Comparison 1.
ORAL FLUPHENAZINE versus PLACEBO
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|---|---|---|---|
| 1 Global state: 1. Not improved or worsened | 3 | Risk Ratio (M-H, Fixed, 95% CI) | Subtotals only | |
| 1.1 short term (CGI/MDRS) | 3 | 125 | Risk Ratio (M-H, Fixed, 95% CI) | 0.80 [0.57, 1.12] |
| 1.2 medium term (MDRS) | 1 | 50 | Risk Ratio (M-H, Fixed, 95% CI) | 1.12 [0.79, 1.58] |
| 2 Global state: 2. Relapse | 3 | 124 | Risk Ratio (M-H, Random, 95% CI) | 0.35 [0.07, 1.68] |
| 2.1 short term | 1 | 38 | Risk Ratio (M-H, Random, 95% CI) | 0.25 [0.06, 1.03] |
| 2.2 long term | 2 | 86 | Risk Ratio (M-H, Random, 95% CI) | 0.39 [0.05, 3.31] |
| 3 Global state: 3. Percentage of time in prodrome state (skewed data) | Other data | No numeric data | ||
| 3.1 one-year data | Other data | No numeric data | ||
| 3.2 two-year data | Other data | No numeric data | ||
| 4 Global state: 4. Percentage of time in exacerbated state (skewed data) | Other data | No numeric data | ||
| 4.1 one-year data | Other data | No numeric data | ||
| 4.2 two-year data | Other data | No numeric data | ||
| 5 Global state: 5. average score: CGI - severity of illness score (high = poor) | 1 | Mean Difference (IV, Fixed, 95% CI) | Subtotals only | |
| 5.1 short term | 1 | 36 | Mean Difference (IV, Fixed, 95% CI) | −0.77 [−1.39, −0.15] |
| 6 Leaving the study early: 1. Non-specific reasons | 5 | 363 | Risk Ratio (M-H, Fixed, 95% CI) | 0.73 [0.49, 1.10] |
| 6.1 short term | 2 | 227 | Risk Ratio (M-H, Fixed, 95% CI) | 0.68 [0.43, 1.07] |
| 6.2 medium term | 1 | 50 | Risk Ratio (M-H, Fixed, 95% CI) | 5.0 [0.25, 99.16] |
| 6.3 long term | 2 | 86 | Risk Ratio (M-H, Fixed, 95% CI) | 0.69 [0.24, 1.97] |
| 7 Leaving the study early: 2. Specific reason - short term | 3 | Risk Ratio (M-H, Fixed, 95% CI) | Subtotals only | |
| 7.1 administrative/hospital transfer | 1 | 37 | Risk Ratio (M-H, Fixed, 95% CI) | 1.06 [0.07, 15.64] |
| 7.2 AWOL | 1 | 37 | Risk Ratio (M-H, Fixed, 95% CI) | 1.06 [0.07, 15.64] |
| 7.3 court cases, transfer, eloped | 1 | 190 | Risk Ratio (M-H, Fixed, 95% CI) | 10.65 [1.39, 81.58] |
| 7.4 incorrect diagnosis | 1 | 190 | Risk Ratio (M-H, Fixed, 95% CI) | 1.07 [0.07, 16.78] |
| 7.5 marked early remission | 1 | 190 | Risk Ratio (M-H, Fixed, 95% CI) | 2.13 [0.20, 23.10] |
| 7.6 serious complication of treatment | 1 | 190 | Risk Ratio (M-H, Fixed, 95% CI) | 11.71 [0.66, 208.85] |
| 7.7 severe extrapyramidal effects | 1 | 50 | Risk Ratio (M-H, Fixed, 95% CI) | 3.0 [0.13, 70.30] |
| 7.8 treatment failure | 1 | 190 | Risk Ratio (M-H, Fixed, 95% CI) | 0.11 [0.03, 0.35] |
| 8 Leaving the study early: 3. Marked improvement/ hospital discharge | 1 | Risk Ratio (M-H, Fixed, 95% CI) | Subtotals only | |
| 8.1 discharged due to marked improvement | 1 | 36 | Risk Ratio (M-H, Fixed, 95% CI) | 3.0 [0.13, 69.09] |
| 9 Adverse effects: 1. Anticholinergic effects - short term | 2 | Risk Ratio (M-H, Fixed, 95% CI) | Subtotals only | |
| 9.1 blurred vision | 1 | 37 | Risk Ratio (M-H, Fixed, 95% CI) | 5.26 [0.27, 102.66] |
| 9.2 constipation | 1 | 190 | Risk Ratio (M-H, Fixed, 95% CI) | 2.22 [1.19, 4.15] |
| 9.3 drooling | 1 | 37 | Risk Ratio (M-H, Fixed, 95% CI) | 3.16 [0.14, 72.84] |
| 9.4 dryness mouth or throat | 2 | 227 | Risk Ratio (M-H, Fixed, 95% CI) | 3.62 [1.39, 9.42] |
| 9.5 gastrointestinal distress and nausea | 2 | 227 | Risk Ratio (M-H, Fixed, 95% CI) | 0.90 [0.30, 2.72] |
| 9.6 increased salivation | 1 | 190 | Risk Ratio (M-H, Fixed, 95% CI) | 18.10 [1.06, 309.15] |
| 9.7 nasal congestion | 1 | 37 | Risk Ratio (M-H, Fixed, 95% CI) | 3.16 [0.14, 72.84] |
| 9.8 urinary disturbance | 1 | 190 | Risk Ratio (M-H, Fixed, 95% CI) | 3.20 [0.34, 30.17] |
| 9.9 vomiting | 1 | 190 | Risk Ratio (M-H, Fixed, 95% CI) | 5.32 [0.26, 109.41] |
| 10 Adverse effects: 2. Cardivascular effects - short term | 2 | Risk Ratio (M-H, Fixed, 95% CI) | Subtotals only | |
| 10.1 dizziness, faintness, weakness | 1 | 190 | Risk Ratio (M-H, Fixed, 95% CI) | 2.34 [0.85, 6.49] |
| 10.2 hypotension | 1 | 37 | Risk Ratio (M-H, Fixed, 95% CI) | 3.16 [0.14, 72.84] |
| 10.3 syncope | 1 | 37 | Risk Ratio (M-H, Fixed, 95% CI) | 3.16 [0.14, 72.84] |
| 10.4 tachycardia | 1 | 37 | Risk Ratio (M-H, Fixed, 95% CI) | 3.16 [0.14, 72.84] |
| 11 Adverse effects: 3. CNS - short term | 2 | Risk Ratio (M-H, Fixed, 95% CI) | Subtotals only | |
| 11.1 anxiety, agitation, excitement and confusion | 1 | 37 | Risk Ratio (M-H, Fixed, 95% CI) | 1.06 [0.17, 6.72] |
| 11.2 convulsion or seizures | 1 | 190 | Risk Ratio (M-H, Fixed, 95% CI) | 0.35 [0.01, 8.60] |
| 11.3 depression | 1 | 37 | Risk Ratio (M-H, Fixed, 95% CI) | 0.35 [0.02, 8.09] |
| 11.4 drowsiness | 1 | 190 | Risk Ratio (M-H, Fixed, 95% CI) | 3.91 [1.98, 7.71] |
| 11.5 headache | 1 | 190 | Risk Ratio (M-H, Fixed, 95% CI) | 1.17 [0.52, 2.63] |
| 11.6 sedation and lethargy | 1 | 37 | Risk Ratio (M-H, Fixed, 95% CI) | 1.06 [0.31, 3.60] |
| 12 Adverse effects: 4. Death - long term | 1 | 50 | Risk Ratio (M-H, Fixed, 95% CI) | 2.38 [0.10, 55.72] |
| 13 Adverse effects: 5. Endocrine - short term | 1 | Risk Ratio (M-H, Fixed, 95% CI) | Subtotals only | |
| 13.1 amenorrhea | 1 | 190 | Risk Ratio (M-H, Fixed, 95% CI) | 1.07 [0.27, 4.14] |
| 13.2 lactation | 1 | 190 | Risk Ratio (M-H, Fixed, 95% CI) | 7.45 [0.39, 142.32] |
| 13.3 swelling of breasts | 1 | 190 | Risk Ratio (M-H, Fixed, 95% CI) | 5.32 [0.26, 109.41] |
| 14 Adverse effects: 6a. Extrapyramidal effects - short term | 2 | Risk Ratio (M-H, Fixed, 95% CI) | Subtotals only | |
| 14.1 akinesia | 1 | 37 | Risk Ratio (M-H, Fixed, 95% CI) | 3.16 [0.14, 72.84] |
| 14.2 akathisia | 2 | 227 | Risk Ratio (M-H, Fixed, 95% CI) | 3.43 [1.23, 9.56] |
| 14.3 associated movements | 1 | 37 | Risk Ratio (M-H, Fixed, 95% CI) | 7.37 [0.41, 133.37] |
| 14.4 dystonia | 1 | 190 | Risk Ratio (M-H, Fixed, 95% CI) | 13.84 [0.79, 242.25] |
| 14.5 facial rigidity | 1 | 190 | Risk Ratio (M-H, Fixed, 95% CI) | 2.77 [1.03, 7.46] |
| 14.6 loss of associated movements | 1 | 190 | Risk Ratio (M-H, Fixed, 95% CI) | 6.39 [1.95, 20.98] |
| 14.7 restlessness, insomnia | 2 | 227 | Risk Ratio (M-H, Fixed, 95% CI) | 0.99 [0.69, 1.40] |
| 14.8 rigidity | 2 | 227 | Risk Ratio (M-H, Fixed, 95% CI) | 3.54 [1.76, 7.14] |
| 14.9 tremor | 2 | 227 | Risk Ratio (M-H, Fixed, 95% CI) | 3.19 [1.25, 8.11] |
| 15 Adverse effects: 6b. Extrapyramidal effects - medium term | 1 | Risk Ratio (M-H, Fixed, 95% CI) | Subtotals only | |
| 15.1 akathisia | 1 | 50 | Risk Ratio (M-H, Fixed, 95% CI) | 1.2 [0.42, 3.43] |
| 15.2 akinesia | 1 | 50 | Risk Ratio (M-H, Fixed, 95% CI) | 11.0 [0.64, 188.95] |
| 15.3 dystonia | 1 | 50 | Risk Ratio (M-H, Fixed, 95% CI) | 1.09 [0.92, 1.29] |
| 15.4 parkinsonism | 1 | 50 | Risk Ratio (M-H, Fixed, 95% CI) | 5.5 [1.36, 22.32] |
| 16 Adverse effects: 7. Others - short term | 2 | Risk Ratio (M-H, Fixed, 95% CI) | Subtotals only | |
| 16.1 convulsion or seizures | 1 | 190 | Risk Ratio (M-H, Fixed, 95% CI) | 0.35 [0.01, 8.60] |
| 16.2 diarrhoea | 1 | 190 | Risk Ratio (M-H, Fixed, 95% CI) | 5.32 [0.26, 109.41] |
| 16.3 intercurrent infection | 1 | 190 | Risk Ratio (M-H, Fixed, 95% CI) | 1.07 [0.22, 5.14] |
| 16.4 rash | 2 | 227 | Risk Ratio (M-H, Fixed, 95% CI) | 0.76 [0.15, 3.78] |
| 17 Sensitivity analysis: 1. CHRONIC versus ACUTE | 2 | Risk Ratio (M-H, Fixed, 95% CI) | Subtotals only | |
| 17.1 Acute: Global state - not improved - short term | 1 | 37 | Risk Ratio (M-H, Fixed, 95% CI) | 0.59 [0.24, 1.42] |
| 17.2 Chronic: global state - not improved - short term | 1 | 50 | Risk Ratio (M-H, Fixed, 95% CI) | 0.93 [0.56, 1.55] |
| 18 Sensitivity analysis: 2. LOW DOSES (1-5 mg/day) versus HIGH DOSES (5mg/day>) | 3 | Risk Ratio (M-H, Fixed, 95% CI) | Subtotals only | |
| 18.1 High dose: Global state - not improved - short term | 1 | 38 | Risk Ratio (M-H, Fixed, 95% CI) | 0.79 [0.48, 1.31] |
| 18.2 Flexible dose: Global state - not improved - short term | 2 | 87 | Risk Ratio (M-H, Fixed, 95% CI) | 0.80 [0.51, 1.25] |
| 19 Sensitivity analysis: 3. OPERATIONAL CRITERIA versus LOOSE DEFINITIONS | 3 | Risk Ratio (M-H, Fixed, 95% CI) | Subtotals only | |
| 19.1 DSM-III-R: Global state - not improved - short term | 1 | 38 | Risk Ratio (M-H, Fixed, 95% CI) | 0.79 [0.48, 1.31] |
| 19.2 Loose definition: global state - not improved - short term | 2 | 87 | Risk Ratio (M-H, Fixed, 95% CI) | 0.80 [0.51, 1.25] |
| 20 Sensitivity analysis: 4. BEFORE 1990 versus AFTER 1990 | 3 | Risk Ratio (M-H, Fixed, 95% CI) | Subtotals only | |
| 20.1 Before 1990: Global state - not improved - short term | 2 | 87 | Risk Ratio (M-H, Fixed, 95% CI) | 0.80 [0.51, 1.25] |
| 20.2 After 1990: Global state - not improved - short term | 1 | 38 | Risk Ratio (M-H, Fixed, 95% CI) | 0.79 [0.48, 1.31] |