Good News for Obese People--Naturally
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Some dieters are now thinking twice about taking the popular diet pill combination phen-fen, or its chemical cousin, Redux.
They’re wary of the potential side effects or scared by a recent wrongful death lawsuit brought by the family of a woman who died after taking phen-fen.
And waiting in the wings to cater to our quick-fix fantasies is a number of other options:
* “Herbal phen-fen,” a pill offered by Nutri / System and soon to be sold in health food stores.
* Pyruvate, a simple organic acid that some say aids weight loss.
* By next month, a new prescription drug, orlistat (Xenical), is expected to get the blessing of the Food and Drug Administration.
Overweight people “are looking for something natural,” contends Joseph DiBartolomeo, vice president of scientific affairs for Nutri / System and its affiliate, U.S. Medical Weight Loss Clinics, which together operate more than 500 weight-loss clinics nationwide.
That was the impetus, he says, for the launching earlier this month of “herbal phen-fen,” a pill that includes St. John’s wort, an herb often used to treat depression, and the herb ma huang (also known as ephedra). Recommended doses, DiBartolomeo says, are 800 milligrams of St. John’s wort and 40 milligrams of ephedra.
In the first two weeks, DiBartolomeo says, more than 100,000 bottles were shipped. A 15-day supply costs $14.95 to $24.95 for Nutri / System members.
St. John’s wort “has never been tested for appetite suppression,” DiBartolomeo says. So the company, with the help of a New York City physician, conducted a study of the combined herbs. They tested “50 or 60” people, ages 25 to 40, most needing to lose 15 or 20 pounds, over a period ranging from six weeks to three months, DiBartolomeo says. “More than 80% reported they could eat less and feel full,” he says.
“Weight loss at four or five weeks was about 7 1/2 pounds on average,” DiBartolomeo says. Subjects also were counseled to restrict calories and to begin a regular walking program.
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But the use of “herbal phen-fen” sparks concern from other weight-loss experts, who point out that a three-month study of 60 people is much too small and much too brief. Nor has the study been published in a peer-reviewed medical journal.
“Everyone wants natural products, but none of them has been proved,” says Dr. Morton Maxwell, clinical professor of medicine and director of the University Obesity Center at the UCLA School of Medicine, where participants who qualify are given phen-fen and Redux, which are meant for obese patients.
“It’s possible [St. John’s wort] can be effective in weight loss,” says Drew Francis, a doctor of Oriental medicine who owns Golden Cabinet Herbs in West Los Angeles.
Even though ephedra is found in many weight-loss and energy-promoting products, its use as a diet aid drew concern from both Maxwell and Francis.
Since 1993, the FDA has received 800 reports of adverse health effects associated with the use of ephedrine-containing dietary supplements, says spokeswoman Judith Foulke. The herb has been linked to at least two deaths and is believed to be associated with several others, she says.
In 1995, a federal advisory panel recommended that the FDA take action to address the concerns associated with the herb. At this time, Foulke says, the FDA is considering the recommendation and will determine how or if the herb can be used in dietary supplements.
Meanwhile, Francis cautions that the herb “has a lot of possible side effects and contraindications” and warns people with high blood pressure, men with an enlarged prostate, or women experiencing hot flashes during menopause not to take the herb.
And Maxwell worries that in the rush to get thin fast, “a lot of people will take six tablets instead of one.”
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Another option, heavily marketed at some health food stores, is pyruvate, a breakdown product of glucose.
Keeping it in stock is a challenge, says Larry Goodermont, manager of Capitol Drugs in West Hollywood, who says he sells at least 48 bottles a week. One brand sells for about $25 for 60 tablets; other brands are less expensive.
Behind the craze, discovered first by body builders, is 50-year-old Dr. Ronald T. Stanko, associate professor of surgery at the University of Pittsburgh Medical Center and a paid consultant to Med-Pro Industries, which secured the rights to market pyruvate from Stanko.
Pyruvate enhances oxidation of fat and fat synthesis, says Stanko, who takes the product to stave off middle-age spread. Taking the supplement, he adds, can help people maintain weight control or lose weight slowly. “There seems to be selective fat loss in the abdomen and the thighs,” he says. But it’s not a miracle worker; Stanko cautions users to follow a prudent diet and to exercise regularly.
Optimal doses vary, he says. A 130-pound woman, for instance, who takes 3 milligrams a day would probably lose three pounds in two months without changing her diet, he says.
Stanko has published studies in respected journals such as the International Journal of Obesity and the American Journal of Clinical Nutrition, reporting that the pyruvate increases weight loss and inhibits weight regain.
But his colleagues, many of whom say they have not seen his published studies, are skeptical.
“Products sold as food supplements usually don’t have credible scientific studies,” says Frances Berg, adjunct professor of health and wellness at the University of North Dakota School of Medicine in Grand Forks. “Otherwise they’d be sold as prescription drugs.”
Berg coordinates the task force on Weight Loss Abuse of the National Council Against Health Fraud, based in Loma Linda, and edits the Healthy Weight Journal.
Under the Dietary Supplement Health and Education Act of 1994, products sold as supplements do not need FDA approval but cannot make medical claims and cannot cause harm, Foulke says.
“People can lose weight on placebo,” Berg says. The real bottom line, she emphasizes, is long-term weight maintenance after the loss for at least 2 1/2 years.
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By next month, yet another prescription anti-obesity drug is expected. The fat blocker drug Xenical (orlistat) acts in the gastrointestinal tract to prevent absorption of fat by about 30% and is meant for obese dieters.
Earlier this month, a federal advisory panel to the FDA recommended approval of the drug, manufactured by Hoffman-LaRoche.
But no matter what the next “miracle” drug is, says Bruce Chassy, head of Food Science and Nutrition at the University of Illinois Urbana-Champaign, there’s no substitute for the basics. “Maintenance of successful weight loss depends on proper diet, restriction of caloric intake and regular exercise,” says Chassy, who was on the advisory panel to the FDA for ephedrine-containing supplements. “There are no shortcuts. There are no magic bullets.”