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by Ken Alltucker - Oct. 24, 2010 12:00 AM
The Arizona Republic
It's a diet that promises quick, effective results.
Limit yourself for six weeks to just 500 calories a day. Inject or ingest a daily dose of a pregnancy hormone. Eat healthy foods such as vegetables and lean chicken or fish. Drink lots of water.
Watch the pounds melt away.
The so-called HCG diet has become wildly popular in Phoenix and across the nation over the past few years. Naturopaths, clinics and spas tout its benefits. And people who have shed weight on the controversial regimen offer testimonials, pointing to slimmer waistlines and smaller clothing sizes as proof that the diet works.
But could there be a harmful side to what proponents hail as a miracle diet?
Some medical professionals warn of health risks associated with a diet that includes a prescription hormone not approved for weight loss. And a handful of naturopathic doctors in Arizona have been reprimanded or investigated for their oversight of patients who were on the diet.
"Anybody who uses this is at risk," said Craig Primack, a Scottsdale M.D. who specializes in weight loss.
The diet relies on the use of human chorionic gonadotropin, or HCG, a naturally occurring hormone made by cells that form in the placenta during pregnancy. Synthetic versions of the hormone are prescribed by doctors to induce fertility in women and to boost testosterone for boys who face delayed puberty or underdeveloped sex glands.
The hormone, injected by syringe or taken orally, is combined with a strict diet of just 500 calories per day.
The treatment is pricy, but proponents say that people can lose a pound a day on the diet over six weeks.
Naturopathic doctors, alternative physicians licensed by their own professional board, say the diet is ideal for people who can't shed weight with conventional diet and exercise. The HCG diet, they say, acts as an appetite suppressant and helps burn stored fat, and it helps dieters attain a natural weight by balancing calorie intake with energy demands.
The idea of a fat-busting diet has captured the attention of the Phoenix metro area and the nation. But even as the diet explodes in popularity, with spot shortages of the hormone, mainstream medical doctors warn that people cannot sustain themselves on 500 calories a day. People lose weight because they eat so little, and the hormone is little more than a placebo, they say.
"It is the fad diet of the last two years," said Primack, who predicts the diet will fade in popularity. "In another two years, it will no longer be a fad."
Popular, controversial
HCG is offered by weight-loss clinics, spas and dozens of naturopathic physicians across the Phoenix area. Friends, family and co-workers recommend the diet through word of mouth. People chat about it at grocery stores. Health-food stores and websites hawk homeopathic versions of HCG. Restaurants are getting in on the action, creating low-calorie dishes tailored to HCG dieters.
The diet has been so popular that pharmacies last year experienced spot shortages of the hormone, leaving some fertility doctors in the lurch. The hormone must be prescribed by a doctor or other licensed medical professional with the ability to prescribe.
The Food and Drug Administration has approved HCG for three medical uses: fertility treatment, hormone deficiencies and hastening testicular descent in boys.
Medical professionals who prescribe HCG for weight loss are doing so "off label," which means they are recommending the hormone for purposes other than approved uses.
Naturopathic doctors, who are licensed to prescribe drugs, buy the hormone from pharmacies and suppliers.
As the HCG diet has gained popularity, Internet businesses and health-food stores have sold less-potent HCG drops that do not require a doctor's approval. This homeopathic version of HCG is not as strong as the medical-grade HCG, but people are using it in a quest to lose weight.
The use of HCG for weight loss is not endorsed by medical doctors nor federal health officials.
The American Society of Bariatric Physicians, who specialize in weight loss, last December issued a statement recommending against using the HCG diet.
The FDA requires drugmakers that sell HCG to include labels that there is no evidence the hormone triggers weight loss or affects "fat mobilization, appetite or sense of hunger."
More than one dozen medical studies have arrived at the same conclusion - there is no scientific evidence the diet is effective in treatment of obesity.
"You will lose weight," Primack said. "It's the fact that you can't keep it off afterward. It's not a healthy way to lose weight."
Primack said patients initially lose weight because they don't consume enough calories. Reduced protein intake can lead to loss of muscle mass and slow metabolism.
Primack said there is no medical evidence that HCG suppresses appetite or redistributes body fat as naturopaths contend.
And there are known side effects, including headache, fatigue, irritability and sore nipples in males.
Some women who have used higher doses of HCG for fertility have developed ovarian hyperstimulation syndrome, which can cause rapid weight gain, abdominal pain, shortness of breath and vomiting. The babies of pregnant women who use HCG can develop birth defects. The hormone also has been linked to blood clots.
Primack said the lack of scientific evidence that the diet works combined with the potential for side effects should discourage people from its use.
Despite skepticism from the mainstream medical community, the diet has appealed to naturopaths, whose views on weight loss and medical treatments may differ from conventional medical practice. And with an estimated two-thirds of the United States population overweight and one-third of U.S. residents obese, diet proponents face no shortage in finding potential customers.
"It is absolutely like a miracle cure for people," said Kathy Kamin, a naturopath who offers the diet on her website and at her office. "Who cares if science says it works or it doesn't work. Are you going to take charge of your own health?"
Old is new again
Even though popular now, it's not a new diet.
British physician Dr. Albert Simeons published details of the diet in 1954, recommending a daily hormone shot with a low-calorie diet.
The diet gained popularity in the 1970s as a can't-miss weight-loss method before several medical studies cast doubt on its effectiveness.
More recently, naturopaths, weight-loss and pain-management clinics and medical spas have jumped on the bandwagon, some charging more than $1,000 for a six-week regimen.
The diet has been promoted nationally by infomercial pitchman Kevin Trudeau, who touted a version of the diet in his best-selling book "The Weight Loss Cure 'They' Don't Want You to Know About."
In November 2008, a federal judge ordered Trudeau to pay $37.6 million and banned him from pitching his products via infomercials to settle charges he misled consumers about the diet.
Naturopaths say the strict diet, if done correctly, produces results. Naturopathy is an alternative medical system that focuses on natural remedies and the body's healing powers. Naturopathic doctors encourage patients to use diet, exercise and lifestyle changes to ward off disease.
Arizona is one of 15 states that license naturopathic doctors.
"Anyone who cuts calories is going to lose weight," said Jason Sherbondy, a naturopath in Gilbert. "I can tell you, through experience, the weight comes off differently with HCG. People are not as hungry."
The diet burns fat in hard-to-reach places such as the belly, hips and thighs, Sherbondy said.
Nearly two dozen people contacted by The Republic said they had few, if any, side effects from the diet. They also reported rapid weight loss, higher energy levels and elevated feelings of self-worth. Some have been able to discontinue medications to lower blood pressure and cholesterol levels.
After the initial six weeks of 500 calories a day, dieters switch to a strict maintenance diet that allows them to increase calories to a range of 1,000 to 1,500 per day from food such as fish, chicken, fruits and vegetables.
Weight loss varies among dieters. Some shed the weight and keep it off. Others gain some weight back following the initial six weeks.
DeAnn Willis of Phoenix started the diet this summer because she said she needed a shock to her system.
She paid nearly $1,000 for the diet, which lasted 42 days, but said it was worth it because she dropped 27 pounds. She's been able to keep most of the weight off because she changed her eating habits.
"It worked out great for me," Willis said. "It is certainly the fastest weight I lost and the most I lost. I felt fabulous, and my mood was great."
Yet others say the diet left them exhausted and did not help them lose weight over the long haul.
Christine Dahl of Bullhead City tried the diet when it was popular in the 1970s. She lost 50 pounds, but she said she felt weak and tired. She said she had trouble with her thyroid, and she discontinued the diet.
The diet can fluctuate from doctor to doctor with varying recommendations on hormone, daily calorie intake and time period. Some recommend the strict 500 calorie-per-day approach for just three weeks. Others say dieters need 1,000 or so calories each day to avoid lethargy or muscle loss.
Naturopaths who offer the diet warn that consumers should be picky when selecting a doctor for this diet. Some are more comprehensive than others, ordering blood tests and checking thyroid levels. Other naturopaths give dieters supplements and vitamin B-12 injections to boost energy.
Some naturopaths say they are reluctant to offer the diet, but they say they recognize its benefits.
"My approach with patients is using everything else to help them lose weight and using HCG as a last resort," said Amy Terlisner, a Scottsdale naturopath.
Problem cases
Yet as with anything that gains popularity quickly, problems can emerge.
"It is the Wild West," said Brendan McCarthy, an East Valley naturopath. "There's a lot of bad medicine being done with this."
The Arizona Naturopathic Physicians Medical Board has investigated a handful of complaints about doctors improperly administering the diet.
One Arizona case involved naturopath Nicole Barreda, who gave the diet to a 71-year-old woman with a history of diabetes, breast cancer and a thyroid condition. The woman was told to restrict her calories, take HCG injections and drink three to four liters of water daily.
Naturopathic board documents show Barreda never conducted a physical exam during five visits from May through July 2008, instead relying on an earlier exam done by the patient's primary-care physician.
The woman later was hospitalized and treated for hyponatremia, a potentially life-threatening condition of low sodium levels in body fluids that can be caused by drinking too much water or an underlying medical condition.
The board found that Barreda should have "carefully reviewed the medications prescribed by other doctors and ordered more frequent lab work," as an early-warning signal to problems that led to the patient's hospitalization.
Barreda declined to discuss details of the case with The Republic, other than indicating the hospitalization was due to "extenuating circumstances, unrelated to the diet itself."
Barreda accepted a consent agreement with the board that required she complete eight hours of continuing medical education about weight loss.
The board also is probing a case that involved the death of 79-year-old Jean Howland. She had no major health problems when she visited a Scottsdale naturopathic doctor to inquire about the weight-loss program.
After a 15-minute consultation and no physical exam, she received instructions on the diet. She also received syringes and HCG, according to her son, Craig Howland.
Jean remained on the diet for about three weeks before she complained of shortness of breath and was placed in a hospital, where she was diagnosed with a blood clot on her lung. She died days later in the hospital.
Craig filed a complaint against the doctor with the naturopathic board. Board representatives declined to discuss the case because it is under investigation.
No autopsy was performed on Jean, but her son is convinced the hormone shots contributed to his mother's death because she had no other known health problems other than minor orthopedic issues, and blood clots can be a side effect of HCG use.
Craig, who lives in Virginia and is a supervisor with the Federal Bureau of Investigation, said he filed a complaint with the naturopathic board because he believes the doctor's oversight of the diet was lax.
In another case, the board also issued a letter of concern in December to Kamin, who operates Harmony in Health in Scottsdale. The board recommended that Kamin be more accessible to her patients, comply with medical record-keeping requirements and monitor her staff to ensure that they don't give medical advice.
Kamin said the complaint stemmed from a disagreement with a customer. She said she gives her cellphone number to all of her patients, including those who purchase the diet from her over the Internet.
Kamin said her Internet customers must fill detailed patient history forms as well as consent forms for the diet. She consults patients remotely, and if she decides the patient is healthy enough, she starts them on the diet and ships the hormone treatment. Some of these patients are required to send blood-test results. Others are not.
"We can ship the shots to them on dry ice," Kamin said. "I do quite a bit of business out of state."
Critical oversight
Yet even though the naturopathic board has received a handful of complaints about doctors administering the diet, state regulators see no major problems.
Craig Runbeck, executive director of the board, said there is no convincing evidence the diet is harmful. However, he warns its popularity may have prompted some doctors to quickly process patients and skimp on important oversight such as physical exams and blood work.
"If the doctor is just bringing the people off the street and shuffling them through, those are the points that we do come concerned," Runbeck said.
"I am constantly reminding doctors not to practice with their hands on the door."
Runbeck said he is convinced that the diet, if done properly, is safe. After all, he has lost weight on the diet, and so did his wife.
The FDA collects and maintains a database of side effects from prescription drugs. These reports can come from doctors, consumers or others. An FDA spokeswoman said the agency cannot easily tell whether such adverse reports are the result of off-label use of a prescription drug, such as HCG for weight loss. That's because most consumers don't report whether they are using a drug for an approved use or an off-label use, the FDA spokeswoman said.
Medical doctors remain skeptical of the diet.
They say the bigger question is the unknown damage that the diet may cause. While the prescription hormone has been vetted by the FDA for its use as a fertility drug, no similar study has been completed for dieters on the hormone.
"We are always looking for the next great weight-loss method," Primack said. "It has to be safe and effective."
Reach the reporter at ken.alltucker@arizonarepublic.com.
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