A Summary Look at CES Sleep Studies

Ray B. Smith, PhD

Click here to view the PDF version of this article.

Executive Summary

Eighteen studies, in which a total of 648 patients with various types of sleep disorders were treated with cranial electrotherapy stimulation (CES), were combined statistically in order to get a more confident look at the effectiveness of CES for treating this condition. While most of the studies were of the classic double blind protocol, others used either the single blind, the cross over design or were open clinical trials. The result of the analysis showed that the overall effectiveness of CES was an impressive 62% improvement, and when the studies were weighted in terms of the rigorousness of the study design employed, the improvement was found to be an even stronger 67%. The results also indicated that a wide range of sleep disorders can be expected to respond to CES treatment.

Introduction

Meta-analysis is a way of combining the results of many separate studies to see the effectiveness of a treatment when different types of patients are studied, under different study conditions, with different study protocols, and who came to the various studies with differing symptoms accompanying their sleep problem.

The goal of clinical studies is always to first test the effectiveness of a potential treatment and secondly to discover which patients the treatment may be most effective in treating. Meta-analysis has the effect of allowing us to essentially study a larger number of patients than can usually be assembled for a single study, and the larger the combined study sample, the greater is the confidence that can be placed in the study outcome: that the study findings are true and accurate. Also, the more diverse the study group is in the combined sample, the more confident can we be in generalizing the study outcome to larger groups of people outside the study. That is, it increases the range of potential types of insomnia patients that we can predict will be effectively treated with CES.

In the table below is a summary of 18 studies that were combined into the meta-analysis reported on here.

CES Sleep Studies Completed Over the Past 43 Years


Study Design

Zr Scorea

No. Subjects

Measure Usedb

Reference

Double Blind

.388

27

EEG, Clinician’s Rating

1

Double Blind

.908

30

Self Rating Scale

2

Double Blind

.875

60

Self Rating Scale

3

Double Blind

.590

18

Clinician’s Rating

4

Double Blind

.448

21

Self Rating Scale

5

Double Blind

1.127

22

Clinician’s Rating

6

Double Blind

1.528

10

EEG, Self Rating Scale

7

Totals

5.864

188

 

 

Average

.838

 

 

 

Effect Sizec

r = .69

 

 

 

Single Blind

1.650

28

PRN Sleep Meds

8

Single Blind

.448

28

Clinician’s Rating

9

Single Blind

.693

18

Clinician’s Rating

10

Totals

2.791

74

 

 

Average

.930

 

 

 

Effect Size

r =.73

 

 

 

Crossover

.678

19

Clinician’s Rating

11

Crossover

.343

34

Self Rating Scale

12

Crossover

.343

34

Clinician’s Rating

13

Totals

1.364

87

 

 

Average

.455

 

 

 

Effect Size

r =.43

 

 

 

Open Clinical

.511

28

Clinician’s Rating

14

Open Clinical

.633

186

Self Rating Scale

15

Open Clinical

.549

9

Clinician’s Rating

16

Open Clinical

1.071

20

Self Rating Scale

17

Open Clinical

.590

56

Self Rating Scale

18

Totals

3.335

299

 

 

Average

.671

 

 

 

Effect Size

r =.59

 

 

 

SUMMARY, ALL SLEEP STUDIES REPORTED ABOVE

Grand Total

13.354

648

 

 

Average

.724

 

 

 

Total Effect Size

r =.62

 

 

 

a Since percent improvement scores can not legally be averaged, they are converted into Zr scores, averaged, and then converted back to percent improvement (effect size.)

b Most of the rating scales, both by the patients and the clinicians were of published reliability and validity, though some were Likert Scales with face validity and assumed test-retest reliability, since the error variance within each patient was assumed to be relatively constant, and therefore carry over between pre and post testing.

c Effect size, here, is a statistician’s basic estimate of the overall percentage improvement by the patients as a result of the treatment

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%.

Safety

It is interesting to note that not one problem from negative side effects has ever been found in any published CES sleep study. None of the patients have raided the fridge during the night and gained weight. None have complained of grogginess the next day. None have complained of headaches or a foggy feeling at the office the next day. When asked, CES patients have reported instead feeling more rested, more alert, and less tired the day following treatment.

One interesting clinical detail we learned early on is that patients who have not been sleeping well when they enter a study – most of them, by definition – sometimes make up for lost REM sleep during CES treatment and have the most vivid, most colorful dreams they have ever had. We learned to warn study participants of this in advance, since some earlier patients associated this with incipient schizophrenia or some other serious mental condition. Once alerted to the possibility they have always looked forward to the effect with real anticipation.

References

1.         Hozumi, S., H. Hori, M. Okawa, Y. Hishikawa, and K. Sato (1996). Favorable effect of transcranial electrostimulation on behavior disorders in elderly patients with dementia: a double-blind study. International Journal of Neuroscience. 88:1-10.

2.         Lichtbroun, A.S., Mei-Ming Raicer, R.B. Smith (1999) The use of Cranial Electrotherapy Stimulation in the Treatment of Fibromyalgia. Presented at the 15th Annual International Symposium on Acupuncture and Electro-Therapeutics., Columbia University, New York City, October 21-24.

3.         Lichtbroun A.S., Mei-Ming Raicer, R.B. Smith (2001) The treatment of fibromyalgia with cranial electrotherapy stimulation. Journal of Clinical Rheumatology 7(23):72-78.

4.         Patterson, M., N.V. Flood, and L. Patterson (1992) Neuroelectric therapy (NET) in addiction detoxification.Subtle Energies 3(3):1-22.

5.         Philip P., J. Demotes-Mainard, M. Bourgeois, and J.D. Vincent (1991) Efficiency of transcranial electrostimulation on anxiety and insomnia symptoms during a washout period in depressed patients; a double-blind study. Biological Psychiatry. 29:451-456.

6.         Rosenthal, S.H. (1972) Electrosleep: A double-blind clinical study. Biological Psychiatry. 49(2)179-185.

7.         Weiss, M.F. (1973) The treatment of insomnia through use of electrosleep: an EEG study. Journal of Nervous and Mental Disease 157(2):108-120.

8.         Gomez, E., and A.R. Mikhail (1978) Treatment of methadone withdrawal with cerebral electrotherapy (electrosleep) British Journal Psychiatry. 134:111-113.

9.         Hearst, E.D., C.R. Coninger, E.L. Crews, and R.J. Cadoret (1974) Electrosleep therapy: A double-blind trial.Archives of General Psychiatry. 30(4):463-466.

10.      Rosenthal S.H., and N.L. Wulfsohn (1970) Studies of electrosleep with active and simulated treatment.Current Therapeutic Research. 12(3):126-130.

11.      Feighner, J.P., S.L. Brown, and J.E. Olivier (1973) Electrosleep therapy: a controlled double-blind study.Journal of Nervous and Mental Disease 157(2):121-128.

12.      Moore, J.A., C.S. Mellor, K.F. Standage, and H. Strong (1975) A double-blind study of electrosleep for anxiety and insomnia. Biological Psychiatry. 10(1):59-63.

13.      Straus, B., A. Elkind, and C.A. Bodian (1964) Electrical induction of sleep. American Journal of Medical Sciences. 248:514-520.

14.      Flemenbaum A. (1974) Cerebral electrotherapy (electrosleep): An open clinical study with a six month follow-up. Psychosomatics. 15(1):20-24

15.      Patterson, M.A., J. Firth, and R. Gardiner (1984) Treatment of drug, alcohol and nicotine addiction by neuroelectric therapy: Analysis of results over 7 years. Journal of Bioelectricity. 3(1,2):193-221.

16.      Rosenthal, S.H. and N.L. Wulfsohn (1970) Electrosleep: a preliminary communication Journal of Nervous and Mental Disease. 151(2) 146-151.

17.      Tyres, S., and R.B., Smith (2001) Treatment of fibromyalgia with cranial electrotherapy stimulation.Original Internist. 8(3):15-17.

18.      Tyres, S., and R.B. Smith (2001) A comparison of cranial electrotherapy stimulation alone or with chiropractic therapies in the treatment of fibromyalgia. The American Chiropractor. 23(2):39-41. rats. Science

Click here to return to the main Research page.