Table 1.
Blinding scenarios [13].
Experimental arm (verum) | Control arm (sham) | Possible blinding and clinical effectiveness interpretations | Trials number (%) |
---|---|---|---|
Random guess | Random guess | Ideal, possibly most ideal from the scientific or statistical perspective | 8 (15) |
Random guess | Opposite guess | Rare | 2 (4) |
Random guess | Unblinded | Possibly little treatment effect and completely no effect in control arm | 3 (6) |
Unblinded | Unblinded | Possibly problematic. Treatment effect in experimental arm and no treatment effect in control arm (e.g., patients tend to know what to expect) | 4 (7) |
Unblinded | Opposite guess | Ideal (e.g., patients tend to have wishful thinking, strong placebo effect, and any treatment administered is perceived as real treatment) | 25 (46) |
Unblinded | Random guess | Possibly problematic. Treatment effect in experimental arm and no treatment effect in control arm (e.g., patients do not know what to expect in the absence of treatment) | 12 (22) |
Opposite guess | Opposite guess | Rare | 0 (0) |
Opposite guess | Random guess | Rare | 0 (0) |
Opposite guess | Unblinded | No treatment effect at all; patients may have low expectations | 0 (0) |