Diener 2002.
Methods | Double‐blind, parallel group RCT, set in Germany | |
Participants | 94 participants (aged 18 to 70 years) who experienced at least 6 muscle cramps in 2 weeks | |
Interventions | Quinine sulphate 400 mg daily or placebo for 2 weeks | |
Outcomes | Cramp number, cramp days, cramp intensity (scale not stated), sleep disturbance (scale not stated), global efficacy rating by participant and doctor (scale not stated), adverse events | |
Notes | Multicentre trial in Germany; participants taken from 17 general practices | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomisation used permuted blocks of four patients stratified by the centre...... when the sealed envelopes were collected and the blind review written, the code was revealed." Comment: probably done |
Allocation concealment (selection bias) | Low risk | Quotes: "All investigators enrolled in the study and all participants were unaware of the treatment allocation, because tablets were identical..."; "A sealed envelope assigning either verum or placebo was available in each centre for each patient..." Comment: probably done |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "...because the quinine and placebo tablets were identical in appearance." |
Incomplete outcome data (attrition bias) All outcomes | High risk | According to the table of results ('Table 2' in the study), there were 6 drop‐outs; none of these are mentioned in the text |
Selective reporting (reporting bias) | Low risk | All outcome measures mentioned in the protocol were addressed in the analysis |
Other bias | Low risk | Trial completed at designated time period. Well‐matched participant characteristics at baseline |