Therefore, Hexsel's study will not be included in this analysis for failure to meet the study protocol.
Another human study involved a case study of a single patient. This Brazilian study represented a case study and does not meet the protocol for inclusion in this analysis either (Rittes, 2001). As there have been no human studies in the United States to date, we must rely on studies published in other countries for our meta-analysis. A study conducted in Vienna by Karl Heinrich will be used as one of the studies to be analyzed. This was the only study that could be located involving an actual population of human subjects, as this type of research is prohibited in the U.S. At this time.
The sample population used by Heinrich consisted of 86 individuals who received a standardized series of treatments. This study suffered from significant flaws that make the results questionable. For instance, the patients received between 1-3 injections, but no analysis between these groups was reported. Heinrich reports a reduction in 100% of the test subjects. However, there was no control group. To be considered valid according to FDA protocols, the study must be double-blind with one group receiving a placebo and the other receiving the treatment. This was not done in any study found during this research.
Heinrich reported different injection sites were used in the study, but did not group these sites by location on the body. No standardized amount of phosphatidylcholine was used. Amount to be injected were determined to be "according to the needs of the patient" (Heinrich, p. 120). It is impossible to determine effective dosages with this method. Some patients received one injection and others received three injections. However, these groups were not statistically separated, but rather were combined into one group. Patients were instructed to hold their body weight steady during the course of the study, but there was no verification that they were able to do so. Due to a lack of documentation, it is not known if intentional weight reduction affected the results of the study.
Heinrich noted that average reductions in fat area were "2.41 cm" per application. However, it is not known which concentrations were the most effective. Heinrich concluded that this reduction was statistically significant to warrant a broad conclusion that phosphatidylcholine is an effective treatment for fat deposits. The study makes conflicting statements such as, "Cosmetic improvement was seen in every patient" (Heinrich, p. 122). However, there were 13 cases where no reduction in the size of the fat area, corresponding to a non-response rate of 5.06%.
Heinrich noted that patients responded to the treatment to different degrees. This might have been due to the differing dosages and number of treatment sessions. However, Heinrich did not provide sufficient information make this determination. These differences could be due to confounding variables, but without a control group for comparison, there is no way to know this. Hexsel's study in the U.S. suffers from this same flaw, but goes even further away from empirical protocol by introducing "unknown" substances into the study to cover for fact that is was not conducted according to FDA protocol.
One could combine the study results of the only two human studies conducted thus far and obtain a sample population of 104 human patients. Both researchers reported a reduction in fat in all of the respondents. If one combines these statistics, this means that approximately 13% of all respondents did not respond to the treatment.
Table 1. Combined Results 1.
Hexsel did not provide sufficient statistical data to perform any further analysis on the combined data. The problem with the synthesis of this data is that the two studies do not have enough similarities to combine in a meaningful manner. Both concluded that treatment was 100% effective. However, without a control group and stricter experimental protocol, it is difficult to validate the results of either study.
Both Heinrich and Hexsel used before the after photos as their primary presentation method reports. It does appear from the photos that the injections were effective in reducing the fat deposits. However, as we discussed previously, photos of before and after photos do not meet the criteria of a valid research study.
Figure 1. Before and After Photos from Heinrich 1.
Figure 2. Before and After Photos from Hexsel 2.
These before and after photos were used as the primary evidence of improvement. As one can see from Heinrich's photos, it is difficult to see the results in some cases. However, in the lower photos, the improvement is much more obvious. Both authors substituted this photo evidence for graphic displays of their analysis.
Numerous studies were located that supported the use of phosphatidylcholine solubolized with deoxycholate as a means to reduce unwanted body fat. The fat reducing characteristic of the compound was later used for the reduction of fat in other parts of the body as well. Phosphatidylcholine is a natural byproduct of certain bacteria (Sohlenkamp, Lopez-Lara, and Geiger, 2003). Several pathways of biosynthesis have been found in bacteria. Brucella melitensis, P. aeruginosa and Borrelia burgdorferi (Martinex-Morales, et al., 2003). Many of the studies conducted in the United States are animal studies using different species..
However, several studies were found that used antidotal evidence from South America, where the treatment is used as a low cost alternative to surgery (Takahashi, Y, Miaunuma, T., and Kishino, Y., 1982).One might note that drug testing in the U.S. is considered to be more rigorous than in other parts of the world. One must be careful when making assumptions based on evidence from another country as there testing methods might not meet the standards of those in the United States.
Research reports few side effects from treatments using phosphatidylcholine on humans for the reduction of fat. However, there is strong theoretical suggestion that there may be some more serious side effects present, such as kidney or liver damage (Hanin and Ansell, 1987). Yet, the popular media promotes the treatment as relatively safe. At this time there are insufficient studies to indicate that the compound is either safe or non-safe for human usage.
Claims in the mass media differ in tone from those in academic journals. Mass media reports tend to favor the use of phosphatidylcholine solubolized with deoxycholate as an alternative to liposuction or other surgery (Reiman, 2005). The primary use of phosphatidylcholine solubolized with deoxycholate is the cosmetic removal of fat tissue from specific areas of the body. Doctors in the United States are promoting the use of phosphatidylcholine solubolized with deoxycholate as an alternative to liposuction. They claim that it is less risky traditional surgical methods. However, the media might have jumped ahead of themselves by promoting as procedure that has been accepted in other countries, but that has not been approved for use in the United States for this purpose (Reiman, 2005).
Although research has indicated that the injections may have other medical uses, such as triglyceride metabolism, the primary use of this treatment remains cosmetic treatment of fat deposits. According to and interview with Dr. Hexsel (Reiman, 2005), the fat deposits cause "discomfort and anguish." Often the patients will choose to undergo surgery in order to alleviate these symptoms. The primary promoter of the technique in the United States is Dr. Hexsel, a former Brazilian dermatologist, now living in the United States. Dr. Hexsel is the primary source of much of the information regarding this treatment in the United States and backs up her claims with clinical research (Hexsel, 2003).
Phosphatidylcholine alters the structure of fat tissue (Reiman, 2005). According to Dr. Hexsel, the mechanism of this action has not been determined by histological or pharmacological methods. There are a number of hypotheses regarding how the mechanism works, but it cannot be definitively determined. This is one of the key criticism regarding the use of this agent in clinical use. There is evidence that phosphatidylcholine might not be the active ingredient responsible for the fat reducing action, but rather that it may be the solution into which it is desolved, deoxycholate, that is responsible for the actions (Rotunda, et al., 2006).
Typically, mass media articles have little value in an empirical study. However, in this case claims being made have filtered into mainstream society and might sway public opinion on the safety or efficacy of the treatment before the safety and efficacy can be established, according to FDA standards. Dr. Hexsel minimizes the risks discovered in other articles regarding the potential side effects and risks associated with the treatment, relying instead, on long-term use in Brazil. The same concerns cited in this research article were addressed by the Brazilian National Agency of Health Inspection (ANVISA), which regulates the use of medication in Brazil. They determined that there was insufficient evidence regarding the uncontrolled and overuse of phosphatidylcholine injections.
One of the key criticisms of Dr. Hexsel's experiment that is most cited in media articles promoting…