10. Summary of findings table: intravenous cefotaxime compared to intravenous penicillin G for Lyme neuroborreliosis (acute).
Intravenous cefotaxime compared to intravenous penicillin G for Lyme neuroborreliosis (acute) | ||||||
Patient or population: Lyme neuroborreliosis (acute) Settings: Southern Germany, hospital Intervention: intravenous cefotaxime Comparison: intravenous penicillin G | ||||||
Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
Assumed risk or score/value | Corresponding risk or score/value | |||||
Intravenous penicillin G | Intravenous cefotaxime | |||||
Improvement in a measure of overall disability in the long term (3 or more months) following treatment | See comment | See comment | Not estimable | ‐ | See comment | Not reported |
Resolution of the person's presenting neurological deficits in the long term (3 or more months) following treatment1 | 800 per 1000 |
816 per 1000 (536 to 1000) |
RR 1.02 (0.67 to 1.55) | 21 (1 study) | Low2 | Investigators' nonstandardized judgement of improvement or resolution of symptoms reported at 7.7 months. |
Improvement in a measure of overall disability in the short term (2 weeks) following treatment | See comment | See comment | Not estimable | ‐ | See comment | Not reported |
Resolution of CSF pleocytosis following treatment | 1000 per 1000 | 920 per 1000 (710 to 1000) | RR 0.92 (0.71 to 1.18) | 21 (1 study) | Very low3 | Follow‐up: mean 7.7 months |
All adverse events | See comment | See comment | Not estimable | 21 (1 study) | Low4 | No adverse events occurred. |
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; CSF: cerebrospinal fluid; RR: risk ratio | ||||||
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate. Evidence based on randomized controlled trials begins as high‐quality evidence, but confidence in the evidence was decreased for several reasons, including the following.
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1Improvement in all participants at an average of 7.7 months. 2Downgraded twice: for study limitations (unclear risk of selection bias and lack of blinding) and imprecision (small sample size). We did not downgrade the quality of evidence for indirectness as, although flawed, the measure is likely to reflect clinical reality. 3Downgraded three times: for study limitations (unclear risk of selection bias), imprecision (small sample size), and indirectness (limitation to acute Lyme neuroborreliosis, indirectness of pleocytosis as an outcome measure). One participant in the cefotaxime group had mild residual pleocytosis. Resolution reported in 20/21 participants. 4Downgraded twice: for study limitations (unclear risk of selection bias and lack of blinding) and imprecision (small sample size). In the absence of comprehensive adverse event reporting in the included trials, the table presents ‘all adverse events’ with a comment on severe adverse events when these data are presented in the trial.