TITLE

HOW BEST TO ASSESS SYMPTOMATIC OUTCOMES OF THERAPY IN GASTRO-OESOPHAGEAL REFLUX DISEASE TRIALS: A SYSTEMATIC REVIEW

AUTHOR(S)
Sharma, N.; Donnellan, C.; Preston, C.; Delaney, B.; Duckett, G.; Moayyedi, P.
PUB. DATE
April 2003
SOURCE
Gut;Apr2003 Supplement 1, Vol. 52, pA45
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
Introduction: Traditionally drug trials have used oesophagitis healing as the main outcome of treatment success and the performance of oesophagitis scales have been well characterised. Symptoms are also an important outcome for clinical trials to measure. The optimal symptoms to assess however have not been well characterised. We conducted a systematic review to assess the symptoms that have been evaluated and how well these correlate with oesophagitis healing and relapse. Methods: The Cochrane Controlled Trials Register, Medline, EMBASE, and CINAHL electronic databases were searched for RCTs evaluating drug therapies in oesophagitis. Experts in the field and pharmaceutical companies were contacted For information on any unpublished RCTs. Articles were included on predefined eligibility and validity criteria. Data were extracted on scales used, method of collecting data, duration of assessment, individual and global symptoms assessed, and whether improvement or absence of symptoms was the main outcome measure, types of symptoms assessed, frequency and severity of symptoms. The proportion of patients with a successful outcome according to these different symptom measures was compared with the proportion of oesophagitis healed/relapsed after therapy. The results are primarily evaluated in the form of L'Abbé plots. Results: 324 papers were evaluated and data were extractable from 143 eligible trials. L'Abbé plots suggested no or minimal symptoms correlated well with oesophagitis healing and relapse whereas symptom "improvement" overestimated treatment effects. Trials that measured symptoms over a fixed period of time correlated better with oesophagitis healing and relapse than those that did not state the time period. Heartburn was the most important symptom to measure to predict oesophagitis healing but L'Abbé plots suggested additional information may be obtained from regurgitation and dysphagia. Conclusions: This systematic review provides...
ACCESSION #
9747570

 

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