Van Heel and West (Gut 2006;55:1037–46) published a very complete and up to date review on coeliac disease (CD), dealing very clearly with all aspects of CD, from clinical problems to basic science. In the last paragraph they introduce a very “hot topic”, future therapeutic perspectives of CD, involving immunosuppressive drugs, introduction of non‐toxic cereals, development of inhibitors of the enzyme tissue transglutaminase, etc. However, the possibility of introducing drug based therapy for CD brings forth some ethical considerations.
A gluten free diet (GFD) is currently the only available therapy, and resolves the intestinal damage, normalises serological markers, and leads to disappearance of symptoms in the vast majority of cases. Compliance with GFD is not perfect because of the widespread use of gluten in Western diets, but clearly improves if patients are clinically followed up.1 Moreover, so called “hidden gluten” is a problem that frightens CD patients, although not a proven danger to their prognosis, and the outcome of sporadic gluten ingestion in asymptomatic patients is unknown.
For these reasons, there is considerable interest in the development of alternative therapies.2 However, GFD remains the only treatment that does not involve drugs, side effects, or long term risks, and has an almost 100% success rate, and so any “better than GFD” therapy should therefore not only allow gluten ingestion without stimulating an immunological response but also have no side effects, no long term risks, and be highly effective and cheap. This is a very difficult goal and poses ethical problems for future trials.
Three strategies can be considered for alternative therapy: (1) a vaccine‐like therapy; (2) an on‐demand therapy available during sporadic gluten intake; and (3) life long immune therapy allowing complete or partial gluten reintroduction. However, all of these pose problems: a “vaccine” must be safe and have no long term consequences on immunity, and an on‐demand approach requires knowing the exact amount of gluten that can be blocked by the drug and, given that gluten induced damage is dose independent, estimating possible intake frequencies. It is also important to note that compliance with drug based therapies is not perfect and that determining drug effectiveness requires a very long follow up because it is well known that CD can relapse after many years of a gluten containing diet.3
Another problem concerns the selection of trial patients because heavily symptomatic patients may have difficulty in giving consent and asymptomatic patients could have different degrees of intestinal involvement.1
In general, presenting possible new therapies to patients should include a clear explanation of the pros and cons in order to allow their free and informed adherence to experimental trials.
Footnotes
Conflict of interest: None declared.
References
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