About this item:

97 Views | 89 Downloads

Author Notes:

E-mail: wcymanu@163.com

Conceived and designed the experiments: CW XL.

Performed the experiments: XL CW.

Analyzed the data: XL CW.

Contributed reagents/materials/analysis tools: XL CW.

Wrote the paper: XL YT.

We wish to thank Prof. Phil Wiffen (Training Director of UK Cochrane Center) and Dr. Jun Xia (Cochrane Schizophrenia Group) for their system review courses.

We wish to thank Dr. Zhirui Zhou (Radiotherapy Department, The Tumor Hospital of Jilin Province) for his comments on the manuscript.

Competing Interests: The authors have declared that no competing interests exist.


Research Funding:

The study was supported by the National Natural Science Foundation of China (81071083).

This study was also funded by the Beijing Science and Technology Commission (D101107047810001 ).

The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.


  • Antipsychotic Agents
  • Aripiprazole
  • Humans
  • Hyperprolactinemia
  • Piperazines
  • Placebos
  • Quinolones
  • Randomized Controlled Trials as Topic
  • Treatment Outcome

Adjunctive Aripiprazole Versus Placebo for Antipsychotic-Induced Hyperprolactinemia: Meta-Analysis of Randomized Controlled Trials


Journal Title:



Volume 8, Number 8


, Pages e70179-e70179

Type of Work:

Article | Final Publisher PDF


Objective:To compare the safety and efficacy of adjunctive aripiprazole versus placebo for antipsychotic-induced hyperprolactinemia.Methods:Population: adult patients presenting with antipsychotic-induced hyperprolactinemia diagnosed by prolactin level with or without prolactin-related symptoms. Interventions: adjunctive aripiprazole vs. adjunctive placebo. Outcome measures: adverse events and efficacy of treatment. Studies: randomized controlled trials.Results: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 < 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.Conclusion: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.

Copyright information:

© 2013 Li et al.

This is an Open Access work distributed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/).
Export to EndNote