up to April 2013, focusing on core ID symptoms.
Two investigators extracted outcome data independently.
Bias-corrected standardized mean difference (Hedge’s
Twenty-two placebo-controlled double-blind RCTs met the inclusion criteria (n = 721, mean age = 17.1 years, 62% men, mean trial duration = 35 weeks). There was a significant overall placebo response from pre- to post-treatment in patients with ID (
Results suggest that patients with genetically determined ID improve in the placebo arm of RCTs. Several mechanisms may contribute to placebo effects in ID, including expectancy, implicit learning and “placebo-by-proxy” induced by clinicians/family members. As the condition is refractory, there is little risk that improvements are explained by spontaneous remission. While new avenues for treatment of genetically determined ID are emerging, our results demonstrate how contextual factors can affect clinical outcomes and emphasize the importance of being vigilant on the role of placebos when testing novel treatments in ID.
Url:
DOI: 10.1371/journal.pone.0133316
PubMed: 26226597
PubMed Central: 4520690
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PMC:4520690Le document en format XML
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<country xml:lang="fr">États-Unis</country>
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<placeName><region type="state">Massachusetts</region>
</placeName>
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<affiliation wicri:level="1"><nlm:aff id="aff007"><addr-line>School of Psychology, Plymouth University, Plymouth, United Kingdom</addr-line>
</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>School of Psychology, Plymouth University, Plymouth</wicri:regionArea>
<wicri:noRegion>Plymouth</wicri:noRegion>
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<author><name sortKey="Gollub, Randy L" sort="Gollub, Randy L" uniqKey="Gollub R" first="Randy L." last="Gollub">Randy L. Gollub</name>
<affiliation wicri:level="2"><nlm:aff id="aff001"><addr-line>Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, Martinos Center for Biomedical Imaging, Boston, Massachusetts, United States of America</addr-line>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, Martinos Center for Biomedical Imaging, Boston, Massachusetts</wicri:regionArea>
<placeName><region type="state">Massachusetts</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Des Portes, Vincent" sort="Des Portes, Vincent" uniqKey="Des Portes V" first="Vincent" last="Des Portes">Vincent Des Portes</name>
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</nlm:aff>
<country xml:lang="fr">France</country>
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</nlm:aff>
<country xml:lang="fr">France</country>
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<wicri:noRegion>Bron</wicri:noRegion>
<wicri:noRegion>Bron</wicri:noRegion>
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<affiliation wicri:level="4"><nlm:aff id="aff004"><addr-line>Université Claude Bernard Lyon1, Lyon, France</addr-line>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Université Claude Bernard Lyon1, Lyon</wicri:regionArea>
<placeName><region type="region">Auvergne-Rhône-Alpes</region>
<region type="old region">Rhône-Alpes</region>
<settlement type="city">Lyon</settlement>
</placeName>
<orgName type="university">Université Claude Bernard Lyon 1</orgName>
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<author><name sortKey="Kaptchuk, Ted J" sort="Kaptchuk, Ted J" uniqKey="Kaptchuk T" first="Ted J." last="Kaptchuk">Ted J. Kaptchuk</name>
<affiliation wicri:level="2"><nlm:aff id="aff006"><addr-line>Program in Placebo Studies, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts, United States of America</addr-line>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Program in Placebo Studies, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts</wicri:regionArea>
<placeName><region type="state">Massachusetts</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Jensen, Karin B" sort="Jensen, Karin B" uniqKey="Jensen K" first="Karin B." last="Jensen">Karin B. Jensen</name>
<affiliation wicri:level="2"><nlm:aff id="aff001"><addr-line>Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, Martinos Center for Biomedical Imaging, Boston, Massachusetts, United States of America</addr-line>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, Martinos Center for Biomedical Imaging, Boston, Massachusetts</wicri:regionArea>
<placeName><region type="state">Massachusetts</region>
</placeName>
</affiliation>
<affiliation wicri:level="2"><nlm:aff id="aff006"><addr-line>Program in Placebo Studies, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts, United States of America</addr-line>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Program in Placebo Studies, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts</wicri:regionArea>
<placeName><region type="state">Massachusetts</region>
</placeName>
</affiliation>
<affiliation wicri:level="3"><nlm:aff id="aff008"><addr-line>Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden</addr-line>
</nlm:aff>
<country xml:lang="fr">Suède</country>
<wicri:regionArea>Department of Clinical Neuroscience, Karolinska Institute, Stockholm</wicri:regionArea>
<placeName><settlement type="city">Stockholm</settlement>
<region nuts="2">Svealand</region>
</placeName>
</affiliation>
</author>
</analytic>
<series><title level="j">PLoS ONE</title>
<idno type="eISSN">1932-6203</idno>
<imprint><date when="2015">2015</date>
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<front><div type="abstract" xml:lang="en"><sec id="sec001"><title>Background</title>
<p>Genetically determined Intellectual Disability (ID) is an intractable condition that involves severe impairment of mental abilities such as learning, reasoning and predicting the future. As of today, little is known about the placebo response in patients with ID.</p>
</sec>
<sec id="sec002"><title>Objective</title>
<p>To determine if placebo response exists in patients with genetically determined ID.</p>
</sec>
<sec id="sec003"><title>Data sources and Study selection</title>
<p>We searched Medline/PubMed, EMBASE, CENTRAL and PsycINFO to find all placebo-controlled double-blind randomized clinical trials (RCTs) in patients with genetically determined ID, published up to April 2013, focusing on core ID symptoms.</p>
</sec>
<sec id="sec004"><title>Data extraction and synthesis</title>
<p>Two investigators extracted outcome data independently.</p>
</sec>
<sec id="sec005"><title>Main outcomes and measures</title>
<p>Bias-corrected standardized mean difference (Hedge’s <italic>g</italic>
) was computed for each outcome measure, using the Comprehensive Meta-Analysis software. A priori defined patient sub-groups were analyzed using a mixed-effect model. The relationship between pre-defined continuous variable moderators (age, IQ, year of publication and trial duration) and effect size was analyzed using meta-regression</p>
</sec>
<sec id="sec006"><title>Results</title>
<p>Twenty-two placebo-controlled double-blind RCTs met the inclusion criteria (n = 721, mean age = 17.1 years, 62% men, mean trial duration = 35 weeks). There was a significant overall placebo response from pre- to post-treatment in patients with ID (<italic>g</italic>
= 0.468, p = 0.002), both for “subjective outcomes” (a third-person’s evaluation of the patient) (<italic>g</italic>
= 0.563, p = 0.022) and “objective outcomes” (direct evaluation of the patient’s abilities) (<italic>g</italic>
= 0.434, p = 0.036). Individuals with higher IQ had higher response to placebo (p = 0.02) and no placebo response was observed in ID patients with comorbid dementia. A significant effect of age (p = 0.02) was found, indicating higher placebo responses in treatment of younger patients.</p>
</sec>
<sec id="sec007"><title>Conclusions and relevance</title>
<p>Results suggest that patients with genetically determined ID improve in the placebo arm of RCTs. Several mechanisms may contribute to placebo effects in ID, including expectancy, implicit learning and “placebo-by-proxy” induced by clinicians/family members. As the condition is refractory, there is little risk that improvements are explained by spontaneous remission. While new avenues for treatment of genetically determined ID are emerging, our results demonstrate how contextual factors can affect clinical outcomes and emphasize the importance of being vigilant on the role of placebos when testing novel treatments in ID.</p>
</sec>
</div>
</front>
<back><div1 type="bibliography"><listBibl><biblStruct></biblStruct>
<biblStruct><analytic><author><name sortKey="Teipel, Sj" uniqKey="Teipel S">SJ Teipel</name>
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<author><name sortKey="Hampel, H" uniqKey="Hampel H">H Hampel</name>
</author>
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<biblStruct><analytic><author><name sortKey="Picker, Jd" uniqKey="Picker J">JD Picker</name>
</author>
<author><name sortKey="Walsh, Ca" uniqKey="Walsh C">CA Walsh</name>
</author>
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