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Oral non‐steroidal anti‐inflammatory drug therapy for cystic fibrosis

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Abstract

Background

Progressive lung damage is responsible for the majority of deaths in cystic fibrosis (CF). Non‐steroidal anti‐inflammatory drugs may prevent progressive pulmonary deterioration and morbidity in CF.

Objectives

To assess the effectiveness of treatment with non‐steroidal anti‐inflammatory agents in CF.

Search methods

We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register comprising references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. Pharmaceutical companies manufacturing non‐steroidal anti‐inflammatory drugs were also contacted to identify any relevant trials.

Most recent search of the Group's Trials Register: February 2005.

Selection criteria

All randomised or quasi‐randomised controlled trials, published and unpublished, comparing non‐steroidal anti‐inflammatory drugs, administered orally at any dose for a period of at least two months, to placebo in people with CF.

Data collection and analysis

Two authors independently assessed trials for the review. They considered objective measures of lung function, nutritional status, radiological assessment of pulmonary involvement, intravenous antibiotic usage, hospital admissions, survival, frequency of major and minor adverse effects and compliance with therapy.

Main results

Five trials were identified by the searches. Three of these met the inclusion criteria involving 145 participants, aged from 5 to 39 years, with a maximum follow up of four years. Methodological quality was deemed good or adequate in two trials. Two trials reporting effectiveness of ibuprofen in people with mild lung disease were from the same centre and included some of the same participants. The third assessed piroxicam in participants with more severe impairment of respiratory function. Variation in outcomes reported and their summary measures precluded calculation of pooled treatment estimates. Only one trial reported within‐participant changes in pulmonary function and the findings suggested a greater absolute annual decline in per cent predicted forced expiratory volume in one second among controls than among those treated with ibuprofen. In a post‐hoc subgroup analysis, this effect was confined to children aged 5 to 13 years. Additionally, in this one trial long‐term use of high dose ibuprofen was associated with reduced intravenous antibiotic usage, improved nutritional and radiological pulmonary status. No major adverse effects were reported, but the power of the trials to identify clinically important differences in the incidence of adverse effects was low.

Authors' conclusions

While there is preliminary evidence to suggest that non‐steroidal anti‐inflammatory drugs may prevent pulmonary deterioration in people with mild lung disease due to CF, currently their routine use cannot be recommended.

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Plain language summary

There is not enough firm evidence to show whether non‐steroidal anti‐inflammatory drugs can reduce the progression of lung disease in cystic fibrosis

Inflammation contributes to lung damage, which, in the long term, is the most common reason for premature death in cystic fibrosis. In high doses, non‐steroidal anti‐inflammatory drugs may work against inflammation, but in low doses there is some evidence that they may cause inflammation. In high doses, they may cause a number of unwanted effects, including bleeding in the gut. The review found that, while the studies to date are encouraging, there is not enough firm evidence from trials to show whether non‐steroidal anti‐inflammatory drugs are of benefit or harm for people with cystic fibrosis.