Thomsen 1973.
Methods | Cross‐over trial Number of centres not stated Period of inclusion not stated |
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Participants |
Inclusion criteria
Exclusion criteria Not stated Baseline data: tetracycline 250 mg twice daily vs placebo (n = 40)
Withdrawal: 2 participants stopped taking treatment after 2 courses because of side effects |
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Interventions |
Intervention 1 A: tetracycline 250 mg twice daily (40 participants, cross‐over design) Intervention 2 B: placebo twice daily (40 participants, cross‐over design) Co‐interventions: none Duration of treatment: 12 weeks |
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Outcomes | No primary or secondary outcome pre‐specified
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Notes | Funding: not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "The treatment was randomised in three periods of 4 weeks each. Thus, each patient had one course of tetracycline and two courses of placebo or vice versa. The treatment periods followed immediately upon each other, but the sequence was accidental" Comment: unclear how randomisation was done |
Allocation concealment (selection bias) | Unclear risk | Comment: no information on method to guarantee allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "double blind technique was applied. Tetracycline, 250 mg, and identical‐looking lactose capsules were used, the dosage being one capsule twice daily" Comment: we consider blinding at low risk for trial vs placebo with no obvious clinical adverse events or known specific taste of experimental drug |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "double blind technique was applied" Comment: we consider blinding at low risk for trial vs placebo with no obvious clinical adverse events or known specific taste of experimental drug |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Of the forty patients treated thirty‐eight completed the study. Two patients stopped taking the drug after two courses because of side effects. Nevertheless, these two patients are included in the analysis" Comment: the 2 dropouts were included in the statistical analysis |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol found to guarantee that all planned outcomes are presented in the results |