Transjugular Intrahepatic Portosystemic Shunt or Sclerotherapy: Which Would You Choose?

IN RESPONSE:

Drs. Marshall and King take exception to two of my opinions. First, they take issue with my statement that endoscopic sclerotherapy is the standard therapy for bleeding varices. They believe that endoscopic variceal ligation has already supplanted endoscopic sclerotherapy. Our disagreement is about the tense of the verb-“is” versus “was.” I have no doubt that endoscopic variceal ligation will supplant endoscopic sclerotherapy in the future, but the standard of care is defined as the treatment of choice now. The medical device industry standard for tracking such data indicates that of more than 38 000 patients who bled from varices in 1996, 65% will have been treated with sclerotherapy and 35% will have received variceal ligation during 1997. Parity will not occur until 1999. Greg Steigmann, the leading proponent of endoscopic variceal ligation, concurs with this opinion (Steigmann G. Personal communication). Some time thereafter, endoscopic variceal ligation will truly become standard therapy. Prudence dictates that physicians await data sufficient to establish unequivocally that endoscopic variceal ligation is the standard. Embarrassing examples of other premature ejaculations abound in the medical literature.

Marshall and King's second exception is to my hypothetical statement that I would refuse endoscopic therapy if I were randomly selected to receive it. In his superb book, Ethics and Regulation of Clinical Research, Robert J. Levine discusses informed consent in great detail [1]. He discusses the presentation of an investigation to prospective participants, which involves a description of discomforts, risks, and alternative therapies and outlines participants' rights. He emphasizes that “… the subject may discontinue participation at any time” and explicitly states “… that even though they have consented to participate, they may change their minds” and “withdraw without prejudice.” He suggests that the investigators ask the participant whether there are “… a priori reasons that he or she may have to withdraw.” In my hypothetical remarks, I identified such a reason: my strong, irrational distaste for endoscopy. What are my alternatives? I may choose not to participate in the investigation at all, even after randomization; may exert my right to withdraw; or may change my mind and agree to participate “for the good of others.” In accord with the concept of clinical equipoise, it is now acceptable for a physician to perform a randomized, controlled trial even if he or she earnestly believes that one of the therapies under investigation is superior to the other; this participation is a manifestation of respect for colleagues who sincerely believe that the other therapy is superior [2]. As an experienced clinical investigator, I know (to paraphrase John Donne) that every participant's dropout diminishes my trial. Such dropouts could conceivably undermine the validity of a study.

When serious illness strikes me, my friends, or my family, I seek the advice and services of the most knowledgeable and experienced physicians in the field. When I am in doubt about therapy, I enter them into ongoing randomized, controlled trials. If I were to bleed from varices, the bete noire of hepatologists, my knowledge of the literature would permit me to select specific therapies, physicians, and institutions. I have already tentatively enlisted a TIPSologist, a clinical pharmacologist an endoscopist, a vascular surgeon, and a transplant surgeon by whom I would want to be treated, if necessary. It is not required that the shoemaker's children be the worst shod.

• Copyright ©2004 by the American College of Physicians