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Rapid Responses: Rapid Responses published:
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Glucose values should be reported
- Ingrid Mühlhauser (14 February 2007)
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Lifestyle Changes and/or Drugs for overweight patients without obesity ?
- PATRICE COUZIGOU, COUZIGOU P (15 February 2007)
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Re: Glucose values should be reported
- Clare L Gillies, Keith R. Abrams, Paul C. Lambert, Nicola J. Cooper, Alex J. Sutton, Ron T Hsu, Kamlesh Khunti (23 February 2007)
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Re: Lifestyle Changes and/or Drugs for overweight patients without obesity ?
- Clare L Gillies, Keith R. Abrams, Paul C. Lambert, Nicola J. Cooper, Alex J. Sutton, Ron T Hsu, Kamlesh Khunti (23 February 2007)
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Re: Re: Glucose values should be reported
- Ingrid Mühlhauser (28 February 2007)
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Ingrid Mühlhauser, Professor of Health Sciences and Education University Hamburg, D-20146 Hamburg
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In their systematic review of diabetes prevention studies the authors have reported only data on diabetes risk. We have shown that this is misleading and results in substantial overestimation of the clinical relevance of the effects of interventions for diabetes prevention (1). The authors should also report the data on the underlying changes of glucose and HbA1c values. Health professionals rate diabetes prevention studies as being important much more frequently when results are shown as changes in diagnostic categories rather than as changes in the continuously distributed measure of glucose (1). In our survey of diabetologists and diabetes educators effects were interpreted as important or very important by 92% (255 of 276 survey participants) when results were presented as proportions of subjects with diabetes (14% intervention group, 29% control group), by 87% (248/285) when communicated as a risk reduction of 57%, but by only 39% (110/284) when the corresponding fasting plasma glucose values were presented (mean difference 0.3 mmol/L), and by only 18% (52/283) when glycosylated haemoglobin values were used (6.0% versus 6.1%). These results show that health care professionals view the benefit of preventive interventions substantially higher when changes in diabetes risk are communicated rather than related glycaemic parameters. Transformation of continuous metabolic data into diagnostic categories may interfere with understanding of study effects. This aspect has also been addressed in a recent editorial in Lancet (2). 1) Mühlhauser I, Kasper J, Meyer G, FEND. Understanding of diabetes prevention studies: questionnaire survey of professionals in diabetes care. Diabetologia 2006; 49:1742-1746 2)Tuomilehto J, Wareham N. Glucose lowering and diabetes prevention: are they the same? The Lancet 2006;368:1218-1219. Competing interests: None declared |
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PATRICE COUZIGOU, head department Hepatogastroenterology Haut leveque hospital university victor segalen bordeauxII336OO Pessac France, COUZIGOU P
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Lifestyle Changes and/or Drugs for overweight patients without obesity ? Sir, Successful maintenance of the lifestyle changes needed for optimum bodyweight is usually considered to be uncommon and the current methods for lifestyle modifications (alone) as treatment for obesity are widely regarded as ineffective(1).Meta-analysis by Gillies et al in BMJ challenge this point (2) Absence of durable efficacy of lifestyle modifications is generally observed using data collected in obese patients with BMI ≥30 Kg/m2.The results could be different in individuals with overweight and BMI between 25 ans 30 kg/ m2.. Comparison with alcohol is interesting : for alcohol ,withdrawal or return to moderate consumption is clearly more effective in excessive alcohol consumption without dependency(efficacy of brief intervention) than in case of alcoholism .Public health impact of general practitioner using brief intervention is considerable as the number of alcohol at risk population is more important than alcohol dependant population (3,4).In a similar way , this aspect could be of major importance in nutritional problem with overweight and obese patients: the number of overweight patients in the world exceed for three-four times the number of obese patients ; however the pessimistic view of physicians for lifestyle modifications duration effect in case of overweight has as a consequence too frequent systematic prescription of drugs. It would be problematic to prescribe a drug in all the world for all the overweight individuals, even if the promising new drugs (5) were largely available . So, the question for Gillies et al is : are data available focusing not only on obese patients but also in overweight patients without obesity, looking at the durability of the weight loss under lifestyle prescription only? it could be suspected that durability of the weight loss induced by lifestyle changes would be longer in patients with overweight and BMI less than 30 Kg/m2(6),potentially less “dependent” of nutritional intake . If so , a more positive aspect of lifestyle prescriptions could be proposed in the so call metabolic syndrom in prevention of diabetes but also for the other complications ( cardiovascular ,hepatic..) of this syndrom. Consequences in term of public health would be of major importance . (1) National Heart ,Lung and Blood institute Obesity Education initiative.Clinical guidelines on the identification ,evaluation and treatment of overweight and obesity in adults .the evidence report .Bethesda,MD:US department of Health and Human services .1998 (2 ) Gillies CL, AbramsKR, Lambert PC,Cooper NJ,Sutton AJ,Hsu RT,Khunti K Pharmacological and lifestyle interventions to prevent or delay type 2 diabetes in people with impaired glucose tolerance : systematic review and meta-analysis BMJ 2007 jan 19 on line (3) Miller WR, Rollnick S : Motivational interviewing : preparing people to change addictive behavior . New York : Guilfort Press, 1991 (4) O’Connor PG, Schottenfeld RS : patients with alcohol problems. N Engl J. Med 1998 ; 338 : 592-602 (5) Padwal RS , Majumdar SR .Drug treatments for obesity:orlistat ,sibutramine and rimonabant The Lancet 2007;369:71-77 (6) Wing R,Tate D ,Gorin AA, Raynor HA,Fava JL .A self-regulation Program for maintenance of weigth loss .N Engl J Med 2006;355:1563-71 Patrice Couzigou Pr Patrice COUZIGOU Service d’HépatoGastro-Entérologie Hôpital du Haut-Lévèque Pessac Bordeaux University France patrice.couzigou@chu-bordeaux.fr Competing interests: None declared |
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Clare L Gillies, Medical Statistician University of Leicester, Leicester, UK, LE1 7RH, Keith R. Abrams, Paul C. Lambert, Nicola J. Cooper, Alex J. Sutton, Ron T Hsu, Kamlesh Khunti
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We would like to thank Ingrid Mühlhauser for her comments. Ideally all the important outcomes would have been considered in our meta-analyses of diabetes prevention studies, unfortunately we were restricted by the outcomes reported. As you point out in your paper(1) the DPP study did not report results of HbA1c in their main publication, and neither blood glucose nor HbA1c values were reported as outcomes in the core publications of the STOP-NIDDM study, the smaller studies used in our meta -analyses were further limited in their reported results. It is true that taking a continuous variable and categorising it into IGT and diabetes using arbitrary cut-offs is oversimplifying the problem, especially when risk of complications increase with increasing blood glucose and HBA1c levels. But the important issue for patients is whether they have the disease or not. As only those classified as having diabetes will receive treatment, it could be argued that presence or absence of diabetes is the most important clinical outcome to report. We agree that it is important to report results in a manner that enables clinicians to make an accurate interpretation of the intervention effect. To this end we reported our results not just as relative risks but, as suggested in your paper (1), also in the form of absolute risk reduction and numbers needed to treat. 1) Mühlhauser I, Kasper J, Meyer G, FEND. Understanding of diabetes prevention studies: questionnaire survey of professionals in diabetes care. Competing interests: Kamlesh Khunti has received sponsorship for attending conferences and small honoraria from pharmaceutical companies that manufacture hypoglycaemic and anti-obesity drugs. |
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Clare L Gillies, Medical Statistician University of Leicester, Leicester, UK, LE1 7RH, Keith R. Abrams, Paul C. Lambert, Nicola J. Cooper, Alex J. Sutton, Ron T Hsu, Kamlesh Khunti
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Thank you for your interest in our paper and for raising some interesting issues. Of the trials studying lifestyle interventions in our meta-analyses the majority focused on overweight individuals, with only the DPP and DPS trials having a mean study BMI within the obese range. No single study restricted participants to only those in the overweight range. To assess the effect of interventions in the overweight, individual patient data, or data stratified by BMI category would be needed, and this was not available to us. Competing interests: Kamlesh Khunti has received sponsorship for attending conferences and small honoraria from pharmaceutical companies that manufacture hypoglycaemic and anti-obesity drugs. |
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Ingrid Mühlhauser, Professor of Health Sciences and Education; associate editor of DIABETOLOGIA University Hamburg, D-20146 Hamburg
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I do not agree with the authors' response. The important outcome measure for diabetes prevention intervention studies should not be a more or less arbitrarily defined and obviously misleading diagnostic category (1). It is worrying that the metabolic parameters (glucose and HbA1c values) that are the basis for the diagnostic categories (diabetes yes/no) and which have been defined as outcome parameters in study protocols are not reported in all studies or difficult to extract from the publications (1). Also, in the recently published follow-up of the Finnish Diabetes Prevention Study neither glucose values nor HbA1c values are reported (2). It may be speculated that this information is withheld because of only marginal changes without clinical relevance. What really would matter to persons who undergo diabetes prevention interventions is the effect on clinically relevant outcome measures such as microvascular or cardiovascular complications. There is no evidence to support an important effect of such minimal changes of blood glucose values on microvascular complications, and, there is still lack of evidence of relevant effects on cardiovascular disease. The question remains whether it is justified to label persons as "diabetic" just because of minimal changes in blood glucose values which are insufficiently understood even by diabetes health care providers (1). In any case the authors should include the available information on glucose values in their review. Otherwise, this review will further promote misconceptions about efficacy of diabetes prevention intervention studies. 1) Mühlhauser I, Kasper J, Meyer G, FEND. Understanding of diabetes prevention studies: questionnaire survey of professionals in diabetes care. Diabetologia 2006; 49:1742-1746 2) Lindström J et al. Sustained reduction in the incidence of type 2 diabetes by lifestyle intervention: follow-up of the Finnish Diabetes Prevention Study. Lancet 2006; 368: 1673-1679 Competing interests: None declared |
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