Open Label Trials The Caveat

The enthusiasm by investigators involved in current endo-scopic GERD treatment trials is prompted by apparent symptom improvement in many patients following application of these devices. Interpretation of results in an open-label trial is suspect. The initial open-label Stretta trial of 47 patients which prompted FDA approval likened the Stretta Device equivalent to fundoplication surgery (Triadofilopoulos et al, 2001). In rebuttal to this "premature judgment," Dr Peter Kahrilas (1996) wrote "with a disease (GERD) that can have a 60% placebo response rate, it is simply not good enough to equate a 60% symptomatic response in an uncontrolled trial to existing data on alternative therapies that utilized different trial design, different clinical end points and very different patients" (Kahrilas, 2003). Schoenfeld and Scheiman (2003) are quite explicit in their concerns about the composition of an appropriately designed treatment trial. Randomization, concealed allocation and double-blinding are the only study design techniques proven to prevent an inflated estimate about the benefits of treatment."

It is worthwhile to point out that the results of the only randomized sham controlled trial (Stretta) (Corley et al, 2003) heartburn severity and associated QOL measures were significantly improved for up to 12 months in the treated group. However acid exposure and antacid requirements were similar in both treatment and sham groups.

Constipation Prescription

Constipation Prescription

Did you ever think feeling angry and irritable could be a symptom of constipation? A horrible fullness and pressing sharp pains against the bladders can’t help but affect your mood. Sometimes you just want everyone to leave you alone and sleep to escape the pain. It is virtually impossible to be constipated and keep a sunny disposition. Follow the steps in this guide to alleviate constipation and lead a happier healthy life.

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