Zemer 1974.
| Methods | RCT. Cross‐over design, 2 months of first treatment and then crossed over to second arm with no washout period. Location: Israel. Single centre. |
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| Participants | 22 participants with FMF. Gender: 4 females, 18 males. |
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| Interventions | Intervention: 0.5 mg oral colchicine 2 times daily for 2 months.
Control: placebo 2 times daily for 2 months.
Treatment 1 for 2 months, then cross‐over to alternate treatment for a further 2 months. No washout period, but have used paired t‐test to account for cross‐over design for the outcome 'number of attacks'. |
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| Outcomes |
Outcomes measured at 1, 2, 3 and 4 months. |
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| Notes | The outcome data, except "number of patients experiencing an attack", could not be distinguished between phase I and II of the cross‐over study. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described. |
| Allocation concealment (selection bias) | Unclear risk | Not described. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "double‐blind". "They (participants) were not informed what drug was being tried or that administration of placebo was part of the program. None of them were known to be on any maintenance therapy or had taken part in a previous drug study". |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The physicians of the follow‐up clinic were responsible for the referral of patients for the study and tabulating their attacks. They had no knowledge of whether the patient was receiving drug or placebo, or of the randomization schedule." |
| Incomplete outcome data (attrition bias) All outcomes | High risk | In the first treatment phase: 3 participants lost to follow‐up, 1 in the colchicine group and 2 in the control group, and no ITT analysis was performed In the whole treatment process: "Of the 22 patients who entered the study, nine failed to complete it." |
| Selective reporting (reporting bias) | Unclear risk | Protocol could not be reviewed; moreover, the methods section did not predefine outcome measurements. |
| Other bias | High risk | Difference in severity of FMF between groups were not described. |
CRP: C‐reactive protein ESR: erythrocyte sedimentation rate FMF: familial Mediterranean fever ITT: intention‐to‐treat MEFV: Mediterranean fever RCT: randomized controlled trial SAA: serum amyloid A protein concentration SD: standard deviation SE: standard error WBC: white blood cell count