Tag Archives: BMI

Very low calorie diets in diabetes: the Bournemouth experience

Pat Miles, David Kerr

Introduction

The therapy of obese patients with poorly controlled diabetes is a complex area. Despite the best efforts of healthcare professionals and patients, therapy is too often associated with repeated failure, which can give rise to frustration and sometimes despondency. Very low calorie diets (VLCDs) have been advocated for this population group. This article looks at the process and outcomes of one VLCD programme. The results support the wider adoption of VLCDs, but there are significant resource implications which are also discussed.

The treatment of the obese individual with poorly controlled diabetes is a common and perplexing problem. Wading in with ever increasing amounts of insulin without giving thought to ameliorating the inevitable weight gain will cause desperation in the multidisciplinary team and despondency in the patient. Very lowcalorie diets (VLCDs), of <800 kcal perday, are designed to achieve substantial weight loss while preserving lean body mass and are typically associated with a 20 kg weight reduction in three months (NTFPTO, 1993). Unfortunately, regain of half to two-thirds of the initial weight loss is common within 12 months after cessation of the diet, although there may be longer term benefits in terms of a reduction in the need for medication in obese individuals with diabetes (Wing et al, 1994). Recently, Paisey et al (1998) compared VLCD with a traditional intensive dietary regimen in 30 obese (BMI>30) patients with diabetes and 19 obese controls without diabetes. After four months of VLCD, subjects were switched to a low-fat diet and continued to be seen weekly by the multidisciplinary team. Weight loss was substantial and maintained after cessation of VLCD (mean 14kg at 12 months), and 14 of the 15 patients who had chosen VLCD had normal blood glucose and fructosamine levels despite stopping all medication. For four patients with recent-onset diabetes, normalisation of blood glucose levels was sustained for 12 months.

Study aim

A pilot study was carried out to examine the effect of a VLCD programme on a group of obese (BMI30) patients with diabetes. These patients remained obese despite enormous efforts by the multidisciplinary team (including primary care). Usually, there was also poor glycaemic control. Method Between January and June 1999, 24 patients aged 29–76 years were enrolled into Lipotrim (Howard Foundation Research, Cambridge, England), a VLCD programme which gives 450 kcal per day for women and 600 kcal per day for men. For entry to the programme, each patient had to:

Understand the programme
Desire to take partUndertake to attend weekly individual and group sessions
Have family support
Be desperate or determined to lose weight.

The product was available from the hospital at a cost of £18 per week for women and £24 per week for men. The expenditure for each patient was offset against money saved by not purchasing normal food. Lipid-lowering medication was stopped on entry to the programme. Weight, blood pressure and urinary ketones were measured once weekly up to refeeding then weight and blood pressure were measured at every patient contact thereafter. Lipid levels and HbA1c were measured at the start of the programme, every month for the first six
months then at three-monthly intervals for the next six months. Patients were expected to attend the individual and group sessions at each visit (every week). In the individual sessions with the nurse, patients could discuss any problems they had encountered (Figure 1). Group sessions provided support, an opportunity to exchange experiences and preparation
for refeeding. The dietitian was involved around the time of refeeding, to reinforce product literature from the company. Most patients refed at 3–4 months, and then followed a low fat healthy eating plan. After refeeding, follow up continued weekly for the first month, then every 2–4 weeks (frequency at the patient’s discretion). However, group sessions stopped at six months into the programme.

Results

Average body mass index (BMI) was 39.5 at the start of the study.

Of the 24 patients:

16 were being treated with insulin
14 were hypertensive and were receiving appropriate medication
14 had dyslipidaemia and were receiving appropriate medication
2 were suffering from sleep apnoea requiring continuous positive airways pressure

Following the introduction of VLCD, there were significant reductions in body weight (Figure 2) and BMI (Figure 3). Data on HbA1c levels, plasma lipids, blood pressure and insulin requirements of programme participants are shown in Table 1. Plasma lipid levels remained largely unchanged. Only four patients restarted lipid-lowering medication after refeeding.
Blood pressures dropped significantly within the first week, and adjustment of antihypertensive medication was necessary on a regular basis. Eleven patients stopped all antihypertensive medication. For most patients, ketone levels were moderate to high during the VLCD (indicating adherence to the programme and utilisation of fat stores). Insulin doses were decreased by two thirds on commencement of the programme, and this seemed to work well, with insulin doses continuing to decrease as weight loss proceeded. Most patients who remained on insulin were changed to nocte insulin

when their requirements were less than 14 units a day. Sulphonylureas were also halved or stopped on commencement of the programme. Only 13 patients completed follow up for the 12 months of the programme. The three case histories (see page 111) provide further detail about some of the patients in the programme.

Discussion
Benefits of VLCD

VLCDs can be an effective method of reducing weight, improving glycaemic control
— at least in the short term — and reducing the need for concomitant medication in
obese people with diabetes. They can also allow individuals to gain insights into the potential benefit of weight reduction and to learn about the relationship between food and obesity. When asked why this diet had worked while all others had failed, our patients said that it was easier to have no food at all, than to try to make choices from food offered, particularly on social occasions. Also the rapid weight loss experienced on the programme was positive reinforcement, together with the feeling of ‘wellbeing’ experienced as a consequence of ketosis (Burley et al, 1992).

Some considerations

It is well known, however, that helping someone to maintain weight loss is often the most difficult and disappointing task (Wing, 1995). In addition, the process is very time consuming for any healthcare professional involved. This pilot project to examine the effectiveness of VLCDs involved seeing 24 patients every week for 3–4 months, then at least monthly for the following nine months. We have only touched the ‘tip of the iceberg’ in our clinic population. If this service were offered to all of our obese patients (at least 60% of the total), a 50% uptake would involve 2250 patients who would require 11 whole time equivalent healthcare professionals just to provide weekly visits! In practice, this would be unrealistic and unlikely to attract funding, though one could argue that treating the root cause of the problem is far better than attempting to treat the effects. Putting VLCD into practice In many areas, primary care is offering Lipotrim to its obese patients. If the expertise of practice nurses and community dietitians in using this product could be built up, and the diabetes team was available for advice on medication changes for people with

diabetes, then it could be possible to offer this service more widely and cost effectively.
However, because of the additional risks of hypoglycaemia and ketoacidosis in patients with type 1 diabetes, we feel that they should only be offered the programme under the supervision of an experienced diabetes team, and then only if the patient is able to self-adjust insulin appropriately and understands the risks.

Conclusion
This study advocates the use of VLCDs for reducing weight and improving glycaemic control in obese people with type 2 diabetes (as well as carefully selected people with type 1 diabetes under close supervision). VLCDs can also reduce the need for concomitant medication. While on a VLCD, individuals can become empowered through their increased awareness and knowledge of their diabetes and the positive feedback provided by the rapid weight loss. It is likely that lack of time would limit the widespread adoption of the VLCD service used in this pilot study. However, the potential benefits of VLCD make it worthwhile to try to produce a costeffective service, perhaps by increased primary care involvement.

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Support GPs in tackling obesity

Feb 2013

The Royal College of Physicians (RCP) suggested in a report last month (Action on obesity: comprehensive care for all) that GPs
should direct obese patients to community services, including pharmacies, rather than offering in-house clinics. The report pushes for multi-disciplinary teams with pharmacists working alongside GPs, dieticians, counsellors and physiotherapists, and called for a national model for the commissioning of community services for obese patients.

This is further testament that pharmacists must be doing something right here.
Pharmacies have been running dedicated weight management services for over a decade. In the last couple of years the Royal
Society for Public Health has become more involved in pharmacy, and the NHS has given the nod to the Healthy Living Pharmacy initiative.
The big sticking point for pharmacy has been demonstrating value. But this has all started to change over the last couple of years with the introduction of the Lipotrim Patient Tracker, an online IT programme that keeps patient records for their weight management service and provides for comprehensive audits to be produced.
The evidence produced so far from Lipotrim pharmacies clearly shows that pharmacy offers a very successful and costeffective
service that will make a big impact in reducing the obesity epidemic and the costs to the NHS.
With only two months until clinical commissioning groups (CCG) take over from PCTs, it’s crucial that pharmacists embrace
and push for the RCP model to work and shout out about the evidence.

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Promoting adherence to your weight management service

Jun 2012

Adherence is an area that pharmacy is claiming for its own. The New Medicines Service (NMS) and Medicines Use Reviews (MURs) are both based on promoting adherence to prescribed medication.
But what about adherence to weight loss? The principles of adherence are the same and the semi structured questionnaire used in these services could be adapted for your weight management, for example by asking the customer how they are getting on, if they are having any problems, if they think it’s working, if there have been any lapses and if there is any further information or support they need.
However, weight loss, like smoking cessation, are complicated by an addiction element (one to food, the other to nicotine) so
any counselling will also take into account motivation and willpower.
The Lipotrim Pharmacy Programme has been designed to help patients adhere to the diet and maintain their weight afterwards. Total Food Replacement with Lipotrim uniquely allows the dieter to totally stop the substance of abuse, which is an essential component of addiction management. The initial consultation and subsequent weekly visits help you to educate and encourage dieters and address any concerns. This gives dieters confidence in your service and also means you can help them maintain their target weight, such as with Lipotrim maintenance products.
The programme also comes with resources and tools which include factsheets, patient progress cards and a new engaging patient DVD that uses the latest animation to explain weight loss and the Lipotrim programme. The Lipotrim Pharmacy Patient Tracker has a patient interface, complete with graphs and charts, which means patients can login securely into their records and monitor their own progress to keep motivated.

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Conducting your own audit of evidence

Apr 2012

Getting evidence from services is no longer a luxury for pharmacy. With the new NHS bill, every healthcare professional and service will have to demonstrate value if they want a future.
However, collating evidence has been a particular challenge for pharmacy – pharmacists are not in the habit of documenting the value of their services and they often don’t have the means to do this efficiently, relying too much on paper.
Conducting an audit and gathering evidence for your service is easier if you have an online recording system and the PSNC are going that way with Pharmabase.
When it comes to your weight management service, the evidence from your audit can be compelling. Using the Lipotrim Patient Tracker, you can pull off data to demonstrate benefits using a range of criteria, for example by gender, BMI, age and co-morbidities such as hypertension and diabetes, all at the click of a button. It allows you to continuously audit your pharmacy service for evidence based commissioning while at the same time monitor and support your patients and cut down on paperwork and filing.
Getting started is easy. Draw up objectives and then decide on what evidence you want to present, to whom and for when. Set aside time to become familiar with the Lipotrim Patient Tracker or simply book a quick 20-minute online demo to see it in action and get your first patient record in place.

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Worth the weight

The market for weight loss products is moving in the direction of a personalised, supportive and structured service offer, says Christine Michael

At New Year millions of people are likely to resolve to lose weight and get fitter, but all too often their good intentions prove short-lived, and obesity remains an intractable public health problem. Data compiled by the World Cancer Research Fund show that in 2010 in England, 62.8 per cent of adults were overweight or obese, and the direct cost of obesity related illness to the NHS was estimated at £5.1bn a year. In Scotland, 65 per cent of adults were overweight or obese, while the figures for Northern Ireland and Wales are 59 per cent and 57 per cent respectively.
For pharmacies, January and February are key times of the year to engage with customers who want to slim, whether on an opportunistic basis, as part of a broader healthy lifestyle offering, or as a commissioned enhanced service.
Keeping track
NPA Board Member and Alliance Healthcare Awards Welsh Pharmacy of the Year shortlisted nominee,

Chris Jenkins, of St Clears Pharmacy in Carmarthenshire, introduced a weight loss service earlier this year, and says it has created a “virtuous cycle” for the pharmacy as a whole. “We enjoy a positive reputation for our successful weight management service, strengthening our position and creating a benchmark in customer care within the local community,” he says. “More than 50 people have enrolled, and some travel up to 30 miles for the service; it even has a local Facebook page.”
One advantage of offering a service based weight loss programme rather than a more ad hoc approach is the opportunity it provides to compile data for potential commissioners. This lies behind the introduction of a ‘Patient Tracker’ audit tool, a new feature of the Lipotrim VLCD programme, which has been running for 25 years and is now available in nearly 2,000 pharmacies. “It is important to have the tools that can satisfy the need for documentation of achievement in this era of evidence-based treatments,” says Gareth Evans, a community pharmacist who offers the Lipotrim programme in East Anglia. His analysis shows that the mean weight loss of 382 people who completed three or more weeks on total food replacement was around 10kg, from 91kg to 81kg on average. “The Patient Tracker software allows me to present evidence not only of individual patients’ experience but also the achievements of cohorts of patients, which has become important for commissioning – for example, to show that successful weight loss is found even in patients with extremely high BMI,” says Mr Evans.

Diet demand
Market analysts Euromonitor International sees growth in `one stop shop’ weight loss services like the Lipotrim programme, as consumers “shift away from weight loss tablets and pills, and towards meal replacement programmes and holistic diet alternatives… due in part to the prevailing economic conditions”.
Its analysis shows some volatility in the retail weight loss category, explained mainly by the dramatic impact of Alli, from GlaxoSmithKline Healthcare (GSK), from its launch as an OTC product in 2009, to a subsequent fall off in sales in 2011.
However, having resolved difficulties with supplies of the product, GSK relaunched Alli in time for the 2012 Christmas and New Year market. Their major campaign of press and online advertising and in-store support, was primarily aimed at females aged 35 and over, with a BMI of 28 or more.
Nevertheless, Euromonitor still forecasts virtually flat sales in the category between 2012 and 2016, with compound annual growth of only 0.4 per cent, rising to an annual total of £128.6m by 2016.
One catalyst for change in the slimming supplement market is the latest batch of claims guidelines from the European 27Food Safety Agency (EFSA), which came into force in December 2012, and which may now lead to some products that make unapproved claims being withdrawn or relaunched with amended packaging.

Products with approved claims are likely to benefit, says Sanjay Mistry of Inovate Health. His company markets Slimsticks, a product containing konjac mannan, a vegetable fibre that the EFSA approves for “weight loss in the context of a hypocaloric diet”. Launching with a short term listing in selected Boots stores, Slimsticks will be rolled out to independent pharmacies through 2013. Other products that have EFSA approved claims are also now likely to want to push their advantage.
Compared with offering slimming products, introducing a personalised service may seem onerous in terms of time and training, but Chris Jenkins believes it is still worthwhile.
“Two members of staff have taken full responsibility for the weight loss service and have great pride in doing this,” he says. “They have the chance to develop new skills, and although it takes time to run such a service it is well invested time – time to care for patients and to make a real difference in their lives.”

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LIPOTRIM PHARMACY WEIGHT LOSS PROGRAMME : EVIDENCE BASE

Providing routine clinical evidence documenting efficacy in pharmacy under real life conditions

There is probably no current medical discipline more in need of evidence of efficacy than the field of weight loss, especially when the patients are obese and/or with co-morbidities. There is now overwhelming experience with total food replacement programmes (VLCD) , nutrient complete formula diets that are essentially low fat, very low calorie enteral feeds. Over the past four decades, these have gained recognition and acceptance as safe and effective where they are supervised by healthcare professionals, people who are medically experienced so that they can restrict access to the diets or modify treatments when necessary. Real weight loss, beyond simply depleting stored glycogen and water, has physiological implications and the real weight losses due to VLCD programmes, such as Lipotrim, are rapid and substantial. These programmes, run by trained pharmacists and GPs, compete with bariatric surgery in the magnitude of the losses routinely achieved, but without the negatives of substantial costs, higher risks and post weight loss addiction transfer,

EVIDENCE BASE

While a total food replacement formula diet can obviously not be blind to the dieter and a placebo would be unsafe, an innovative patient tracker system introduced into the Lipotrim pharmacy weight loss programme, allows for on demand, virtually instant, assessment of the secure data kept by the pharmacists offering the service. Statistical evidence can be provided for an individual patient or all the patients from a particular medical practice. Evidence can be provided for a single pharmacy or a pharmacy group or, as required, any selected collection of pharmacies, If necessary evidence can be provided from all the pharmacies in an area, as was recently reported for 150 pharmacies in Northern and Southern Ireland by pharmacist Brendan Feeney.

The flexibility of the tracker is such that statistics can be obtained, for example, within a defined BMI range, such as above BMI 40 or perhaps between BMI 25 and 30, or a defined age range or by gender. It can compare the first dieting period with that of subsequent dieting intervals. It can provide statistics on long term weight maintenance after dieting and the stability of the weight during transition from dieting to maintenance.

Critically, it is possible to quantify the dieting successes of people with concurrent medical issues – diabetes, high blood pressure, hypothyroid, depressive illness or any medical condition where weight loss will have an impact on the condition or treatment protocols. The Ireland assessment, previously referred to, provided statistics of the magnitude of the weight losses, the percent of initial weight lost and BMI changes for a cohort of type 2 diabetes patients – all of whom stopped oral diabetes medications prior to dieting, and remained in remission long after the documented weight loss.

Pharmacist Fin McCaul of Prestwich pharmacy and chairman of the Independent Pharmacy Federation, recently presented data to a National Obesity Forum Conference based on a successful cohort with an initial BMI in excess of 40. At Prestwich 1148 patients with a median BMI of 33.6 kg/m²used the Lipotrim weight management service. 25% were morbidly obese with a BMI > 40 kg/m². At the time of audit, during which many patients were still dieting, the median BMI had decreased to < 30 kg/m². 94% of the dieters lost more than 5% of their pre-diet weight, 47% lost more than 10% and 21% of the patients lost more than 20%. Importantly, all patients with type 2 diabetes had their medication stopped by their GP.

Providing clinical evidence of efficacy under real life conditions, is now routine for pharmacists offering the Lipotrim weight loss service and documenting results with the Patient Tracker software.

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AUDIT RESULTS USING THE LIPOTRIM PATIENT TRACKER BY PHARMACIST GARETH EVANS

Audit Results using the Lipotrim Patient Tracker

by Gareth Evans

The current excitement generated by the press coverage of the Newcastle University study of diabetic patients using weight loss by a very low calorie diet to “cure” diabetes, necessitates a wider recognition of the well established programmes already available. The Lipotrim weight loss programme, monitored exclusively by healthcare professionals has been in extensive use in the UK for more than 25 years. A rapidly expanding network of nearly 2000 pharmacies currently offer the VLCD service and although many have used manual methods to audit their patients’ achievements, the newly provided Patient Tracker computer software for managing patient records has permitted continuous auditing of results and detailed evaluation of population subsets.

For example, in addition to auditing the total experience of patients enrolled in the pharmacist-run service, the results can be examined in many different ways. The cohort can be divided by gender, by age, by initial or final BMI, by amount or percentage of weight loss achieved, or by medical history (hypertension, diabetes, depression, thyroid problems etc.). The programme extends beyond weight loss, as there is a refeeding transition back to ordinary foods and a full maintenance programme, which is proving extremely successful in the pharmacy environment. With this Tracker audit tool, therefore, evidence is also available documenting the long term maintenance outcome after dieting.

As a pharmacist who has been using the Tracker to keep my Lipotrim patients’ records for some time now, I would like to share a current audit of my patients’.

Materials and Methods

Overweight or obese people requesting the programme are assessed for suitability on the basis of initial BMI and a detailed medical history. Those requiring medical cooperation, such as those with type 2 diabetes or medicated hypertension make suitable arrangements with their GP prior to dieting or are excluded. Those with contraindicated conditions, such as insulin dependant diabetes or pregnancy are excluded from the programme.

Suitable candidates follow a strict regime of total food replacement using nutrient complete formulas, essentially very low fat enteral feeds, with adequate fluid intake and only black tea or coffee permitted in addition. Appropriate prescribed medications are continued as well. No other foods, beverages or supplements are permitted.

Dieters are monitored and weights recorded weekly – only 1 week’s supply of formulas can be obtained at each visit and obvious non-compliance is corrected or the dieter is offered alternative weight loss advice.

Records are maintained on the Patient Tracker programme.

Results

Total Population of Dieters completing 3 or more weeks on Total Food Replacement

Mean Start Weight 91 kg – Mean End Weight 81 kg

Total weight lost to date of audit – 3865 kg

Table 1 N= 382 330 Females 52 Males

Mean	Start wt	91kg	Start BMI	32.7	End BMI	29.0	% wt loss	10.8
Median	Start wt	88.2 kg	Start BMI	32.0	End BMI	28.4	% wt loss	9.0

The next series of tables demonstrates the value of the Lipotrim service in overweight patients, reducing the likelihood of their progression to obesity, as well as obese, super obese, morbid obese or even super-morbid obese patients.

Table 2 N= 121 BMI 25-30

Mean	Start BMI	28.1	End BMI	25.4	% wt loss	9.3
Median	Start BMI	28.3	End BMI	25.4	% wt loss	8.0

Table 3 N= 141 BMI 30-35

Mean	Start BMI	32.4	End BMI	28.9	% wt loss	10.9
Median	Start BMI	32.3	End BMI	29.1	% wt loss	12.0

Table 4 N= 73 BMI 35-40

Mean	Start BMI	36.9	End BMI	32.4	% wt loss	12.9
Median	Start BMI	36.7	End BMI	32.6	% wt loss	11.0

Table 5 N= 29 BMI 40-45

Mean	Start BMI	42.2	End BMI	36.1	% wt loss	14.4
Median	Start BMI	42.0	End BMI	36.3	% wt loss	11.0

Table 6 N= 5 BMI 45-50

Mean	Start BMI	47.4	End BMI	37.2	% wt loss	21.2
Median	Start BMI	47.3	End BMI	36.9	% wt loss	22.0

Other subsets of the patient information that are of interest include:

Table 7: Obese people who exceeded the 5% criterion for medical benefit of weight loss.

Tables 8and 8a: Some dieters choose to interrupt their diet for varied reasons and then return for a subsequent diet period. Their first and second dieting courses can be examined separately.

Table 9: After a period of weight loss, it is necessary to re-introduce carbohydrates in a controlled manner to minimise weight regain due to carbohydrate loading. Minimal weight change is expected despite reintroduction of normal foods. This phase is 1 week long.

Table 10: The Tracker software distinguishes between periods of dieting and maintenance providing evidence of minimal recidivism when patients are properly supported in the pharmacy environment.

Table 7 N= 231 BMI > 30 who lost 5% or more of initial weight

Mean	Start BMI	35.3	End BMI	30.8	% wt loss	12.7
Median	Start BMI	34.5	End BMI	30.1	% wt loss	11.0

Table 8 N= 78 Dieters who had 2 dieting courses First time

Mean	Start BMI	32.1	End BMI	29.1	% wt loss	9.0
Median	Start BMI	31.2	End BMI	28	% wt loss	7.5

Table 8a N= 78 Dieters who had 2 dieting courses Second time

Mean	Start BMI	31.1	End BMI	29.6	% wt loss	4.7
Median	Start BMI	29.7	End BMI	28.1	% wt loss	3.5

Table 9 N= 140 Refeeding week

Mean	Start BMI	27.5	End BMI	27.4	% wt loss	-.2
Median	Start BMI	26.6	End BMI	26.6	% wt loss	0

Table 10 N= 249 Maintenance after dieting

Mean	Start BMI	28.1	End BMI	28.1	% wt loss	0.1
Median	Start BMI	27.2	End BMI	27.0	% wt loss	0

Patients who are medicated for various weight related ailments can often be considered as different categories of patient. Many hypothyroid patients have experienced great difficulty with weight management. Depression and hypertension often have a weight component in the aetiology of the problem.

Table 11: Examines patients on medication for hypertension

Table 12: Examines patients on medication for hypothroidism

Table 13: Examines patients on medication for Depression

Table 11 N= 22 Patients with High Blood Pressure

Mean	Start BMI	36.2	End BMI	32.0	% wt loss	11.6
Median	Start BMI	37	End BMI	32.2	% wt loss	8.5

Table 12 N= 9 Patients with thyroid hormone replacement

Mean	Start BMI	34.5	End BMI	29.4	% wt loss	14.2
Median	Start BMI	34.7	End BMI	28.9	% wt loss	10.0

Table 13 N= 13 Patients with Depression

Mean	Start BMI	33.2	End BMI	28.2	% wt loss	13.0
Median	Start BMI	32.2	End BMI	28.9	% wt loss	11.0

Discussion

The extreme flexibility of the Patient Tracker software, in addition to documenting and visualising each individual patient’s experience, allows for presentation of evidence of the weight loss achievements of cohorts of patients. This has become important for commissioning and the new ability of grouping patients from an individual surgery permits certification to the surgery of the collective progress of their patients, These results can be of value for CPD as well.

As can be seen from the multiple tables presented as illustration, the percentage of initial weight lost generally averages well over 5% and in most cases over 10%. Even the median values, which documents the half-way values of the ranges, are generally very close to the mean. Successful weight loss is found even in the extremely high BMI patients, who are usually refractory to weight management attempts.

In addition to demonstrating the successful loss of weight by the dieters, regardless of the sub-category for grouping, it is important to note that even though there are some variations in patients’ experiences with re-feeding (Table 9) and follow on maintenance (Table 10), the overall lack of weight regain from the patients post-diet demonstrates the value of the pharmacist and the Lipotrim programme for long term weight control.

Conclusion

Despite the fact that these results reflect the efforts of a single pharmacist in a programme that currently lists nearly 2000 pharmacies throughout the UK and Ireland, it is important to have the tools that can satisfy the need for documentation of achievement in this era of evidence-based treatments. The success of this pharmacy service has considerably enhanced my professional satisfaction as a pharmacist.

OBESITY PANDEMIC – DIABETES DETERRENCE BY WEIGHT LOSS: PHARMACY BENEFITS PRIMARY CARE

Stephen Kreitzman Ph.D, R.Nut. (UK Registered Nutritionist) & Valerie Beeson
Howard Foundation Research Ltd. Cambridge UK

It should be reasonable to justify practice time and resources to assist overweight and obese patients lose their weight. The link to type II diabetes alone is sufficient. With rapid weight loss, normalisation of blood sugar
levels is achieved in days and with further weight loss, the disease can be held in remission. Better long term glycaemic control is achieved with rapid weight loss, even after some weight regain, than is achieved with the same weight lost more slowly. About 50% of hypertensive patients can reduce drug treatments with weight
loss. Surgical interventions can be scheduled when substantial weight is lost. Fewer anti-depressants are required and overall, the frequency of GP visits is significantly lower for leaner patients.

There is no shortage of choice to meet the weight loss needs of individual patients. Drugs, both current and promised for the future, dietetic referral, exercise on prescription, and pharmacy based treatment programmes are all needed in order to deal with the massive problem of obesity. Each has a place depending upon the specific clinical needs of the patient. An exercise prescription may not be the best choice for a 40 stone patient who may struggle simply to walk, which at this weight is considerable exercise. Weight loss has been advocated as an adjunct to treatment for patients with conditions such as diabetes type 2, hypertension,
osteoarthritis and a catalogue of other disabilities. Generally, little attention is paid to this option because of the difficulty patients have experienced in losing adequate amounts of weight and keep it off. The widespread availability of effective weight loss programmes in UK and Irish pharmacies, however, argues strongly for offering overweight patients, especially type 2 diabetics, an opportunity to try a course that leads to less dependence on drugs and frequently leads to long term remission of disease.

Diabetes type ll is nearly 100% reversibly related to excess weight

For diabetes, there are really two basic facts to consider. The first is that type II diabetes is a disease that has a primary etiology which is close to 100% REVERSIBLY related to excess body weight. The second fact is that diabetic patients can lose enough weight within a few days to bring their blood sugars under control and enough further weight within weeks to crucially reduce cardiovascular risk factors and apparently keep the disease in remission, even with some weight regain.

WEIGHT SPIRAL:

Standard treatment for type 2 diabetes, with emphasis on using drugs to lower the blood sugar levels, often results in a relentless vicious circle. High blood sugar leads to drug intervention, which results in increased body weight, which in turn elevates the blood sugar, which increases the requirement for more potent drugs,
which spirals to obesity and possible insulin dependency. Patients are getting fatter as a result of treatment and this necessitates more aggressive rug usage. With significant weight loss, drug usage can be reduced and in many cases stopped permanently.

LONG TERM WEIGHT MANAGEMENT

While willpower can often help people lose weight over a short defined period, control for the months, years or even decades required for stability is quite a different story. Loss of weight by any means confers absolutely no
lasting legacy for weight maintenance. Weight loss, however achieved, is only the beginning of the treatment, not the end point. When the drug therapy is discontinued. When the counsellor moves on. When the patient is “cured” of excess weight. This is the point at which a dieter requires the maximum attention and assistance.
Weight management requires control of eating behaviour over a sustained period of time and the implementation of lifestyle changes. Justifying practice time and resources for a patient who has achieved weight loss and is now both healthier and at a normal weight is difficult. The expectation that this patient will sustain the weight loss without considerable help, however, is naïve. Pharmacy based programmes are ideal for the varying long term weight management needs of patients.

Obesity prevention can also be part of the pharmacy contribution to health promotion services; dealing with excess weight before it reaches obese levels and exacerbates comorbidities. The care of patients during
weight loss, is advantageous when monitored by a pharmacist, who understands the implications of other drug
treatments that may interact with the weight loss programme. But it is at the post diet stage that the pharmacist
is best equipped to provide essential long range guidance, support and education that will increase the
length of time that the weight loss is maintained.
Both the new GP and the pharmacy contracts strongly encourage interactive efforts to deal with a range of health problems, most of which have weight related implications. Weight loss is vital for management of, cholesterol, blood lipids, diabetes, hypertension or asthma. It even impacts programmes for smoking cessation.

ACHIEVING A MAXIMUM SAFE RATE OF WEIGHT LOSS

Modest reductions in Calories can theoretically result in weight loss. Of course, the modest reduction has to be from the equilibrium level, not from current intake. If a person is overeating by 2000 Calories a day (very common in the obese), a modest reduction in Calorie intake will not cause weight loss.
There is a maximum rate of weight loss for any individual. A total fast provides zero calories and therefore requires that all the Calories necessary for life come from the body fuel reserves. A total fast, however, provides no nutrients and since an obese patient has a far greater reserve of calories than stores of other essential nutrients, a total fast is out of the question as a treatment. To be healthy, a diet has to supply
adequate essential amino acids, essential fatty acids, vitamins, minerals and trace elements. A total fast cannot be a valid treatment for obesity. The simple idea of reducing fat levels in an enteral formula solves both the Calorie and the nutrient problem. An ideal nutritional product with the absolute minimum of Calories consistent with a healthy diet is achieved. Lipotrim is an example of such a product, providing a maximum safe rate of weight loss. The literature on safety and efficacy is massive. The time has really come to pay attention to it.

BENEFITS OF WEIGHT LOSS

There is also an extensive literature on the beneficial effects of weight loss on cardiovascular risk factors, on blood lipid profiles and blood pressure. Managing weight in general practice is time consuming. The beneficial results from reliable weight loss on the glycaemic control and the cardiovascular risk factors more than justifies pharmacy cooperation. It benefits patients and makes good use of pharmacists’ training and facilities.
Weight is extremely important to patients generally and has a critical influence on the clinical course of many medical conditions. Uniquely, however, with type II diabetes, because the blood sugar can normalize so quickly under conditions of rapid weight loss, it is essential that hypoglycaemic medications are stopped prior to dieting. This requires an understanding, on the part of the prescribing GP, of the need to stop drug treatment and follow up of the patients.

THE IMPORTANCE OF PHARMACY IN WEIGHT MANAGEMENT

The need to deal with excess weight is no longer simply a cosmetic issue. Obesity has become pandemic. The serious consequences of excess weight are being acknowledged as type 2 diabetes rates soar in children as well as adults. There is probably no other service that a pharmacist can provide that will prove to be as valuable to the needs of general practice as weight management. When effective self-funding programmes are available that do not require allocation of scarce resources from PCTs, it is hard to imagine any pharmacy failing to cooperate with a weight management programme. The problem has become so pervasive, that it will take a wide variety of treatments, drugs and public education to have any impact. Hospital programmes for weight management are overwhelmed. Pharmacy is the best community resource and pharmacists’ training ideal for providing professional assistance in dealing with the major health issue of the decade.

REFERENCES

Wing RR, Blair E et al. Calorie restriction per se is a significant factor in improvement in glycemic control and insulin sensitivity during weight loss in obese NIDDM patients. Diabetes Care 17:30-36,1994.
Wing RR, Marcus M & Bononi P. Glycemic control after weight loss is affected by how weight loss is achieved. Diabetes, 39: suppl 1, 50A,1990.
Wing RR, Marcus MD, Salata R, Epstein LH, Miaskiewicz S & Blair EH. Effects of a very low calorie diet on long term glycemic control in obese type II diabetic subjects. Arch Int Med, 151: 1334-1340, 1991.
Weck M, Hanefeld M & Schollberg K. Effects of VLCD in obese NIDDM (noninsulin dependent diabetes) on glucose, insulin and C peptide dynamics. Internat J Obes, 13: suppl 2, 159-160, 1989.
Uusitupa M, Alaakso M et al. Effects of a very-low-calorie-diet on metabolic control and cardiovascular risk factors in the treatment of obese non-insulindependent diabetes. Amer J Clin Nutr. 51:768-773,1990.
Shaper AG, Wannamethee SG & Walker M. Body weight: implications for the prevention of coronary heart disease, stroke and diabetes mellitus in a cohort study of middle aged men. Brit Med J, 314: 1311-1317, 1997.
Reports on tasks for scientific cooperation (EU SCOOP)
Report of experts participating in Task 7.3, September 2002 Collection of data on products intended for use in very-low-caloriediets Directorate-General Health and Consumer Protectionz

PDF version: 2-4-obesity-pandemic

SUCCEEDING WITH YOUR DIET – YOU HAD BETTER STOP

S.N Kreitzman Ph.D. R.Nutr. (UK Registered Nutritionist), S. A. Kreitzman, & V. Beeson,
Howard Foundation Research Ltd. Cambridge UK
The treatment of overweight and obese patients by healthcare professionals is increasingly being recognised as necessary. Unfortunately, the treatment options available have become more and more limited due to serious side effects or lack of sufficient efficacy. Currently in the UK, the major weight loss tools available are essentially limited to either a single drug or invasive surgery (with high morbidity and mortality rates).
In recent years, UK and Irish Pharmacists have been implementing strictly monitored Very Low Calorie Diet protocols, and have demonstrated that non-invasive weight management can be a viable option for healthcare professionals. It is however ironic that the appropriate medical management of obese patients could be potentially disrupted by an arbitrary limitation of use, which interferes with treatment and ultimately restricts the potential medical benefit of the weight loss effort.
It is worth taking a moment to look at some numbers in context.
Obese people (defined generally as those with a BMI above 30) have excess weights greater than 3 stone (roughly 20kg). In examining audit data from 1148 people being treated with Lipotrim at the Prestwich Pharmacy in Manchester, they presented with an average (mean) BMI of 35 and median BMI of 34. Therefore 574 of the 1148 started with a BMI in excess of 34. Ten percent began their diet with morbidly obese BMI’s of greater than 46 and 5% with a BMI over 50. In a separate audit of a further 9071 Lipotrim dieters from pharmacies in the Republic of Ireland, the mean starting BMI was 33 and more than half were over BMI 32. However 10% (more than 900 people) presented to the pharmacy for weight loss at BMI over 41 and over 450 people presented with a BMI in excess of 44. Unfortunately, many patients presenting to GPs have even larger weight problems, almost universally complicated by weight co-morbidities.
Limiting the time allocated for effective treatment is ill advised, just as it would be to withdraw antibiotics before a course is complete. Yet the rhetoric for ending VLCD treatment prematurely has become ritualized, and is often proclaimed without the recognition that it has no
basis whatsoever.
This piece of dietary Urban Legend has its origins over 30 years ago, when an over-zealous company marketed a product which claimed to be a commercial version of Dr George Blackburn’s highly successful ‘Protein Sparing Modified Fast’. Dr. Blackburn’s programme – essentially a home version of a low calorie enteral feed – was based upon a high-quality protein source (generally beef) supplemented with an intelligently constructed micronutrient collection of vitamin and mineral formulations. The commercial product exploiting his work was dubbed the ‘Liquid Protein Diet’ and promoted in 1976 by a book called The Last Chance Diet. Unfortunately, for many people it proved to be exactly that, as there were many deaths. The Liquid Protein product was an ill-conceived concoction of hydrolyzed cow hide and cherry syrup. It was nutritionally deadly. Banned in the late 1970s, such products bear no relationship to the modern nutrient complete low calorie enteral feeds (now generally called VLCD). Modern VLCD have more than 30 years of documented safe and effective use, and comparing them with the Liquid Protein experience is spurious.
When the protein sparing modified fast concept was extended (using proper scientific expertise) into a variety of commercial VLCD products an attemptwas made by one particular company in 1980 to sell it as a mail order product. With the memory of the Liquid Protein disaster still fresh in the public consciousness, the US Postal authorities refused to carry the VLCD unless the retailer agreed to recommend that its use be limited to a period of four weeks. Their logic, not unreasonable for the knowledge at the time, was that even a total fast was perfectly safe for up to 4 weeks. None of the victims of the Liquid Protein experience had problems in less than 8 weeks.
Following more than a decade of worldwide medical study involving several commercial VLCD, one large hospital based programme, limited the programme to 12 weeks of continuous VLCD treatment and used the experience to publish a considerable number of research papers, using data derived from these patients. The 12 week decision was totally arbitrary and there was never any suggestion that harm would have followed from extending the treatment. Protocols from other medical programmes were not constrained. Under the care of health professionals, who recognise that the hazards from weight loss treatment are only related to the impact on existing disease treatments, such as diabetes or hypertension, VLCD can be safe for as long as required, if BMI does not go below the normal range. Weight loss with VLCD in diabetics requires cessation of medication prior to dieting as the diet will normalise blood sugar in days. Weight
loss for people on hypotensive medication requires professional attention, since more than 50% of hypertension is weight related and the treatment must be altered in line with the BP reduction. Weight loss can alter the absorption rate of many drugs and those with a narrow safety spectrum must be monitored carefully. In healthy people, VLCD induced weight loss is benign.
Because of their research papers, and because the product in question became a brand leader, the “12 week” policy adopted in the hospital trials quickly became a common guideline.
The wisdom of interrupting treatment was rarely questioned by committees such as Codex or NICE; they simply accepted it as reasonable. There are many reasons, however, why such an arbitrary recommendation is not wise.
Firstly (and probably least important) is the well documented observation that once interrupted, VLCD is surprisingly difficult to restart. Virtually all of the metabolic adaptations that allow the body to use fat as a fuel (rather than glucose) occur at the start of dieting and ‘dietus interruptus’ is perhaps the most metabolically stressful.
The most important reason, however, can be understood from the audit statistics presented earlier. Twelve weeks is not enough diet time for any obese person’s treatment.
Consider: The average woman is said to be using about 2000 kcal per day. (It can be argued that as she gets heavier and movement becomes more difficult, even this number might be excessive). If no calories at all were eaten by the dieter, the calorie deficit would obviously be 2000 calories per day. To support life, body stores (eventually of fat) would have to provide all of the calories. Obviously, this creates the fastest possible scenario for the utilization of stored fat.
Each pound of fat tissue provides 3500 kcal. Therefore, the maximum weight loss, fasting totally, would be around 1/2 pound per day. In 12 weeks, no more than about 42 pounds of fat can be utilized. This weight loss is insufficient. It would leave the vast majority of obese dieters far short of the achievement of normal weight. Where co-morbidities are being treated by weight loss, there would be a high likelihood of treatment failure.
There is no justification for healthcare professionals who use an effective, noninvasive, dietary treatment for weight management to limit that treatment to some arbitrary time. No evidence for harm exists to warrant terminating treatment, and there is considerable evidence to justify the completion of the treatment. It is time for excathedra comments to be justified with evidence or silenced. •

PDF version: 2-3 NAPC REVIEW 2010 12 WEEKS

PHARMACIES LEAD THE WAY IN OBESITY MANAGEMENT

Pharmacists can play an important role in weight management.
And there’s evidence to support their effectiveness.

Early in October 2010, the National Obesity Forum Conference in London heard a presentation by Fin McCaul, the pharmacist at Prestwich Pharmacy in Manchester. Mr McCaul, who is also chair of the Independent Pharmacy Federation, was presenting his pharmacy’s outstanding results in treating overweight and obesity at the pharmacy. His paper, ‘Options for the orbidly obese’, was based on 1,148 overweight patients with a median initial BMI of 33.6 kg/m2
enrolled into the Lipotrim weight management programme. Of these patients, 25 per cent were morbidly obese with a BMI >40 kg/m2. At the time of audit, during which many patients were still actively dieting, the median BMI had decreased to <30 kg/m2. Results showed that 94 per cent of the dieters lost more than 5 per cent of their pre-diet weight, 47 per cent lost more than 10 per cent, and 21 per cent of the patients lost more than 20 per cent. The presentation highlighted the impressive weight loss results being achieved in pharmacy. Given that the organisers of the programme chose to position the presentation in the section of the conference devoted to bariatric surgery, Mr McCaul concentrated his results on the subset of the dieters who were of greatest relevance to the surgeons – the morbidly obese. Morbidly obese people are generally considered ‘heart sink’ cases; they are notoriously difficult to treat. The reason is largely due to the common chemistry with other examples of substance abuse. Recognition of this common chemistry is now leading to the development of weight management strategies involving drugs which are important in the treatment of alcohol and drug addictions.

Advantages of weight loss
There is certainly plenty of justification for helping overweight patients. Weight loss can lower blood pressure, normalise blood lipids, practically eliminate type 2 diabetes, reduce the severity of asthma, bring relief to arthritics, increase the fertility of women hoping for pregnancy, relieve sleep apnoea, and provide an opportunity for patients to be considered for Pharmacists can play an important role in weight management. And there’s evidence to support their effectiveness. elective surgery. Loss of weight can decrease the need for antidepressants, make exercise more possible – thus improving cardiovascular health, and can vastly improve the quality of life for patients. Methods of treatment, however, are not universally agreed upon. Somewhat unsurprisingly, bariatric surgeons tend to favour the surgical approach to weight loss. According to the Department of Bariatric Surgery at Imperial College, the current burden of morbid obesity in the UK is approximately 720,000 patients who meet NICE criteria for eligibility for surgery. In 2008 only 4,000 operations for morbid obesity were performed in the public and private sector combined. Even if the number of patients being treated by surgery was doubled, the impact on the problem would still be small and fall far short of the treatment needs of the seriously overweight population. Most surveys estimate that in the UK about 60 per cent of the population are overweight and about 30 per cent are already obese. Assuming a 60 million UK population, the number of people with a weight problem calculates to 36 million overweight and 18 million obese. Treating this many people surgically is unrealistic, to say the least. In addition, there is an increasing tendency for people to seek less expensive or more readily available bariatric surgery abroad, which has led to an ethical dilemma for NHS specialists. The costs to the NHS of providing aftercare, expected free by UK citizens, or emergency subsequent surgery when procedures initiated abroad go wrong, can be unplanned for and a substantial drain on NHS resources2.
Pharmacists’ role
Bariatric surgeons (in the current absence of a selection of effective weight loss drugs) are increasingly attempting to convince the public and the professionals that surgery is the only method of effectively treating seriously overweight people. The evidence presented by Mr McCaul clearly demonstrated that there is a non-invasive treatment that can be as effective. Like the claims for remission of diabetes as a result of the surgery, diabetes remissions are obtained by pharmacists as well since it is the loss of weight that leads to the remission. Usually, the blood sugar control is so rapid that it has become mandatory to get the doctor’s cooperation in stopping oral hypoglycaemic medications prior to the patient dieting. Without this step, patients are not permitted to participate in the Lipotrim programme. The results presented for this difficult cohort of morbidly obese patients was suitably impressive. These were very large individuals indeed, with half presenting with a BMI above 45 – the heaviest just below BMI 70. From this subset of 267 patients, the results reported were:

Median BMI was 45.1 at enrolment;
237 patients lost over 5 per cent of pre-diet weight;
141 had lost over 10 per cent of pre-diet weight;
34 patients had lost over 20 per cent.

The programme at Prestwich is only one of more than 1,500 UK pharmacies treating overweight patients in this way. What’s more, the introduction of Lipotrim’s patient tracker software now permits on-demand audits of the results obtained by each pharmacy – essential for demonstrating effectiveness for commissioning requirements. Mr McCaul’s audience – primarily surgeons – listened for the most part in attentive silence, but the questions put to him at the end of his presentation were extremely revealing and illuminating. One overly distressed questioner was seriously worried that a few weeks of what is essentially a nutrientcomplete enteral feed (to effectively treat morbid obesity and its medical consequences) would compromise the patient’s relationship with food and cause chaos in the family dynamic. As she summed it up: there was a risk of “demonising food”. Leaving aside for a moment the point that bariatric surgery is an invasive and dangerous procedure that results in a state of permanent malnutrition, it is worth remembering that morbidly obese individuals generally have a very destructive relationship with food. To these individuals, food is a substance of obsession and addiction, and eating is a compulsive behaviour. Modifying the patient’s relationship with food is arguably a very worthwhile goal.

One of the more disturbing post-surgical problems (being widely reported from the US, where large numbers of surgeries are performed) is the unexpected and unwelcome problem of addiction transfer. A quick Google search unearths the massive scope of the problem, in which the loss of the ability to eat (due to weight loss surgery) is apparently leading to the development of substitute addictions – to alcohol, drugs and other destructive activities.

Total food replacement
The total food replacement programme owes its success in no small part to the first principle that – instead of inducing malnutrition – the formulated enteral feeds are generally much more nutritious than the ordinary food choices of the
patients. As all essential nutrients are provided, the patients remain healthy throughout their programme. Where there
is a component of food abuse associated with the weight problem, the nutrient formulas are the only way that normal
foods – the addictive substances – can be safely eliminated so that the dieter can have a better chance of success.
An expanding network of pharmacists is offering a range of treatments for weight problems. Pharmacists have the training, the respect of the public, the contact hours and the desire to offer weight management as a professional service.
The National Institute for Health and Clinical Excellence (NICE) recommends that specialists be used for extended treatments involving total food replacement. Pharmacists that join this programme are trained and experienced specialists in this area.
Unlike surgery, there is no cost to the NHS, and no serious sideeffects.

The cost to the patient is less than the money a morbidly obese individual will have been spending on food, and the level of weight loss is sufficient to put type 2 diabetes into remission. The documented and audited successes of these dieters is a welcome testament to the leadership role that pharmacists are taking by providing important healthcare services to their community

PDF version: 1-6-pharmacist

Lipotrim Resources

VLCD diet resources from Lipotrim