In the article by Peter Oehen at al., authors mentioned the lack of recent studies of the post-traumatic syndrome. The new medicine (±3,4-Methylenedioxymethamphetamine) is a way out for those who tried to cure the psychiatric disorder with the help of additional intervention. However, authors pointed that the lack of special medicines had a negative consequence that relied on high rates of uncured patients and different issues that are present during the treatment process. Moreover, drugs appeared to have an unpredicted effect on different individuals and cause different problems. Some of those drugs were even abandoned as the abuse drugs, but they were the most effective ones. On the other side, the positive emotional response was an eternal goal for all of those medicines so that people could experience happiness rather than depression and mental pain. Post-traumatic memories also had to be melded by the help of drugs sometimes. Therefore, they decided to invent something new and test that in order to find a new way to help patients with the post-traumatic syndrome. Their goal was to study the effect of MDMA (±3,4-Methylenedioxymethamphetamine) and prove results of previous research as well. The group studied the patients' set up that included the overnight stay after each intake of the MDMA for safety reasons. 12 patients with the chronic disorder were examined by the scientists, and the study performed on that basis was double-blinded. The research also embraced a comparison of active placebo patients with the low-dose of MDMA and normal-dose patients. Additional objectives were to understand either it is better for patients to go through two regular sessions or three, and to know the effectiveness of that treatment at the 1-year follow-up.
To start the study, Oehen, Traber, Widmer, and Schnyder carefully chose patients. They asked only those who attended regular sessions and reported the presence of the post traumatic syndrome. After that, a phone interview was organized to check special criteria to include or exclude patients from the study. The next step was a full diagnosis of their health and the evaluation of their medical history. Obviously, the researchers also had a psychiatric examination of the patients' current state.
Subjects of the study were chosen by specific criteria that included the rejection of specific drugs and the specific previous therapy. There were 10 female and 2 male subjects who were allowed to continue their recent treatment with their therapists but were not allowed to increase the frequency of their treatments. However, their mental state was also examined in order to understand the cause of the problem. One of the patients died of cancer during the study that had no correlation with their research so that she could not finish the 1-year follow-up.
The setup of the experiment was double-blinded, which means that therapists and patients did not know who was in the active placebo group. There were 4 patients in the active placebo group that underwent the treatment with 5-times lower dose of the MDMA. The analysis of results was also done blindly to prevent any problems with interpretation. Unfortunately, some patients with the full dose of MDMA did not show any response to the treatment after all.
Each subject was also guided by the set of 12 extra non-drug therapeutic sessions so that researchers had to make sure of the psychological well-being of the patients. Their study was also supported by different psychological methods that included the music play during sessions and other related psychological tricks to stabilize the patient's mental and physical state.
8-hours long sessions were conducted by one male and one female therapist. After each session, patients had a special meal that was designed by their loved one or related people. However, they had to stay overnight after that for safety reasons. In addition, women had a pregnancy test before the therapy to exclude some unnecessary outcomes. The safety was also provided by the specific measures of the patient's health characteristics and response to stressors like MDMA.
The study required specific systems of evaluation to get the perfect data. However, scientists predicted the need of the third session by analyzing the data of improvements. All positive changes were recorded for both active placebo and normal group of patients. Both CAPS and PDS measured were evaluated and analyzed.
After all, scientists showed that CAPS and PDS results reported the impact of placebo and normal treatment. The normal treatment appeared to be consistent and ensure better results, but the placebo group also had some improvements. Therefore, MDMA had an impact for some patients that showed the increase in their mental health. No outside drugs were used to satisfy that need in patients' life.
On the other side, therapists realized that the majority of those patients have gone through sexual assault, violence, childhood sexual harassment, and other significant negative events in their life. Therefore, they had to use some extra medications in order to relief pain and calm stresses.
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On the other side, patients reported some spontaneous reactions as the loss of appetite so that only non-significant effects occurred during the medicine intake. The physical environment was approximately stable, and scientists reported that no outside effect could have a significant impact on the recent study. Unfortunately, only slight improvements were observed in patients with non-placebo treatment compared to placebo patients so that it is hard to say for sure that MDMA has an impact here. Due to additional psychotherapeutic session, it could be possible that patients were just feeling better due to the extra care and the right choice of methods to cure them. Some patients even required more than 20 extra therapeutic meetings.
As the result, three patients did not respond to MDMA and had zero improvements with a slight CAPS increase. It was decided to increase their dose of MDMA, but no effect occurred. Active placebo patients also had zero response to the treatment, while it was possible that even a small dose of the MDMA might have an impact on their overall state.
The experiment was held in blindness so that patients would not damage results. Further research is claimed to be needed in order to understand the influence of outside effects such as culture, race, and other things. It is hard to compare all characteristics with previous results of the Mithoefer and colleagues' study because they might be based on the difference that is unclear at the recent point.
To summarize the issue, authors pointed on the significance of their study and claimed that more research is needed to prove Mithoefer’s results (Mithoefer, 2011). Over the top of that, they recognized different limitations that relied on the dose and non-treatment aspects of patients' life. The background therapy could also have an impact on the overall state of those patients. It was important to clearly understand all limitations in order to highlight goals for further potential studies. They made clear directions that could rely on the different physical and psychological environment, different dose intake, and also general characteristics of the patients. The choice of subjects and other related decision appeared to be significant to achieve the best result and improvements in disorder treatment.