Is Alli A Safe Drug For Weight Loss? Does It Really Work?

Is Alli, also known as Orlistat, an effective medication for long-term weight loss ?  The popularity of this product led me to write an article giving both sides of the Alli picture . Alli is a class  Edit this text  of drug known as an “enzyme blocker.”  When fat is eaten , the body produces an enzyme called lipase that is responsible for breaking it down into a form that is easily utilized in your body.  When Alli is swallowed it willimpair the activation of the enzyme lipase resulting in about 30% less absorption of fat .  Less fat being absorbed results in less caloric absorption , and thus weight reduction .
Does it Work?
There have been several large double blind research studies that have been completed to test the efficacy of this medication .  Two research studies tested 120 mg of Alli ingested three times daily with a low calorie diet for a year followed by an additional year of the drug while on a weight maintenance diet (JAMA, 281:235, 1999; Lancet, 352:167, 1998).  The Alli group exhibited a weight reduction of about 19.8 - 22 pounds during the course of the study as compared to an average of 13.2 pounds in the placebo group a difference of 6.6 - 8.8 pounds.  In the second year of the research the placebo group regained between 8.8 - 13.2 pounds while the Alli group gained 3.3 - 6.6 pounds.  In a 3rd research study , participants were put on a low calorie diet which led to the loss of 22 pounds.  Half the group was then put on Alli while the other half received a placebo.  After one year the Alli group had regained 5.7 pounds and the non-Alli group gained back 9.7 pounds.  In addition, 24% of the group taking Alli did not regain any weight while 16% of the placebo group remained weight stable .  A 4th study looked at the effect of Alli in diabetic patients .  This group given Alli lost approximately 4additional pounds compared to the placebo group (Am J Clin Nutr, 69: 1108, 1999). The determination of the sum of these trials is that Alli does in fact promote weight loss . This data does not tell us how much of this weight loss comes from muscle and how much comes from fat . One can assume that weight loss from fat reduction will result in loss from both fat and muscle to a degree . These studies can not guarantee sustained weight loss beyond two years since the participants in the studies were only monitored for this period .
Neglecting the Side Effects
More recently a study out of Quebec confirmed the results found above .  Dr. Michael Lean (could the last name be a coincidence?) stated, “This drug works effectively for around three-quarters of the people who take it… because the drug is not absorbed, side effects are negligible, provided patients stay on a low fat diet.”  This is an interesting comment because we have not met a patient taking Alli who would agree that the side effects are negligible and we are willing to bet that Dr. Lean has not spent too much time on Alli himself.  These side effects include flatulence with discharge, oily spotting and fecal urgency in 20 - 40% of the patients.  The side effects are significantly lessened if the patient maintains a low fat diet .  This begs the question, why are we giving a fat blocker to someone who requires a fat restricted diet anyway?  Is the weight loss due to the efficacy of the medication or is it the intentional or subconscious fat restriction from the fear of “negligible” side effects?
Aside from the uncomfortable side effects stated above there are many more health impairing side effects that happen “behind the scenes.”  To begin with, absorption of fat is non-selective.  There are two main fats that are found in the diet… omega-3 and omega-6 (this is  an oversimplification for the point of our brief discussion).  The omega-6 fats are the fats that are principally responsible for fat gain, blood clotting and inflammation .  These fats are found abundantly in vegetable oils, farm grown animal fats and certain nuts such as peanuts and cashews.  The omega-3 fats are responsible for higher metabolism, reducing inflammation, protecting the blood vessels and inhibiting clotting.  These fats are found in wild harvested, cold Atlantic fish, certain seeds such as flax seed, certain nuts such as walnuts and range grown animal foods.  Alli does not distinguish between the two types of fats and thus will inhibit both.  This would usually not be a problem if, as a result of the Standard American Diet (SAD), we were not so deficient in omega-3 fats.  However, a individual taking Alli may run the risk of severe health effects as a result of a deificiency of these healthy fats.
A study recently published in the reputable journal, Archives of Internal Medicine, reviewed the current literature on omega-3 fats and came to some astounding conclusions.  The main conclusion was that the omega-3 fats from dietary sources could prevent cardiac death and nonfatal heart attack (Arch Intern Med 2001; 161: 2185-92).  An earlier review of the literature found that people who were at high risk of heart disease could decrease their risk of heart disease related death by 40 - 60% simply by eating 1.3 - 2 oz of fish weekly (Eur J Clin Nutr 1999; 53: 585-90).  The average Alli patient may need to double or triple this amount in order to maintain healthy levels of this fat, and that is assuming that the person has chosen the correct kind of fish and prepared it properly .
There are other concerns regarding Alli’s potential adverse effects to the heart, and overall health.  It is well known that Alli will prevent the body from absorbing fat soluble vitamins such as A, D, E and K.  Vitamin E plays an crucial role in the prevention of heart disease and immune function, vitamin K is important in the maintenance of healthy clotting and vitamin D is essential in the prevention of calcification of the arteries (Circulation. 1997; 96: 1755-1760) and proper maintenance of strong bones.
Although these vitamins can be replaced through supplementation , another class of critical nutrient is not so simple to replace.  These nutrients make up a class called carotenes and are found in colorful fruits and vegetables such as carrots, tomatoes, radishes, etc.  The carotenes include beta carotene, alpha carotene, gamma carotene, lutein, lycopene, zeaxanthine, and many others.  Scientists believe that they have only touched the surface of the list of carotenes that are found in foods.  Because there are literally hundreds of carotenes in nature, we cannot readily supplement appropriately.  Studies have determined that higher carotene intake results in a protective effect against heart disease (J Nutr 1999;129:5-8 [review]) and cancer.  Research has also determined that Alli may decrease circulating carotenes by as much as 50%.  This would surely have a negative effect on the cardiovascular system as well as the immune system.  The producer of Alli suggests that Alli has been shown to improve blood pressure, cholesterol and blood sugar, thus resulting in protection from heart disease.  They conveniently fail to mention the minimal amounts by which these parameters change such as a 2 point decrease in blood pressure, 5 point decrease in total cholesterol and a change in hemoglobin A1C (long term blood glucose control) of one-fifth of one percent (0.18%).  They also fail to take into account the effect of decreased omega-3 fats, fat-soluble vitamins and carotenes.
Data pooled from 7 controlled studies showed that 9 out of 747 patients on Alli developed breast cancer compared to only 1 out of 579 on placebo.  These results could not be confirmed in the two published two-year studies (Medical Letter 41: 1055 June 18, 1999: 56).  Although we cannot definitively link Alli use to breast cancer at this time, the possibility is there and needs to be considered when choosing this therapy.  Alpha linolenic acid, one of the omega-3 fatty acids, and the carotenes may help prevent breast cancer.  Alli’s inhibitory effect on the absorption of this fat may predispose the patient to breast cancer.
One final concern worth mentioning is that when a person takes “a pill” to lose weight, many other healthy habits have a tendency to disappear, with the underlying thought that “I’m taking a pill, so I don’t have to exercise, etc.”  Ever see a person order a Diet Coke with their piece of cake for dessert?
The Cost of Weight loss
Alli is very expensive, with a monthly cost of $65.  This translates into approximately $1500 per two-year course of treatment at which time you can expect to lose a maximum of 15 pounds.  Thus the cost of one pound of weight loss is approximately $100 (this does not factor in the cost of new undergarments or the use of Depends for the up to 40% of people with the “negligible” side effects).  Compared to other, more traditional forms of weight loss, including proper exercise, this is very expensive.  Some people will make the argument that their insurance covers it, but keep in mind that one way or another we end up paying for those drugs, usually through increased insurance premiums.
I Have Read… but I Still Want to Take Alli
Thank you for educating yourself before choosing your path.  As an educated consumer you can now work to decrease the potential for side effects.  Below we have listed some suggestions for foods and products that may help you maintain at least a minimal level of health while on this medication.

1. Eat foods that are high in carotenes.  These include any of the following: carrots, sweet potatoes, squash, corn, tomatoes, watermelon, spinach, colorful peppers, lemons, oranges, prunes, greens, mangoes, tangerines.  Any fruit or vegetable that is colorful is likely to have larger amounts of carotenes.  A dietary supplement containing mixed carotenoids should be added as well.  One such product is Caroteam by Vitamin Research Products.


2. When you eat foods with fat try to eat cold Atlantic fish or free range meats such as range grown cattle and/or chickens .  Range grown refers to animals that are permitted to graze in fields eating live food instead of refined animal feeds.  This will help assure the presence of beneficial fats.  Those who cannot work these foods into their diet should take an essential fatty acid supplement such as potent fish oil capsules .


3. You should get at least 800 I.U. of vitamin E, 25,000 IU of carotenoids and 1,000-2,000 mg of vitamin D daily.  Although these recommendations exceed the RDA, keep in mind that the RDA was not developed to apply to people on Alli.

Please understand that following the above suggestions will most definitely result in weight loss, regardless of taking Alli or not .  In our opinion it makes sense to try the less expensive way first.
Before you go out and try a product like this, you may want to surf around and read through a weight loss blog or two and down load some reputable weight loss podcasts.
**Alli is a registered trademark of Roche

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