TABLE 11.
AEROSOLIZED ACETYLCYSTEINE MONOTHERAPY GRADE EVIDENCE PROFILE*
|
Quality Assessment |
|||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No. of
Studies |
Design |
Limitations |
Inconsistency |
Indirectness |
Imprecision |
Other
Considerations |
|||||||
| Quality of Life (follow-up 12 mo; measured with SF36; better indicated by higher values) | 1 | Randomized trials | No serious limitations | No serious inconsistency | No serious indirectness | Serious‡ | None | ||||||
| Exercise Capacity (follow-up 12 mo; measured with 6-minute-walk test; better indicated by higher values) | 1 | Randomized trials | No serious limitations | No serious inconsistency | Serious¶ | Serious‡ | None | ||||||
| Adverse Effects (follow-up 12 mo; better indicated by lower values) | 1 | Randomized trials | Serious‖ | No serious inconsistency | No serious indirectness | Serious‡ | None | ||||||
| Vital Capacity (% of predicted) (follow-up 12 mo; better indicated by lower values) | 1 | Randomized trials | No serious limitations | No serious inconsistency | Serious** | Serious‡ | None | ||||||
| Oxygen
Saturation (follow-up 12 mo; measured with: SaO2; better indicated
by higher values) |
1 |
Randomized
trials |
No serious
limitations |
No serious
inconsistency |
Serious¶ |
Serious‡ |
None |
||||||
| Summary of
Findings |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| No. of
Patients |
Effect |
|||||||||
| N-acetylcysteine |
Bromhexine
Hydrocholoride |
Relative
(95% CI) |
Absolute |
Quality |
Importance† |
|||||
| Quality of Life (follow-up 12 mo; measured with SF36; better indicated by higher values) | 10 | 12 | — | —§ | ⊕⊕⊕○ Moderate | Critical | ||||
| Exercise Capacity (follow-up 12 mo; measured with 6-minute-walk test; better indicated by higher values) | 10 | 12 | — | MD 66.4 higher (37.9 lower to 170.7 higher) | ⊕⊕○○ Low | Critical | ||||
| Adverse Effects (follow-up 12 mo; better indicated by lower values) | 10 | 12 | — | — | ⊕⊕○○ Low | Critical | ||||
| Vital Capacity (% of predicted) (follow-up 12 mo; better indicated by lower values) | 10 | 12 | — | MD 2.4 higher (6.9 lower to 11.7 higher) | ⊕⊕○○ Low | Important | ||||
| Oxygen
Saturation (follow-up 12 mo; measured with: SaO2; better indicated
by higher values) |
10 |
12 |
— |
MD 7.1
higher (5.45 to 8.75 higher) |
⊕⊕○○ Low |
Important |
||||
Data are from Reference 253.
The overall quality of evidence rating is listed in the first row and is the one used in the text of the document. The quality rating for outcomes listed in other rows may differ. How these additional outcomes are rated in terms of quality does not influence the final quality rating as they are to inform, but not to make, decisions.
Importance rating: the relative importance of the outcome for decision making. The rating “critical” indicates making recommendations on choice of testing and treatment strategies. The rating “important” indicates that the outcome is important but not critical for making recommendations.
Small sample size with wide confidence intervals leading to uncertainty about the actual magnitude of any effect.
No signficant differences on the SF36 and direction of change inconsistent among instruments indic.
Oxygen saturation is a surrogate for patient important outcomes and the direct relation unclear.
Unclear if adverse events were specifically measured, however, authors report that none were observed.
Pulmonary function is a surrogate for patient important outcomes and the direct relation unclear.