Special issue treatment of type 2 diabetes a matter of proof
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Special issue treatment of type 2 diabetes a matter of proof

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Never did I read a document so impregnated with intelligence and tenderness directed to the medical profession!!! I can say that I am happy to have already talked with Professor Derek R Matthews from ...

Never did I read a document so impregnated with intelligence and tenderness directed to the medical profession!!! I can say that I am happy to have already talked with Professor Derek R Matthews from Oxford (UK).

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Special issue treatment of type 2 diabetes a matter of proof Special issue treatment of type 2 diabetes a matter of proof Document Transcript

  • editorial Diabetes, Obesity and Metabolism 14 (Suppl. 1): 1–2, 2012. © 2011 Blackwell Publishing LtdWisdom-based and evidence-based medicineEvidence seems to be what we need in medicine. Decades ago,at the time of the Spanish Civil war and Second World War, RegulatorsArchie Cochrane, a young physician in a prison camp, worriedthat his advice to colleagues about treating tuberculosis mightnot be appropriate and feared indeed that some proceduresand medications might be harmful: ‘I knew that there was “Experts” Research Evidence andno real evidence that anything we had to offer had any effect Guidelines Baseon tuberculosis, and I was afraid that I shortened the livesof some of my friends by unnecessary intervention’ [1]. So Decisionbegan the history of evidence-based medicine, and its laudableenlargement and formalization—the Cochrane Reviews andthe Cochrane Collaboration—with their careful approach togrades of evidence. Standing on this firm platform of evidential Physician Patientpractice we are sure in our prescribing, now, that tuberculosiscan, usually, be eliminated by triple therapy, that ACE inhibitorslower blood pressure and can improve longevity, and that DRM 2011peptic ulceration is often caused by Helicobacter pylori andcan be treated with a 1-week course of antibiotics. These are Figure 1. Decision making is a four-sided process: no one domain hastriumphs of research and the accumulation of evidence. primacy. Regulators have effects on research generally, but influence and However, with time the complexity of medicine increases. are influenced by evidence and by experts.Faced with diabetes, what are we hoping to treat? If we aresimply trying to improve mortality does this not marginalizethe significance of reducing morbidity? Would our patients medicine which is to do the right thing for the right reason.prefer to live longer but live with renal failure? Is the prevention No physician is needed when therapy can be read from anof stroke less important than absolute longevity? At this point in algorithm.our medical practice we arrive at a dilemma. We have evidence- In these proceedings, we have published articles by fourbased medicine pointing in different directions depending on opinion leaders in the field. They address the issue of the roleour choice of what it is that we are trying to treat or prevent, of therapy in general and sulphonylureas in particular fromand so it emerges that clinical practice becomes knowledge- different standpoints and are a perfect illustration of the ways inbased rather than evidence-based. Knowledge is wider than which medical practice moves forward. We need insights intoevidence. Evidence implies that we are facing a situation where the molecular basis of sulphonylurea action [2], into clinicala decision can be right or wrong. The word ‘evidence’ is most studies of sulphonylureas—and gliclazide in particular [3] andcommonly used in courts of law where a jury is assessing we need experience in synthesizing the totality of evidencewhether something is right or wrong. Is someone innocent [4, 5].or guilty? Courts do not like the concept of someone being Intersecting with what we know and the trial evidence are some other crucial considerations. We cannot prescribe e d i tor i a lpartly guilty! But in medicine our knowledge tells us that agentsor procedures or policies or combinations of drugs work in regardless of cost in the current environment; we cannot ignoregeneral but not in everyone. The cry goes up that we need more regulators even when we think our opinion is better than theirs;evidence. But if we were going to use randomized control trials we cannot ignore the pragmatic issues of availability and supply;to look at permutations and combinations of five agents that finally we cannot ignore the role of the patients themselves inwe know would work to reduce glycaemia in type 2 diabetes, being part of the decision-making process. All the therapeutic conclusions from randomized controlled trials are based onthen we would need a trial with 120 arms. This is never going mean or median response—when faced with a single patientto happen. even our strongest evidence can fail us. Is this patient ‘typical’ or So we decide, discuss and prescribe on the basis of our was the trial of ‘typical patients’? So our guidelines are flawed,knowledge base. Our deliberations may not be strictly evidence- not in their generality but in their specificity. Explicit problemsbased, but we would hope they might be rational. Figure 1 with guidelines include:shows how the evidence base that we embrace is not necessarilythe leading influence on a therapeutic decision—indeed were • Guidelines cannot usually be strictly evidence-based,it to be we would feel that much had been lost from the art of simply because the head-to-head trials of the wide
  • editorial DIABETES, OBESITY AND METABOLISM range of agents have not been carried out, or drugs hypoglycaemia, social environment (e.g. living alone), age used in previous trials are now no longer prescribed or or even life expectancy in some circumstances. available or thought to be appropriate. In the Consensus We have to begin an open dialogue about patient wishes, statement Algorithm published in 2009 [5], for example, fears, circumstances and resources. This is neither evidence- after the use of metformin the only subset that was based medicine nor solely knowledge-based medicine. It labelled as having a ‘well-validated’ evidence base was requires listening, thought, experience and wisdom. It is for the use of sulphonylureas—based on the UKPDS. rationally based medicine which in the best hands is The guidelines explicitly suggested, however, that what compassion-based medicine too. should be used should be ‘sulfonylureas other than glybenclamide (glyburide) or chlorpropamide’. However, these agents were exactly the ones that were used in the D. R. Matthews UKPDS. Professor of Diabetes Medicine, University of Oxford; • The US and European regulators take a different view NIHR Senior Research Fellow; about pharmaceutical agents, so there cannot be an agreed Oxford Centre for Diabetes, endocrinology and Metabolism clinical view that has transatlantic credence, much less a global one. • ‘Expert’ committees may have their expertise limited References by geographic experience, or by an approach that is 1. Cochrane AL, Blythe M. One Man’s Medicine: An Autobiography of Professor clinically monocular. So clinician-based guidelines may Archie Cochrane. London: British Medical Journal, 1989. differ from those of providers (e.g. health management 2. Seino S, Takahashi H, Takahashi T, Shibasaki T. Treating diabetes today: organizations in the USA and the National Institute a matter of selectivity of sulphonylureas. Diab Obes and Metab 2012; for Clinical Excellence—NICE—in the UK). Under 14(Suppl. 1): 9–13. these circumstances guidelines may suggest one path 3. Hamet P. What matters in ADVANCE and ADVANCE-ON. Diab Obes and where public health or finance restraints may dictate Metab 2012; 14(Suppl. 1): 20–29. another. 4. Avogaro A. Treating diabetes today with Gliclazide MR: a matter of numbers. • Guidelines abstract public domain data (usually random- Diab Obes and Metab 2012; 14(Suppl. 1): 14–19. ized controlled trials from large research populations) for 5. Colagiuri S. Optimal management of type 2 diabetes: the evidence. Diab evidence on how to treat individuals [7]. Although this is Obes and Metab 2012; 14(Suppl. 1): 3–8. better than prescribing on the basis of opinion, it does 6. Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R not allow for the fact that patients differ widely in their et al. Medical management of hyperglycemia in type 2 diabetes: a pathology and phenotypes (phenotype may include age, consensus algorithm for the initiation and adjustment of therapy: a sex, weight or co-morbidity). Physicians and governments consensus statement of the American Diabetes Association and the espouse patient involvement in therapy [3,8] yet guidelines European Association for the Study of Diabetes. Diab Care 2009; 32: appear to show pathways undirected by patient liaison or 193–203. consultation. 7. Grant PJ. The EASD/ADA consensus: trick or treat?. Diabetes Vasc Dis Res • Nodal decision points on guidelines may not be explicit in 2009; 6: 5–6. terms of timing or reasons for increasing/altering therapy. 8. Glasgow RE, Peeples M, Skovlund SE. Where is the patient in diabetes Adding or altering therapy may be based on complex performance measures? The case for including patient-centered and self- decisions relating to such issues as co-morbidity, risks of management measures. Diabetes Care 2008; 31: 1046–1050.2 doi:10.1111/j.1463-1326.2011.01514.x Volume 14 No. (Suppl. 1) January 2012