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.
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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
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
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
Facing the Real Issue
Different Solutions; Same Objective Planned, Agreed and Appropriate
There is now a pandemic of obesity, and the problem is causing increasing levels of type 2 diabetes. Cooperation with effective pharmacy weight loss programmes can reliably provide rapid and potentially long-term clinical benefits from weight loss. Stephen Kreitzman and Valerie Beeson explain how Lipotrim can help
diabetes is a progressively debilitating disease, often requiring increasingly aggressive therapy. The treatment protocols with oral hypoglycaemics usually lead to increasing body weight. The increased weight degrades insulin sensitivity and can ultimately lead to a need for insulin. With insulin, a common outcome is yet further weight gain, and the disease gets increasingly worse. This entire cascade of events can be avoided.
There are really two basic facts to consider. The first is that type 2 diabetes is a disease that has a primary aetiology, which is close to 100% reversibility 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.
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 2,000 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.
There is also extensive literature on the beneficial effects of weight loss on cardiovascular risk factors, on blood lipid profiles and on blood pressure. Managing weight in practice, however, can be time consuming. The beneficial results from substantial and rapid weight loss on the glycaemic control and the cardiovascular risk factors more than justify consideration of this approach. Cooperative efforts with local pharmacists, however, benefit patients, pharmacists and also the primary care
Weight is extremely important to patients and has a critical influence on the clinical course of type 2 diabetes. It would appear prudent and considerate to give diabetic patients an opportunity to lose weight using Lipotrim under your own care or encourage them to seek care from a local pharmacist.
Stephen Kreitzman PhD RNutr, Valerie Beeson Clinical Programme Director
People suffer terribly from the consequences of their excess weight and many expect help from the health service. Here are some options…
A 5’2 woman who weighs 100 kg (15 st 10) has a BMI of 40 and is morbidly obese. If she manages to lose 5% of her weight, she will weigh 95 kg (14 st 13), which is a BMI of 38.6. Can anyone honestly say that this has been a sufficient treatment? To get her down in weight to the top of the normal range (BMI 25) she will have to lose 38.5 kg (approximately 6 stone).
Tell her to exercise?
The calories used in exercise will make a difference only if the patient is in calorie balance. Most overweight people are routinely eating in excess of their daily needs. Around 2,000 calories can be consumed with very little recognition that the average daily expenditure has been matched. Assuming, however unlikely, that calorie balance has been achieved, the excess weight represents 296,400 calories below the calorie balance level that will have to be used up by increased activity. At 100 calories for a mile run, the patient will simply have to run 3,000 miles (without any additional overeating).
Cut back a little to lose weight slowly?
Modest reductions in calories could theoretically result in weight loss, although the best efforts of the Swedish healthcare system could not produce any.1,2 Of course, it can’t be emphasised often enough, the modest reduction has to be from the equilibrium level, not from current intake. Standard advice has been to limit the rate of weight loss by encouraging a small calorie gap. This most often assures failure to lose substantial weight. Arguing that slow weight loss somehow results in better weight maintenance (except perhaps maintenance of the prediet weight) was convincingly demonstrated
to be false as far back as 1959. Stunkard showed that regardless of the programme for weight loss, or the expertise of the clinic, after one year 95% had put back all the lost weight.3 After two years 98% and by five years virtually all of the dieters had put the weight back on.
Faster weight loss is actually better
Very low calorie diet (VLCD) treatment has a well-documented, vastly better, record for weight loss and weight maintenance.4 The fallacy that reducing calorie intake sufficiently low to encourage a rapid loss of weight was harmful, resulted from the fact that the poor distribution of essential nutrients in ordinary foods makes it very difficult to create a nutrient-complete diet under conditions of food restriction. It is actually impossible to achieve an unsupplemented nutrient complete diet at intakes below 1,200 calories. When traditional food diets were attempted below 1,000 calories, dieters were put at risk. When the need for dieting was for a prolonged period, it was inevitable that various nutrient stores were depleted. The result was some sort of health compromise. The nature of the compromise and the consequences depended upon which nutrients happened to be depleted by the unique food choices of the dieter. What was required was a nutrient-complete source, which guaranteed nourishment and at the same time provided the least possible calorie levels so that a maximum rate of safe weight loss could be achieved. Liquid enteral feeds meet the nutrient criteria, but are usually designed to cause weight stability or even weight gain. These high-calorie levels are generally met by relatively high levels of fat. Simply reducing fat levels in enteral formulas solved the calorie problem. An ideal nutritional product with the absolute minimum of calories consistent with a healthy diet is achieved. The modern VLCD can be used with confidence, both in the reliability of the weight loss, and the safety of the monitored programmes. There are contraindications and medical issues that need to be understood, but under proper care the weight loss needs of seriously overweight patients can be met.
Help is available and simple to use
An expanding network of pharmacists are 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 VLCD treatment.5 These pharmacists are trained and experienced specialists in the use of VLCD. Suggest a pharmacist to offer your patients real help with their excess weight. This will even reverse the ever increasing prevalence of type 2 diabetes.
1. Sjöström D, Peltonen M, Wedel H, Sjöström L. Differentiated long-term effects of intentional weight loss on diabetes and hypertension. Hypertension 2000;36:20-5.
2. Karlsson J, Taft C, Rydén A, Sjöström L, Sullivan M. Ten-year trends in health related quality of life after surgical and conventional treatment for sever obesity: the SOS intervention study; Int J Obesity 2007;31:1248.
3. Stunkard A, McLaren- Hume M. Results of treatment for obesity (a review of the literature and report of a series). AMA Arch Intern Med 1959;103:79-85.
4. Saris WH. Very-lowcalorie diets and sustained weight loss. Obes Res 2001;9:295S-301S.
5. MIMS. NICE publishes guidance on overweight and obesity. London: MIMS; 2007.
PDF version: 4-4-Treating-overweight-patients
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.
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.
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
…the strongest evidence for therapeutic interventions is provided by systematic review of randomized, double-blind, placebo-controlled trials involving a homogeneous patient population and medical condition. In contrast, patient testimonials, case reports, and even expert opinion have little value as proof because of the placebo effect, the biases inherent in observation and reporting of cases, difficulties in ascertaining who is an expert, and more.
Stephen Kreitman Ph.D. R.NJutr. (UK Registered Nutritionist) and Valerie Beeson Howard Foundation Research Ltd, Cambridge UK.
The Wikipedia quote above is one of countless examples that show the almost universal acceptance of this principle. There are, however, serious implications when the criteria for “evidence’ are defined in a manner that excludes other forms of valid evidence. A cliche catchphrase can become a cloak of invisibility. The idea of evidence based medicine would seem to be fairly uncontroversial, and indeed guides the actions of the UK healthcare community. After all, if there is no proof of efficacy, there is no justification for the use of a given treatment.
The classic randomised. double blind, placebo controlled trial is undoubtedly a powerful tool in the development of therapeutic treatments and procedures in the world of healthcare. The placebo effect is a well-known and unquestioned factor in the assessment of any potential treatment, andit is therefore logical to defer to any study that works to eliminate this effect. For this reason, all respected medical journals, most of the healthcare community, and certainly the government regulators require studies to meet these criteria before a treatment will even be considered.
Unfortunately, there are drawbacks. The most immediate difficulty with the classic notion of evidence based research is that some situations do not lend themselves well (or at all) to placebo controlled, double blind studies. In such cases, valuable information may be filtered out by the qualifiers set during literature searches and that information will never be seen by the very community that stands to benefit.
As a case in point, one of the more serious current healthcare problems is the rapid proliferation of type 2 diabetes. Current estimated costs to the NHS for treatment of this problem are a staggering E1 million per hour. However, a weight loss approach is available that costs the NHS nothing. can usually 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 virtually unknown because in this instance, it is impossible to design a placebo controlled study. Even thorough research of existing literature will be futile, since the information will usually be filtered out and not available for consideration.
Type 2 diabetes is usually a consequence of excess weight and it has been recognised for decades that weight loss will improve the clinical condition. In recent years, bariatric surgeons have become bolder with their own assertions and many now claim to ‘cure’ diabetes or at least put the disease into remission. It is certainly true that the weight loss associated with bariatric surgery can indeed put diabetes into remission, but the secondary claim – that surgery is the only means of accomplishing this – cannot be supported. If however, evidence of alternative means of substantial weight loss are filtered out and never even considered. bariatric surgery (by default) becomes the method of choice.
Shifting the balance of evidence
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 very low calorie diets and monitoringtheir progress weekly over the course of their treatment. Those medical details and weekly progress reports have all been recorded, and a number of audits from individual GP practices and a 25 practice meta-audit have been published. As it is impossible to provide a placebo control for a VLCD, these results have been Largely unrecognised.
As the population of GP practices and pharmacies managing weight with VLCD has expanded and computer records become more available, it has become theoretically possible to audit the entire population. An audit from a group of pharmacies in the Republic of Ireland has provided data for over 9,000 Lipotrim patients. A single pharmacy in Prestwich. Manchester has provided audit data for over 1.100 dieting patients. Since these patients are seen weekly and their progress recorded by the health professionals, the information should be viewed as highly credible. The weight losses are having the same effect on type 2 diabetes as that reported for surgery. Patients, therefore, are not permitted to start the diet unless the GP has stopped diabetic medication. Blood sugars will normalise within a few days, and with a few weeks weight loss it is unlikely that any further diabetic medication will be required as long as they maintain some of the weight loss.
The key to the safety and efficacy of weight loss with VLCDs is the knowledgeable screening and continued monitoring by well trained health professionals. The extension of the medical programme as a pharmacy service has proven invaluable since pharmacy offers many advantages over GP treatment for a substantial number of reasons, not the least of which are accessibility and the availability for continued support long after the weight is lost.
The benefits of weight loss
NICE guidelines acknowledge extended use of VLCDs when properly monitored by healthcare professionals. 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 fertility, relieve sleep apnoea, provide an opportunity for patients to be considered for elective surgery, decrease the need for antidepressants, make exercise more possible – thus improving cardiovascular health and vastly improve the quality of life for patients.
There is now a 30 year history of safe and effective worldwide usage of total food replacements based upon the concept of low fat nutrient-complete enteral feeds (VLCDs as they came to be known). An enormous volume of scientific and medical literature has been thoroughly evaluated by expert committees and they have been recognised as safe and, in cases such as type 2 diabetes, more effective than standard weight loss methods. An expanding network of health professionals in UK and Irish pharmacies are now 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 an expanded professional service. NICE recommends that specialists be used: these trained and experienced pharmacists and GPs are achieving considerable success and their success should not remain invisible for want of a suitable placebo.
“The current burden of morbid obesity in the UK is approximately 720,000 patients who meet NICE criteria for eligibility for surgery. Lost year, 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. Doubling the costs of the surgery and aftercare would raise the percentage from a paltry 0.5 per cent to a marginally Less paltry 1.1 per cent_ This is still far short of the treatment needs of the seriously overweight population. Most surveys now estimate that 60 per cent of the UK population is overweight and about 30 per cent already obese. Assuming a total population of 60 million in the UK the number of people with a weight problem calculates to 36 million overweight and 18 million obese. In the audit from the Irish pharmacies mentioned earlier, 7,259 people lost more than 5 per cent of their prediet weight. 2.969 lost more than 10 per cent. In the Prestwich pharmacy, 94 per cent lost more than 5 per cent of their prediet vveight, 47 per cent lost more than 10 per cent and. 21 per cent of the patients lost more than 20 per cent.
Obviously, something more readily available than just surgery is needed, not only for treatment but also to prevent the progression from overweight to obesity to the massive obesity that passes the threshold for surgical intervention. Such methods are already available and would be more widely recognised if the usual search limits for evidence based treatments were modified to accept other perfectly valid forms of evidence. In
1. Thc Provision of Bariatric Surgery in the United Kingdom! Past, Present and Future Considerations: The Road to Excellence. Department of Bariatric Surgery, Imperial College Healthcare, Charing Cross Hospital, London, September, 2009.
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