Shao 2014.
Methods | Allocation: randomised. Blindness: not stated. Duration: 6 weeks. |
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Participants | Diagnosis: schizophrenia (CCMD‐3; TCM Diagnostic criteria cited from text book of “TCM Internal Medicine”). N = 200. Age: 17‐62 years. Sex: 107 men 93 women. History: average duration ill ˜ 4 years (SD ˜ 0.8). Inclusion criteria: Aged 17‐62; Patients and their families signed the informed consent. Exclusion criteria: Other diseases or complications; accepted related treatments, and may affect observations; accompanied with situations that may affect observations; serious heart, liver and kidney damage, affect drug metabolism; special groups (pregnant women, lactating women, infants, minors, the elderly, critical condition, terminally ill); patients who were receiving drug treatment, could be included after a washout period. |
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Interventions | 1. WDD (please see details in Table 5) + antipsychotics (Exciting: quetiapine 300 mg to 600 mg twice daily and olanzapine 10 mg to 30 mg twice daily; looks dull, visual hallucinations, auditory hallucinations: perphenazine 20 mg to 40 mg twice daily, risperidone 3 mg to 6 mg twice daily, clozapine 200 mg to 400 mg twice daily.). N = 100. 2. Antipsychotics (Exciting: quetiapine 300 mg to 600 mg twice daily and olanzapine 10 mg to 30 mg twice daily; looks dull, visual hallucinations, auditory hallucinations: perphenazine 20 mg to 40 mg twice daily, risperidone 3 mg to 6 mg twice daily, clozapine 200 mg to 400 mg twice daily). N = 100. | |
Outcomes | Global state: cure (binary 'symptoms disappeared' ‐ all, partly, slightly , no change). Mental state: BPRS total scores. Mental state: PANSS negative subscale score, positive subscale score, and PANSS total score. Adverse effects: RSESE, constipation (dry stool), abnormal liver function. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomly divided in to intervention group and control according to random number table…" |
Allocation concealment (selection bias) | Unclear risk | Not stated. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not stated. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data. |
Selective reporting (reporting bias) | Low risk | We were unable to locate original study protocol, however, all outcomes listed in the 'methods' section of the paper appear to have been measured and reported. |
Other bias | Low risk | No obvious other bias. |