Adjunctive aripiprazole versus placebo for antipsychotic-induced hyperprolactinemia: meta-analysis of randomized controlled trials

To compare the safety and efficacy of adjunctive aripiprazole versus placebo for antipsychotic-induced hyperprolactinemia. adult patients presenting with antipsychotic-induced hyperprolactinemia diagnosed by prolactin level with or without prolactin-related symptoms. adjunctive aripiprazole vs. adju...

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Veröffentlicht in:PloS one 2013-08, Vol.8 (8), p.e70179
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description To compare the safety and efficacy of adjunctive aripiprazole versus placebo for antipsychotic-induced hyperprolactinemia. adult patients presenting with antipsychotic-induced hyperprolactinemia diagnosed by prolactin level with or without prolactin-related symptoms. adjunctive aripiprazole vs. adjunctive placebo. adverse events and efficacy of treatment. randomized controlled trials. Five randomized controlled trials with a total of 639 patients (326 adjunctive aripiprazole, 313 adjunctive placebo) met the inclusion criteria. Adjunctive aripiprazole was associated with a 79.11% (125/158) prolactin level normalization rate. Meta-analysis of insomnia, headache, sedation, psychiatric disorder, extrapyramidal symptom, dry mouth, and fatigue showed no significant differences in the adjunctive aripiprazole treatment group compared with the placebo group (risk difference (Mantel-Haenszel, random or fixed) -0.05 to 0.04 (95% confidence interval -0.13 to 0.16); I(2) =0% to 68%, P=0.20 to 0.70). However, sedation, insomnia, and headache were more frequent when the adjunctive aripiprazole dose was higher than 15 mg/day. Meta-analysis of the prolactin level normalization indicated adjunctive aripiprazole was superior to placebo (risk difference (Mantel-Haenszel, random) 0.76 (95% confidence interval 0.67 to 0.85); I(2) =43%, P
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Five randomized controlled trials with a total of 639 patients (326 adjunctive aripiprazole, 313 adjunctive placebo) met the inclusion criteria. Adjunctive aripiprazole was associated with a 79.11% (125/158) prolactin level normalization rate. Meta-analysis of insomnia, headache, sedation, psychiatric disorder, extrapyramidal symptom, dry mouth, and fatigue showed no significant differences in the adjunctive aripiprazole treatment group compared with the placebo group (risk difference (Mantel-Haenszel, random or fixed) -0.05 to 0.04 (95% confidence interval -0.13 to 0.16); I(2) =0% to 68%, P=0.20 to 0.70). However, sedation, insomnia, and headache were more frequent when the adjunctive aripiprazole dose was higher than 15 mg/day. Meta-analysis of the prolactin level normalization indicated adjunctive aripiprazole was superior to placebo (risk difference (Mantel-Haenszel, random) 0.76 (95% confidence interval 0.67 to 0.85); I(2) =43%, P&lt;0.00001). The subgroup analysis confirmed that the subjects who received adjunctive aripiprazole 5 mg/day showed a degree of prolactin normalization similar to that of all participants. No significant differences between groups in discontinuation and improvements of psychiatric symptoms. Adjunctive aripiprazole is both safe and effective as a reasonable choice treatment for patients with antipsychotic-induced hyperprolactinemia. 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Five randomized controlled trials with a total of 639 patients (326 adjunctive aripiprazole, 313 adjunctive placebo) met the inclusion criteria. Adjunctive aripiprazole was associated with a 79.11% (125/158) prolactin level normalization rate. Meta-analysis of insomnia, headache, sedation, psychiatric disorder, extrapyramidal symptom, dry mouth, and fatigue showed no significant differences in the adjunctive aripiprazole treatment group compared with the placebo group (risk difference (Mantel-Haenszel, random or fixed) -0.05 to 0.04 (95% confidence interval -0.13 to 0.16); I(2) =0% to 68%, P=0.20 to 0.70). However, sedation, insomnia, and headache were more frequent when the adjunctive aripiprazole dose was higher than 15 mg/day. Meta-analysis of the prolactin level normalization indicated adjunctive aripiprazole was superior to placebo (risk difference (Mantel-Haenszel, random) 0.76 (95% confidence interval 0.67 to 0.85); I(2) =43%, P&lt;0.00001). The subgroup analysis confirmed that the subjects who received adjunctive aripiprazole 5 mg/day showed a degree of prolactin normalization similar to that of all participants. No significant differences between groups in discontinuation and improvements of psychiatric symptoms. Adjunctive aripiprazole is both safe and effective as a reasonable choice treatment for patients with antipsychotic-induced hyperprolactinemia. 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Tang, Yilang ; Wang, Chuanyue</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c692t-b68f17ae188476d6569a4e7e9e865fb636bb369b4ce6b1df52b6a73533396ca23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Anesthesia</topic><topic>Antipsychotic Agents - adverse effects</topic><topic>Antipsychotics</topic><topic>Archives &amp; records</topic><topic>Aripiprazole</topic><topic>Breast cancer</topic><topic>Care and treatment</topic><topic>Clinical trials</topic><topic>Collaboration</topic><topic>Confidence intervals</topic><topic>Dopamine</topic><topic>Dosage and administration</topic><topic>Drug dosages</topic><topic>Drug therapy</topic><topic>Extrapyramidal system</topic><topic>Fatigue</topic><topic>Headache</topic><topic>Health aspects</topic><topic>Herbal medicine</topic><topic>Humans</topic><topic>Hyperprolactinemia</topic><topic>Hyperprolactinemia - chemically induced</topic><topic>Hyperprolactinemia - drug therapy</topic><topic>Insomnia</topic><topic>Medicine</topic><topic>Mental disorders</topic><topic>Meta-analysis</topic><topic>Patients</topic><topic>Pharmacology</topic><topic>Piperazines - adverse effects</topic><topic>Piperazines - therapeutic use</topic><topic>Placebos</topic><topic>Prolactin</topic><topic>Psychiatry</topic><topic>Psychosis</topic><topic>Psychotropic drugs</topic><topic>Quinolones - adverse effects</topic><topic>Quinolones - therapeutic use</topic><topic>Randomization</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Risk factors</topic><topic>Schizophrenia</topic><topic>Sleep disorders</topic><topic>Studies</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Li, Xianbin</creatorcontrib><creatorcontrib>Tang, Yilang</creatorcontrib><creatorcontrib>Wang, Chuanyue</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Gale In Context: Opposing Viewpoints</collection><collection>Gale In Context: Science</collection><collection>ProQuest Central (Corporate)</collection><collection>Animal Behavior Abstracts</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Biotechnology Research Abstracts</collection><collection>Nursing &amp; 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Five randomized controlled trials with a total of 639 patients (326 adjunctive aripiprazole, 313 adjunctive placebo) met the inclusion criteria. Adjunctive aripiprazole was associated with a 79.11% (125/158) prolactin level normalization rate. Meta-analysis of insomnia, headache, sedation, psychiatric disorder, extrapyramidal symptom, dry mouth, and fatigue showed no significant differences in the adjunctive aripiprazole treatment group compared with the placebo group (risk difference (Mantel-Haenszel, random or fixed) -0.05 to 0.04 (95% confidence interval -0.13 to 0.16); I(2) =0% to 68%, P=0.20 to 0.70). However, sedation, insomnia, and headache were more frequent when the adjunctive aripiprazole dose was higher than 15 mg/day. Meta-analysis of the prolactin level normalization indicated adjunctive aripiprazole was superior to placebo (risk difference (Mantel-Haenszel, random) 0.76 (95% confidence interval 0.67 to 0.85); I(2) =43%, P&lt;0.00001). The subgroup analysis confirmed that the subjects who received adjunctive aripiprazole 5 mg/day showed a degree of prolactin normalization similar to that of all participants. No significant differences between groups in discontinuation and improvements of psychiatric symptoms. Adjunctive aripiprazole is both safe and effective as a reasonable choice treatment for patients with antipsychotic-induced hyperprolactinemia. The appropriate dose of adjunctive aripiprazole may be 5 mg/day.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>23936389</pmid><doi>10.1371/journal.pone.0070179</doi><tpages>e70179</tpages><oa>free_for_read</oa></addata></record>
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subjects Anesthesia
Antipsychotic Agents - adverse effects
Antipsychotics
Archives & records
Aripiprazole
Breast cancer
Care and treatment
Clinical trials
Collaboration
Confidence intervals
Dopamine
Dosage and administration
Drug dosages
Drug therapy
Extrapyramidal system
Fatigue
Headache
Health aspects
Herbal medicine
Humans
Hyperprolactinemia
Hyperprolactinemia - chemically induced
Hyperprolactinemia - drug therapy
Insomnia
Medicine
Mental disorders
Meta-analysis
Patients
Pharmacology
Piperazines - adverse effects
Piperazines - therapeutic use
Placebos
Prolactin
Psychiatry
Psychosis
Psychotropic drugs
Quinolones - adverse effects
Quinolones - therapeutic use
Randomization
Randomized Controlled Trials as Topic
Risk factors
Schizophrenia
Sleep disorders
Studies
Treatment Outcome
title Adjunctive aripiprazole versus placebo for antipsychotic-induced hyperprolactinemia: meta-analysis of randomized controlled trials
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