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Summary of RCTs in CF measuring QoL: mucolytic therapies, exercise and pancreatic enzymes |
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| Authors |
Brief description |
Sample |
QoL scale used |
Authors' main conclusion |
Authors' conclusion about QoL outcome |
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| MUCOLYTIC THERAPIES |
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| Ranasinha et al. [27] |
DNase vs placebo; two parallel groups |
n = 71 (age = 16–55 years) mean FEV1 ≈ 47% |
Ad hoc 9-item scale |
Significant improvement in FEV1 but not in FVC |
DNase did not improve overall well-being but improvements in feeling, cough frequency and chest congestion |
| Ramsey et al. [28] |
3 doses of DNase vs placebo; 4 parallel groups |
n = 181 (age 8–65 years) mean FEV1 between 58.6% and 84.6% for the 4 groups |
Ad hoc 9-item scale |
FEV1 and FVC improved across all doses compared with placebo |
DNase associated with decreased dyspnoea and improved well-being |
| Fuchs et al. [29] |
2 doses of DNase vs placebo; 3 parallel groups |
n= 968 (age 5–54 years) mean FEV1 ≈ 60% |
Ad hoc 9-item scale |
Improved lung function on DNase |
Increase in general well-being |
| Wilmott et al. [30] |
2.5 mg DNase or placebo twice daily |
n = 80 children and adults (age >5 years; mean ≈ 20) mean FEV1 ≈ 40% |
Ad hoc scale |
No effect of drug on change in FEV1 or FVC |
No differences on well-being scales |
| Suri et al. [31-33] |
Open crossover study of DNase once daily 2.5 mg vs alternate day 2.5 mg and saline |
n = 48 (age 7–17 years) (n = 40 completed study) |
QWB-SA |
No evidence of differences between active treatments; daily treatment better than saline for FEV1 |
No effects |
| Eng et al. [34] |
10 ml of either normal or hypertonic saline; parallel groups |
n = 58 (age 7–26 years) mean FEV1≈ 52% |
Ad hoc VAS of perceived change |
Significant differential improvement from baseline in FEV1 for hypertonic saline |
An improvement, but group difference did not reach statistical significance |
| EXERCISE |
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| Selvadurai et al. [36] |
Comparison of aerobic/ resistance training and standard care; 3 parallel groups |
n = 66 (age 8–16 years) mean FEV1 ≈ 57% |
QWB |
Aerobic training better for peak aerobic capacity. Resistance training better for weight gain, lung function and leg strength |
Aerobic training associated with better QoL |
| Klijn et al. [37] |
Anaerobic training vs normal daily activity; 2 parallel groups |
n = 20 (age 9–18 years; mean 14 years) mean FEV1 = 75.2% (exercise group); 82.1% (control group) |
Dutch CFQ |
Anaerobic and aerobic performance improved in training group, but not control group |
QoL improved in training group but not in control group |
| Orenstein et al. [38] |
Aerobic versus upper-body strength training |
n = 62 (age 8–18 years) Analysis on 53 cases of complete data |
QWB |
Strength and aerobic training may increase upper-body strength, and physical work capacity |
No significant effects |
| PANCREATIC ENZYMES |
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| Gan et al. [39] |
4 versus 1 capsule daily crossover design |
n = 13 (age 19–46 years; mean 28 years) mean BMI = 21 |
Symptoms and general well-being on 10-point scale |
No difference between treatments |
No significant changes in scores for well-being |
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FEV1 = forced expiratory volume in one second, expressed as percent predicted; FVC = forced vital capacity; QWB = Quality of Well-being Scale; CFQ = Cystic Fibrosis Questionnaire; BMI= body mass index, ≈ = approximately. QoL is secondary outcome measure unless otherwise indicated. All authors refer to QoL in the title, abstract or paper except [34] [39] who refer to well-being. | |||||
Abbott and Hart Health and Quality of Life Outcomes 2005 3:19 doi:10.1186/1477-7525-3-19 |
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