Concerns about drug efficacy, safety surround mesotherapy

January 1, 2006

Atlanta — Mesotherapy, a method of delivering drugs or mixtures subcutaneously, has been used in Europe for more than 50 years and in the United States for about five. According to one physician, there are reasons that mesotherapy has gained less-than-rave reviews domestically.

Lisa M. Donofrio, M.D., heads a private practice in New Haven, Conn., and is associate clinical professor of dermatology at the Yale University School of Medicine. She discussed some of the controversy surrounding mesotherapy in a seminar, "The Cons of Mesotherapy," at the annual meeting of the American Society for Dermatologic Surgery here.

Dr. Donofrio provided some background on mesotherapy and its applications before detailing her concerns regarding its efficacy.

"Mesotherapy was named by a French doctor, Michel Pistor, in 1952, and was used first as a subcutaneous injection for tinnitus," she says. "In 1964, the French Society of Mesotherapy was founded, and in 2000, mesotherapy began being used in the United States."

What's in there?

Dr. Donofrio tells Dermatology Times that mesotherapy "cocktails" are tailored to the condition being treated. Ingredients may include anti-inflammatory agents, anesthetics, herbs, enzymes, hormones, vasodilators, muscle relaxants, methylxanthines and beta-adrenergic agonists. She notes that there is a lack of standardization in these tailor-made cocktails.

"For male pattern baldness, cocktails can include finasteride, T3, minoxidil and lidocaine," she says. "Mesotherapy for facial rejuvenation typically includes lidocaine, tretinoin, vitamins C and E, hyaluronic acid and alpha-lipoic acid."

Both cellulite and fat-loss mesotherapy cocktails can include yohimbe, carnitine, hyaluronidase, collagenase, ginko biloba, aminophylline and isoproterenol.

Dr. Donofrio says the wide variety of drugs and other medicines typically used in mesotherapy is one reason for concerns about efficacy.

"All drugs used have oral, intravenous or topical efficacy, but none have proven efficacy when applied subcutaneously or intradermally," she says. "There are other potential problems involving precursors - conjugation and enzymes for activation - dosages, quality control and deactivation with sterility."

Complications and concerns

Mesotherapy complications can include urticaria, Koebner phenomenon, atrophy/necrosis and infection, Dr. Donofrio says. She notes that there have been seven case reports of atypical mycobacterium infection following mesotherapy.

"Even given that mesotherapy can be effective, concerns remain," Dr. Donofrio says. "Where does the fat go, for instance? How do the drugs interact? What are the systemic side effects? What are the long-term side effects?"

In discussing concerns about the safety of mesotherapy, she cited a 2004 study that found the detergent effects of deoxycholate to be a major feature of an injectable phosphatidylcholine (PC) formula used for fat dissolution. The PC formula and isolated deoxycholate cause cell membrane lysis in porcine tissue and act as nonspecific detergents.

"This study shows that phosphatidylcholine and deoxycholate cause cell lysis - and that they warrant further investigation as a lipolytic agent," she says.

Dr. Donofrio emphasizes that mesotherapy is an injection technique, not a specific procedure.

"There are concerns because there is such a wide variety of drugs and drug cocktails that include herbs and vitamins that are used in mesotherapy," she says. "Add to that unanswered questions on drug efficacy and safety, and you have a situation where much evaluation and research needs to be done before mesotherapy can be used with confidence and assurance."

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