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About the Author
I am board certified in internal medicine and in endocrinology and metabolism, and have been in private practice for 18 years specializing in the treatment of diabetes. Since most of my diabetic patients have medically significant obesity I have also specialized in the medical treatment of obesity. I have been able to help hundreds of my obese patients lose weight with BioLean and Satieté.

Background
Obesity is a major public health problem and for many obese patients pharmacologic therapy is needed. However, there are very few approved medications for the treatment of obesity, and their effectiveness is limited.

Methods
An unselected group of 128 patients seen in my office who were being treated with one of two different herbal treatments for obesity were retrospectively analyzed for their weight loss response to treatment. All of the patients had been unsuccessful losing weight with diet and exercise alone There were 90 patients treated with the herbal product BioLean and 38 treated with the combination of prescription phentermine and the herbal product Satieté. Both herbal products are manufactured in F.D.A. licensed and supervised manufacturing facilities and both are listed in the Physician Desk Reference for Nonprescription Drugs and Dietary Supplements.

Results
The patients on BioLean were on therapy for an average of 18.7 weeks and lost on average 0.73 pounds per week. The phentermine and Satieté group were on treatment for an average of 12.4 weeks and on average lost 0.87 pounds per week. 79% of the BioLean users and 87% of the phentermine and Satieté patients lost an average of 0.5 pounds per week. There were no significant adverse reactions to either treatment.

Conclusion
Safely made herbal products that can help increase energy expenditure in motivated patients can be very effective in helping to treat medically significant obesity, a very important public health problem in the United States.

Introduction
It is well recognized that obesity is becoming a major public health problem in this country (1-5). From an endocrinologic viewpoint the increasing incidence of type 2 Diabetes can, in part, be tied into the increasing prevalence of obesity (6). Many obese patients try to reduce their caloric intake, but still are unable to lose weight, and pharmacologic therapy of obesity is recognized as an important factor in the overall management of many obese patients (7-9). At present the only F.D.A. approved medications for the treatment of obesity are phentermine, sibutramine and orlistat, all of which have well recognized potential side effects.

When fenfluramine was withdrawn from use, I personally tried sibutramine in about 50 patients and observed almost no effect on weight loss. At that time I started offering my obese patients the option of trying two different herbal products to help with weight loss. This paper details my experience with an unselected group of patients using either BioLean or phentermine and Satieté.

Methods and Materials
BioLean is an herbal and amino acid combination with a daily dose composed of 400 mg of the following mix: L-Phenylalanine, L-Tyrosine and L-Carnitine; and 650 mg of the following herbal mix: Ma Huang, Green Tea, Schizandrae Berry, Rehmannia Root, Hawthorne Berry, Jujube Seed, Alisma Root, Angelicae Dahuricae Root, Epemidium, Poria Cocos, Rhizoma Rhei, Stephania Root, Angelicae Sinensis Root, Codonopsis Root, Eucommium Bark, Notoginseng Root (8). A daily dose of Biolean contains 35 mg of Ma Huang (Ephedra). Satieté is a herbal, mineral and vitamin combination with a daily dose composed of 150 mg Griffonia Seed Extract (95% minimum naturally occurring L-5hydroxytryptophan), 99 mg Gymnema Sylvestre, 1980 mcg Vanadyl Sulfate, 19.5 mg Vitamin B-2, 19.5 mg niacinamide, 165 mg Magnesium (Oxide), 19.5 mg Vitamin B-1, 19.5 mg Vitamin B-6, 300 mg Malic Acid, 150 mg St. John's Wort Extract (0.3% hypericin content), 60 mg Gingko Biloba Extract (24% gingko flavonglycosides and 6% bilobalides), 300 mcg Vitamin B-12, and 99 mcg Folic Acid (10).

Although herbal products are classified as food supplements and thus are not under F.D.A. regulation, both BioLean and Satieté are manufactured in F.D.A. licensed and supervised pharmaceutical manufacturing facilities, and both products are listed in the Physicians' Desk Reference for Nonprescription Drugs and Dietary Supplements (10). The manufacturing of these two products in F.D.A. licensed and supervised facilities guarantees their purity and consistency. The unregulated manufacturing process of herbal products in general does pose a problem with product purity and consistency (11-13), but not with BioLean and Satieté.

Over a two week interval all patients seen in my office who had or were taking either BioLean or phentermine and Satieté for at least four continuous weeks were included in this study. Patients who had stopped and then restarted either therapy were considered as two "patients". The dosage of BioLean was one package per day; the dosage of phentermine was 15-30 mg per day with most patients using 30 mg, and the dosage of Satieté was one tablet three times a day before each meal. Most of the patients in this study were diabetic, hypertensive and hyperlipidemic, with their diabetes and blood pressure under good control. Neither therapy was started in any patient who had uncontrolled diabetes, moderate to severe hypertension, unstable angina, any cardiac tachydysryhthmia, uncontrolled hyperthyroidism, symptomatic prostatic hyperplasia or glaucoma. The Satieté was not started in any patient on moderate or higher dosages of any antidepressants. All of the patients had stated that they were trying very hard to follow a low caloric diet without success with weight loss before they were started on either of the two weight loss therapies.

Results
There were 90 patients who had used BioLean and 38 patients who had used phentermine with Satieté (Table 1). The BioLean patients were on therapy for an average of 18.7 weeks and on average lost 0.73 lbs/week (Table 2). The phentermine and Satieté patients were on therapy for an average of 12.4 weeks, and on average lost 0.87 lbs/week (Table 3). 79% of the BioLean users and 87% of the phentermine and Satieté users lost at least an average of 0.5 lbs/week. 89% of the BioLean patients and 95% of the phentermine and Satieté patients lost at least an average of 0.35 lbs/week.

There were no clinically evident serious adverse reactions amongst any of the 128 patients. Specifically, there was no evidence for any increase in blood pressure, cardiac dysrhythmia, cardiac valvular abnormalities, pulmonary hypertension, angina, heart failure or any increased blood sugar levels.

Discussion
Obesity has been firmly established as a very significant medical condition resulting in excess morbidity and mortality. There is a long list of endocrinologic and nonendocrinologic conditions that obesity increases in frequency (4,7,14,15), not the least of which is the insulin resistance syndrome which is associated with a clearly recognized increased incidence of atherosclerotic cardiac disease (16,17). Many authorities on obesity have stated that in appropriate patients medication therapy should be part of the treatment process (7-9,18). A recent consensus statement by the American Association of Clinical Endocrinologist (AACE) commented that herbal therapies for obesity may be beneficial, but studies were needed to prove their safety and efficacy (18). This report is a first step in showing that herbal products can effectively help treat medically significant obesity.

In this study the herbal product BioLean and the combination of phentermine with the herbal product Satieté were highly efficacious, helping over 80% of patients to lose on average at least 20 lbs/year. It is important to note that this was a motivated group of patients who were already trying very hard to lose weight through diet and exercise modalities, but without success.

However, because these patients generally did not change their eating or exercise behaviors to any appreciable extent, it does help to prove that the herbal products used were mostly responsible for the weight loss experienced.

BioLean helps with weight reduction and loss of excess body fat by increasing thermogenesis through an increase in the beta response of muscle and adipose cells which increases fat metabolism (10,19-21). Sympathetic beta stimulation to skeletal muscle and adipose cells causes energy production and increases thermogenesis both of which requires caloric expenditure. The ephedra in BioLean is a sympathomimetic beta agonist. Satieté helps to promote weight loss primarily through its herbal source of 5HT which increases serotonin levels thereby helping with appetite control (7). When Satieté is combined with phentermine the combination offers the potential of promoting weight loss like the combination of phentermine and fenfluramine, but without the potential cardiac valvular problems seemingly caused by excessive serotonin tissue levels due to nerve terminal release and reuptake blockage.

The results of this study show the therapeutic potential of certain herbal products in the treatment of obesity. Clearly, placebo controlled studies using products such as BioLean and Satieté need to be performed, but some recent papers have shown that estimates of treatment effects in observational studies are very similar to those obtained from randomized, placebo controlled trials (22,23). Additionally, there are an increasing number of studies proving the beneficial effect of different herbs (24-26).

It needs to be emphatically emphasized that no physician should use any herbal product to help with weight loss unless that product is made in an F.D.A. licensed and supervised pharmaceutical manufacturing facility. The two biggest potential dangers in patients taking herbal products are (1) excess dosing and (2) impurities and/or toxins in the product (8,9). Herbal supplements that are made in F.D.A. licensed and supervised pharmaceutical manufacturing facilities will not have impurities or toxins in them, and the dosing of the herbal ingredients can be assured.

A daily dose of BioLean contains 35 mg of Ephedra. There has never been a credible report to the F.D.A. of any person taking BioLean having any serious adverse effects (personal communication with the company), because the dosing is proper and the manufacturing process is of the highest standards and quality.

In summary, this study shows that two herbal products manufactured in F.D.A. licensed and supervised pharmaceutical manufacturing facilities can safely and effectively help to treat obesity, a very important public health problem in the United States.

Table 1

Demographics of Patient Population

	BioLean	Phentermine & Satieté
Number of Patients	90	38
Number of Men	33	8
Number of Women	57	30
Age Range	19-81	33-82
Average Age	57	54
Weight Range	146-365	126-351
Average Weight	229	213

Table 2

Response to BioLean Therapy

	Men	Women	Total
Weight Loss Range	2-70 lbs	0-50 lbs	0-70 lbs
Weeks of Therapy Range	4-76	4-76	4-76
Total Weight Loss	454 lbs	781 lbs	1235 lbs
Total Weeks of Therapy	569	1114	1683
Average Weight Loss	13.75 lbs	13.7 lbs	13.7 lbs
Average Weeks of Therapy	17.2	19.5	18.7
Average Weight Loss/Week	0.8 lbs	0.7 lbs	0.73 lbs
% of Patients Losing > 0.50 lbs/wk	79 (26/33)	79 (45/57)	79 (71/90)
% of Patients Losing > 0.35 lbs/wk	91 (30/33)	88 (50/57)	89 (80/90)
Average Weight Loss/Wk of the 80 Responders	0.91 lbs	0.77 lbs	0.84 lbs

Table 3

Response to Phentermine and Satieté Therapy

	Men	Women	Total
Weight Loss Range	4 - 22 lbs	0 - 21 lbs	0 - 22 lbs
Weeks of Therapy Range	4 - 20	4 - 28	4 - 28
Total Weight Loss	97 lbs	315 lbs	412 lbs
Total Weeks of Therapy	98	374	472
Average Weight Loss	12.1 lbs	10.5 lbs	10.8 lbs
Average Weeks of Therapy	12.2	12.5	12.4
Average Weight Loss/Week	0.99 lbs	0.84 lbs	0.87 lbs
% Patients Losing >0.5 lbs/week	87 (7/8)	87 (26/30)	87 (33/38)
% Patients Losing >0.35 lbs/week	100 (8/8)	93 (28/30)	95 (36/38)
Average Weight Loss/Week for the 36 Responders	0.99 lbs	0.89 lbs	0.91 lbs

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Conflict of Interest and Acknowledgments

Bruce Sindler, M.D. is an independent distributor with Wellness International Network. Wellness International Network markets BioLean and Satieté. Dr. Sindler can earn income from the usage of products marketed by Wellness International Network.

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