New independent study: Deoxycholate cause lipoclasis, not lipolysis

New York [FEBRUARY 1, 2008] Plastic Surgeon, Dr Giovanni Salti from Florence, Italy, has published an interesting and objective double-blind study comparing the efficiency of Phosphatidylcholine verses Deoxycholate in cosmetic treatment.

Phosphatidylcholine, a soy based lipid, has been in popular use in cosmetic treatments, and been approved by the FDA as an active ingredient in several drugs e.g. Infasurf, Calsurf, Rapamune and Ablecet amongst others. Phosphatidylcholine (PPC) is one of several compositions contained in the ASAL Lipodissolve protocols that is increasingly receiving worldwide attention and has already caused an international fascination with "fat loss injections".

The cosmetic use of deoxycholate, a bile acid, as an addition to phosphatidylcholine or in primary use to reduce adipose cells has been aggressively marketed in the United States as an option to phosphatidylcholine use, and is becoming more and more wide spread in clinical use.

In recent years opposing opinions have been voiced whether deoxycholate acid has any valued addition to treatments that aim to reduce body fat. While Lipodissolve developers insist that PPC contain sufficient volume of deoxycholate in the manufacturing process which should not be elevated, other groups persist that deoxycholate is the actual active principle in the process of lipolysis in Lipodissolve treatments. This theory has been questioned in recent University studies on lipomas with phosphatidylcholine, conducted by German researchers. In a private study from Italy published in a recent issue of Dermatologic Surgery Journal, the conclusions indicate that phosphatidylcholine may still play a greater role in cosmetic use than deoxycholate.

Deoxycholate Marketing

The marketing efforts for Deoxycholate in cosmetic use originates with a venture capital group, under collaboration of Kythera Pharmaceuticals, that is financing the licensing approval of a new drug manufactured from base deoxycholate.

Deoxycholate is an acid composite, commonly used in small quantities to liquify raw materials in drug manufacturing and is contained in many injectable drugs. In phosphatidylcholine (PPC), deoxycholate is added in the actual manufacturing process. In cosmetic use, deoxycholate has been known and used on its own without any supporting additive, or been used in excess volume beyond normal standards added in phosphatidylcholine (known as PCDC). The acid composition of deoxycholate make the product painful or uncomfortable, often deterring patients from returning for follow-on treatment sessions. ASAL observations with deoxycholate use in 2004 did not provide sufficient positive outcome to encourage its use.

Italian Study on Deoxyhcolate: is it worth the side-effects?

A recent independent study published by Dr Giovanni Salti in Italy, add more questions to what the developers of Lipodissolve have considered for several years: Deoxycholate burst the fat cell membrane, and, without the PPC induces fat cell destruction (lipoclasis not lipolysis) due to its detergent action. PPC which has been believed to initiate lipolysis, has an active role in determining a faster elimination of the lipids from the treated area.

Dr Salti notes, "The DEOX-treated side, despite a slightly smaller dose of drugs, had the same results, but greater side effects and a much slower resolution."

"On the DEOX-treated side, the nodules were sometimes visible even 1 month after the treatment and could be easily felt to the touch, as well as being moderately painful. Their clinical resolution was often not complete 2 months after the treatment. At the ultrasonographic examination, these nodules were larger (7 to 8 mm) and more hyperechogenic."

In many years of observing the results of Lipodissolve use, the developer has not come across any cases where deoxycholate use has shown significantly better results, and the disadvantages clearly outweigh the advantages.

Dr Salti observes that, "Previous ultrasonographic evaluations showed that, after a treatment with the PPC compound, the fat cell lysis possibly evolves through nodule formation and subsequent tissue resorption in a time span of approximately 8 weeks. Because the resorption of the nodules could be the mechanism of tissue reduction, we set our treatments at an 8-week interval from each other, but our study proves that DEOX seems to induce much slower reabsorbable nodules."

"The clinical and ultrasonographic features of the hypodermic nodules are the major difference between treatments. The PPC-treated sides had a much easier postoperative recovery, with less pain, fewer nodules, and faster resolution."

Summary

In the study 500mg PC was used on one side of the treated area, while 475mg DEOX was used on another side. Both side were studies with 7.5MHz ultrasonography both prior and after treatments. Circumferential metric measurements, photographic evaluation on a metric panel, and symptoms were also recorded.

The DEOX (475mg) treated side had over 22% more pain, 8.1% more bruising, 21.6% more swelling and induration.
The DEOX side induced much slower reabsorbable nodules. Nodules were clinically visible beyond 1 months after treatment, were painful, easily felt to touch.
The PC side compared to DEOX side, had a much easier postoperative recovery, less pain, fewer nodules, and faster resolution.

The summary from the Italian studies demonstrated that DEOX use caused a visually insignificant improvement. The improvement in reduction with DEOX was less than 1% (0.31%) compared with the PC side. These results were visible only through ultrasonographic measurements.

Reference:

Phosphatidylcholine and Sodium Deoxycholate in the
Treatment of Localized Fat: A Double-Blind, Randomized Study
Dermatol Surg 2008;34:60–66