The British Medical Journal has published the results of a study that aimed to assess the impact of self monitoring of blood glucose (SMBG) on HbA1c.
The study recruited 453 patients with type 2 diabetes controlled by diet or oral medication. The patients were randomly assigned to open treatment with standard care in the control group or one of two intervention arms consisting of SMBG with medical advice or SMBG with training on interpretation of the results. The patients were followed up every 3 months for 1 year.
Approximately one third of the patients in each of the intervention groups failed to persist with the monitoring for the duration of the study. The data were analysed on an intention to treat basis.
There were no differences in HbA1c between any groups at 12 months after correction for baseline levels. There was a statistically significant decrease in total cholesterol in the group using SMBG with training. Since the primary outcome was not significant this finding should be interpreted with caution.
It was also noted that significantly more patients in the intervention arms of the study experienced episodes of grade 2 hypoglycaemia defined as "mild symptoms requiring minor intervention".
The authors conclude that SMBG, for reasonably well controlled patients with type 2 diabetes, offers little in terms of advantage while it is poorly tolerated by patients. It is also suggested that the cost, time and effort involved could be better used in alternative areas of healthcare provision.
Action: Clinicians should consider the place of SMBG for their patients and avoid routinely recommending this intervention for reasonably well controlled patients with type 2 diabetes controlled by diet or oral medication.
The Archives of Internal Medicine has published the results of a randomised controlled study into a commercially available portion control plate on weight loss in a cohort of patients with type 2 diabetes.
The study recruited 130 obese patients with type 2 diabetes (including some on insulin). The participants were randomised to standard dietary advice in the control group or daily use of a portion control plate in the intervention group. The study ran for 6 months and percentage reduction in body weight was assessed.
Patients in the intervention group lost an average of 1.8% body weight (SD ±3.9%) while those in the control group lost 0.1% (SD ±3.0%). The difference was statistically significant (p=0.006). In addition to this finding more patients in the intervention group required a dose reduction of their diabetes medications (26.2% vs. 10.8%, P = .04).
The authors conclude that, "the portion control tool studied was effective in inducing weight loss". They also state that the weight loss achieved allowed patients to decrease their hypoglycaemic medications without sacrificing glycaemic control.
Action: Clinicians can be confident in advising patients to use portion control measures as an aid to weight loss. Commercially available plates are an option for patients (at their own cost) or perhaps a more practical approach is to simply use a smaller plate.
The National Institute of Health and Clinical Excellence has published new guidance for the month of June.
Only one of the six publications has a direct impact upon primary care, the Faecal Incontinence Guideline. The Quick Reference Guide (QRG) advises that faecal incontinence should be managed with an integrated continence service.
It is also advised that primary care clinicians should actively enquire about symptoms in high-risk groups such as: (see QRG for a complete list)
- frail older people
- people with loose stools or diarrhoea from any cause
- women following childbirth (especially following third and fourth degree obstetric injury)
- people who have had colonic resection or anal surgery
- people who have undergone pelvic radiotherapy
- people with perianal soreness, itching or pain
- people with learning disabilities
In addition to this, a proactive approach to bowel management is recommended in specific groups as listed in the QRG
Action: Primary care clinicians should be aware of the availability and referral arrangements to local continence services. Active enquiry, proactive treatment and referral to continence services are likely to improve quality of life for these patients.
The National Institute for Health and Clinical Excellence has released Final Appraisal Determinations (FADs) for primary prevention and secondary prevention of osteoporosis in postmenopausal women.
Both of these appraisals are FADs and are therefore currently open to appeals. They may not reflect the completed guidance due for release in August 2007.
Both documents provide recommendations for when treatment should be initiated based upon the age of the patient, bone mineral density and other clinical risk factors. Only alendronate is recommended for treatment initiation. Patients currently on treatment with another drug covered by the appraisals (etidronate, risedronate, raloxifene, strontium or teriperatide) should have the option to continue treatment.
These documents are not final guidance and may be revised before official publication. Since NICE are already the subject of extensive media coverage relating to the judicial review in progress over the recent guidance for Alzheimer's Disease, these publications may be covered in the general media provoking patient enquiries.
Action: Clinicians should await the finalised NICE guidance before making changes to current practice or existing treatments.
The New England Journal of Medicine has published a sub-group analysis of the Women's Health Initiative. This trial has been reported in the Daily Mail and Daily Express although one report suggested that the trial compared two active treatments.
This analysis examined coronary artery calcification in post-menopausal women aged 50 to 59 years at enrolment. Each patient had undergone hysterectomy and was randomised to hormone replacement therapy (HRT) with conjugated equine oestrogen 0.625mg per day or placebo.
Each participant in the study received HRT or placebo for the duration of the study (average 7.4 years) and approximately one year after stopping treatment underwent a CT scan to measure coronary artery calcium score. The results of the scans were assessed independently without knowledge of the treatment used. Coronary artery calcium score is a surrogate marker and is predictive of future risk of cardiovascular events.
The study found that the average coronary artery calcium score was statistically significantly lower in those patients who had been taking HRT than in those who had taken placebo. Correction for baseline cardiovascular risk did not change the outcome of the study.
The authors of the paper conclude that, "oestrogen has complex biologic effects and may influence the risk of cardiovascular events and other outcomes through multiple pathways". One potential flaw in the study was the fact that treatment had been stopped for a year before the CT scans were performed.
It is already known from the complete WHI studies that combined HRT is not cardioprotective and may increase the risk of cardiovascular disease. The oestrogen only study failed to demonstrate cardiovascular benefits and was stopped early due to an increase risk of stroke
Action: HRT should only be used for menopausal symptom control. HRT (combined and oestrogen only) is not an appropriate intervention for prevention of cardiovascular events.