6. Suggested design for a trial.
Methods | Allocation: randomised, clearly described, concealed.
Blindness: double, described and tested.
Duration: 4‐week washout period + 24 weeks treatment period. Follow‐up: 2 years. |
Participants | Diagnosis: schizophrenia (DSM V) with one TCM type according to TCM diagnosis standard. N = 300*. Age: any. Sex: both. History: duration of schizophrenia over 1 years. |
Interventions | 1. Wendan decoction: N = 150.
2. Sham decoction**: N = 150. The blend of herbs and their dosages clearly described. |
Outcomes | 1. Global state: CGI ‐ clinically important changes. 2. Mental state: BPRS ‐ changes in mental state. 3. Behaviour: clinically important changes in general behaviour. 4. Service outcomes: hospitalisation, time in hospital, time until readmission. 5. Adverse effects: clinically important general adverse effects. 6. Engagement with service: clinically important engagement. 7. Satisfaction with treatment: recipient of care not satisfied with treatment. 8. Quality of life: clinically important changes in quality of life. 9. Economic outcome: costs of care. |
Notes | * Powered to be able to identify a difference of ˜20% between groups for primary outcome with adequate degree of certainty. **In case of administering WDD in the form of decoction, the sham decoction should be mixed with flavourings and edible pigments. Further, we suggested WDD administered in the form of powder into capsule, and placebo in capsule as control, which should be a better way to blind. |
BPRS: Brief Psychiatric Rating Scale CGI: Clinical Global Impression Scale DSM: Diagnostic and Statistical Manual TCM: Traditional Chinese medicine WDD: Wendan decoction