Pfister 1989.
Methods | Prospective, randomized, parallel‐group, open‐label study with an active comparator, no placebo | |
Participants | Participants had acute painful LNB radiculitis (n = 18) or LNB meningitis (n = 3). The diagnostic criteria included the following1:
See Table 2 and Table 3 for diagnostic criteria and additional baseline characteristics. |
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Interventions | 10‐day treatment with either:
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Outcomes | Neurologic examination was performed daily. Improvement or resolution in the neurological history and physical exam (cranial nerve palsies, pareses of extremities and abdominal muscles, headache, and sensory disturbances) was recorded on day 10 (early outcome) and on average 7.7 months later (longer‐term outcome). The severity of radicular pain was scored daily with a 0‐to‐10 rating system. For evaluation, the medians of the corresponding maximum daily pain scores in the penicillin group (n = 7) were compared with those in the cefotaxime group (n = 8). Trialists recorded the daily dose of analgesics during the 10‐day treatment period and measured the total amount of analgesics taken during the 10‐day treatment period. Investigators performed lumbar puncture prior to (n = 21) and on the 8th to 10th day of treatment (n = 17) and quantified CSF‐WBC, CSF protein, and intrathecal IgG synthesis. They visualized oligoclonal bands and cultured CSF in BSK media. In addition, the investigators measured B. burgdorferi‐specific antibody concentration in serum at randomization and follow‐up. |
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Funding | Not disclosed | |
Conflicts of interest | Not disclosed | |
Notes |
1At the time of the onset of therapy, radicular pain and headache had already subsided in 3 participants with radiculitis and in 1 participant with meningitis, respectively. 6 of 21 participants were seronegative: 6 participants had normal (n = 5) or marginal (n = 1) B. burgdorferi‐specific antibody titers in the serum and normal B. burgdorferi‐specific CSF antibody titers. 4 of these 6 participants had a history of erythema migrans, which was still present in 2 participants at the time of hospital admission. The other 2 seronegative participants (1 participant from each treatment group) had no history of erythema migrans but reported multiple "insect bites" and bites by horseflies within a few weeks prior to the onset of the neurologic disease. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Participants were randomly allocated to treatment groups, but the report does not describe the method of randomization. |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Neither participants nor investigators were blinded to treatment allocation. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcome assessors were not blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The majority of participants returned for longer‐term follow‐up. |
Selective reporting (reporting bias) | Unclear risk | No evidence that all outcomes were prespecified; the pre‐study protocol was not available for review, and the study was not registered prior to initiation. |
Other bias | Low risk | No other bias identified |