In a 2009 study of 42 patients, Rotunda et al. assessed the safety and efficacy of subcutaneously injected deoxycholate alone compared with a conventionally used phosphatidylcholine/deoxycholate combination in patients with unwanted submental fat. In this single-center, randomized, double-blind study, 28 subjects received 1-mL injections of one of the test compounds into submental fat, and 14 received 2-mL injections, with up to five treatments administered every 4 weeks. Patients completed diaries at home as well as post-treatment self-assessments. Modest changes (ranging from none to mild) in submental profiles based on photographic assessment were reported for both groups. No significant differences between the groups were seen based on patient self-assessment; physical examination; or incidence, duration, and severity of adverse events (e.g., burning, edema, erythema, and pain). The investigators reported that minimal aesthetic improvement was observed from the injection of either deoxycholate or phosphatidylcholine/deoxycholate into submental fat. They also suggested that further study is warranted based on the belief that proof of concept was supported by improved neck profiles in multiple participants. In particular, they suggested that additional work is needed to establish a validated submental profile grading scale and optimal doses and techniques (Dermatol. Surg. 2009;35:792-803).
Conclusions
Clearly, new research is slowly emerging on the use of phosphatidylcholine injections for the in-office reduction of fat deposits. The weight of this new evidence, particularly in light of the Brazilian ban on Lipostabil, strongly suggests continued optimism for the eventual use of phosphatidylcholine for fat reduction, but much more research is necessary to develop safer applications.
I would like to see larger sample sizes in randomized, placebo-controlled trials. At this point, I strongly advise against the use of Lipostabil, which, unfortunately, is available in kits sold over the Internet (lecithin and phosphatidylcholine are not regulated as drugs, though they should be, and are even sold as supplements). Several companies are working to develop safer versions of Lipostabil. I recommend that physicians advise their patients to wait until such products are vetted and validated.