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Discussion

In several of the studies, sleep was but one symptom within a larger syndrome, so that in almost one fourth of the patients, fibromyalgia was the presenting symptom, while in another fourth of the studies the drug abstinence syndrome was the presenting diagnosis. In the majority, however, insomnia, alone, was the diagnosis.

A word about the study types. In the open clinical study, the patients know they are being actively treated for their insomnia, the clinicians know who is being treated, and the statistician who summarizes the study data also knows, since there is only one group of patients

In the single blind study, the patients do not know which are getting treated and which are getting sham treatment, but the clinician providing the treatment knows which are the treated patients. In the single blind study, the clinician doing the post study evaluation of the patients is often blinded to treatment conditions when he completes his evaluation. The statistician is usually blinded also, so that he is given two sets of scores to compare, and doesn’t know which of them received the treatment. This study design was used earlier on before treatment blinding devices came on stream. In such studies, the treatment was administered sub sensation threshold, in which the clinician turned up the current intensity until the patient just felt it, then turned it back down until the patient said he could no longer feel the stimulation. At that point, the clinician either left the current at that level or turned the unit off (down to, but not including the final click). Because both the patients and the statistician are both blind to the study conditions, some authors have unwittingly published this design as a double blind experiment. But that term is generally reserved for the true double blind experimental design as described next..

The double blind study, the gold standard of science, is usually confined to studies in which neither the patient or the clinician knows who is being studied. Those designs became available when a double blinding box could be inserted between the patient and the CES device. The double blinding box often had three, four or more settings in addition to a “0” setting in which current flowed freely between the CES unit and the patient. Among the other settings available, some passed current to the patient and some blocked it entirely. The clinician would begin the double blind treatment session by setting all double blinding boxes to the “0” position, would connect the patient to the CES electrodes, turn the current up slowly until the patient signaled he could just feel it, then reduce the stimulus level until the patient signaled that he could no longer feel it. At that point, the clinician set the double blinding box to one of the other settings available and left the patient on the device for 30 minutes to an hour.

Interestingly, in a good double blind experimental design, such as was the case in the majority of those reported in the table, the persons who were responsible for measuring or rating patient improvement were also blind as to whom was treated, as was the statistician who was given anonymous groups of data to analyze. Note that, in effect, that makes such studies quadruple blind, but that term is not used in science.

In the crossover design, half the patients get treated the first week or two of the study, while the other half receive sham treatment. In the second half of the study, the formerly treated patients now receive sham treatment while the formerly sham treated patients now receive treatment. If the crossover does not involve a sham treatment condition, then the crossover study is treated as an open clinical trial where all patients and staff know who is being treated at each cross of the study. That design is often referred to as a study with “wait in line” controls, in that the patients waiting to begin treatment are tested before and at the end of the waiting period before going into treatment. That is thought to control for environmental factors such as unusual stressors on the 10 O’clock news, any local dramatic weather changes, and so forth..

Interestingly we learned early on in CES work to stay clear of the cross over design in CES studies, after we discovered that the improvement begun by a week or so of CES treatment continues after treatment is stopped. That is, the patients continue to get better as time goes on following treatment. One can imagine what that does to the statistical analysis when at the end of the study, both groups have improved significantly, but the patients treated first are no longer behaving as good controls should, but are getting even better than the final treatment group is showing. Many otherwise good studies were lost early on due to that effect, and one can see in the table above that the crossover patients did the least well from CES treatment than any other groups when the statistical analysis was completed.

It is also interesting that the two studies that blinded the patients had the best results. If we omit the results obtained in the difficult cross over designed studies, the average treatment effect rises to an impressive 67%.