Tag Archives: VLCD

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.”


PDF Version: Weight-loss-Jan13


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,


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/m2 used 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.

PDF Version: 28_Lipotrim_advertorial_v1


diet-bariatric-surgeryBy S.N Kreitzman,V. Beeson and S.A. Kreitzmanof Howard Foundation Research Ltd

Interest in the use of weight loss to treat type 2 diabetes has been intensifying in recent years, despite the fact that the rapid therapeutic effect of weight loss on type 2 diabetes has been
well documented for decades and has been hitherto largely ignored. The current interest may be attributed in large part to a number of publications generated by evidence (from bariatric surgery) of the almost universal prompt remission of diabetes with weight loss after successful surgery.
One such study was published in the Journal of Endocrinology and Metabolism in 2004 by Cummings et al – ‘Gastric Bypass for Obesity:
Mechanisms of Weight Loss and Diabetes Remission’. In support of their efforts to promote the use of surgical techniques, the authors claimed that no more than 5-10 per cent of body weight can be lost through dieting, exercise or the few available anti-obesity medications. They further write, correctly, that: “Importantly, even mild weight loss confers disproportionate health benefits, in terms of ameliorating obesity-related comorbidities. Nevertheless more substantial and durable weight reduction would improve these ailments more effectively.”
And not correctly that:
“At present, bariatric surgery is the most effective method to achieve major weight loss. The best operations reduce body weight by 35-40 per cent.”
Quite a dramatic claim, but surgery is not the only effective means of achieving this amount of weight loss when necessary.

The very low Calorie diet

There is a readily available alternative to bariatric surgery, without the problematic aspects of bariatric surgery:
high morbidity and mortality risk, prohibitively high cost, possible post-operative addiction transfer and (in consideration of the large numbers of severely overweight people with or without diabetes) extremely limited availability. This alternative is the very low Calorie diet.
Detailed records have been kept of the weight loss results from GP practices and pharmacies. Using audit data, accumulated from UK pharmacies, it was possible to document cases where
dieters successfully lost in excess of 35 per cent of their pre-diet weight. These pharmacy weight loss programmes are based upon a replacement of all normal foods with a nutrient complete formula. There are many advantages to this approach over bariatric surgery, especially with severely overweight people. There is now an expanding literature – based upon numerous investigations into addiction – which demonstrate that in a considerable percentage of high BMI people, the same metabolic pathways that are generally recognised as part of the addiction profile are shared by people who are using food as a substance of abuse. In the case of every known addiction it is absolutely necessary to completely stop the abused substance. This is difficult when the substance in question is alcohol, tobacco or drugs; it is literally unachievable when the addictive substance is food, which is required in order to stay alive. While ultimately food is required for energy, there is no shortage of energy stored as fat and glycogen in overweight people. What must be supplied in order to keep people healthy are the vitamins, minerals, trace elements, essential amino acids and essential fatty acids. Depletion of any of these nutrients will compromise health. Post bariatric surgery patients are expected to reintroduce foods in limited quantities. In contrast, use of a nutrient complete formula provides all the essential nutrients in the absolute minimum number of Calories. This allows weight loss at the maximum safe rate, while allowing the person to completely stop eating the foods that they are abusing. This is the only approach that will interfere with the addictive problem and offer a reasonable chance of establishing a normal relationship with food in the future.

Counting the Calories

There is yet another important benefit to using a foodreplacement formula instead of traditional foods. Traditional foods are derived from various plants and animals and naturally differ in nutrient composition and Calorie contribution, so it is not possible to get an accurate estimate of the energy intake. Food composition tables (which present averages from a large number of samples) can differ widely from the composition of a specific sample. In contrast, the Caloric composition of a defined formula can be known with considerable precision. Dieters therefore can know exactly the number of Calories they are eating each day. It is well known that the Calorie deficit required to lose a pound of body fat is fixed at 3,500. The difference between the Calories in the formula and the Calories used by the individual based upon genetics and lifestyle will represent the rate at which the 3500 Calories is being depleted. Calorie utilisation for most people, especially severely overweight people who are not usually involved in massive exercise programmes, does not vary a great deal from day to day. Variations are trivial when it is realised that running a mile only consumes an additional 100 Calories, so the number of Calories used each day is basically constant. This explains the essentially straight line pattern of weight loss with VLCD. From the daily changes in weight, it is easy to determine the number of Calories used by each individual day after day. This then will inform the individual of the critical Calorie intake that will determine whether weight is gained, lost or maintained. There is no other method to gain this information under real life conditions. Cummings et al, in the paper cited above, provide estimates of the cost of bariatric surgery (2004 data) represented as QALY (quality adjusted life years), ranging from 5,400 to $36,300, which they state is well under the $50,000 generally regarded in the United States as being cost effective. It might be worth considering a VLCD pharmacy programme
which will routinely provide weight losses of one stone (6.3 kg) a month for women and one and a half stone (10 kg) for men. And unlike bariatric surgery, the programmes can be used with people who have far less weight to lose than the BMI 35-40 subjects reported here. These programmes are even suitable for obesity prevention in overweight (but not yet obese) individuals who fall into the range of BMI 25-30. This is a far more appropriate contribution to public health and prevention of diabetes.

Weight loss and type 2 diabetes

Type 2 diabetes is a disease of excess weight. There are countless thousands of papers in the literature that concur with this statement. It would seem to be obvious therefore that treatment protocols should focus on rapid and effective weight loss for patients with diabetes. If one thinks ‘diabetes is excess weight’, one would be right most of the time.
Conventional weight loss options have generally proven so unreliable that it is understandable and (almost) forgivable that weight loss is not vigorously promoted for treatment of
type 2 diabetes. Nevertheless, there is a much better option than bariatric surgery for weight loss. Worldwide research spanning a period approaching 40 years has repeatedly
demonstrated that sufficient weight loss to treat diabetes can be achieved, and indeed is currently being achieved in the UK and Ireland by a large number of pharmacists.
Furthermore, fully established diabetes is only part of the problem (even though the UK is reported to be spending about £9 billion a year dealing with diabetes).
There is also a well recognised pre-diabetes syndrome with resistance to insulin, hypertension and elevated blood sugar and lipids, the so-called syndrome X. The best recognised treatment is also, of course, weight loss. A very detailed meta-analysis and review of co-morbidities related to obesity and overweight from British Columbia, published in 2009, identified 18 co-morbidities contributing, according to the authors, to a very large future disease burden as weight continues to be a medical problem. Pharmacists deserve considerable recognition for providing a service for remission of diabetes and relief of co-morbidities, where present, without depleting the assets of the National Health Service.
And, crucially, praise for the effective treatment of excess weight in hundreds of thousands of documented patients.


PDF version: contrast vlcd & surgery pharmicist 2012(1)


We all know that the key to weight loss is eating less and exercising more. However, dropping to under 1,200 calories without supplementation leads to nutrient deficiencies, which perpetuates the myth that lower calorie diets are dangerous

It is comforting to know that nurses are one of the few groups left who understand the suffering experienced by patients who are overweight and who recognise obesity as a problem worthy of effective action. Weight control is difficult and unfortunately it is much easier to eat calories than it is to exercise them away. A calorie gap of 3,500 calories between the calories eaten and those used is necessary to dispose of a single pound of excess body fat – 3,500 calories represent
a substantial amount of exercise. If the calories actually eaten are more than the calories used by the other activities of the day, the exercise will only reduce the calorie excess and not result in weight loss. It might, however, slow the weight gain. It really is necessary to eat less in order to manage weight.

No easy solution

There is no secret to weight management: the calories eaten have to be considerably less than those being used for a sustained period of time. The continued health of the patient requires them to consume all the essential nutrients necessary for life and health, which becomes increasingly difficult as the amount of food consumed is reduced or treatments actively promote malabsorption.
If we maintain a varied selection of foods, we can feel reasonably confident that we are getting the complete array of essential nutrients. However, while the plants and animals we choose for food each have some of the essential nutrients required by man, none has them all. To get the right amounts for sustained health from unsupplemented foods it is absolutely essential that we eat in excess of 1,200 calories. Eating foods with lower calorie totals cannot provide all the nutrients that we need. The myth that dropping calories below about 1,200 in order to lose weight is unhealthy is true, but not because the calories are low – a fat person has an enormous store of calories available. The problem is that dieters become nutrient deficient.
Providing the missing nutrients, however, permits dropping the calorie intake much further without harm, as long as there are reserves of fuel left in the body. Fuels available for the body are glucose (stored as glycogen) and fat. An obese individual has about 37,000 calories in reserve for each stone of excess weight and therefore has no realistic need to eat more. He just needs to get the essential nutrients. When these come from a nutrient-complete formula food, the results are ideal: complete nourishment and minimal calories. Supplying the essential nutrients in a prepared mixture, such as in an enteral feed, assures that nutrient deficiencies do not occur.

The role of the pharmacist

An expanding network of pharmacists is offering a range of treatments for weight problems. They have the training, the respect of the public, the contact hours and the desire to offer weight management as a professional service. NICE recommends that specialists be used for extended very low calorie diets (VLCDs).1 These pharmacists are trained and experienced specialists in the use of VLCD.
Pharmacies following this route are achieving a great deal and GPs and nurses are becoming much more comfortable directing overweight patients to these highly trained and experienced pharmacists. At the same time the availability of trained pharmacists is becoming more widespread, which is making these experts much more accessible to a wider deserving population.


Weight loss is more than a cosmetic issue. 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, relieve sleep apnoea, provide an opportunity for patients to be considered for elective surgery, decrease the need for antidepressants, make exercise more possible and thus improve cardiovascular health, and vastly improve the quality of life for patients in a prejudiced and intolerant world. Pharmacists are emerging as the weight management specialists, providing lifestyle advice, effective treatments and support, as well as follow-on help for the most difficult aspect of managing weight: the longterm maintenance of weight lost. Your overweight patients will appreciate knowing about it.

PDF version: 4-3-sharing-advice


S.N Kreitzman Ph.D. (Nutritional Biochemistry) R.Nutr. (UK Registered Nutritionist),
S. A. Kreitzman, & V. Beeson Howard Foundation Research Ltd. Cambridge UK

Obesity is a serious problem in modern society, and one that needs to be urgently addressed by healthcare professionals. Unfortunately, widespread obesity management will not be possible until healthcare professionals accept the brutal fact that advising an obese patient to ‘eat less” is as misguided as managing an alcoholic by advising him or her to “drink less.”
In the first instance, advanced obesity management must recognise that there is a difference between people who become .)ese and the rest of the normal weight j,opulation. Not every drinker becomes an alcoholic, and in the same way, only some people become obese. This is not a trivial comparison. Many people can and do control their eating behaviour arid never appear to be in danger of escalation into obesity. For those who do become obese, however, their food behaviour often displays the compulsions and cravings of an addiction. Indeed, it is when food consumption is put into the context of other addictive behaviours that the nature of the roblem
becomes clear.
The link between addiction and obesity is finally now being reflected in the search for drugs to combat obesity, as can be seen
in the 30 July, 2010 report in the Lancet on the use of naltrexone in conjunction with bupropion as a weight loss treatment. It is important to recognise the basic fact that there is a component of addiction in food abuse and ultimately obesity. The most powerful long term treatment for addictions is complete abstinence from the addictive substance. A reformed smoker is someone who does not smoke, and a reformed alcoholic is someone who does not drink Comprehending this simple reality explains why total food replacement formula (very low calorie diets) are extremely effective and conventional low calorie diets are much less effective for seriously overweight patients. To treat any addiction (including obesity) effectively it is necessary to stop the substance of abuse. Very low calorie diets – essentially low fat enteral feeds – are absolutely necessary because they permit a patient to safely stop eating for prolonged periods. No lifestyle or behavioural change can be effective while the patient is caught in the biological quagmire of addiction. The advantage of a Total Food Replacement programme is that nutrition is provided by an engineered
formula that is nutritionally complete,
allowing the dieter to remove the addictive substance (food) from his or her life and remain healthy while the weight is lost. The value of a total food replacement formula programme in the treatment of overweight and obesity should now be obvious. TOTAL food replacementis the only means by which those who are subject to food abuse may avoid the addictive stimulus that perpetuates their weight problem.
The rapid proliferation of type 2 diabetes is currently one of the more serious healthcare problems. Current estimated costs to the NHS for treatment of this problem are a staggering El million per hour. In almost all cases however, a simple treatment exists that costs the NHS nothing, can normalise blood sugars within a few days (even in long standing diabetes) and in most cases actually put type 2 diabetes into remission. This important clinical knowledge is inadequately recognised because of the mantra for evidence based care. It is impossible to design a double blind placebo controlled study of VLCD.
While case studies are often considered to be a lesser level of evidence, the balance of believable evidence must shift, especially when the number of cases being audited becomes virtually the entire treatment population. For the past 25 years GPs and pharmacists have been treating overweight and obese patients with VLCDs and monitoring their progress weekly over the course of their treatment. Those medical details and weekly progress reports have all been recorded over the years, and a number of audits from individual GP
practices and a 25 practice meta-audit have been published.
As the population of GP practices and pharmacies has expanded and computerised patient records have become more available, it has become Training to use VLCD properly requires education
Dieters can safely remove the addictive substance (food) and remain healthy theoretically possible to audit the entire population. A sample from a group of pharmacies in the Republic of Ireland has provided audit data for over 9000 Lipotrim patients. A single pharmacy in Prestwich, Manchester has provided audit data for over 1100 dieting Lipotrim patients. Since these patients are seen weekly and progress recorded by health professionals, the information should be viewed as highly credible and EVIDENCE BASED.
At Prestwich 1148 overweight patients with a median BMI of 33.6 kg/m’ were enrolled into the Lipotrim weight management programme. Of these, 25% were morbidly obese with a BMI >40 kg/ m2. At the time of audit, during which manypatients were still actively 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.’ The weight losses (comparable in most cases to that achieved by bariatric surgery) are having the same effect on type 2 diabetes as that reported for surgical procedures. The effect is in fact so dramatic, patients are not permitted to start the diet unless the GP has stopped diabetic medication. Blood sugars will normalize within a few days, and with afew weeks weight loss it is unlikely that any further diabetic medication will be required.
Training to use VLCD properly requires education. There are simply too many myths. The training programme for pharmacists running the Lipotrim weight management programme was awarded the SMART Best Educational Training Award For Pharmacists in 2002. Based upon sound physiological principles that most professionals know but are continuously seduced to ignore, there must be a greater recognition of need for VLCD, the only widely available tool for obese patients mired in the addiction aspect of food abuse. •
1. (Data presented at the 2010 National Obesity Forum Conference by Pharmacist Fin McCaul)

PDF version: 2-1NAPC advanced obesity management


Special report in PDF


Foreword 3 John Hancock, Editor

Diabetes and Obesity
A Modern Problem; an Eternal Obstacle 3
Stephen Kreitzman Ph.D, R.Nutr. Valerie Beeson, Shawm Kreitzman, Howard Foundation Research, Cambridge UK

The Case for VLCDs over Medication Benefits of Rapid Weight Loss Overeating Akin to Alcoholism The Lipotrim Alternative
No Excuse for the Current Level of Type 2 Diabetes
Prevention More Cost Effective than Treatment 10
John Hancock

Prevalence and Impact A Range of Solutions Shortfalls in Care
A Lack of Awareness
Prevention More Cost Effective than Treatment Stronger Together
Reform to Rethink
Make What Works Work Well 12

Not Unseen but not Understood
A Realistic and Achievable Programme Achieving and Maintaining a Healthy Weight An Integrated Approach
Education for Better Outcomes

Lipotrim 14 Camilla Slade, Staff Writer

Too Much and Too Little Less Calories, Less Weight
Reform to Rethink 15
Camilla Slade, Staff Writer

GPs at the Heart of Things NHS Diabetes
Getting it Right Matters Nutrition
Make What Works Work Well 17
John Hancock

Facing the Real Issue
Different Solutions; Same Objective Planned, Agreed and Appropriate
References 18



8-1To fully understand the medical value of nutrient- complete formulated foods as a tool for weight management, there are a few fundamental concepts that need to be explained. These include the protein sparing modified fast; the mechanisms and value of ketogenic diets, minimum safe energy intakes and enteral food formulas. The value of this approach is amply demonstrated by substantial clinical evidence accumulated over a period of nearly 40 years.
Beginning in 1975, a series of reports from the Bistrian and Blackburn medical team demonstrated the value of a very low-energy dietary regime for weight management in a variety of difficult obese patients. This team had the advantage of considerable nutrition expertise and they devised a protein sparing modified fast — essentially a home-concocted Very Low Calorie Dietary formulation that was nutrient complete. Unfortunately the remarkable success (and safety) of this approach was obscured by commercial greed – not by the medical team, but by external commercial exploitation. A commercial product was developed and widely sold that contained virtually no nutrition. it was based upon a hydrolyzed nutritionally incomplete protein (collagen) in cherry syrup. This product was heavily promoted and widely hyped and inevitably, it resulted in a number of deaths.
Quite properly, the Liquid Protein Diets have not been available since the late 1970s. Unfortunately however, a total lack of nutritional understanding led to the assumption that low energy liquid formulations were dangerous as a concept. In fact there are now nearly 40 years of worldwide experience with numerous properly formulated nutritionally complete products which should be evidence enough of safety.
There is an often stated mantra, surprisingly even from nutrition specialists, that there must be some level of calorie intake (in the neighbourhood or 1000 to 1200 calories per day) below which diets become unsafe. Once again, it is simply the superficial understanding of food and nutrition biochemistry that has given this notion some credence. All common foods may be thought of basically as recycled nutrients from the plants and animals we choose to consume. All are complex formulations of the chemicals that make up the composition of those plants and animals. Many of these chemicals are common to all living things and some of them are useful and even necessary for human health. They also contain large numbers of chemicals that are either inert or toxic to other animals, including humans. The key point, however, is that there is no naturally occurring food that contributes all the required nutrients for humans. We therefore require a varied diet to attempt to create a mix that will maximize the chemistry we need and minimise the problematic substances.
The crucial point here is that – given the varying chemistry of the plants and animals we consume — it is virtually impossible to assemble a nutrient-complete daily diet with a total of less than around 1200 calories. When food diets with lower calorie intakes are provided, nutrient deficiencies invariably cause illness. It is very important to note here that it is the nutrient deficiencies — and not the low calorie count — that causes the problems.
When it became clear that nutrient complete enteral feeds could be provided that contained, by design, all the essential nutrients, it demonstrated that the minimum calorie intake was nowhere near the 1200 calorie barrier. In fact, modern formulations have a calorie component determined primarily by the calorie contribution of the essential amino acids and essential fatty acids (and to a lesser extent by the lactose from the necessary milk component, which provides very high quality proteins to the formulations). These limits however are closer to 400 calories per day, not 1200.
The most effective and safe formulations are those that induce ketosis. Ketones are a by-product of the incomplete breakdown of free fatty acids. They are essential for sparing protein utilization and helpful in controlling the hormonal balance between insulin and giucagon, which helps control hunger. Many of the body’s tissues can use free fatty acids as fuel, but critically there are a few (including the brain) that cannot. Unless there are sufficient ketones present, which are water soluble and can pass through the blood brain barrier to provide energy for brain function and survival, the body must de-aminate amino acids from proteins to create glucose. Glucose can not be created from fat. This is why ketones are protein sparing. Virtually all tissues, with the possible exception of liver, can use ketones for energy.
It is clear from the controlled accessibility of very low energy diets through healthcare professionals, that detailed records are available of the successful results of this form of treatment. A large number of these results have been published. Proper nutrition, provided in defined very low calorie formulations, results in maximum safe rates of weight loss and there is considerable evidence to support its value to modern medicine.
S.N Kreitzman Ph.D, R.Nutr. (UK Registered Nutritionist)
V. Beeson Howard Foundation Research Ltd.

PDF version: 8-1-nhsta0002a


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.



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



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.




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.






S N Kreitzman PhD and V Beeson
(University of Cambridge, Howard Foundation Research, Cambridge, UK)

Objectives: To assess the weight losses and weight maintenance achieved with obese, often medically compromised, patients following a common Lipotrim treatment protocol.
Design: Data collation from voluntary responses by the practices to a general request for weight statistics, in a way that respects patient confidentiality. The sample of practices represents approximately 15% of those following the common protocol at the time of assessment.
Setting: 25 general practices and 2 hospital clinics in the UK.
Subjects: 818 obese patients registered with the practices or under medical referral to the hospital clinics The medical conditions ranged from apparently uncomplicated obesity to severely medically compromised patients, all treated under closely monitored conditions. Initial BMIs ranged from 24.4 to 78.7.
Interventions: Three, phased protocols, for weight loss, transitional refeeding and weight maintenance. Weight loss phase based upon Total Food Replacement under strict medical control – with specific, nutrient complete formula VLCD. Weight maintenance based upon modification of eating behaviour to significant dietary fat restriction. Considerable educational
materials provided throughout programme; approached conceptually as an addiction control problem.
Main outcome measures: Body weight and Body Mass Index at start of programme, at end of weight loss phase and the most recent follow-up available for each patient.
Results: Weight losses totalling in excess of 16,000kg with high levels of compliance and clinically encouraging weight maintenance results.
Conclusions: Obesity can be managed effectively under a variety of practice conditions, even in ‘heart sink’ patients who have repeatedly failed in the past to control their weight, despite the best efforts of the clinical team.

Despite the prevalent academic knowledge of the medical problems associated with obesity (1-13), the frequent failure to achieve weight loss in obese patients has discouraged many practitioners from using weight loss as a primary treatment (2,18). Unless obesity is tackled, however, the scenario of a possible 25% of the population being obese by the year 2005 instead of the Health of the Nation target levels of 6 to 8 percent as in 1990 (14,15), will continue to be a health care frustration.

The impact of effective obesity treatment in general practice, however, is very dramatic. When patients with type II diabetes lose significant weight quickly, glycaemic control is improved better than the same weight loss achieved more slowly, and this appears robust even in patients where some weight is regained (7, 9, 10, 11, 16, 17).

In non insulin dependent diabetes mellitus (NIDDM), hypoglycaemic agents are generally stopped within a week or two (9). An impressive percentage of patients with hypertension have
also been able to reduce dosage or totally eliminate medication, often after only modest weight loss (7,11).

The impact of such major health improvement sin patients with long-standing and progressive disease provides the momentum for practices to continue to devote effort and resources to obesity management (25).
This paper reports a META-AUDIT of weight loss and maintenance results from ongoing obesity management programmes in UK general medical practice sites and hospital clinics following a common treatment protocol.
Total weight lost by 818 patients was 16,211kg (16+ tonnes).

Weight information relating to the obesity control programmes was obtained from 25 UK general practices and 2 hospital clinics. Patients were not identified to the investigators, except by a sequential code number at each site. The information provided from each location included height, initial weight and date, end of weight loss phase (refeed) weight and date, and the last recorded follow-up weight and date. About half of the patients were still in the weight loss phase of the protocol at the time of the audit. This posed analytical dilemma. It was decided to treat the weight of those still dieting at the date of audit as if it were a refeed weight with a maintenance time of zero. Only in the separate maintenance data analysis does the category of
refeed refer purely to those patients who have completed their weight loss phase and resumed conventional food for at least one month.

At each site, patients join the programme solely at the medical discretion of the doctor who is versed in the protocol. In accordance with NHS practice, there is no financial consideration to the practice, from any source. The role of the GP is primarily the medical selection of appropriate patients and the monitoring of prescribed medications, which often have to be reduced or stopped as a result of the weight loss.
Patients are seen weekly, usually by a designated and trained practice nurse. In rare cases, extremely medically fragile patients are dieted and these cases are generally seen regularly by the GP. In general practice, the GP orders the Lipotrim formula foods weekly by positive release using a Special Order. This assures that patients cannot obtain the diet from the chemist without the knowledge and approval of the GP who is properly informed about the Lipotrim programme (26-28).
The Lipotrim is a nutrient complete very low calorie diet (VLCD) formulation. The diet is purchased from a local Pharmacist. This is the patient’s only access to the diet. Control of access is totally under the GP’s authority. Patients are expected to comply with the rigid diet and maintenance protocols. These are explained in detail by written material, video and audio taped sessions. Interactive lecture sessions are provided for patients and staff. Most practices limit the number of patients treated at any one time. Available places are rapidly filled from a waiting list.

The results demonstrate that significant (Table 1) and sustained (Table 2) improvement in the weight of obese patients can be achieved under varied medical practice conditions.

Individual practices were able to achieve a range of mean rates for weight loss in their patients (figure 1). The expected rate of weight loss for full compliance with the programme is an average of 1.46kg per week (1 stone per month). This was achieved.

A subset of 414 patients, who had completed their weight loss phase at the time of audit and were attempting to maintained their weight, were evaluated.

The clinical options for very fat people are limited. Most GPs despair of treating the massively obese. The population in this audit compilation included 215 patients over BMI 40, 30 patients over BMI 50 and 7 patients over BMI 60. Results from these patients are documented in Table 3 A-C respectively. Many of these patients are still in the weight loss phase (see Table 3).

The widespread apathy apparent in the general medical reluctance to deal with the obesity problem stems from a long history of futile efforts. Whether this is related to the ineffective modes of treatment offered, a general lack of understanding by either the patient or health professional, or a combination of both, is not clear. The prevailing view has become ‘diets do not work’ (18, 27). This view needs to be altered to reflect the very real difference between dieting protocols. Some standard weight reduction diets can work for some overweight patients. Applying the same approaches to the obese, however, will frequently result in failure. Obese patients require a more decisive treatment protocol (28). Rates of weight loss achieved per practice were shown in Figure 1.

The premise that weight control is futile is unjustified and clinically insupportable when one considers that obesity itself is a risk factor for many serious clinical conditions (19). A large proportion of normal surgery time is spent dealing with many minor ailments, which are fundamentally weight related and which can escalate into serious disease when the weight problem reaches obesity (Body Mass Index >30) (20). Obesity occurring within a family unit can compromise the well being of that unit. The family ‘ill health’ is particularly problematic when the mother is obese. Depressive states and impaired quality of life (8) can affect a significant part of the patient’s daily routine and impact on the rest of the family members. A multiplicity of problems can be traced to obesity within the family.

Much is said about the need to educate and modify lifestyle (20), but the impact of dietary education is considerably grater when the patient is in a positive state of mind, with improved self esteem resulting from weight loss. Sedentary lifestyles are often a consequence of the excessive weight. With weight loss, most patients become significantly more active. This has been shown to increase the probability of maintenance of the lost weight (21).

For the obese, clinical weight goals may not necessarily be to achieve thinness. A more immediate goal may be to control elevated blood sugar or high blood pressure. It may be to allow
the patient access to certain surgical procedures, for blood lipid control or increased mobility or pain relief in an arthritic patient. Clinical judgement will require consideration of age, lifestyle and medical condition in setting realistic weight targets for an individual patient. The current ‘fashion figure’ is not the appropriate determinant of the weight target in the obese.

Weight regain needs to be put into perspective. The percentage of patients maintaining weight loss after medical obesity treatment far exceeds previous statistics (22). Long term weight maintenance at encouraging levels is now commonly reported for medical VLCD programmes (23,24), particularly when these include behavioural modification. There are no permanent cures for obesity. Despite this, an increasingly large number of patients can manage to maintain control for long periods after weight loss, albeit to varying degrees. A patient, however, who has lost 100kg and has regained 50kg is still 50kg lighter. This is particularly important where the lowered weight has allowed necessary surgery to be performed or improved another condition. The evidence of Wing, previously cited, and others (7, 11, 16, 17), suggests that some health benefits of weight loss (glycaemic control) can outlast the weight loss.

Dropout rates are important, but difficult to document. While the weight losses in this assessment are dramatic, no weight programme is universally successful. It is especially difficult to
assess the proportion of non-starters from the data available. The referral procedures into the programme vary widely from site to site. At some sites, access to the programmes is exclusively based upon the medical requirement for weight loss in an attempt to mitigate a pre-existing clinical condition. These referred patients are sometimes reluctant to comply or are disinterested in weight loss. In others, there is a component of self-referral, although the regulation of admission to the programme still remains entirely under the control of the practice. How many patients are referred to the programmes and decline participation cannot be estimated from the data available.
Also difficult to document accurately are the percentages of patients who attempt the protocol but find the initial days too difficult for their current level of motivation. Some practices
provided data from those patients who failed to attend beyond 1 week, but most did not.

Our analysis, therefore, includes all patients who participated for at least 2 weeks. The data demonstrates that established patients complete the course. Figure 2 depicts the fraction of the 818 patients who stopped dieting within monthly intervals.

In Figure 3, the mean BMI changes for the subset of patients whoceased dieting within those monthly checkpoints are presented. Patients conclude dieting for many and varied reasons, only one of which is non-compliance and failure. These failures are included in the 6 percent (51 patients) of patients who discontinued during the first 4 weeks of treatment. Patients stop when they have achieved clinical goals, as discussed previously. It is evident from this graph that patients, on average, continue their weight loss programmes until they are no longer obese, regardless of their BMI at the start.

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In order for weight loss programmes to be successful, it is essential to conduct post-diet monitoring and provide the overweight patient with long-term support. The Lipotrim pharmacy-based programme, therefore, encourages an interactive approach with GPs to ensure successful, sustained weight management

it seems easy to justify practice time and resources to assist overweight and obese patients lose weight. The link to type 2 diabetes alone is sufficient. With rapid weight loss, normalisation of blood sugar levels is achieved in days. 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 by losing the same amount of weight more slowly. Almost 50% of hypertensive patients can reduce drug treatments with weight loss. Surgical interventions can be scheduled when substantial weight is lost. Fewer antidepressants 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. 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.
While willpower can often help people lose weight over a short defined period, upholding control for the months, years or even decades required for maintenance 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. A difficulty comes with justifying practice time and resources for a patient who has achieved weight loss and is now both healthier and at a normal weight. The expectation that this patient will sustain the weight loss without considerable help is naïve.

Lipotrim pharmacy-based programmes are ideal for the varying weight management needs of patients. Obesity prevention is part of the pharmacy complement of 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 the 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 and asthma. It even impacts upon programmes for smoking cessation. The success of the Lipotrim pharmacy-based programmes in dealing with weight loss and maintenance should not be overlooked.

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