Ranjbar 2007.
Methods | Randomized controlled trial Duration: 1999‐2001 |
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Participants | Number: 228 patients enrolled Inclusion criteria: (1) brucellosis clinical features including fever, sweats, arthralgia, hepatomegaly, splenomegaly, and/or signs of focal disease with a ≥1/160 standard tube agglutination titer of antibodies to Brucella; or (2) a tissue sample or blood culture positive for Brucella bacteria; or (3) a four‐fold increase in Wright titer in a two‐week interval with compatible clinical findings Exclusion criteria: Pregnant women, children under eight years of age, and patients with endocarditis and neurobrucellosis |
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Interventions | 1‐ doxycycline 100 mg twice a day plus rifampicin 10 mg/kg body weight/day every morning, both taken orally for eight weeks 2‐doxycycline 100 mg twice a day and rifampicin 10 mg/kg body weight/day every morning, both taken orally for eight weeks, plus 7.5 mg/kg amikacin intramuscularly twice a day for seven days. |
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Outcomes | 1‐relapse 2‐therapeutic failure 3‐symptom relief 4‐negative 2ME titer 5‐adverse drug reactions |
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Notes | Location: Sina Hospital, Hamedan, Iran Setting: hospitalised and ambulatory patients Source of funding: not mentioned |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Using a table of random numbers |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding (performance bias and detection bias) All outcomes | High risk | Open study |
Incomplete outcome data (attrition bias) All outcomes | High risk | 114 patients were randomized to each group. In DR group, 3 did not take the drugs correctly, and 1 lost to follow up. In DRA group, 2 did not complete the treatment, and 2 lost to follow up. The proportion of missing outcomes compared with observed event was considerable. |
Selective reporting (reporting bias) | Low risk | Important outcomes were reported |
Other bias | Low risk |