Confusion after diabetes study abandoned - February 07, 2008
Doctors aggressively pushing down blood sugar levels in diabetic patients have found their treatment appears to increase deaths in high risk patients. This finding could call into question the entire approach to treating these patients.
The ACCORD trial of 10,000 type 2 diabetics was supposed to continue for 18 months more but the National Institutes of Health pulled the plug after 257 patients whose blood sugar was intensely lowered died, compared with 203 patients who received standard care.
“A thorough review of the data shows that the medical treatment strategy of intensively reducing blood sugar below current clinical guidelines causes harm in these especially high-risk patients with type 2 diabetes. Though we have stopped this part of the trial, we will continue to care for these participants, who now will receive the less-intensive standard treatment,” says Elizabeth Nabel, director of the NIH National Heart, Lung, and Blood Institute (press release).
Experts are keen to stress that lowering blood sugar levels is beneficial to diabetes but the new results mean it is unclear how low you should go. “It’s profoundly disappointing. This presents a real dilemma to patients and their physicians. How intensive should treatment be? We just don’t know,” says Richard Kahn, chief scientific and medical officer for the American Diabetes Association (Washington Post).
“It’s confusing and disturbing that this happened. For 50 years, we’ve talked about getting blood sugar very low. Everything in the literature would suggest this is the right thing to do,” says James Dove, president of the American College of Cardiology (NY Times).
The Seattle Times also quotes Dove: “Everything else has suggested, for 50 years or more, that tight control was good. We’ve got half a century of literature that is put on the back burner right now by one study.”
More
Background details and implications from the American Diabetes Association
NIH Q&As
Press briefing prepared remarks PDF
ACCORD trial homepage
Image: diabetic patient / Punchstock
Comments
As regards type 2 diabetes(about 95% of all cases), and consequently Diabetes Primary Prevention, there is a great, distressing,general mistake among physicians. I mean that they do not know dyslipidaemic "and" diabetic biophysical-semeiotic Constitutions, and the relaive Inherited Real Risk.Unfortunately,nowadays scientific advances continue to encounter the same difficults of earlier periods. Let's remember, e.g., Pasteur and Sammelweiss. What accounts for the reason is wellknown. Only one example: "Why neither websites nor peer reviews give information on Biophysical Semeiotics?" (http://www.semeioticabiofisica.it and the linked one Microangiology). In fact, new theories are better than the old ones, if they permitt us to forsee more events!
With the aid of such efficacious clinical tool, I've recently discovered the untill now unknown, newborn, subtype a) and b), type I Endoarterial Blocking Devices in tissue wherein does really exsist the real risk of human common and severe diseases, as malignancy and diabetes. Obviously that happens in individuals with defined Biophysical Semeiotics Constitutions (Bibliography in the above-cited website) (1-6).
Interestingly, e.g., in Diabetes Primary Prevention (PP), we need new paradigms: http://www.semeioticabiofisica.it, Practical Applications: Diabetes, and Biophysical-Semeiotic Constitutions (1-7). For instance, in the normal Langheran’s islets microcirculatory bed, ther'are exclusively “normal” type II (arterioles, according to Hammersen), but not type I (small arterioles) endoarterial blocking devices, i.e. EBD, of first and second classes, according to S.B.Curri (See http://www.semeioticabiofisica.it/microangiologia). In fact, in health, not involved by Diabetic Constitution, we cannot observe type I, newborn, pathological, EBD in above-mentioned biological system.
On the contrary, in individuals involved by diabetic constitution as well as diabetic "Real Risk" and overt diabetes, of course, we observe with the aid of Biophysical Semeiotics also type I, newborn, subtype b), EBD, facilitating the diagnosis and consequently diabetes primary prevention. In addition, the evaluation of Insulin Secretion Acute Pick Renal Test is significantly impaired, corroborating the clinical diagnosis (1-3) (See above cited-website, Practical Applications, and Glossary)
1) Stagnaro S., Stagnaro-Neri M. Valutazione percusso-ascoltatoria del Diabete Mellito. Aspetti teorici e pratici. Epat. 32, 131, 1986
2) Stagnaro-Neri M., Stagnaro S. Introduzione alla Semeiotica Biofisica. Il Terreno Oncologico. Travel Factory, Roma, 2004. http://www.travelfactory.it/semeiotica_biofisica.htm
3) Stagnaro S., Stagnaro-Neri M., Le Costituzioni Semeiotico-Biofisiche.Strumento clinico fondamentale per la prevenzione primaria e la definizione della Single Patient Based Medicine. Travel Factory, Roma, 2004. http://www.travelfactory.it/libro_costituzionisemeiotiche.htm
4) Stagnaro S., Stagnaro-Neri M. Single Patient Based Medicine.La Medicina Basata sul Singolo Paziente: Nuove Indicazioni della Melatonina. Travel Factory, Roma, 2005. http://www.travelfactory.it/libro_singlepatientbased.htm
5) Stagnaro S. Pivotal role of Biophysical Semeiotic Constitutions in Primary Prevention. Cardiovascular Diabetology, 2:1, 2003 http://www.cardiab.com/content/2/1/13/comments#5753
6) Stagnaro Sergio. Newborn-pathological Endoarteriolar Blocking Devices in Diabetic and Dislipidaemic Constitution and Diabetes Primary Prevention. The Lancet. March 06 2007. http://www.thelancet.com/journals/lancet/article/PIIS0140673607603316/comments?totalcomments=1
7) Stagnaro S., West PJ., Hu FB., Manson JE., Willett WC. Diet and Risk of Type 2 Diabetes. N Engl J Med. 2002 Jan 24;346(4):297-298. [Medline]
Posted by: Sergio Stagnaro MD | February 17, 2008 12:41 PM