Adjunctive aripiprazole vs. placebo for antipsychotic-induced hyperprolactinemia: forest plot for a secondary analysis of insomnia, headache, sedation and forest plot for extrapyramidal symptoms, dry mouth, and fatigue.

<p>Adjunctive aripiprazole vs. placebo for antipsychotic-induced hyperprolactinemia: forest plot for a secondary analysis of insomnia, headache, sedation and forest plot for extrapyramidal symptoms, dry mouth, and fatigue.</p

Risk of bias summary: review authors' judgments about each risk of bias item for each included study.

<p>Risk of bias summary: review authors' judgments about each risk of bias item for each included study.</p

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

<div><p>Objective</p><p>To compare the safety and efficacy of adjunctive aripiprazole versus placebo for antipsychotic-induced hyperprolactinemia.</p><p>Methods</p><p>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.</p><p>Results</p><p>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); I² = 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); I² = 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.</p><p>Conclusion</p><p>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.</p></div

GRADE Analysis: quality assessment of adjunctive aripiprazole versus placebo for antipsychotic-induced hyperprolactinemia.

*<p><b>Decrease quality of evidence:</b> a) single-blind method; b) randomization by the antipsychotic weight; c). I²>50%; <b>^$Increase quality of evidence:</b> d) RR >5 or <0.2; <b>GRADE Working Group grades of evidence: # High quality:</b> Further research is very unlikely to change our confidence in the estimate of effect. <b>Moderate quality:</b> Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. <b>Low quality:</b> Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. <b>Very low quality:</b> We are very uncertain about the estimate.</p

Summary of studies.

<p>Summary of studies.</p

Summary of adverse events and discontinuation.

<p>Summary of adverse events and discontinuation.</p

Individual study.

<p>Individual study.</p