A very interesting study by one of the doctors that I work with. Herbal Therapy for the Treatment of Obesity By: Bruce Sindler, M.D. About the Author I am board certified in internal medicine and in endocrinolgy 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 Satiete. -------------------------------------------------------------------------------- Abstract 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 Satiete. 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 Satiete 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 Satiete 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 Satiete. 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). Satiete 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 Satiete 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 Satiete. Over a two week interval all patients seen in my office who had or were taking either Biolean or phentermine and Satiete 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 Satiete 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 Satiete 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 Satiete (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 Satiete 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 Satiete users lost at least an average of 0.5 lbs/week. 89% of the Biolean patients and 95% of the phentermine and Satiete 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 Satiete 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. Satiete helps to promote weight loss primarily through its herbal source of 5HT which increases serotonin levels thereby helping with appetite control (7). When Satiete 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 Satiete 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. Herbal Therapy for the Treatment of Obesity Bruce H. Sindler, M.D., F.A.C.E. 1314 Bedford Avenue #101 Baltimore, MD 21208 Table 1 Demographics of Patient Population Biolean Phentermine & Satiete 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 Satiete 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 Bibliography 1. 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J Clin Invest 1995; 95: 1109-16. 22. Benson K, Hartz AJ. A Comparison of Observational Studies and Randomized, Clinical Trials. NEJM 2000; 342: 1878-86. 23. Concato J, Shah N, Horowitz RI. Randomized, Controlled Trials, Observational Studies, and the Hierarchy of Research Designs. NEJM 2000; 342: 1887-92. 24. Philipp M, Kohnen R, Hiller KO. Hypericum Extract Versus Imipramine or Placebo in Patients With Moderate Depression: Randomized Multi center Study of Treatment for Eight Weeks. BMJ 1999; 319: 1534-39. 25. Pittler MH, Ernst E. Efficacy of Kava Extract for Treating Anxiety: Systematic Review and Meta-analysis. J Clin Pyschopharmacol 2000; 20: 84-9. 26.Vuksan V, Stavro MP, Sievenpiper JL. Similar Postprandial Glycemic Reductions With Escalation of Dose and Administration Time of American Ginseng in Type 2 Diabetes. Diabetes Care 2000; 23: 1221-26. Conflict of Interest and Acknowledgments Bruce Sindler, M.D. is an independent distributor with Wellness International Network. Wellness International Network markets Biolean and Satiete. Dr. Sindler can earn income from the usage of products marketed by Wellness International Network. 1996-2000 Wellness International Network, Ltd.-All rights reserved. Image Copyright 1994 Photo Disc Inc.