A META-ANALYSIS COMPARING INDUSTRY AND NON-INDUSTRY FUNDED TRIALS OF ANTI CHOLINERGIC MEDICATIONS

A.A. Ayers, P.K. Tulikangas, D.M. O’Sullivan

Hartford Hospital, Hartford, CT

OBJECTIVE:  To determine if there was a significant difference in outcomes of industry vs. non-industry funded clinical trials of anti cholinergic medications used to treat over active bladder symptoms and detrussor instability.

MATERIALS AND METHODS:  A MEDLINE search was conducted from January, 1966 to June, 2003 to identify human clinical trials of oxybutynin and tolterodine published in English. Randomized controlled trials on subjects 16 years or older who were being treated with oxybutynin or tolterodine for overactive bladder symptoms or detrussor instability.  Twenty-five studies were identified.

RESULTS:  End points assessed were overactive bladder symptoms or changes in uninhibited detrussor contractions on cystometrogram.  The outcome variables were dichotomized as improvement or no improvement.  Odds ratios and 95% confidence intervals were calculated for each study based on data derived or extracted from tables and figures.  Meta-analysis did not demonstrate a significant difference in the outcomes of industry vs. non-industry funded trials.  Trials were then reviewed to determine their adherence to the CONSORT guidelines for randomized trials.(odds ratio table inserted here-would not transmit for electronic submission)

CONCLUSIONS:  Clinical trials are important for clinicians when selecting medical therapies.  This analysis finds no difference in outcomes when comparing privately funded industry trials to publicly funded studies for tolterodine and oxybutynin.  No study conformed completely to the CONSORT guidelines.  The quality of all trials would be improved by close adherence to the CONSORT guidelines for randomized clinical trials.

Disclosure - Speakers Bureau: P.K. Tulikangas, Pfizer.