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Guidelines in IBD: A conspiracy?
In order to improve and standardise treatment for difficult conditions it has become common cause to design guidelines for clinicians to follow. In spite of these good intentions the care given to patients is often suboptimal for the individual.The reasons for this are threefold.
1. The speed of innovation and development of the new
The management of inflammatory bowel disease (IBD) has been complicated by the lack of a clear etiological factor. Even the histology is confused and the two main conditions Ulcerative Colitis and Crohn's Disease cannot always be distinguished. Treatment has therefore been largely empirical and its efficacy explained by the concepts of the day.
Salazopyrine was developed in 1946, intravenous steroids in the Truelove Regimen in 1956, immunosuppressants in 1990 and lastly anti-TNF drugs in 1998. These developments mirrored our current understanding of the causes of these diseases at the time, namely infective, inflammatory, autoimmune and lastly deranged immunity.
Clinical practice continues to follow this sequence of medication as echoed by the published guidelines (eg SAGES guidelines for management of IBD can be downloaded from www.sages.co.za.
The guidelines suggest initial treatment with Salazopyrine or mesalazine for mild cases followed by steroids orally or parenterally and then immunosuppressants such as azathioprine or methotrexate. If the patient does not respond satisfactorily surgery or anti-TNF drugs are considered.
The reality is that Salazopyrine and mesalazine are only marginally better than placebo in the treatment of iIBD. Corticosteroids will bring approximately 70% of patients into remission but have a complication risk in the short and long-term which reduces their usefulness. Immunosuppressants are largely used in the maintenance of IBD patients but after a year of therapy only 40% will still be in remission as opposed to 25% on placebo. Finally with the anti-TNF drugs, Revellex and Humira, 89% of patients can be expected to respond and of these 63% will still be benefiting after five years. So clearly the anti-TNF drugs are very much more powerful than any other drug available.
In 2008 Geert d’Haens proposed that we should treat patients with the most effective drugs initially to get patients into remission as soon as possible. This is the so-called top-down approach. It has also been shown that these patients cost less money to the funder over time than those treated in the traditional bottom up approach. This method involves starting a patient on mesalazine or corticosteroids and moving up to the more powerful/expensive agents.
2. The lack of review and redevelopment of the old
In addition to the slow adoption of new methods there has been little review of the old. Newer and better formulations of mesalazine are available but not always used. The specific avoidance of the side-effects of corticosteroids are not addressed from the time that corticosteroid therapy is started. The dosage of azathioprine, the main immunosuppressant used, can be fine-tuned by measuring its metabolites.
3. Misunderstanding where the treatment of IBD is going.
While traditionally the aim of treatment is to cure or control the symptoms of the disease. The exact endpoint was not always formalised. Over the last five years the importance of mucosal healing in patients with IBD has been recognised. The how and when continue to be debated but the intention is clear. Patients should be treated until the mucosa has healed.
The guidelines however do not yet recommend the top-down approach and nor do they recommend that mucosal healing be the target of therapy. The question is “Why is this?” The answer I suggest is related to the Abilene paradox.
This was described by Jerry B Harvey in 1974. The Abilene paradox occurs when a group of people collectively decide on a course of action that is counter to the preferences of any of the individuals in the group. It involves a common breakdown of group communication in which each member mistakenly believes that their own preferences are counter to the group’s and, therefore, does not raise objections.
As opposed to the individual's dilemma “When the king has no clothes”, in this case the group has authority and their advice is followed. Indeed it is in the elevation of the guidelines to a set of rules by health authorities and funding organisations that compound the problem. The reasons for this are largely financial as inevitably newer medication is more expensive than the old.
The proof of the Abilene paradox in action is in a recent consensus/guideline paper which did not recommend the top down approach nor treatment to mucosal healing. In spite of this the senior author of this publication when writing in his own name, strongly recommends both the top-down approach and the target of mucosal healing.
As always it is up to the responsible primary physician to treat patients on the basis of his or her experience of the disease guided by the evidence available. If the physician does not have the experience, patients should be referred to those who do rather than simply following published guidelines...