Table 3

Summary of GRADE evidence profile of TMP-SMX/clindamycin vs no antibiotic

Outcome/timeframeStudy results and measurementsAbsolute effect estimatesCertainty in effect estimates (quality of evidence)Plain text summary
No antibioticsAntibiotics
TMP-SMX vs no antibiotic
Sepsis/1 monthOR 7.24 (95% CI 0.14 to 364.86)
Based on data from 1247 patients in one study
Follow-up 49–63 days
0
per 1000
2
per 1000
Moderate
Due to serious imprecision*
Antibiotics probably do not decrease the risk of sepsis.
Difference: 2 more per 1000
(95% CI 3 fewer—6 more)
Death/3 monthsOR 0.98 (95% CI 0.06 to 15.68)
Based on data from 1763 patients in two studies
Follow-up 30–90 days
1
per 1000
1
per 1000
High
Borderline imprecision
Antibiotics do not reduce the risk of death.
Difference: 0 fewer per 1000
(95% CI 4 fewer—4 more)
Gastrointestinal side effects/while taking antibioticsOR 1.28 (95% CI 1.04 to 1.58)
Based on data from 2124 patients in four studies
Follow-up 30–90 days
85
per 1000
106
per 1000
Moderate
Due to serious imprecision†
TMP-SMX probably increases the risk of gastrointestinal side effects.
Difference: 21 more per 1000
(95% CI 3 more—43 more)
Nausea/while taking antibioticsOR 1.49 (95% CI 0.98 to 2.25)
Based on data from 1975 patients in three studies
Follow-up 30–63 days
24
per 1000
35
per 1000
Moderate
Due to serious imprecision‡
TMP-SMX probably increases the risk of nausea.
Difference: 11 more per 1000
(95% CI 0 fewer—28 more)
Diarrhoea/3 monthsOR 0.92 (95% CI 0.7 to 1.22)
Based on data from 1912 patients in three studies
Follow-up 30–63 days
67
per 1000
62
per 1000
Moderate
Due to serious imprecision§
TMP-SMX probably does not increase the risk of diarrhoea.
Difference: 5 fewer per 1000
(95% CI 19 fewer—14 more)
Anaphylaxis/minutes to daysOR 2.32 (95% CI 0.67 to 8.06)
Based on data from 877 patients in three studies
Follow-up 30–90 days
7
per 1000
15
per 1000
Low
Due to serious risk of bias and imprecision¶
Antibiotics probably not increase the risk of anaphylaxis.
Difference: 8 more per 1000
(95% CI 2 fewer—44 more)
Clindamycin vs no antibiotics
Gastrointestinal side effects/while taking antibioticsOR 2.29 (95% CI 1.35 to 3.88)
Based on data from 520 patients in one study
Follow-up 30–90 days
90
per 1000
185
per 1000
HighClindamycin increases the risk of gastrointestinal side effects.
Difference: 95 more per 1000
(95% CI 28 more—187 more)
Nausea/while taking antibioticsOR 0.96 (95% CI 0.31 to 3.02)
Based on data from 520 patients in one study
Follow-up 30–63 days
24
per 1000
23
per 1000
Moderate
Due to serious imprecision**
Clindamycin may not increase the risk of nausea.
Difference: 1 fewer per 1000
(95% CI 16 fewer—45 more)
Diarrhoea/3 monthsOR 2.71 (95% CI 1.5 to 4.89)
Based on data from 520 patients in one study
Follow-up 30–63 days
67
per 1000
162
per 1000
HighClindamycin increases the risk of diarrhoea.
Difference: 96 more per 1000
(95% CI 30 more—193 more)
Anaphylaxis/minutes to daysOR 2.17 (95% CI 0.62 to 7.58)
Based on data from 520 patients in one study
Follow-up 30–90 days
12
per 1000
26
per 1000
Low
Due to serious risk of bias and imprecision††
Antibiotics probably not increase the risk of anaphylaxis.
Difference: 14 more per 1000
(95% CI 5 fewer—72 more)
  • *Imprecision: Serious. Due to serious imprecision.

  • †Imprecision: serious. CI approaches no effect.

  • ‡Imprecision: serious. CI approaches no effect.

  • §Imprecision: serious. CI approaches no effect.

  • ¶Risk of bias: serious. Selective outcome reporting: studies without any events are likely to have not reported this outcome, leading to overestimation of risk; imprecision: serious. Few events. Not all studies reported anaphylaxis.

  • **Imprecision: very serious. CI approaches no effect.

  • ††Risk of bias: serious. Selective outcome reporting: studies without any events are likely to have not reported this outcome, leading to overestimation of risk; imprecision: serious. Few events. Not all studies reported anaphylaxis.

  • GRADE, Grading of Recommendations Assessment, Development and Evaluation; TMP-SMX, trimethoprim and sulfamethoxazole.