Hassanjani Roushan 2010.
Methods | Randomized controlled trial Duration: April 2005 to September 2008 |
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Participants | Number: 164 patients enrolled [2 patients in DS and 1 in DG groups excluded due to spondylitis] Inclusion criteria: Patients > 10 yrs. The diagnosis of brucellosis was made by using standard tube agglutination (STA) titre >= 1:320 and 2‐mercaptoethanol (2ME) titre >= 1:160, together with compatible clinical findings (fever, sweating, arthralgias, peripheral arthritis, sacroiliitis, and epididymo‐orchitis). Exclusion criteria: age of <10 years, spondylitis, endocarditis, neurobrucellosis, pregnancy, and the history of >2 days of antibiotic treatment before enrolment. |
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Interventions | 1‐doxycycline 100 mg orally twice daily for 45 days, plus streptomycin 1g intramuscularly daily for 14 days 2‐doxycycline 100 mg orally twice daily for 8 weeks, plus gentamicin 5 mg/kg/day intramuscularly for 5 days |
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Outcomes | 1‐relapse 2‐therapeutic failure 3‐adverse drug reactions |
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Notes | Location: Babol, Northern Iran Setting: inpatient and outpatient Source of funding: the Infectious Diseases Research Center and Tropical Diseases of Babol Medical University. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Shuffling envelopes |
Allocation concealment (selection bias) | Low risk | "For each patient, a record was drawn and the therapy regimen, which was noted on it, was administered. We could not predict the therapy regimen for any patient." |
Blinding (performance bias and detection bias) All outcomes | High risk | |
Incomplete outcome data (attrition bias) All outcomes | High risk | 82 patients were randomized to each group. Three were excluded due to the diagnosis of spondylitis. Five patients in DS and 2 in DG lost to follow‐ups. The proportion of missing outcomes compared with observed events was considerable. |
Selective reporting (reporting bias) | Low risk | |
Other bias | Low risk |