Study was conducted at a medical university outside of the United States. The study design included 20 control patients (no LE) and 33 LE patients. The machine was used in specific time increments for 3 weeks. Measurements were assessed by self-done questionnaires and several mechanical measuring devices.
The control population lost an average of 1.32 pounds; the LE patients lost 1.33 pounds. The control population lost an average of 1.5 fluid ounces; the LE patients lost an average of 11.16 fluid ounces. Some fluid returned after completion of treatment. LE patients reduced leg circumference an average of .4 cms; control patients were not measured.
Only 8 patients agreed to lymphoscintigraphy - a scan involving injecting dye into the affected limb. It is not stated how many patients responded positively to the machine, but it is stated that those who did showed dramatic improvement in lymphatic function.
Now, let's review and see how we all interpreted this article -
Large scale clinical trial - how many patients are needed to be called a large scale clinical trial? How were the LE patients selected? Was it randomized or were they specifically assigned? Were the results published? Where? Peer-reviewed medical journals with known content are the best. I don't believe that 33 patients and 20 controls is a large scale clinical trial.
Since most conventional LE therapy lasts longer than 3 weeks, I don't believe this is long enough for a good sampling. Also, since the machinery was used at home, without supervision, it is difficult to know if all the participants used the machine properly, for the stated amount of time or even in the same manner as the other study members.
Weight loss is almost exactly the same for both groups. While the LE patients lost more fluid, the article states that some of the fluid returned. It does not state how much fluid, or by how many participants.
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