Summary of findings for the main comparison. Aspirin plus antipsychotics compared to placebo plus antipsychotics for people with schizophrenia.
| Aspirin + antipsychotics compared to placebo + antipsychotics for people with schizophrenia | ||||||
| Patient or population: people with schizophrenia Setting: inpatients and outpatients Intervention: aspirin + antipsychotics Comparison: placebo + antipsychotics | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Risk with placebo + antipsychotics | Risk with aspirin + antipsychotics | |||||
| Global state: any change in global state – unspecified problem necessitating change in dose or type of antipsychotics – medium term | 243 per 1000 | 182 per 1000 (73 to 457) | RR 0.75 (0.30 to 1.88) | 70 (1 RCT) | ⊕⊝⊝⊝ Very lowa,b,c | Data for our predefined outcome, clinically important change in global state, were not reported. Data on global state outcomes were very sparse. This was the only outcome in the global state domain. |
| Mental state: general – mean endpoint score (PANSS total, high = poor) – medium term | — | MD in the intervention group was 6.56 lower (12.04 lower to 1.08 lower) | — | 130 (2 RCTs) | ⊕⊝⊝⊝ Very lowb,c,d | Data for our predefined outcome, clinically important change in mental state were not reported. |
| Cognitive functioning: clinically important change in cognitive functioning | See comment | See comment | — | — | — | Unable to retrieve usable data on this outcome. |
| Leaving the study early: short‐term – for any reason | 105 per 1000 | 118 per 1000 (42 to 331) | RR 1.12 (0.40 to 3.14) | 130 (2 RCTs) | ⊕⊝⊝⊝ Very lowa,b | — |
| Adverse events: gastrointestinal – dyspeptic symptoms – self‐assessed as at least 'moderate' | 405 per 1000 | 418 per 1000 (223 to 786) | RR 1.03 (0.55 to 1.94) | 70 (1 RCT) | ⊕⊝⊝⊝ Very lowa,b | Combined data for self‐assessed 'moderate', 'serious' and 'very serious' symptoms. According to the study's authors, there were no complaints requiring medical attention. Data on adverse events were sparse and reported only in 1 study. |
| Quality of life: clinically important change | — | — | — | — | — | We were unable to retrieve any outcomes related to quality of life. |
| Service use: change in hospital status – any change | 54 per 1000 | 30 per 1000 (3 to 319) | RR 0.56 (0.05 to 5.90) | 70 (1 RCT) | ⊕⊝⊝⊝ Very lowa,b,c | Data for our predefined outcome 'hospital admission' were not reported. |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; MD: mean difference; PANSS: Positive and Negative Symptom Scale; RCT: randomised controlled trial; RR: risk ratio. | ||||||
| GRADE Working Group grades of evidence High quality: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low quality: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low quality: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. | ||||||
aImprecision: downgraded two levels for small sample size or wide confidence intervals, or both. bPublication bias: downgraded one level since a number of unpublished trials were identified in search. Number of trials included for this outcome was very low. cIndirectness: downgraded one level as outcomes were proxy measures of what had been prestipulated within the original protocol for this review. dImprecision: downgraded one level for small sample size.