Lipodissolve Summary 2008

The Lipodissolve developers and groups in the USA and Europe review the current status of research surrounding Lipodissolve to date.Lipodissolve or injection lipolysis, has developed enormously since early 2000 thanks to the efforts by speakers, our members and the work of several independent studies from both private clinics and universities. This review has the aim of briefly summarizing the current state of the art.
The protocol developed for Lipodissolve has been continuously reviewed. The list of contra-indications has been adjusted each year in line with the latest insights; the treatment observation and feedback form is now in new version for 2009. The list of indications for Lipodissolve (liploysis) are as follows: Aesthetic indications that produce particularly good results: Double chin Jowls Abdomen Love handles Inner side of the legs Dorsal fat i. Aesthetic indications with variable results: Cheeks Nasolabial groove Axillary folds Saddle Bags Upper arms Knee Cellulite 3-step therapy Lipomas Pseudogynaecomasty (lipomasty) Skin tightening Our lecturers have maintained a consultation service for dealing with urgent questions, even though our rate of complications are very low (0.00173%) if the recommended ASAL Lipodissolve protocols are followed and the recommended pharmaceutical provider is used. A study has been completed focusing on clinical observations on side-effects on over 11,600 treatments by ASAL physician members. The study has been issued for publication. Complications from Lipodissolve was extremely small, particularly considering the huge volume of treatments being performed in the country [over 250,000 treatments were estimated in the USA in 2008]. The same study revealed that in average 6/10 clinics provide treatments outside the standard protocols which can affect the outcome. Many would either inject too low volume, or too little per injection point. A few reported volumes far beyond the protocols with injections up to 3 x over the recommended limit, in which a handful of cases lead to necrosis. These were the only reported cases of serios side-effects. Those who followed protocols had good report on outcome and no observations of adverse side-effects were noted. All of the participating physician evaluated the treatment as very safe with minimal risks. Only one doctor, a plastic surgeon who participated in the feedback, noted no results or achievements in any of his treatment efforts. The feedback contained too little details to evaluate the reasons for his poor outcome. All other feedback rated the treatment very high, including those from other surgeons. Best aesthetic results was achieved when the treatment was combined with aftercare, or with pharmacological weight loss management. The aesthetic outcome was highly impressive in these cases. In our standard protocols we recommend at least low frequency ultrasound for inexpensive aftercare options. Other aftercare modules such as CO2 laser achieved extremely good results, often equal to surgical results. But other non-surgical options as thermage, ultrashape, accent and so on would all aid to maximize a positive outcome on the overall aesthetic results, and lower the number of treatments necessary until the patient is satisfied. To learn the right methods and protocols for treatment, register for our seminar. Three publications on the issue of safety based on retrospective studies by physicians, both national and international have already been published. The new compound with high grade imported phosphatidylcholine (PCX100) with FDA approved raw materials has proved its efficacy. The normal discomforts, swelling and expected minor side-effects have been reduced. The feedback on PCX100 has been very good from clinical users with emphasis that the PPC in the compound has been of substantially better quality than standard compounds. ASAL is seeking funding to research a new potential compound ingredient for Lipodissolve treatments.
Publications and studies Publications A total of 12 publications have appeared in prestigious medical journals in the course of the last three years. Studies On the topic of lipoma, a team at Bochum University around senior physician Dr. Hoffmann and Dr. Falk Bechara has already produced 2 publications; a 3rd publication is due to appear in the near future. It should be noted at this point that there is one study published by Prof. Daisy Kopera of Graz which comes to the conclusion that lipolysis does not work. Both ASAL in the United States and the European Network for Lipolysis, including researchers in university circles have serious doubts concerning this study – because in our opinion the study design was such that it would inevitably produce redundant results, or the protocols or medications used alters the results of the research, which we have seen evidence of from individual clinical use when Lipodissolve has been adjusted or altered. Its unfortunate that researchers, and often even clinical users, don’t abide by the recommended protocols. Another FDA approved study too has been offered assistance wiuth protocols but has rejected to follow the standard protocols, or the standard medical supplies. A yet unpublished study by Prof. Schuller-Petrovich of Vienna (Austria) states that the active substances, polyenylphosphatidylcholin (PPC) and desoxycholic acid (DOC), massively destroy all the cells. In the case of this study, we have to emphasize that the protocols and source of the substances used are not clarified. We suspect that the design does not meet the necessary standards. However, it will only be possible to say more once the study has been published. A published study, free from commercial support or biases, by Dr Giovani Salti, Italy, investigate whether phosphatidylcholine (PPC) and sodium deoxycholate (DOC) have any clinical efficacy in chemical lipolysis and their respective roles. Both chemicals were investigated separately. It is important to note that compounded medications can differ in quality. Especially PPC exist in over 60 different raw material qualities. In Dr Salti’s observations both treatments have shown moderate and equivalent efficacy in treating localized fat, with sodium deoxycholate having a slower postoperative resolution. The study further confirms that pure DOC injections is a more difficult treatment option due to substantial pain and more pronounced side-effects, although the reduction in fat was almost insignificant (+0.37%) in the DOC treated site compared to the PPC treated side. We have considerable doubts of the benefits of using pure DOC with Lipodissolve. DOC has been aggressively marketed by a pharmaceutical company in the United States with efforts to replace PPC and to disclaim PPC. However, we need to take in consideration the necessary dosage needed with DOC to be able to achieve a better outcome than what is already achieved with current protocols, is not possible due to the acidic and toxic nature of DOC. Furthermore, private studies have shown pure DOC injections to cause intense pain with numbness to the treated area that can last over one year to resolve. Our speakers consider PPC essential to achieve the actual emulsification of the fat and to protect the cell membrane, while the action of the DOC serves to break the wall of the fat cell. In an animal study involving New Zealand rabbits, S.Klein, L. Prantl et al. of Regensburg University have demonstrated that Lipostabil can reduce fat. The results of the study have already been published. (Note: PPC and DOC are the correct chemical abbreviatians, PC and DC are often used in literature and in US) The Institute for Pharmaceutical Technology (Dr. T. Blunk, A.Seitz), S.Klein, L.Prantl et al investigated both the individual substances and the combination of active substances contained in Lipostabil on live fat cells in vitro. The study is already completed, and a publication with the results has been submitted. [Published in February 2009]. The study provides solid research evidence that phosphatidylcholine reduces subcutaneous fat through tissue and cell destruction. A study on the subject of cellulite by Prof. Nor El-Din of Cairo University is currently in progress. The goal of the study is to further improve the results of the Lipodissolve Lipolysis 3-step therapy through combination treatments. Already completed and due for publication in the near future is a study by Prof. Hanan Elkahki of Ain Shams University in Egypt on the topic of skin tightening using Lipodissolve Lipolysis. In Europe: 2 further studies have not yet started but have either been already approved by the Medical Ethics Commissions (FDA equivalent) or are due for assessment by the responsible Medical Ethics Commission. One, under Prof. Roy de Vita of Rome University, relates to the treatment of buffalo hump in HIV patients, the other, conducted by Regensburg University under the leadership of Dr. Lukas Prantl, investigates the treatment of smaller cushions of fat in vivo. In USA: Dr Alan Matarasso published an article to familiaize readers with the evolution of Lipodissolve and Mesotherapy over the past few years. Dr Matarasso, a plastic surgeon practicing in New York, is very positive and optimistic on future developments in Lipodissolve. An extensive book with years of clinical experience, international feedback, and private clinical research on Cellulite treatment, including options using phosphatidylcholine injections and ASAL protocols, has been published by Dr Gustavo Liebaschoff.
Summary Based on evidence, we can state today that the cell membrane of adipocytes is destroyed by certain substances and substance combinations; we can also state what those substances are. We can see this from the feedback of our members concerning unusual results. These take the form of questions on specific results to which we are not yet able to provide answers. However, many interesting studies and evidences have already been completed showing clearly that this treatment does provide an option for lipolysis treatments in a cosmetic medical setting. Lipodissolve is a non-commerical development, not backed by any pharmaceutical company, and is therefore depended on individual studies and feedback from members and physicians in the medical and scientific field. Although much is already understood about Lipodissolve, and the potential for an effective and positive treatment option is evident. From a clinical and scientific basis, there are still many questions that await scientific explanations: If the cell membrane is dissolved, why do different patients respond at different speeds – some already after only 1 treatment, others only after 2-5? If no reduction in volume can be determined after the 1st treatment, is this because the fat that has been released simply stays put in the region until a certain limit (dosage?) is exceeded that triggers the impulse for the loose fat to be transported away. The question also arises concerning the extent to which the substances employed, as well as destroying the membrane, also have an influence on removal of the fat through detergent effects. Sensitivity to pain varies from patient to patient. Nevertheless, the pain must be kept within a certain limit that the patient is well able to tolerate. In a very small number of patients, however, this limit is exceeded, and we have to ask ourselves why that is the case and what we can do to prevent it. Pain can easily be controlled by medication of various potency but the preference is to not use pain medications and keep the treatment as simplified and mild as possible. A further issue is the non-responder rate. Our goal must be to reduce this figure to a minimum. To this end, we need unequivocal answers to the question as to what factors are responsible for non-response: the experience of the treating physician, the choice of patient, mental or physiological factors, diagnosis and anamnesis, consistency of the fat, or simply the number of treatments given, i.e. whether these patients really are non-responders or “simply” therapy dropouts. The process of metabolization is also theoretically understood, but so far there have been no enzymatic studies on the process whatsoever. Such studies could also shed further light on many of the questions raised here. The search for new combinations of active substances is in full swing. We firmly believe that although the results are already very good, they could be improved still further, either through reduction in the side-effects or through enhanced efficacy. ASAL physician trained members have achieved surgical results through some combination efforts which have been very dramatic. To what extent the treatment intervals could be shortened through combination therapies is also a subject of discussion.