Cellulite Treatment Effectiveness Unproven, Studies Flawed
Treatment for cellulite is a multibillion dollar industry of unproved therapies, according to Dr. Matthew M. Avram.
Some treatments that claim to lessen cellulite may have produced minor, temporary improvements in flawed studies, but none has been proven to be truly effective, said Dr. Avram of Harvard University and director of Massachusetts General Hospital’s Dermatology Laser and Cosmetic Center, Boston.
There is no medical reason to treat cellulite, which is normal in the female dermis and is not associated with morbidity or mortality. Many women care about it anyway “because every tabloid likes to show celebrities and their cellulite running around in Hawaii,” he said at the seminar sponsored by Skin Disease Education Foundation (SDEF).
Many physicians and patients misunderstand cellulite, which is simply gender-related differences in the structure of subcutaneous fat lobules and the connective tissue septae that divide them, usually in the thigh area, Dr. Avram said. The treatment industry capitalizes on this ignorance.
“We need to educate our patients that cellulite is a totally normal condition” and treatments are at best mildly helpful for a short period of time, he said. “We need to be skeptical as well. There is a consistent history of inflated and unsubstantiated claims of success.”
Fat removal technologies have no effect on cellulite because fat and cellulite are distinct. Weight and cellulite are unrelated. Cellulite is nearly universal in postpubertal females even if they are lean, but most obese males do not have cellulite unless they have androgen deficiency. “Exercise doesn’t really help it,” he explained.
There is no good evidence for invasive treatments such as liposuction, subcision, mesotherapy, or carboxytherapy. Most data on noninvasive treatments measure results by body circumference, “which isn’t relevant to cellulite, so it’s hard to know whether or not there is improvement,” he noted.
Flawed studies of treatments such as noninvasive Endermologie (mechanical cell stimulation), unipolar and bipolar radiofrequency, devices combining lasers and light sources, and topical treatments show modest, temporary benefit, he said.
Nearly 2 decades ago, a study of topical retinoids for cellulite showed some improvements, but this may have just been temporary improvements in inflammation, Dr. Avram said. Multiple expensive topical formulations have shown no significant efficacy, including xanthines, lactic acid, and aminophylline.
At least three laser devices that are cleared by the Food and Drug Administration are used to treat cellulite, but these devices only needed to prove safety, not efficacy, to achieve clearance, noted Dr. Avram, who is a lawyer as well as a physician. Studies of two of the laser devices suggested that they may produce temporary and limited decreases in limb circumference, which is a poor measure of cellulite.
A study of the third device treated 17 patients twice weekly for 4 weeks with a dual wavelength laser system with vacuum suction and mechanical massage (Plast. Reconstr. Surg. 2010;125:1788-96). The study suggested that 14 patients (82%) showed “improvement” at 1 month as measured by VECTRA 3-D photographs, but initial cellulite irregularities and any possible improvements were more difficult to see by conventional digital photography. The study did not define “improvement” and included no control sites or histology to assess improvement, noted Dr. Avram.
“This is really a flawed study,” he said.
A separate study of a unipolar radiofrequency device for treating cellulite in 30 patients reported a mean 2.45-cm improvement in thigh circumference in 27 patients at 6 months with changes in upper dermis fibrosis on histology (Dermatol. Surg. 2008;34:204-9). However, circumference is an inherently imprecise measure that is irrelevant to cellulite, Dr. Avram noted.
“We need a set of criteria by which we can assess the efficacy of these technologies,” he said. Photography is difficult and easily manipulated to exaggerate results. Ultrasound is imprecise and user dependent. MRI is expensive and requires specific coils for fat and 3-D imaging systems.
“At a minimum we need to have untreated controls, weight maintenance during studies, and laboratory data to confirm safety,” Dr. Avram said. “We must hold our industry and our colleagues to high standards” and demand proof of scientifically important efficacy.
Physicians also should question whether the postulated mechanisms of action for these new technologies make sense with regard to cellulite. Any study without a histology report, for example, has no basis for a claim of efficacy in treating cellulite, he said.
Dr. Avram holds stock options in Zeltiq Aesthetics. SDEF and this news organization are owned by Elsevier.
Source: By SHERRY BOSCHERT, Internal Medicine News Digital Network at http://www.internalmedicinenews.com/specialty-focus/dermatology/single-article-page/expert-cellulite-treatment-effectiveness-unproven-studies-flawed/ce879e15be.html
