Single versus combination intravenous anti‐pseudomonal antibiotic therapy for people with cystic fibrosis

Heather E Elphick; Alison Scott

doi:10.1002/14651858.CD002007.pub4

Tratamiento de antibióticos antipseudomonas intravenosos simples versus combinados para personas con fibrosis quística

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References

References to studies included in this review

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excluded studies
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References to studies excluded from this review

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included studies
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References to other published versions of this review

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included studies
excluded studies
additional references

Elphick HE, Tan A, Ashby D, Smyth RL. Systematic reviews and lifelong diseases. BMJ 2002;325(7360):381‐4.

Elphick HE, Tan AA. Single versus combination intravenous antibiotic therapy for people with cystic fibrosis. Cochrane Database of Systematic Reviews 2005, Issue 2. [DOI: 10.1002/14651858.CD002007.pub2]

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Characteristics of studies

Characteristics of included studies [ordered by study ID]

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excluded studies

Costantini 1982

Methods	No withdrawals, symptomatic regimen.
Participants	28 participants randomised. PsA colonised, age not stated.
Interventions	Carbenicillin 675 mg/kg/day vs sisomycin 10.5 mg/kg/day vs carbenicillin 590 mg/kg/day plus sisomycin. Variable duration of course.
Outcomes	CXR and symptom scores, bacteriology, development of resistant strains.
Notes	Abstract: no data.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomly assigned, but no further details given.
Allocation concealment (selection bias)	Unclear risk	Not directly discussed, but referred to as a controlled clinical trial.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Not discussed.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Not discussed, but appears to be no withdrawals.

Huang 1982

Methods	Double‐blind trial, no withdrawals, symptomatic regimen. Parallel trial.
Participants	16 participants randomised. Mixed PsA and non‐PsA, age not stated.
Interventions	Ticarcillin 300 mg/kg/day vs ticarcillin plus tobramycin 6 mg/kg/day. 10‐day course.
Outcomes	Lung function, number readmitted within one month, CXR and symptom scores, bacteriology.
Notes	Abstract: Lung function, CXR and symptom score data not given.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Mentions randomisation code, but no details given of how it was generated.
Allocation concealment (selection bias)	Unclear risk	Mentions randomisation code, but no details of how this may have been concealed.
Blinding (performance bias and detection bias) All outcomes	Low risk	Stated as double‐blind, but no further details given.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Not discussed, but appears to be no drop outs or withdrawals.

Master 1997

Methods	Double‐blind trial, symptomatic regimen. Parallel trial.
Participants	83 participants randomised. PsA colonised, age not stated. 51 participants randomized, of these, 21 in the tobramycin and ceftazidime group (51 admissions assessed) and 23 in the tobramycin group (47 admissions assessed). 12 participants in the tobramycin and ceftazidime group and 9 participants in the tobramycin group were eligible for long‐term assessment. Participants in both groups experienced an average of 3.1 and 3.0 admissions, respectively, for IV antibiotic treatment during the study period. Tobramycin and ceftazidime group: mean (SD) age 16 (7) years Tobramycin group: mean (SD) age 14 (5) years
Interventions	Tobramycin 24‐hourly vs tobramycin and ceftazidime 8‐hourly. 10‐day course.
Outcomes	Lung function, adverse events.
Notes	Full paper. Exclusion criteria stated. The study was halted for a period of 3 months when one of the study patients committed suicide by utilizing a study syringe to administer a lethal substance. The study was recommenced after the coroner's finding that this was an unrelated death. During this time of study suspension, there were 14 admissions of patients previously enrolled. Data from these admissions were not included.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomization was stratified for age and disease severity.
Allocation concealment (selection bias)	Low risk	The treatment code was broken only at the completion of the study.
Blinding (performance bias and detection bias) All outcomes	Low risk	Medical staff, nursing staff and participants were blinded to the treatment.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Flow chart showing numbers randomized and included/excluded (with reasons) at each stage in paper.

McCarty 1988

Methods	Not double blind, no withdrawals, symptomatic regimen.
Participants	17 participants treated (8 in piperacillin group, 9 in piperacillin plus tobramycin group); 3 participants treated on more than one occasion (2 initially in piperacillin group and several months later randomised to other group; 1 participant enrolled 2x in piperacillin group). 20 data sets. Mixed PsA and non‐PsA, aged 2 to 12 years.
Interventions	Piperacillin 600 mg/kg/day vs piperacillin plus tobramycin 8 to 10 mg/kg/day, minimum duration 10 days.
Outcomes	Lung function, weight, symptom scores, adverse events, bacteriology.
Notes	No data for lung function, weight and symptom scores.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Treatment randomly assigned, no further details.
Allocation concealment (selection bias)	Low risk	Used sequentially numbered envelopes.
Blinding (performance bias and detection bias) All outcomes	High risk	Not double‐blind.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Clear explanation of participants in groups, no drop outs occurred.

McLauglin 1983

Methods	Double‐blind trial, symptomatic regimen.
Participants	41 participants randomised (11 years and older), 34 completed. No ITT analysis. Mean age 21 years. PsA in 98%.
Interventions	Azlocillin 300 mg/kg/day, 4‐hourly plus placebo vs azlocillin plus tobramycin 6 mg/kg/day, 8‐hourly. 10‐day course. Group 1: azlocillin 300 mg/kg/day in 6 divided doses plus tobramycin (6 mg/kg per day) in 3 divided doses. Group 2:azlocillin 300 mg/kg/day in 6 divided doses plus placebo (0.85% NaCl) in 3 divided doses.
Outcomes	Lung function, symptom scores, development of resistant strains, time to next course.
Notes	Participants were white, of various socioeconomic backgrounds and lived in New England. Exclusion criteria stated.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Participants randomly selected, but no further details given.
Allocation concealment (selection bias)	Low risk	Hospital pharmacist used consecutively numbered sealed envelopes.
Blinding (performance bias and detection bias) All outcomes	Low risk	Neither participants or clinicians knew which regimen they were receiving.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	2 participants in azlocillin plus placebo group withdrawn due to suspected drug‐related complications; 2 participants discharged improved before completion of antibiotic course; 3 withdrawn due to incomplete outcome data.

Parry 1977

Methods	Not double blind, alternate allocation, no withdrawals, symptomatic regimen. Parallel trial.
Participants	21 male, 21 female, mean age 15.1 years. PsA colonised. 14 participants in each of 3 treatment groups. Group 1 (ticarcillin): 8 male, 6 female; mean (range) age 16.1 (2 ‐ 30) years Group 2 (ticarcillin & gentamicin): 7 males, 7 females: mean (range) age 16.4 (4 ‐ 30) years Group 3 (gentamicin):6 males, 8 females; mean (range) 12.9 (5 ‐ 31) years
Interventions	Ticarcillin 300 mg/kg/day, 4‐hourly vs gentamicin 3 ‐ 4 mg/kg/day (adults), 4 ‐ 7 mg/kg/day (children) vs combination. Variable length of course.
Outcomes	Lung function, bacteriology, adverse events, CBC, sedimentation rate, urinalysis, serum electrolytes, blood urea nitrogen, creatinine, liver function tests, chest radiographs, blood gas determinations, sputum cultures, change in cough, weight.
Notes	No data available.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No discussion of how first participant was assigned to which treatment group.
Allocation concealment (selection bias)	High risk	Alternation.
Blinding (performance bias and detection bias) All outcomes	High risk	Drugs administered in different ways so clinicians and participants couldn't be blinded, no discussion of blinding of outcome assessors.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	No drop outs or withdrawals.

Pedersen 1986

Methods	Not double blind, elective regimen, crossover ‐ 3 months in between treatment arms.
Participants	20 participants (10 male, 10 female), mean age 12.6 years. PsA colonised. 3 drop outs, 17 completed trial.
Interventions	Ceftazidime 150 mg/kg/day, 8‐hourly vs ceftazidime plus tobramycin 10 mg/kg/day, 8‐hourly, 14‐day course.
Outcomes	Lung function, inflammatory markers, development of resistant strains.
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Described as randomised, but no details of method given.
Allocation concealment (selection bias)	Unclear risk	Not discussed.
Blinding (performance bias and detection bias) All outcomes	Low risk	Both interventions given with same volume and in same way.
Incomplete outcome data (attrition bias) All outcomes	Low risk	3 participants excluded ‐ reasons given (bacteriological resistance developed between treatment arms in 2 participants and a 3rd withdrew on first day of 2nd treatment arm due to nausea).

Smith 1999

Methods	Double‐blind, computer‐generated randomisation, symptomatic regimen. Parallel trial.
Participants	37 male, 39 female, mean age 16.3 years. 111 participants enrolled, 35 withdrawn. 76 participants in total aged 6 ‐ 18 years. PsA colonised. Group 1 (azlocillin): 33 participants (19 male) mean (SD) age 16.07 (7.4) years Group 2 (azlocillin & tobramycin): 43 participants (18 male) mean (SD) age 16.53 (6.9) years
Interventions	Azlocillin 450 mg/kg/day, 4‐hourly plus placebo vs azlocillin plus tobramycin 240 mg/m2/day, 6‐hourly, 14 days course.
Outcomes	Lung function, time to next admission, symptom scores, adverse events, bacteriology, inflammatory markers, resistant strains.
Notes	No data for symptom scores.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation balance by FVC and center.
Allocation concealment (selection bias)	Low risk	Code generated by research pharmacist at the core center.
Blinding (performance bias and detection bias) All outcomes	Low risk	Participants and clinicians blinded, serum concentrations monitored by unblinded 3rd party (research pharmacist).
Incomplete outcome data (attrition bias) All outcomes	Low risk	35 participants withdrawn (21 from azlocillin group), reasons given in a table.

CBC: complete blood count
CXR: chest x‐ray
ITT: intention‐to‐treat
PsA: Pseudomonas aeruginosa

Characteristics of excluded studies [ordered by study ID]

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included studies

Study	Reason for exclusion
Adeboyeku 2011	Comparison of twice daily vs three times daily antibiotics, not single vs combination.
Al‐Ansari 2006	Comparison of once vs multiple daily dosing, not single vs combination.
Aminimanizani 2002	Comparison of single vs multiple daily dosing, not single vs combination.
Balsamo 1986	Comparison of single agent compared with 2 other antibiotics (i.e. drug A vs drug B plus drug C).
Beaudry 1980	Comparison of single agent compared with 2 other antibiotics (i.e. drug A vs drug B plus drug C).
Beringer 2012	Not a comparison of single vs combination antibiotics; a comparison of a single intravenous dose of an antibiotic and multiple oral doses of the same antibiotic.
Blumer 2005	Comparison of two combination regimens.
Bosso 1988	Comparison of single agent compared with 2 other antibiotics (i.e. drug A vs drug B plus drug C).
Church 1997	Comparison of single agent compared with 2 other antibiotics (i.e. drug A vs drug B plus drug C).
Conway 1997	Comparison of colistin with multiple antibiotic combinations.
De Boeck 1989	Comparison of single agent compared with 2 other antibiotics (i.e. drug A vs drug B plus drug C).
De Boeck 1999	Comparison of single agent compared with 2 other antibiotics (i.e. drug A vs drug B plus drug C).
Donati 1987	Home vs hospital therapy, not single vs combination.
Gold 1985	Comparison of single agent compared with 2 other antibiotics (i.e. drug A vs drug B plus drug C).
Hatziagorou 2013	Not a comparison of a single vs combination antibiotics; evaluation of tool to assess treatment response in children.
Hoogkamp 1983	Non‐randomised study: first 7 participants allocated to single treatment; next 7 to combination treatment with marked differences in baseline characteristics.
Hubert 2009	Comparison of intermittent vs continuous infusions, not single vs combination.
Hyatt 1981	Comparison of anti‐staphylococcal drug (oxacillin) vs oxacillin plus 2 anti‐pseudomonal drugs.
Jewett 1985	Comparison of single agent compared with 2 other antibiotics (i.e. drug A vs drug B plus drug C).
Keel 2011	Not a comparison of a single vs combination antibiotic; comparison of intravenous and oral versions of the same agent.
Kenny 2009	Study of eradication of Pseudomonas aeruginosa, not a comparison of single vs combination.
Krause 1979	Pseudo‐randomised study. Treatment and comparison groups were not sufficiently similar at baseline.
Kuni 1992	Not a comparison of single vs combination antibiotics.
Levy 1982	Comparison of 2 single agents.
McCabe 2013	Not a comparison of single vs combination antibiotics; evaluation of a twice‐daily tobramycin regimen.
Nelson 1985	Review article on single vs combination antibiotic treatment, i.e. not an RCT.
Noah 2010	Inhaled vs systemic antibiotics.
Padoan 1987	Reported number of courses of treatment instead of number of people included. Some participants may have been counted twice or included in both treatment group therefore analysis unclear.
Permin 1983	Comparison of single agent compared with 2 other antibiotics (i.e. drug A vs drug B plus drug C).
Prayle 2013	Not a comparison of single vs combination antibiotics; comparison of morning vs evening intravenous tobramycin.
Riethmueller 2009	Continuous vs intermittent infusions.
Roberts 1993	Randomisation method unclear ‐ participants appeared to have been randomised to single or combination therapy each morning using a cross‐over method.
Semykin 2010	Not a comparison of single vs combination antibiotics; trial of inhaled tobramycin therapy.
Stack 1985	Comparison of single agent compared with two other antibiotics (i.e. drug A vs drug B plus drug C).
Turner 2013	Not a comparison of single vs combination antibiotics; study of continuous vs intermittent infusion piperacillin‐tazobactam.
Wesley 1988	Comparison of single agent compared with 2 other antibiotics (i.e. drug A vs drug B plus drug C).
Whitehead 2002	Efficacy of once daily tobramycin, not a comparison of single vs combination agents.

CXR: chest X‐ray
vs: versus

Data and analyses

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Comparison 1. Single versus combination, symptomatic regimen

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Mean FEV₁ at end of course (% pred) Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.1 Comparison 1 Single versus combination, symptomatic regimen, Outcome 1 Mean FEV₁ at end of course (% pred).
1.1 at 10 to 14 days	2	93	Mean Difference (IV, Fixed, 95% CI)	5.25 [‐9.14, 19.64]
1.2 at 2 to 8 weeks	1	41	Mean Difference (IV, Fixed, 95% CI)	0.5 [‐57.36, 58.36]
2 Mean FVC at end of course (% pred) Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.2 Comparison 1 Single versus combination, symptomatic regimen, Outcome 2 Mean FVC at end of course (% pred).
2.1 at 10 to 14 days	2	93	Mean Difference (IV, Fixed, 95% CI)	1.84 [‐11.44, 15.12]
2.2 at 2 to 8 weeks	1	41	Mean Difference (IV, Fixed, 95% CI)	6.90 [‐50.50, 64.30]
3 Mean RV at end of course (% pred) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 1.3 Comparison 1 Single versus combination, symptomatic regimen, Outcome 3 Mean RV at end of course (% pred).
4 Mean TLC at end of course (% pred) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 1.4 Comparison 1 Single versus combination, symptomatic regimen, Outcome 4 Mean TLC at end of course (% pred).
5 Mean RV/TLC at end of course (% pred) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.5 Comparison 1 Single versus combination, symptomatic regimen, Outcome 5 Mean RV/TLC at end of course (% pred).
5.1 at 2 weeks	1	64	Mean Difference (IV, Fixed, 95% CI)	‐1.40 [‐40.68, 37.88]
5.2 At 2 to 8 weeks	1	40	Mean Difference (IV, Fixed, 95% CI)	‐5.20 [‐54.27, 43.87]
6 Mean PFR at end of course (% pred) Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.6 Comparison 1 Single versus combination, symptomatic regimen, Outcome 6 Mean PFR at end of course (% pred).
6.1 at 10 to 14 days	2	91	Mean Difference (IV, Fixed, 95% CI)	3.21 [‐11.49, 17.91]
6.2 At 2 to 8 weeks	1	40	Mean Difference (IV, Fixed, 95% CI)	2.30 [‐60.90, 65.50]
7 Mean MMEF at end of course (% pred) Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.7 Comparison 1 Single versus combination, symptomatic regimen, Outcome 7 Mean MMEF at end of course (% pred).
7.1 at 10 to 14 days	2	91	Mean Difference (IV, Fixed, 95% CI)	7.17 [‐8.22, 22.55]
7.2 At 2 to 8 weeks	1	40	Mean Difference (IV, Fixed, 95% CI)	‐1.90 [‐73.27, 69.47]
8 Mean Schwachman score at end of course Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 1.8 Comparison 1 Single versus combination, symptomatic regimen, Outcome 8 Mean Schwachman score at end of course.
9 Number of Pseudomonas isolates eradicated at end of course Show forest plot	3	72	Peto Odds Ratio (Peto, Fixed, 95% CI)	5.63 [2.12, 14.94]
Open in figure viewer Analysis 1.9 Comparison 1 Single versus combination, symptomatic regimen, Outcome 9 Number of Pseudomonas isolates eradicated at end of course.
10 Mean change Pseudomonas density in cfu/g at end of course Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 1.10 Comparison 1 Single versus combination, symptomatic regimen, Outcome 10 Mean change Pseudomonas density in cfu/g at end of course.
11 Number adverse events Show forest plot	2		Peto Odds Ratio (Peto, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.11 Comparison 1 Single versus combination, symptomatic regimen, Outcome 11 Number adverse events.
11.1 local erythema / irritation	2	131	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.46 [0.09, 2.36]
11.2 generalised rash	1	20	Peto Odds Ratio (Peto, Fixed, 95% CI)	6.16 [0.12, 316.67]
11.3 fever	1	20	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.81 [0.05, 14.14]
11.4 renal impairment (increased creatinine by 50%)	1	80	Peto Odds Ratio (Peto, Fixed, 95% CI)	1.54 [0.15, 15.56]
11.5 auditory impairment	1	76	Peto Odds Ratio (Peto, Fixed, 95% CI)	5.86 [0.11, 305.44]
11.6 proteinuria	1	63	Peto Odds Ratio (Peto, Fixed, 95% CI)	3.62 [0.68, 19.30]
12 Number readmitted Show forest plot	2		Peto Odds Ratio (Peto, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.12 Comparison 1 Single versus combination, symptomatic regimen, Outcome 12 Number readmitted.
12.1 in 1 month	1	16	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.14 [0.01, 1.30]
12.2 in 80 days	1	76	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.30 [0.12, 0.73]
13 Mean time to next course of antibiotics (weeks) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 1.13 Comparison 1 Single versus combination, symptomatic regimen, Outcome 13 Mean time to next course of antibiotics (weeks).
14 Mean WBC count at end of course Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
Open in figure viewer Analysis 1.14 Comparison 1 Single versus combination, symptomatic regimen, Outcome 14 Mean WBC count at end of course.
15 Number resistant strains Show forest plot	2		Peto Odds Ratio (Peto, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.15 Comparison 1 Single versus combination, symptomatic regimen, Outcome 15 Number resistant strains.
15.1 at baseline	2	140	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.83 [0.38, 1.82]
15.2 at end of course	2	99	Peto Odds Ratio (Peto, Fixed, 95% CI)	2.44 [0.94, 6.32]
15.3 at 2 to 8 weeks	2	76	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.44 [0.17, 1.14]
15.4 Difference between baseline and 2 to 8 weeks	1	29	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.27 [0.06, 1.18]

Analysis 1.1

Comparison 1 Single versus combination, symptomatic regimen, Outcome 1 Mean FEV₁ at end of course (% pred).

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Analysis 1.2

Comparison 1 Single versus combination, symptomatic regimen, Outcome 2 Mean FVC at end of course (% pred).

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Analysis 1.3

Comparison 1 Single versus combination, symptomatic regimen, Outcome 3 Mean RV at end of course (% pred).

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Analysis 1.4

Comparison 1 Single versus combination, symptomatic regimen, Outcome 4 Mean TLC at end of course (% pred).

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Analysis 1.5

Comparison 1 Single versus combination, symptomatic regimen, Outcome 5 Mean RV/TLC at end of course (% pred).

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Analysis 1.6

Comparison 1 Single versus combination, symptomatic regimen, Outcome 6 Mean PFR at end of course (% pred).

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Analysis 1.7

Comparison 1 Single versus combination, symptomatic regimen, Outcome 7 Mean MMEF at end of course (% pred).

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Analysis 1.8

Comparison 1 Single versus combination, symptomatic regimen, Outcome 8 Mean Schwachman score at end of course.

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Analysis 1.9

Comparison 1 Single versus combination, symptomatic regimen, Outcome 9 Number of Pseudomonas isolates eradicated at end of course.

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Analysis 1.10

Comparison 1 Single versus combination, symptomatic regimen, Outcome 10 Mean change Pseudomonas density in cfu/g at end of course.

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Analysis 1.11

Comparison 1 Single versus combination, symptomatic regimen, Outcome 11 Number adverse events.

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Analysis 1.12

Comparison 1 Single versus combination, symptomatic regimen, Outcome 12 Number readmitted.

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Analysis 1.13

Comparison 1 Single versus combination, symptomatic regimen, Outcome 13 Mean time to next course of antibiotics (weeks).

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Analysis 1.14

Comparison 1 Single versus combination, symptomatic regimen, Outcome 14 Mean WBC count at end of course.

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Analysis 1.15

Comparison 1 Single versus combination, symptomatic regimen, Outcome 15 Number resistant strains.

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Comparison 1. Single versus combination, symptomatic regimen

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Mean FEV₁ at end of course (% pred) Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

1.1 at 10 to 14 days	2	93	Mean Difference (IV, Fixed, 95% CI)	5.25 [‐9.14, 19.64]
1.2 at 2 to 8 weeks	1	41	Mean Difference (IV, Fixed, 95% CI)	0.5 [‐57.36, 58.36]
2 Mean FVC at end of course (% pred) Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

2.1 at 10 to 14 days	2	93	Mean Difference (IV, Fixed, 95% CI)	1.84 [‐11.44, 15.12]
2.2 at 2 to 8 weeks	1	41	Mean Difference (IV, Fixed, 95% CI)	6.90 [‐50.50, 64.30]
3 Mean RV at end of course (% pred) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4 Mean TLC at end of course (% pred) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

5 Mean RV/TLC at end of course (% pred) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

5.1 at 2 weeks	1	64	Mean Difference (IV, Fixed, 95% CI)	‐1.40 [‐40.68, 37.88]
5.2 At 2 to 8 weeks	1	40	Mean Difference (IV, Fixed, 95% CI)	‐5.20 [‐54.27, 43.87]
6 Mean PFR at end of course (% pred) Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

6.1 at 10 to 14 days	2	91	Mean Difference (IV, Fixed, 95% CI)	3.21 [‐11.49, 17.91]
6.2 At 2 to 8 weeks	1	40	Mean Difference (IV, Fixed, 95% CI)	2.30 [‐60.90, 65.50]
7 Mean MMEF at end of course (% pred) Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

7.1 at 10 to 14 days	2	91	Mean Difference (IV, Fixed, 95% CI)	7.17 [‐8.22, 22.55]
7.2 At 2 to 8 weeks	1	40	Mean Difference (IV, Fixed, 95% CI)	‐1.90 [‐73.27, 69.47]
8 Mean Schwachman score at end of course Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

9 Number of Pseudomonas isolates eradicated at end of course Show forest plot	3	72	Peto Odds Ratio (Peto, Fixed, 95% CI)	5.63 [2.12, 14.94]

10 Mean change Pseudomonas density in cfu/g at end of course Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

11 Number adverse events Show forest plot	2		Peto Odds Ratio (Peto, Fixed, 95% CI)	Subtotals only

11.1 local erythema / irritation	2	131	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.46 [0.09, 2.36]
11.2 generalised rash	1	20	Peto Odds Ratio (Peto, Fixed, 95% CI)	6.16 [0.12, 316.67]
11.3 fever	1	20	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.81 [0.05, 14.14]
11.4 renal impairment (increased creatinine by 50%)	1	80	Peto Odds Ratio (Peto, Fixed, 95% CI)	1.54 [0.15, 15.56]
11.5 auditory impairment	1	76	Peto Odds Ratio (Peto, Fixed, 95% CI)	5.86 [0.11, 305.44]
11.6 proteinuria	1	63	Peto Odds Ratio (Peto, Fixed, 95% CI)	3.62 [0.68, 19.30]
12 Number readmitted Show forest plot	2		Peto Odds Ratio (Peto, Fixed, 95% CI)	Subtotals only

12.1 in 1 month	1	16	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.14 [0.01, 1.30]
12.2 in 80 days	1	76	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.30 [0.12, 0.73]
13 Mean time to next course of antibiotics (weeks) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

14 Mean WBC count at end of course Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

15 Number resistant strains Show forest plot	2		Peto Odds Ratio (Peto, Fixed, 95% CI)	Subtotals only

15.1 at baseline	2	140	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.83 [0.38, 1.82]
15.2 at end of course	2	99	Peto Odds Ratio (Peto, Fixed, 95% CI)	2.44 [0.94, 6.32]
15.3 at 2 to 8 weeks	2	76	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.44 [0.17, 1.14]
15.4 Difference between baseline and 2 to 8 weeks	1	29	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.27 [0.06, 1.18]

Comparison 1. Single versus combination, symptomatic regimen

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References

References to studies included in this review

Costantini 1982 {published data only}

Huang 1982 {published data only}

Master 1997 {published data only}

McCarty 1988 {published data only}

McLauglin 1983 {published data only}

Parry 1977 {published data only}

Pedersen 1986 {published data only}

Smith 1999 {published data only}

References to studies excluded from this review

Adeboyeku 2011 {published data only}

Al‐Ansari 2006 {published data only}

Aminimanizani 2002 {published data only}

Balsamo 1986 {published data only}

Beaudry 1980 {published data only}

Beringer 2012 {published data only}

Blumer 2005 {published data only}

Bosso 1988 {published data only}

Church 1997 {published data only}

Conway 1997 {published data only}

De Boeck 1989 {published data only}

De Boeck 1999 {published data only}

Donati 1987 {published data only}

Gold 1985 {published data only}

Hatziagorou 2013 {published data only}

Hoogkamp 1983 {published data only}

Hubert 2009 {published data only}

Hyatt 1981 {published data only}

Jewett 1985 {published data only}

Keel 2011 {published data only}

Kenny 2009 {published data only}

Krause 1979 {published data only}

Kuni 1992 {published data only}

Levy 1982 {published data only}

McCabe 2013 {published data only}

Nelson 1985 {published data only}

Noah 2010 {published data only}

Padoan 1987 {published data only}

Permin 1983 {published data only}

Prayle 2013 {published data only}

Riethmueller 2009 {published data only}

Roberts 1993 {published data only}

Semykin 2010 {published data only}

Stack 1985 {published data only}

Turner 2013 {published data only}

Wesley 1988 {unpublished data only}

Whitehead 2002 {published data only}

Additional references

Cantin 1995

Cheng 1996

Elbourne 2002

Frederiksen 1999

Hoiby 1993

Katbamna 1998

Konstan 1997

Kucers 1997

Levy 1998

Mulherin 1991

Regelmann 1990

Schulz 1995

Tan 2002

Taylor 1993

Wolter 1999

References to other published versions of this review

Elphick 2002

Elphick 2005

Elphick 2014

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Characteristics of excluded studies [ordered by study ID]

Data and analyses

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Previously accessed institutions

Institutional users

Previously accessed institutions