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The best therapy of diabetes mellitus type 2 and its complications is its primary prevention.
- Sergio Stagnaro (26 October 2001)
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More analyses
- Belinda Ireland (3 November 2001)
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Re: The best therapy of diabetes mellitus type 2 and its complications is its primary prevention.
- Niels de Fine Olivarius (22 November 2001)
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Re: More analyses
- Niels de Fine Olivarius (22 November 2001)
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Sergio Stagnaro, Specialist in Blood, Gastrointestinal, and Metabolic Diseases Riva Trigoso (Genoa) Italy
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Sirs, in their trial, Niels de Fine Olivarius et al. (1) in order to assess the effect of a large variety of intervention at general practitioners on six year mortality, morbidity, and risk factors of patients with "newly" diagnosed type 2 diabetes, have treated individuals aged 40 years or more, who had diabetes diagnosed in 1989-91, i.e. since 1 year or more (sic.). The intervention ameliorated a lot of risk factors, as fasting plasma glucose concentration (7.9 v 8.7 mmol/l, P=0.0007), glycated haemoglobin (8.5% v 9.0%, P<0.0001; reference range 5.4-7.4%), systolic blood pressure (145 v 150 mm Hg, P=0.0004), and cholesterol concentration (6.0 v 6.1 mmol/l, P=0.029, adjusted for baseline concentration). Both groups had lost weight since diagnosis (2.6 v 2.0 kg). It is important to say that predefined clinical non-fatal outcomes, and mortality were the same in both groups. As a matter of fact it is well known that control of hyperglycaemia, hypertension, and dyslipidaemia “postpone” the development of diabetic complications in patients with type 2 diabetes, but notoriously a good diabetes therapeutic control is really difficult. In my opinion, therefore, the war against diabetes mellitus and its well-known and dangerous complications is nowadays possible (See http://digilander.iol.it/semeioticabiofisica;Applications: Diabetes Mellitus) exclusively by means of the "clinical" primary prevention, which must be achieved, of course, at the bed-side, i.e. on very large scale. In fact, it is generally admitted that non-insulin-dependent diabetes mellitus may occur at least 12 years before the clinical diagnosis of DM is made, and retinopathy can develop at least 7 years before the diagnosis. During the time that diabetes is undiagnosed and untreated, as in the patients of the trial, complications, that could be avoided, are developing. Therefore, very early diagnosis , i.e. “before the onset of clinical and laboratory phenomenology” must be established to avoid diabetic complications. It is nowadays both possible and easy to reach this goal by means of Biophysical Semeiotics. In fact, in order to prevent well known diabetic complications, it is extremely necessary that doctors use a “clinical” tool reliable in diagnosing early diabetes mellitus, i.e. from its initial stages in the sense illustrated in my previous papers (Reaven's syndrome, both classic and "variant" in slow diabetic evolution (2, 3, 4). Until now, unfortunately, diabetes mellitus is too often diagnosed accidentally, e.g. by occasional urinary or blood tests. Furthermore, epidemiological studies indicate that 50% of individuals with 2-hour postglucose challenge values over 200 mg/dL, a value diagnostic for diabetes, were not previously diagnosed as being diabetic (5, 6, 7). Fortunately, it is now easy to realize "clinically" an efficacious DM primary prevention in a simple manner, with the aid of some biophysical - semeiotic signs, reliable at the bed-side, in diagnosing promptly diabetes mellitus as well as its initial stages. The described method, easy to perform, can be applied on very large scale, "conditio sine qua non" to prevent a serious disease, that notoriously causes morbidity and mortality, through dangerous lesions in the kidneys, retina, heart, brain, etc. Change in Medicine is an up-hill task, but scientific progresses go on, and on, as demonstrates my “first” article posted in the italian Sit of CNR, Staibene.it, 24 October 2001: “Conoscere il Terreno oncologico per sconfiggere il cancro”. Yours, Stagnaro Sergio MD.,
1 Olivarius N.d.F. et al. Randomised controlled trial of structured personal care of type 2 diabetes mellitus. BMJ 2001;323:970 ( 27 October ). 2.Stagnaro S., Stagnaro-Neri M. Valutazione percusso-ascoltatoria del Diabete Mellito. Aspetti teorici e pratici. Epat. 32, 131 1986 3.Stagnaro-Neri M., Stagnaro S., Sindrome di Reaven, classica e variante, in evoluzione diabetica. Il ruolo della Carnitina nella prevenzione del diabete mellito. Il Cuore. 6, 617 1993 4.Harris MI: Undiagnosed NIDDM: Clinical and public health issues. Diabetes Care 16:642-652,1993 5. Stagnaro-Neri M., Stagnaro S., Semeiotica Biofisica: la manovra di Ferrero-Marigo nella diagnosi clinica della iperinsulinemia- insulinoresistenza. Acta Med. Medit. 13, 125,1997 6. Stagnaro-Neri M., Stagnaro S., Semeiotica Biofisica: valutazione clinica del picco precoce della secrezione insulinica di base e dopo stimolazione tiroidea, surrenalica, con glucagone endogeno e dopo attivazione del sistema renina-angiotesina circolante e tessutale – Acta Med. Medit. 13, 99 1997 |
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Belinda Ireland, Director of Research Department of Community and Family Medicine, Saint Louis University
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Niels de Fine Olvarius and colleagues (1) acknowledge that their findings of no difference for selected primary outcomes may result from underpower or short follow-up. Those findings might also arise because they used intention to treat analysis (the most conservative). This method of analysis would include physician practices in the intervention group even when physicians may not use the descriptive feedback, may not define goals with the patient or may not use the provided patient handouts. If the authors have data on how many physicians in the intervention group actually performed the intervention as designed, it would be valuable to see the analysis presented both ways. I would also like to address the authors' conclusions about risk factors and their analysis to support those conclusions. Some evidence uses median and interquartile ranges, a summary of the distribution of values that is less sensitive to extremes than the mean and range, but that still does not provide a reader with a clinically important comparison of how individuals fare. For measures such as glycosuria, the authors provide an actual count. These counts also represent the prevalence of glycosuria at study end and could be summarized by odds ratio (OR). With data they provide in Table 6, I calculate an unadjusted OR of 0.49 (95% CI 0.36-0.67), using the software package STATA. (2) This means that those in the intervention group had a risk of having glycosuria at study end that was half that of those in the control group, an important finding. Using EBM methods presented by Sackett et al (3), we can calculate NNT, the number of type 2 diabetics we need to treat with the intervention to prevent one case of glycosuria, using the formula, 1/CER-EER, or in this case, 1/(0.37-0.225). The resulting NNT of 7 means we need only treat seven people, a very impressive NNT when compared with others presented in the EBM text (3). The authors could also evaluate glycated haemoglobin and fasting plasma glucose by counting numbers of individuals who achieved a clinically important level or reduction at end of study and derive the same RR and NNT measures. These additional analyses provide a measure of the magnitude of the risk factor reduction associated with the intervention. This is especially important in light of the cost data the authors provide indirectly through measure of office visits. With no detectable difference in primary outcomes, the authors report a 9% increase in intervention group patients over control patients who make 4 consultations per year and a 13 % decrease in patients who make only 1 per year. It would be important to demonstrate a sizeable reduction in risk factors to justify the increased utilization of medical resources. References 1.Olivarius N.d.F et al. Randomized controlled trial of structured personal care of type 2 diabetes mellitus. BMJ 2001;323:1-9. 2.StataCorp. 2001. Stata Statistical Software: Release 7.0. college Station, TX: Stata Corporation 3.Sackett DL et al. Evidence Based Medicine, How to Practice and Teach EBM. Second edition. Churchill Livingstone, 2000. |
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Niels de Fine Olivarius, Associate Professor Central Research Unit of General Practice, Panum Institute, DK-2200 Copenhagen N, Denmark
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Dr. Stagnaro relates to the ongoing debate of prevention vs. treatment. It is true, that the incidence of diabetes is increasing because of developments in society, which means more plentiful and fattier food, too little exercise and increasing overweight. Therefore, for primary prevention we need to inspire our politicians to change the direction of developments. Since type 2 diabetes most often has an insidious start, we have up to 150,000 people with undiagnosed diabetes in Denmark. This is 3% of the population. To find the undiagnosed patients is a difficult task as it remains to be seen that we can find a significant proportion of these patients by screening a relatively small (e.g. 20%) proportion of the population. I will be looking forward to read about Dr. Stagnaros model in English. However, among the approximately 130,000 Danes who have already been diagnosed, there are still at least a quarter who are so badly regulated that they run a very high risk of developing diabetic complications. Since the resources in the health system are limited, we must of necessity focus on effects and thereby also on where we can use the resources most effectively. The study "Diabetes Care in General Practice" exemplifies this. Finally, Dr. Stagnaro questions the "newness" of our newly diagnosed diabetic patients. The median time from the first suspicion was raised until the first clinical examination in the study was about a week. Yours sincerely, Niels Olivarius |
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Niels de Fine Olivarius, Associate Professor Central Research Unit of General Practice, Panum Institute, DK-2200 Copenhagen, Denmark
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Dr. Ireland would like to see more analyses to document the effect of the intervention. It is true, that we have chosen a very conservative interpretation of our results. This is a sound methodological approach as we did not anticipate any subgroup analyses in the protocol. In the near future we will publish papers trying to shed light on the reason why we did see a difference in e. g. risk factors between treatment groups. We will stratify according to the finding of microalbuminuria and doctors' participation in the seminars among other things. We have, however, no information on what really did happen in the individual consultations. In our paper the magnitude of the reduction in risk factors is illustrated in the tables with few details. It is true that the reader may get a more detailed picture of the reduction in HbA1c from NNTs. Such a number will, however, depend on the limit chosen by the author, so we prefer more detailed tables and graphs. Dr. Ireland also suggests a more extensive use of the NNT concept, but the use NNT for intermediate outcomes makes you think of overinterpretation done by enthusiastic researchers. In our opinion, the NNT concept should be used only for statistically significant primary outcomes. Whether our intervention resulted in increased utilization of medical resources is unclear, as we did see a reduction in referrals to diabetes clinics and a minor reduction in the length of stay in hospital in the intervention group. Yours sincerely, Niels Olivarius |
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