Table 5. GRADE Analysis: quality assessment of adjunctive aripiprazole versus placebo for antipsychotic-induced hyperprolactinemia.
Critical outcome | Participants(studies) | Risk ofbias* | Inconsistency * | Largeeffect$ | imprecision | Public bias | Overall quality of evidence# |
Insomnia: All studies | 566(4) | Serious a, b | Serious c | No | No | undetected | +/+/−/−/; low |
Studies with aripiprazole 5 mg/day | 190(2) | Serious a, b | No | No | No | undetected | +/+/+/−/; moderate |
Headache: All studies | 566(4) | Serious a, b | Serious c | No | No | undetected | +/+/−/−/; low |
Studies with aripiprazole 5 mg/day | 190(2) | Serious a, b | No | No | No | undetected | +/+/+/−/; moderate |
Sedation: All studies | 638(5) | Serious a, b | No | No | No | undetected | +/+/+/−/; moderate |
Studies with aripiprazole 5 mg/day | 262(3) | Serious a, b | No | No | No | undetected | +/+/+/−/; moderate |
Psychiatric disorder: | 448(3) | No | Serious c | No | No | undetected | +/+/+/−/; moderate |
Extrapyramidal symptom: | 394(2) | No | No | No | No | undetected | +/+/+/+/; high |
Dry mouth: | 126(2) | No | No | No | No | undetected | +/+/+/+/; high |
Fatigue: | 376(2) | No | No | No | No | undetected | +/+/+/+/; high |
Prolactin level normalization: All studies | 316(4) | Serious a, b | No | Very large d | No | undetected | +/+/+/+/; high |
Studies with aripiprazole 5 mg/day | 262(3) | Serious a, b | Serious c | Very large d | No | undetected | +/+/+/+/; high |
Discontinuation: All studies | 638(5) | Serious a, b | No | No | No | undetected | +/+/+/−/; moderate |
Studies with aripiprazole 5 mg/day | 262(3) | Serious a, b | No | No | No | undetected | +/+/+/−/; moderate |
Decrease quality of evidence: a) single-blind method; b) randomization by the antipsychotic weight; c). I2>50%; $Increase quality of evidence: d) RR >5 or <0.2; GRADE Working Group grades of evidence: # High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: 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. Very low quality: We are very uncertain about the estimate.