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Anxiety / Stress

1. Bianco, Faust. The efficacy of cranial electrotherapy stimulation (CES) for the relief of anxiety and depression among polysubstance abusers in chemical dependency treatment. Ph.D. dissertation, The University of Tulsa, 1994.

Device: LB 2000, 100 Hz, 2mS, <1.5 mA, electrodes behind the ears at the mastoid process

Prior to clinical trials the literature of CES for chemical dependency was subjected to meta-analysis. Initially 180 studies on CES from 1964 through 1987 were reviewed. 8 studies provided the necessary information to calculate means and standard deviations for meta-analysis. The largest effect sizes pertained to the primary withdrawal symptoms of drug use, drug craving, and anxiety specifically among methodone users. In addition the results showed effect sizes beyond that of a placebo effect in several studies relating to anxiety as a secondary withdrawal symptom. However, some studies that considered anxiety as a secondary withdrawal symptom were below the placebo effect level. The analysis displayed an average effect size of 0.940 SD units when comparing CES plus a standard treatment to a CES sham plus a standard treatment, and an effect size of 1.68 when comparing CES plus a standard treatment to standard treatments alone. The average effect sizes for the within groups studies were 0.534 SD units for CES treatments (P<.10), 0.391 SD units for CES sham treatment plus the standard treatment (P<..05) and, 0.171 SD units for the standard treatment alone. The range of the effect sizes for the within group studies were between 0.25 and 0.83 units. The authors concluded that the statistical significance of the within group analysis is quite impressive. To put this into perspective, the average effect size of all psychotherapies are between 0.70 and 0.80 SD units when compared to no treatment (roughly 75% of the pts who receive psychotherapy improve in their condition relative to controls who receive no therapy). The average effect size for non-specific factors or placebo effects among psychotherapies as compared to wait-list controls is about 0.40 SD units.

After achieving IRB approval and informed consent, 65 polysubstance abusers with no history of psychosis were recruited from the Oklahoma Department of Human Services and split into 3 groups for this double-blind study using blinding boxes. Pts were at a lock-in unit at the Chemical Dependency Unit. 36 subjects (18 CES, 16 controls, and 5 sham CES) left AMA. 20 males and 9 females from 20 to 49 years old (mean of 31.3) completed the full course of 45 minutes daily for 6 - 14 days. 9 pts in group 1 (31%) were non-CES controls receiving standard treatment, 9 pts (31%) in group 2 received simulated CES plus standard treatment, 11 pts (38%) received active CES plus standard treatment. The revised Beck Anxiety and Depression Inventories, and the Symptom Check List of the Himmelsbach Scale were administered, along with an attention placebo control interview, and observer-rated measures employed by 2 researchers: the Structured Interview Guide for the Hamilton Anxiety and Depression Scales. In order to achieve a power of .8 (beta = .2), alpha was calculated at .05, effect size at .60, and N at 30 (10 per group). Scheffe tests were performed to determine the significance between the means of each of the 3 groups. There was no significant difference between variables at pretest. Analysis of variance (ANOVA) revealed significant post test group differences. Hamilton Anxiety means for CES pretest was 24.44 9.22 to a post test of 7.09 3.21, for sham CES pretest was 22.56 9.95 and post test was 15.67 7.92, and for controls pretest was 20.56 6.21 and posttest was 16.89 9.06. Scheffe post hoc tests for Hamilton was significant between the CES and controls (P<.05) and between the CES and sham (P<.05), but not the sham and control (P>.05) as measured by the observer ratings. Beck Anxiety post test means were not significant, means for CES pretest was 22.91 10.99 to a post test of 5.27 5.23, for sham CES pretest was 28.78 15.21 and post test was 9.33 7.97, and for controls pretest was 21.44 9.89 and posttest was 9.78 12.17. Although the self reports showed no statistical differences between groups, there was a trend towards significance. The study did not control for medications. The author concluded that the active CES, when combined with the normal treatment regimen given at the treatment facilities was more effective in reducing anxiety and depression than the normal treatment regimen alone and the sham CES plus normal treatment regimen. Thus, the anticipated results regarding CES was supported, while the anticipated results regarding placebo effect was not supported. No side effects were reported.

3. Briones, David F. and Rosenthal, Saul H. Changes in urinary free catecholamine and 17ketosteroids with cerebral electrotherapy (electrosleep). Diseases of the Nervous System. 34:57-58, 1973.

Device: 100 Hz, 1 mS, positive pulses, cathodes over orbits, anodes over mastoids

7 male pts from 22 to 37 years old were given 30 min. of CES for 5 days. 4 were "normal" volunteers and 3 were hospitalized psychiatric pts with neurotic anxiety and depression. 1 alcoholic was dropped because his pre-treatment reading was far outside the range of normal of the other pts. Total free catecholamines were measured by bio-rad column (normal is 0 - 115 microgram per 24 hours) prior to and after 5 CES treatments. Pre and Posttesting means revealed a 23.9 to 47.4 microgram increase in 24 hour urinary free catecholamine across all patients, with the greatest rise in 2 anxiety pts and 1 volunteer who was slightly symptomatic. The average gain in 24 hour urinary 17 ketosteroids was 6.9 mgs, pretreatment mean was 18.5 and post treatment was 25.4 (normal is 10 to 24 mgs per 24 hours). 2 pts had insignificantly reduced levels. The authors suggested that these findings probably reflected change at the hypothalamic or pituitary level in the brain. No side effects were reported.

11. Feighner, John P., Brown, Stuart L., and Olivier, J.Edward. Electrosleep therapy: A controlled double blind study. Journal of Nervous and Mental Disease. 157:121128, 1973.

Device: Electrosone 50: 100 Hz, 1 mS, 100 - 250 µA, cathodes over orbits, anodes over mastoids

23 long term psychiatric pts who had been ill a minimum of 2 years with prominent anxiety, depression, and insomnia, and who did not respond to psychotherapy, psychopharmacology, and ECT in 4 cases, were given 2 weeks of CES and 2 weeks of sham CES in a double-blind crossover design. Treatments were for 30 minutes daily, Monday through Friday. Analyses were done by the 2-tailed Mann-Whitney U test. Scores on the Zung self rating depression scale improved significantly in both groups, but only after 10 days of active treatment, and never during the sham phase of treatment. Actively treated pts also improved significantly on other target symptoms, particularly anxiety and insomnia. The CES-sham group means based on global ratings of anxiety was 4.5 on day 1, 2.5 on day 15 (P<.02), and 3.4 on day 26 (P<.10), and the sham-CES group was 4.4 on day 1, 4.0 on day 15 (not significant), and 3.2 on day 26 (P<.05). 7 of 8 pts who exhibited significant improvement relapsed within the first month after treatment. 4 of 6 long term depressed pts were dropped from the study because of massive worsening of depressive symptoms, 2 of whom exhibited suicidal ideation. The remaining 2 depressed pts had an unremarkable course, but remained in the study. 3 pts benefited more from this therapy than any previous extensive psychiatric care. No side effects were reported.

12. Flemenbaum, A. Cerebral Electrotherapy (Electrosleep): An open clinical study with a six month follow-up. Psychosomatics. 15:2024, 1974.

Device: Electrosone 50: 100 Hz, 1 mS, cathodes over orbits, anodes over mastoids

28 anxiety, depression, and insomnia outpatients who had been symptomatic for at least 3 - 4 years and unresponsive to extensive previous treatments were divided into 3 groups and given 5, 30 minute CES treatments. 3 pts left the study, 1 due to complaints of worsening of her nervousness after 3 treatments, 1 left after 4 treatments and could not be located, another died of an overdose 3 months after the treatments, but before the researchers could determine why he left the study. Group I pts (N=14) had no other serious complicating psychiatric disorders, Group II (N = 7) was comprised of pts whose target symptoms were secondary to physical, somatic difficulties, and group III (N = 4) had a history of psychotic episodes. All pts were on psychotropic drugs. Only historical controls were employed in this study. The Zung depression scale and clinical global impressions (1 - 7 scale) were employed pretreatment, and for follow-up at weeks 6, 16, and 24. By the 6th week the pathology for the 3 groups seemed to be reduced to approximately equal levels. An insignificant trend towards worsening was seen by the 24th week. Comparison of the final results with the pretreatment ratings shows improvement statistically significant at the .01 level. The author noted that at the end of the study 12 of the 25 pts were much, or very much improved, 8 had shown some effect, though minimal, and 5 were not improved or had become worse. Some of these chronic pts were practically asymptomatic, other psychophysiological symptoms like asthma and blood pressure had become controllable by regular medical treatment, and/or their target symptoms showed complete or nearly complete remission. Most remarkable of all, these changes occurred in pts who previously had not responded to extensive treatment. Although about 50% of the pts showed minimal improvement, or none at all, those who had beneficial results maintained them throughout the 6 month follow-up. The author added that side effects are virtually nonexistent. It was concluded that this treatment seems to be an excellent modality for pts. Its safety and economy recommend its freer trial.

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14. Frankel, Bernard L., Buchbinder, Rona, and Snyder, Frederick. Ineffectiveness of electrosleep in chronic primary insomnia. Archives of General Psychiatry. 29:563568, 1973.

Device: Electrosone 50: 100 or 15 Hz, 1 mS, 100 - 700 µA, square waves, cathodes over orbits, anodes over mastoids

17 insomniacs referred from local physicians with an average duration of symptoms for almost 20 years were given 15, 45 minute CES treatments Monday through Friday at 100 or 15 Hz, a week off, then 15 more treatments at 15 or 100 Hz in a crossover design with each group split in half. Both the 100 Hz and 15 Hz groups appeared to be combined for the 3rd week and 7th week measurements. There were no changes in the EEG, sleep onset time, sleep efficiency, total number and duration of awakenings, etc. The Taylor Manifest Anxiety Scale did not change (Pretreatment means of 21.0 9.3, after 15 treatments 19.9 10.1, after 30 treatments 19.2 10.1, at 1 month follow-up 20.5 9.6) nor did the Zung depression scale. 17hydroxycorticosteroid levels did not change. All of these changes have been found in other controlled studies, so Frankel's findings stand virtually alone in the literature. Note: From the write up, it is not clear that the authors did not combine the two groups for the final statistical analysis, even though Frankel noted in his introduction the comment made by Obrosov in the European literature that hertz of different levels should not be mixed when treating the same patient, as was done in this study, since beneficial effects can be eliminated or canceled out. We also now know that beneficial gains from CES treatment tend to increase following the initial treatment. Such effect, when present, would nullify the expected effect in crossover designs involving sham (or other) treatment. A commonly reported innocuous side effect was mild blurring of vision lasting 15 to 30 minutes which resulted from the sustained mechanical pressure of the electrodes on the eyeballs.

15. Gibson, Thomas H., O'Hare, Donald E. Cranial application of low level transcranial electrotherapy vs. relaxation instruction in anxious patients. American Journal of Electromedicine. 4(1):18-21, 1987. Also doctoral dissertation, California School of Professional Psychology, 1983.

Device: Alpha-Stim 350, 0.5 Hz, 50% duty cycle, 50 µA, biphasic rectangular waves, ear clip electrodes

In this single blind study, 64 volunteer subjects responded to newspaper advertisements, 32 males and 32 females, ranging in age from 22 to 55 years old (mean = 36.64), who scored 50 or above on the State/Trait Anxiety Inventory (STAI), completed informed consent and were randomly assigned to 20 minutes relaxation training (RT) on audio tape only, Alpha-Stim CES only, RT plus CES, or to a control group which listened to a neutral audio tape and received sham CES. There were 8 males plus 8 females in each group. 9 of the original 73 subjects were dropped from the study due to failure to meet the study criteria or failure to show up. Treatment time was 1, 20 minute session, and relaxation was measured by frontalis muscle EMG and a post treatment STAI. Subjects responded on the STAI significantly (P<.001) better than controls and equally to either RT alone with a means of 52.88 pretest to 32.19 post, CES alone: 52.31 pre to 30.06 post, or both RT and CES together: 53.69 pre to 30.44 post. The control group only dropped from 53.25 to 51.94. The EMG trend paralleled the STAI with means of 15.64 to 11.10 post test in the RT alone, 17.12 to 11.17 in the CES alone, 17.41 to 9.77 in the combined group, and only 14.14 to 14.47 in the control group. Analysis of variance for EMG scores showed highly significant F-ratios for the time variance term and the group X time interaction term. Results were further verified by Turkey tests for pair-wise comparisons. The authors concluded that the results of this study indicates that the Alpha-Stim may be a useful adjunctive therapy for short term treatment of symptoms of anxiety. The treatment appears to have about the same efficacy as the same amount of time of relaxation instructions, but is easier to administer. No side effects were reported.

17. Gomez, Evaristo and Mikhail, Adib R. Treatment of methadone withdrawal with cerebral electrotherapy (electrosleep). British Journal of Psychiatry (London). 134:111113, 1979. Also in Gomez, Evaristo and Mikhail, Adib R. Treatment of methadone withdrawal with cerebral electrotherapy (electrosleep). Paper presented at the annual meeting of the American Psychiatric Association, Detroit, 1974.

Device: 100 Hz, 2 mS, 0.4 - 1.3 mA, electrodes from the forehead to mastoids

For this single blind study, 28 male heroin addicts, between 18 and 60 years old, undergoing methadone detoxification were selected on the basis of having severe anxiety as measured by the Hamilton Anxiety Scale and Taylor Manifest Anxiety Scale, difficulties in sleeping, willingness to participate in the study for at least 2 weeks in a locked ward, and agreement not to take any tranquilizers or hypnotics while in the study. This was a self medicated withdrawal study in which methadone was given as requested by the patients as needed to control their withdrawal symptoms. The pts were then randomly divided into a CES treatment group (N = 14) who were taking 20 - 60 mg of methadone/day, a placebo group (N = 7) taking 30 to 40 mg/day, and a waiting in line control group (N = 7) taking 25 - 40 mg/day. CES or sham CES was given for 10 days, Monday through Friday, 30 minutes per day. After 6 - 8 CES treatments, methadone intake was 0 in 9 pts, with another 1 at 0 after 10 treatments. 3 were taking 10 - 15 mg after the 10 treatments. The other active pt dropped out of the study after the first treatment. The pts reported feeling restful and having a general feeling of well-being, their sleep was good and undisturbed after 3 treatments. The Taylor Manifest Anxiety Scale scores also came down significantly in the CES group with 7 pts dropping from a mean of 31 before CES to 20 after 10 days (normal is 8 - 18), while the others showed a 25 - 50% reduction. Sham CES pts showed an insignificant change in the mean TMAS scores from 29 to 27. The methadone intake did not change in 4 sham CES pts, and only dropped 5 - 10 mg in the other 3. These pts were anxious and depressed, and complained of difficulty sleeping and somatic problems. The 7 controls also did not do well, TMAS scores increased in 2 cases, was the same in 1, and only decreased 1 - 2 points after 10 days in the remainder. The methadone intake was the same in 3 controls, and decreased in the other 4 after 10 days. These pts were anxious, had difficulty sleeping. HAS scores were also diminished in the CES group but not the placebo or controls. It was noted that with a higher current, the pt felt uncomfortable, but there were no skin burns.

19. Hearst, E.D., Cloninger, R., Crews, E.L. and Cadoret, R.J. Electrosleep therapy: A doubleblind trial. Archives of General Psychiatry. 30:46366, 1974.

Device, Neurotone 101, 100 Hz, 2 mS, alternating and direct current, forehead to mastoid electrodes

28 psychiatric outpatients on medication and undergoing psychotherapy were divided into 4 groups, 22 received CES treatments or sham treatments using alternating current, and 6 more were divided into an alternating or direct current, or sham treatment group. A total of 14 received actual CES. All had 5, 30 minute treatments or sham treatments. Assessment was by the National Institute of Mental Health self rating scale (SRSS) and by physician and pt global ratings for sleep, anxiety, depression, and overall status. The groups did not differ substantially in the number of days they were symptomatic following treatment. However, the pts receiving active treatment were confirmed by Fisher's exact test for 2 x 2 contingency tables to be significantly (P<.05) less depressed than the sham group (79% vs. 21%). Other positive findings showed a trend (P<.10) towards improvements in the CES group over the sham in feeling lonely (64% vs. 21%), having feelings easily hurt (64% vs. 21%), and difficulty falling or staying asleep (71% vs. 29%). Physicians and pts global ratings showed an insignificant tendency towards improvement on the last day of treatment. There was no significant differences between the groups 2 weeks post treatment, and only 2 pts continued improvement, 1 relapsed after 1 month, while another relapsed in 2 months. A third pt showed marked improvement for 1 week, relapsed for 3 weeks, then responded again to biweekly treatments for 2 months. All 3 pts with sustained improvement had active treatment. Self rating scales did not indicate a significant improvement for anxiety, insomnia, or somatic complaints. No pt with primary affective disorder was adversely affected by CES. The authors concluded that either CES may transiently increase the pts tolerance of their depressive symptoms without significantly altering symptom frequency, or that it has a transient mild effect on both symptom frequency and intensity without any appreciable change on the natural course of the illness. There was no report of side effects.

20. Heffernan, Michael. The effect of a single cranial electrotherapy stimulation on multiple stress measures. The Townsend Letter for Doctors and Patients, 147:60-64, October, 1995.

Device: Alpha-Stim 100, 0.5 Hz, 50% duty cycle, 100 µA, biphasic rectangular wave, ear clip electrodes

20 subjects complaining of generalized stress symptoms for at least 1 year, all of whom failed to respond to medication, were selected from the authors private practice and divided into real Alpha-Stim CES (N = 10) and placebo treatment (N = 10) in this double-blind study using double-blinding boxes. None of the treatment or placebo subjects perceived any sensation. Measurements of finger temperature, heart rate, trapezius electromyogram, and brain capacitance were tested before, after, and 1 week following a single 20 minute treatment session. Analysis was performed on each of the dependent variables using the paired t-test. All subjects in the CES treatment group showed immediate declines in EMG and heart rates with simultaneous increases in finger temperature and capacitance. These changes were all significant at the .05 level of confidence with confirmation of the experimental hypothesis that CES would reduce stress physiological measures. The results with CES on EMG, HR, and finger temperature were significant at the .025 level. The placebo group showed small insignificant fluctuations up and down in all dependent measures. 1 week follow-up measures in the CES group showed carryover effects in EMG and HR, but were not significant at the .05 level for finger temperature or capacitance. The author concluded that the psychophysiological reduction in stress response found in this study may be the probable correlate and necessary preconditions for noted anxiety reduction frequently found in the CES literature. No side effects were reported.

21. Henderson, James L., Church, Dixie Jane, and Lee, A. Using electrosleep therapy with university counseling center clients: A preliminary study. Paper presented at both the Southeastern Psychological Association, February, 1973 and the Rocky Mountain Psychological Association, May, 1973.

45 university students were referred to the student counseling center with various anxietytype complaints. The study was completed with historical controls only. Pts were treated with CES an average of 14 days. Significant changes were found on the MMPI, Zung depression scale, Diagnostic Adjective Check List (DACL), systolic and diastolic blood pressure and pulse rates. Abstract courtesy of Ray B. Smith, Ph.D., M.P.A.

24. Jemelka, Ron. Cerebral electrotherapy and anxiety reduction. Masters thesis, Stephan F. Austin State University, May, 1975.

28 male pts in a psychiatric treatment center of the Texas Department of Corrections were divided into an active and a sham CES group, with CES applied for 30 minutes for 7 days. Pts receiving CES improved significantly on the Anxiety Scale Score and on the Anxiety Index Score when compared with the sham treated controls. Abstract courtesy of Ray B. Smith, Ph.D., M.P.A.

26. Krupitsky, E.M., Burakov, G.B., Karandashova, JaS., et al. The administration of transcranial electric treatment for affective disturbances therapy in alcoholic patients. Drug and Alcohol Dependence, 27:1-6, 1991.

Device: 70 - 80 Hz, 4 - 7 mA, square waves, cathodes on forehead, anodes behind ears

20 alcoholic pts with affective disorders who volunteered were equally divided by chance into 2 groups for this double-blind, placebo controlled study. All pts were abstinent for at least 3 weeks, so their affective disturbances were not alcohol withdrawal syndrome (AWS) symptoms. They were all weakly or moderately depressed, and exhibited a high level of reactive and personal anxiety. The CES group (N = 10) had 20 treatments over a 4 week period, and the placebo group (N = 10) were given a weak current, but otherwise the same conditions. There was considerable improvement in the CES group on the MMPI depression scale and Zung's test. Reactive anxiety of the active CES group by Spielberger (pre test mean of 51.7 3.14 to post test 30.6 2.15, P<.05), Personal anxiety by Speilberger (pre test mean of 51.4 3.09 to post test 13.8 5.15, P<.05), and anxiety by Taylor's scale (pre test mean of 26.6 1.79 to post test 14.0 3.63, P<.01) were all reliably diminished. The placebo group demonstrated a tendency toward a definite aggravation of the state and some increase of affective disturbance on all tests: Spielberger reactive anxiety (pre test mean of 51.7 2.81 to post test 63.0 3.44, P<.05), personal anxiety (pre test mean of 66.9 2.71 to post test 51.2 4.93), Taylor anxiety (pre test mean of 20.5 1.99 to post test 28.0 3.21). The activity of MAO-B in blood platelets and GABA concentration in blood were increased in the CES group after 20 treatments. The concentration of serotonin, dopamine, and -endorphin in blood were not substantially changed. The changes of biochemical indices were not registered in the control group where the tendency towards decreased MAO-B and GABA level in blood corresponded with a definite increase of affective disturbances at the end of the course. EEG analysis showed that the latency of -rhythm appearance in occipital leads after closing eyes were decreased after CES, whereas in the control group it was practically not changed and considerably exceeded the indices of the CES group. The CES pts became more tranquil, well-balanced, active, and their mood was improved. The authors concluded that CES is an effective non-pharmacological method to treat affective disturbances (depression, anxieties) in alcoholic pts in remission. They also stated that CES was not accompanied by side effects nor complications and was well tolerated by the pts, and that CES tends to avoid side effects and complications sometimes observed in antidepressant therapy and tranquilizers.

27. Levitt, Eugene A., James, Norman McI, and Flavell, Philippa. A clinical trial of electrosleep therapy with a psychiatric inpatient sample. Australia and New Zealand Journal of Psychiatry. 9:287290, 1975.

Device: Dormed: 100 Hz, 50 - 200 µA, square pulses, cathodes over orbits, anodes over mastoids

This is a double-blind study of 13 chronically distressed pts, 6 male and 7 female, 23 - 63 years old, in an inpatient psychiatric hospital (length of stay, 2 months to 16 years). All were on antidepressant and/or tranquilizing medication, with 9 on sleep medication. They were diagnosed with schizophrenia (N = 4), alcoholism (N = 2), psychotic depression (N = 2), and mixed neurosis and disorders of personality (N = 5). 5 received CES treatment and 6 received simulated treatment for 10 sessions over 2 weeks, 30 minutes per session. Instrument malfunction made it impossible to complete the treatment program with 2 active CES pts. There were no significant changes between groups on the Taylor Manifest Anxiety Scale or the Zung SelfRating Depression Scale. Clinician ratings of anxiety and insomnia were "found to agree to an extremely limited extent" with results on the anxiety and depression scales. 4 of 5 of the active CES pts showed a decrease on Taylor, while the 5th remained constant, for an average drop of 4.4. 5 pts improved with placebo while the remaining 1 got worse, an average drop of 3.2. Therapist ratings of anxiety showed 2 pts to be improved, 2 unchanged, and 1 worse following active CES. Of those receiving sham treatment, 1 was rated improved, 2 unchanged, and 3 more anxious. The Zung depression scores for 2 CES pts showed improvement while the other 3 showed an increase. 5 of 6 sham pts showed a decrease in depression, and 1 was more depressed. Clinician ratings of depression noted improvement in 3, no change in 1, and increased depression in 1 receiving active CES, while 3 sham CES pts improved, and 3 were unchanged. The authors noted that since nightly sedatives were administered the fact of a nonsignificant increase in sleep was hardly surprising. Subjects in both groups reported slight blurring of vision lasting 30 to 45 minutes following treatments. This supports the findings of other researchers that the blurred vision effect is mechanically caused by pressure of eye electrodes, and not electrical current.

29. McKenzie, Richard E., Rosenthal, Saul H., and Driessner, Jerry S. Some psychophysiologic effects of electrical transcranial stimulation (electrosleep). American Psychiatric Association, Scientific Proceedings Summary. 1971. Also in The Nervous System and Electric Currents, Wulfsohn, N.L., and Sances, A. (Eds.) Plenum: New York, Pp. 163167, 1976.

Device: Electrosone 50: 100 Hz, 1mS, 0.1 - 1.9 mA, cathodes over orbits, anodes over mastoids

8 psychiatric pts with a clinical history of chronic anxiety with depression and insomnia, and 4 normal staff "controls" were given 1, 30 minute CES treatment a day for 5 days. Psychophysiological measurements were made on day 1 and day 5. All pts had slower EEG frequencies with increased amplitude in the frontotemporal areas following CES. 7 pts showed increased quality and quantity of alpha with increased amplitude in the occipitalparietal leads. The submental EMG showed increased relaxation but was too variable to be a reliable measure. The skin potential recordings (SPR) revealed a definite overall state of relaxation as the treatments progressed from an average of 24.55 millivolts to an average level of 12.75. Normal controls were comparable with the pts exhibiting a drop in SPR's of 25.29 to 5.76. The subjective reports of the normal subjects were unexpected. Only a mild sedative effect was expected. However, 3 of the 4 normals reported an activation or alerting effect. 1 of these reported hyperalertness with hyperirritability. A second experienced a helpful increase in energy and another a feeling of alertness. 2 controls experienced feelings of euphoria with periods of silliness or giddiness, along with this they felt a lack of worry about real situational problems. In fact, they were worried over not being able to worry. All of these effects dissipated rather rapidly in 24 - 48 hours. The authors noted that blurring of vision due to eye electrode pressure was fairly uniform over the small control sample and was not especially uncomfortable.

31. Magora, F., Beller, A., Assael, M.I., Askenazi, A. Some aspects of electrical sleep and its therapeutic value. In Wageneder, F.M. and St. Schuy (Eds). Electrotherapeutic Sleep and Electroanaesthesia. Excerpta Medica Foundation, International Congress Series No. 136. Amsterdam, Pages 129-135, 1967.

Device: 30 - 40 Hz, 2 mS, 2 mA, forehead to occipital fossa electrodes

20 hospitalized pts suffering from long-lasting insomnia with anxiety, obsessive and compulsive reactions, morphine and barbiturate addiction and involutional depression were given 2 - 4 CES treatments weekly for 2 - 3 hours a day for a total of 10 - 20 treatments. 5 of the 20 showed no improvement, 11 had sedative effects, and 4 had hypnotic effects. The 15 responders all had normal restoration of their sleep rhythm as measured by EEG. Parallel with the return to a normal sleep pattern, all the other psychiatric signs: anxiety, depression, agitation, delusions, abstinence syndrome, improved so that all these pts were able to leave the hospital. Follow-up has continued for 8 - 12 months after treatment and has revealed no relapse.

Also 9 children (aged 5 - 15 years) suffering from severe, long-lasting bronchial asthma, resistant to conventional treatment, including steroids, were given 3 - 24 (Av. 15) CES treatments once a week for 1 - 2 hours. The asthmatic attacks stopped completely in 3 children and 4 months later the children felt well without taking any drugs. 2 children showed objective improvement, no wheezes were found on examination and, the frequency and severity of wheezing spells were diminished. 1 child showed slight improvement, 2 did not respond at all. None suffered an asthmatic attack for 24 hours following CES. Placebo conditions did not cause any improvement. The authors concluded that it appears that CES may be an adjunct to the treatment of asthma in children. Because of the selection for trial of the most severe cases available to us, resistant to any other known treatment, even slight results are encouraging. It was also noted that no ill-effects were noted on prolonged and repeated observations in dogs and in humans.

35. Matteson, M.T., and Ivancevich, J.M. An exploratory investigation of CES as an employee stress management technique. Journal of Health and Human Resource Administration. 9:93109, 1986.

Device: RelaxPak, 100 Hz, 2 mS, <1 mA, electrodes behind ears

40 members of an executive MBA program at the University of Houston, employed in middle management positions in various sized corporations, volunteered as CES subjects. 22 similar subjects served as unmatched controls. 8 of the CES subjects were unable to complete the treatment including 4 who left the study early due to complaints of headache. The final number of active CES subjects was therefore 32. The subjects ranged in age from 28 - 48. CES was given 30 - 40 minutes per day for 14 days. Measures employed were a stress questionnaire developed by the U.H. faculty, the POMS, and the STAI. Significant differences (between P<.05 and P<.001, two-tailed test) were found on all the measures among the CES subjects whereas the control group of 22 showed no meaningful change (positive or negative) on any of the variables. A follow up measure 2 weeks post study found that 11 of the 13 variables were still significantly improved in the treatment group, only the Reeder stress measure and the vigor-activity scale of the POMS failed to maintain a significant difference two weeks after CES was discontinued. State anxiety went from a mean of 42.84 pretest to 36.47 post-test (P<.001) to 39.28 on follow-up (P<.05). Trait anxiety went from a mean of 42.41 pretest to 40.06 post-test (P<.01) to 40.38 on follow-up (P<.05). The POMS Tension-Anxiety scale went from a mean of 16.22 pretest to 10.74 post-test (P<.001) to 10.59 on follow-up (P<.001), the Depression-Dejection scale went from a mean of 12.22 pretest to 8.47 post-test (P<.001) to 8.06 on follow-up (P<.01), the Anger-Hostility scale went from a mean of 16.59 pretest to 12.22 post-test to 11.41 on follow-up (P<.001), the Fatigue-Inertia scale went from a mean of 12.69 pretest to 9.25 post-test (P<.001) to 9.34 on follow-up (P<.001), the Confusion-Bewilderment scale went from a mean of 8.84 pretest to 6.97 post-test (P<.01) to 6.63 on follow-up (P<.01). The authors concluded that CES users reported a fewer number of health complaints, which manifested themselves with less intensity, a lower degree of sleep problems, less stress, faster discharge of tension, depression, anger, fatigue, and confusion, a greater degree of vigor, and lower levels of both state and trait anxiety.

36. May, Brad, and May, Carole. Pilot project using the Alpha-Stim 100 for drug and alcohol abuse. August, 1993.

Device: Alpha-Stim 100, 0.5 Hz, 50% duty cycle, biphasic rectangular wave, ear clip electrodes

14 male volunteers in 2 recovery homes for several days to 7 months received 25, 1 hour Alpha-Stim CES treatments. Multiple Affect Adjective Check List (MAACL) means showed a significant and dramatic decline in the anxiety scores by mid test dropping from 4.07 pretest to 1.00 mid test and 1.00 post test. Depression (3.42 pretest to 0.79 mid- and post test) and hostility scores (2.43 pretest to 0.71 mid- and post test) were also reduced significantly, while significant increases were seen in self-worth, feeling expression, and capacity for intimate contact. The Beck Depression Inventory dropped from 14.50 pretest to 5.00 midtest to 3.50 post test. The investigator commented that verbal feedback was equally exciting. One participant said afterwards, "something inside me has shifted and I just know I'm never going to take another drink of alcohol again." Another said, "I've been sober for about 75 days , but it feels like I've been sober for years." No side effects were reported.

37. Moore, J.A., Mellor, C.S. Standage, K.F., and Strong, H. A doubleblind study of electrosleep for anxiety and insomnia. Biological Psychiatry. L0(l):5963, 1975.

Device: Neurotone, 100 Hz, 2 mS, mean of 480 µA

17 persistent anxiety and insomnia pts (21 - 60 years old, mean of 37.7), without evidence of psychosis, were given 5, 30 minute CES treatments or simulated treatments in a crossover design after providing informed consent. The pts were told not to make any changes in their medication. There was improvement in all measures but one during the first week, but no significant difference between groups on the Taylor Manifest Anxiety Scale, Beck's Depression Inventory, or Eysenck's Lie, Neuroticism, or Extraversion scales, except that subjective insomnia improvement (P<.05) was noted during active treatment. The mean change in ratings over the first week for clinical anxiety was 0.62 for active CES and .61 for sham, for subjective anxiety was 0.37 for active and 0.55 for sham, and on Taylor was -0.75 for active and 2.55 for sham. Over the second week for clinical anxiety the mean was 0.27 for active CES and 0.31 for sham, for subjective anxiety was 0.00 for active and 0.88 for sham, and on Taylor was 1.87 for active and 2.25 for sham. The authors concluded that five, 30 minute sessions might not be sufficient to elicit the effects studied. Also the current was unusually low for the device used. Curiously, the authors noted up front, in the abstract, that despite largely negative findings, several subjects reported a remarkable improvement in their symptoms some 2 - 3 weeks after CES. Note: While this is called doubleblind, only the patients, and not the therapist were blind to treatment conditions. No side effects were reported.

39. Overcash, Stephen J. A retrospective study to determine the effect of cranial electrotherapy stimulation (CES) on patients suffering from anxiety disorders. Submitted to the Journal of Biofeedback and Self Regulation, 1995.

Devices: Alpha-Stim 2000, 350, CS, and 100, 0.5 Hz, 50% duty cycle, <500 µA, biphasic rectangular waves, ear clip electrodes

197 pts diagnosed with anxiety disorders (DSM 300.02, 308.3, 300.00), referred by local physicians, and given an average of 8.9, 25 minute Alpha-Stim CES treatments in conjunction with other treatments from 1989 to 1995 were evaluated. Over 80% of the pts were also provided with an Alpha-Stim on loan to take home and use daily or twice a day. 15 pts did not complete the program, primarily for financial reasons. Of the 182 who completed the prescribed course of therapy, 55 were male, 127 were female, with an average age of 35.6. 26% had unsuccessful treatment with anxiolytic medication. 16% had used antidepressant medications, alcohol, individual psychotherapy or behavior modification therapy. 58% had no previous therapy for their anxiety disorder. All pts were asked to rate their current anxiety on a 1 - 100 scale, with 100 being the highest amount of anxiety they could imagine. Post treatment assessments were made at the beginning of their last session. Pre and post treatment assessments were also made for some pts on 3 objective physiological measures, EMG, electro dermal response (EDR), and peripheral temperature (temp). 73 pts had EMG evaluations, and an average of 8.6 treatments. The EMG group dropped from a pretreatment means of 15.8 to a post treatment of 4.5. 83 pts had EDR evaluations, and an average of 7.4 treatments. The EDR group dropped from a pretreatment mean of 14.6 to a post treatment of 7.6. 26 pts had temp evaluations, and an average of 12.6 treatments. The temp group dropped from a pretreatment means of 81.2 to a post treatment of 92.1. The subjective 0 - 100 scale for all 182 pts dropped form 62.3 to 14.8. Individual (as opposed to average) results were subjected to a paired t-test. There was significant (P<.05) positive changes on all objective and subjective criteria. The mean differences were 9.10 2.00 for the EMG analysis, 6.89 1.08 for the EDR, 9.91 2.69 for the temp, and 27.46 16.34 for the 0 - 100 scale. There was a significant correlation (.860) between the perceived anxiety ratings and the objective measures. No pts were on any anxiolytic or antidepressant medication when they left treatment successfully. During 6 - 8 month follow-up 73% of the pts were "well satisfied" with their treatment and had no significant regression or other anxiety disorders, 18% were "satisfied" but had some problem with anxiety since they stopped the treatment, and 9% chose not to respond, had significant symptoms since they stopped the treatment, or in 1 case, "was not satisfied" with the treatment. There was no reported side effects (short or long term). In conclusion, the author noted that the results appear to be immediate in most cases, and that the CES treatment approach seems to have long lasting results as long as the pt is given a minimum of 4 - 6 treatments.

40. Overcash, Stephen J., Siebenthall, A. The effects of cranial electrotherapy stimulation and multisensory cognitive therapy on the personality and anxiety levels of substance abuse patients. American Journal of Electromedicine. 6(2):105-111, 1989.

Device: Alpha-Stim 2000, 0.5 Hz, 50% duty cycle, <500 µA, biphasic rectangular waves, ear clip electrodes

32 marijuana users with various psychophysiological stress disorders diagnosed with generalized anxiety disorder and substance abuse disorder were referred from family practitioners and randomly assigned to a control group (N = 16) in which they were treated with biofeedback EMG training, Quieting Response (QR) relaxation tapes and psychotherapy, or a CES experimental group (N = 16) which was treated with biofeedback EMG training, QR, psychotherapy, plus multisensory emotional therapy using the Relax and Learn System and Alpha-Stim CES. There were significant differences in the outcomes of the two groups. Although little change was recorded in EMG readings through the second treatment, by the fifth treatment the improvement was remarkable. The experimental group was able to reduce their mean EMG from 38 µV to 3.2. The control group also reduced their mean EMG from 41 µV to 9.6. Analysis of variance (F = 5.43, P<.01) indicate significant differences between the groups. The experimental group averaged the same amount of relaxation at the end of 8 sessions that the control group reached in 10. In the 16PF personality test, there was significant differences between groups in 4 areas. Nervous tension was reduced in both groups. The experimental group was significantly more planful (4.0 pretest to 7.2 post test, P<.01) in the self sufficiency test, a good indicator of reduction in anxiety levels, whereas there was no change in the control group (4.6 to 4.6). In area of dominance, a measure of assertiveness, the experimental group had a significant gain from 3.2 to 7.1, while the control group had an insignificant gain of 4.0 to 4.3. Ego strength for the experimental group rose from 3.0 to 7.6 which represents a significant (F = 6.95, P<.01) increase in decision making skills, while the control group had an insignificant gain (F = .28, P>.75) from 2.8 to 3.0. The experimental group was also able to reduce their use of marijuana more quickly testing drug free in only 6 weeks, and sustained over a longer period of time than the control group which was drug free in 9 weeks. No side effects were reported.

41. Passini, Frank G., Watson, Charles G., and Herder, Joseph. The effects of cerebral electric therapy (electrosleep) on anxiety, depression, and hostility in psychiatric patients. Journal of Nervous and Mental Disease. 163(4):263266, 1976.

Device: Neurotone 101, 100 Hz, 2 mS, cathodes over orbits, anodes over mastoids

60 inpatient volunteers (59 males, 1 female) in a V.A. hospital suffering from either anxiety or depression were randomly assigned to CES treatments or simulated treatments. The diagnoses included alcohol addiction, depressive neurosis, manic-depression, anxiety neurosis, drug dependence, organic brain syndrome, schizophrenia, psychotic depressive reaction, hypochondriacal neurosis, hysterical neurosis, adult adjustment reaction, social maladjustment, acute alcohol intoxication, personality disorder, passive-aggressive personality, and situational disturbance. Both groups were given 10, 30 minute treatments. All subjects in both groups improved significantly (P<.001) on the Multiple Affect Adjective Check List (for anxiety, active CES means was 12.06 pre test to 8.67 post test, for placebo CES 11.47 to 7.90) and on both the State Scale of the STAI (active: 64.93 to 45.20, placebo: 52.17 to 44.10) and Trait Scale of the STAI (active: 52.10 to 46.67, placebo: 50.47 to 43.77). The authors noted that no attempt was made to control the amount or type of psychotropic medication administered to the patients and most of the subjects on the study were on psychoactive drugs. No side effects were reported.

42. Philip, P., Demotes-Mainard, J., Bourgeois, M. and Vincent, J.D. 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, 1991.

Device: Diastim: 350 Hz, 0.7 mS, 1 - 1.2 mA, rectangular monophasic pulses, cathodes over orbits, anodes over mastoids

21 psychiatric inpatients suffering major depressive disorders according to DSM III-R criteria were divided into 2 groups for this double-blind study. The active CES group (N = 10) had 3 males and 7 females (age 44.9 10.3) with an average length of depressive illness of 56 months (1 - 156). The placebo group (N = 11) had 3 males and 8 females (age 36.4 13.8) with an average length of depressive illness of 64 months (5 - 222). All patients completed informed consent. The treatment withdrawn upon admission consisted of benzodiazepines (9 of 10 active and 8 of 11 placebo), barbituates (1 of 10 active), antidepressant drugs (5 of 10 active and 8 of 11 placebo), and neuroleptics (1 of 10 active and 1 of 11 placebo). The study began on the first drug-free day. Depressive pathology was evaluated daily by the Montgomery and Asberg Depression Rating Scale (MADRS). Sleep was evaluated using a sleep diary and questionnaire. Analogic self-rating scales evaluated anxiety, fatigue, arousal, and life events. Student's paired t-test was used to analyze the data. During the 5 day washout period, the natural development of symptoms consists of a rise in anxiety and an exacerbation of sleep disorders. In 2 cases, benzodiazepine withdrawal induced epileptic seizures in pts devoid of epileptic history. These seizures did not occur during CES sessions. The depressive criteria in the CES group paralleled that in the placebo group. Anxiety and sleep criteria showed divergent changes between groups. Anxiety on MADRS was exacerbated in the placebo group but reduced in the CES group (P<.01). The same was true of the ninth criteria of MADRS, pessimism about the future and feelings of guilt and failure. There was no other significant changes on MADRS in either group. Sleep duration improved in the CES treatment group, but was significantly worsened in the placebo group (P<.05). Feelings of fatigue and alertness revealed a positive change in the CES group (P<.05), but not in the placebo group. The authors concluded that the effects of a drug washout period are markedly attenuated by cerebral electrostimulation, which is of possible interest in the management of psychotropic drug withdrawal. No side effects were reported.

44. Rosenthal, Saul H. Electrosleep: A doubleblind clinical study. Biological Psychiatry. 4(2):179185, 1972.

Device, 100 Hz, 1mS, 0.5 - 1.2 mA, orbit to mastoid electrodes.

22 neurotic and personality disorder pts (including 2 inpatients) with anxiety, depression, and insomnia (20 females, 2 males 26 - 63 years old, mean = 43.1 years) were divided into active (N = 11), or sham groups (N = 11), each given 5, 30 minute treatments in a double-blind design. A 1 - 7 clinical rating scale was used by a psychiatrist before the first and after the final treatment for 3 areas of symptomatology: anxiety, sleep disturbance, and depression. The Zung depression scale was also employed at the same times. Pts receiving active treatment had a marked clinical improvement over pts receiving placebo treatment. Of the 11 CES pts, 8 showed a marked improvement, 2 showed a partial improvement, and 1 showed no improvement. Of the placebo group, 1 showed marked improvement, 2 showed partial improvement, and 8 showed no improvement. Average "total clinical ratings" on anxiety, sleep disturbance, and depression fell from 11.3 before CES treatment to 3.2 following treatment. The placebo group only fell from 12.2 to 9.5. In anxiety, the CES group fell from 4.3 to 1.4 while the placebo group only fell from 4.4 to 3.2. 8 of the pts who had sham treatments were then given real CES. Pts receiving active treatment following inactive treatment responded better than pts receiving inactive treatment, but did not respond as well as those who received active treatment first. For example, the anxiety score fell from 4.0 to 2.5. At the end of the CES treatment, pts felt no confusion, memory loss, or disorientation. They usually reported a calm, relaxed sensation during the treatment, and a feeling of sedation with a desire to sleep following the treatment. The author stated that he can not help being a little skeptical at his own results. He added that no treatment in common experience is as effective with this type of pt as these results indicate. No side effects were reported.

46. Rosenthal, Saul H., and Wulfsohn, Norman L. Electrosleep: A preliminary communication. Journal of Nervous and Mental Disease. 151(2):146151, 1970.

Device: Electrosone 50: 100 Hz, 1 mS, 0.5 - 1 mA, cathodes over orbits, anodes over mastoids

10 chronic anxiety, depression, and insomnia pts (25 - 65 years old) unresponsive to medication were selected from a psychiatric "medication clinic" and given from 7 to 10, 10 - 30 minute CES treatments. 6 completed the course of therapy, 4 dropped out because of inability to afford transportation to the clinic, medical illness, recovery after 1 treatment, and "not liking" the treatment. An additional 3 psychotically depressed inpatients were treated for a total N of 9. Of the 6 outpatients, 5 had relatively total remission, and 1 was a treatment failure. Of the 3 inpatients, 2 were treatment failures and 1 had partial improvement. The average score overall for the 9 pts for sleep disturbance fell from 5.8 to 2.9, while the anxiety rating fell from 5.7 to 3.0. The clinical depression rating fell from 5.8 to 3.6 and the Zung Depression Scale scores fell from an average of 62.7 to 44.8. The 5 responders were all females with an average age of 47.6. Their sleep disturbances fell from 5.6 to 1.0 (no sleep disturbance), anxiety fell from 6.0 to 2.0, depression fell from 5.6 to 1.4 with Zung score falling from 60.4 to 29.2. 3 pts reported discontinuing sleeping pills that they had been taking for months or years. There was no side effects reported in any of the pts other than a transient blurring of vision reported by several of the pts, probably associated with the forced closure of the eyes by the eyepads for 1 hour, which cleared within 15 - 30 minutes after treatment.

47. Rosenthal, Saul H. and Wulfsohn, Norman L. Studies of electrosleep with active and simulated treatment. Current Therapeutic Research. 12(3):126130, 1970.

Device: Electrosone 50: 100 Hz, 1 mS, 100 - 250 µA, cathodes over orbits, anodes over mastoids

12 psychiatric outpatients, unresponsive to medications, were selected from an outpatient medication clinic. All were suffering from chronic anxiety, depression, and insomnia. They were given from 5 to 10 CES treatments (12 pts received 10 treatments). They were evaluated before treatment on a 1 - 7 (7 = severe) scale and Zung Self-Rating Scale and reevaluated after 5 sessions. 9 of the 12 pts had relatively total remission of their symptoms, 2 were treatment failures, and 1 was considered to show partial improvement. Overall, the average rating for sleep disturbance fell from 5.8 to 2.3, anxiety fell from 5.9 to 2.7, depression dropped from 5.2 to 2.3 and the average score on the Zung scale fell from 57.4 to 36.3. Following the 5 treatments, 8 of 12 were completely asymptomatic with regard to insomnia. 6 pts selected in the same way were given simulated CES treatments on a single-blind basis. 2 of the 6 remained unchanged. 4 showed partial improvement. None showed the dramatic complete remission that was seen with active CES treatment. The average rating on the anxiety scale for the sham group fell from 4.7 to 4.3, sleep disturbance fell from 6.0 to 4.0, depression fell from 4.8 to 3.7 and the average rating on the Zung scale fell from 55.8 to 46.8. The authors noted that the only side effect was a transient blurring of vision, reported by several of the pts, which cleared within 15 minutes after treatment. It was probably due to the forced closure of the eyes and the pressure of the eye pads. It was seen less often with later pts, and this may be due to less tight placement of the electrodes. The authors concluded that somewhat to their surprise, 9 of 12 pts showed marked responses to treatment.

48. Ryan, Joseph J. and Souheaver, Gary T. Effects of transcerebral electrotherapy (electrosleep) on state anxiety according to suggestibility levels. Biological Psychiatry. 11(2):233237, 1976.

Device: Neurotone 101, 100 Hz, 2 mS, electrodes on forehead and mastoids

42 psychiatric inpatients (41 males and 1 female) at a Veterans Administration hospital without psychosis or neurological impairment manifesting signs of anxiety either not on medication or not responding satisfactorily to medication who gave informed consent were selected for this double-blind study. They were rated as high suggestible (N = 12) or low suggestible (N = 12) as measured on the Harvard Scale of Hypnotic Susceptibility and half of each group were randomly assigned to active or simulated CES and given a pretest STAI. This yielded 6 pts per cell for the 2 x 2 factorial design. The remaining pts were treated, but excluded from the study because they scored in the medium suggestibility range. Experimental subjects ranged in age from 21 to 59 years (mean = 38). Treatments were 5, 30 minute sessions on successive days. 6 - 9 days following the last treatment each subject again completed the STAI. The active CES pts mean pretest to post test state anxiety scores were reduced from 58.33 to 43.50 for the low suggestibility group, and from 57.66 to 50.66 for the high suggestibility group. The placebo pts pretest to post test state anxiety scores were reduced from 57.33 to 57.16 for the low suggestibility group, and from 56.33 to 55.00 for the high suggestibility group. Subjects in the active CES group showed significantly greater anxiety reduction than did subjects in the placebo condition (P<.01, F = 8.26). There was no overall effect of suggestibility, nor was there a significant interaction between suggestibility and type of treatment. That is, CES was related to positive changes, and no placebo effect could be found as measured by the suggestibility level of patients. The authors stated that the management of anxiety is a significant problem for medical and psychiatric practitioners. Chemotherapy, although highly effective in many cases, cannot be considered the final regime. Total reliance upon prescription medications predisposes the patient to possible untoward side effects, physiologic dependence, and overdose. The development of a safe, effective, and economical treatment for anxiety is worthy of serious investigation. They then concluded that this study demonstrated that active CES produced significantly greater reductions in anxiety than did a simulated treatment. No side effects were reported.

49. Ryan, Joseph J., and Souheaver, Gary T. The role of sleep in electrosleep therapy for anxiety. Diseases of the Nervous System. 38(7):515517, 1977.

Device: Neurotone 101, 100 Hz, 2 mS, electrodes on forehead and mastoids

40 neurotic inpatients at a Veterans Administration hospital exhibiting significant symptoms of anxiety without psychosis or neurological impairment either not on medication or not responding satisfactorily to psychotropic medication who gave informed consent were given the A-State Scale of the STAI which measures various emotional reactions such as tension, worry, apprehension, and nervousness. Each pt underwent 5, 30 minute CES treatment sessions, with a therapist in the room to record clinical observations of sleep indicators (e.g., snoring, shallow breathing, difficulty in arousal after treatment). 6 - 9 days after treatment the pts completed the A-State Scale again. 10 males (21 - 59 years old, mean = 34.10) were selected for which there existed a definite agreement between patient and therapist that sleep had occurred during 2 or more treatment sessions. Similarly, 10 nosleep patients (9 males, 1 female, 26 - 57 year old, mean = 41.9) were also selected. Both groups improved significantly (P<.001) on the State Anxiety Scale of the STAI, with no significant differences in improvement in the sleep group when compared with the nosleep group based on a 2 x 2 ANOVA with repeated measures on pre- and post treatment scores. The sleep group went from a pretreatment mean anxiety score of 59.20 12.72 to 49.00 18.52 post treatment. The no-sleep group means fell from 59.80 9.89 to 41.90 15.07. It was concluded that sleep is not necessary for the effects of CES to occur. No side effects were reported.

50. Sausa, Alan De, Choudhury, P.C. A psychometric evaluation of electrosleep. Indian Journal of Psychiatry. 17:133137, 1975.

Device: Somlec, 16 volts

160 anxiety pts were divided into 4 groups: group A, simulated CES; group B, auditory stimulus; group C, CES; group D, CES plus auditory stimulus. Pts were pre and post tested on the Taylor Manifest Anxiety Scale (TMAS), the Hamilton Anxiety Scale (HAS), and by clinical evaluation. The pts had been given 30, 30 minute treatments on a 3 per week schedule. Statistics were not performed but percentages computed. In the CES group C, there was a 35% improvement on the TMAS, 45% on the HAS, and 35% on clinical evaluations. In the simulated CES group A, there was a 0% improvement on the TMAS, 5% on the HAS, and 10% on clinical evaluations. In the auditory group B, there was a 20% improvement on the TMAS, 25% on the HAS, and 25% on clinical evaluations. In the combined group D, there was a 60% improvement on the TMAS, 80% on the HAS, and 75% on clinical evaluations. The authors concluded that the results of this study indicate that the suggestibility and the process of transference produced an improvement rate of 10% clinically and 5% on the Hamilton Anxiety Scale, and CES is beyond doubt, a useful adjunct in the management of anxiety. No side effects were reported.

52. Schmitt, Richard, Capo, Thomas, Boyd, Elvin. Cranial electrotherapy stimulation as a treatment for anxiety in chemically dependent persons. Alcoholism: Clinical and Experimental Research. 10(2):158-160, 1986.

Device: Neurotone 101, 100 Hz, 20% duty cycle, <1 mA, electrodes behind each ear

60 inpatient alcohol and/or polydrug abusers (mean age = 33.9) volunteered for this double-blind study. 30 were given CES, 10 sham CES, and 20 served as normal hospital routine controls. Dependent measures of anxiety were the Profile of Mood States, the IPAT Anxiety Scale, and the State Trait Anxiety Index. The CES and sham pts received 15 daily, 30 minute treatments. Based on Fisher t-tests of the means, CES treated patients showed significantly greater improvement on all anxiety measures than did either control group. There were no differences in response between older and younger patients, or between the primarily drug or alcohol abusers. No placebo effect was found on any of the measures. The authors concluded that CES is rightfully gaining increasing use in American medicine as it gains increasing confirmation as a significant treatment adjunct for stress and cognitive dysfunction in chemical dependency treatment programs, regardless of the chemical of abuse or the age range of the patients treated. No side effects were reported.

53. Shummer, Gary J. The effect of alpha/theta neurofeedback and alpha-stim treatment on immune function, physical, symptoms, and subjective stress within a group of HIV+ subjects, a controlled study. In progress, 1995.

Device: Alpha-Stim 100, 0.5 Hz, 50% duty cysle, 100 µA, biphasic rectangular wave, ear clip electrodes

40 subjects who signed informed consent were assigned to 1 of 4 groups: Alpha-Stim CES only, neurofeedback only, both CES and neurofeedback, or a control group. For inclusion, all subjects had T-cell counts between 200 and 400, and range in age from 18 - 55. Subjects receiving neurofeedback had 2, 30 minute sessions per week and were instructed to practice at home 20 minutes daily. Subjects treated themselves at home for 20 minutes daily for 4 months, with active or placebo CES devices. Effects are being measured through changes in blood panels before, during, and after treatment as well as changes in physical symptoms and subjective measures of stress. The dependent variables include: T-4 level changes, Symptom Check List (SCL-90-R), and the Stress Audit Test. Dependent variables are being analyzed utilizing standard statistical techniques. To date, the Alpha-Stim CES group are reporting excellent ability to cope more effectively with stress, they appear to be reducing their levels of physical symptoms, and it shows promise in assisting T-cell replication, presumably through learning to cope with stress better or perhaps through hypothalmic regulation.

60. Smith, Ray B., McCusker, Charles F., Jones, Ruth G., and Goates, Delbert T. The use of cranial electrotherapy stimulation in the treatment of stress related attention deficit disorder, with an eighteen month follow up. Unpublished, 1991 and follow-up in 1993.

Devices: Alpha-Stim CS, CES Labs, Liss Stimulator (randomly assigned)

This study compared the effects of 3 randomly assigned CES devices which had marked differences in electrical stimulation parameters, in the treatment of stress related attention deficit disorder in 23 children and adults, 9 males, 14 females, 9 - 56 years old (average 30.96) with an average education level of 10.56 years. All had been diagnosed as having generalized anxiety disorder (61%), and/or depression (45%), and/or dysthymia (17%). 8 had a primary diagnosis of ADD. CES treatments were given daily, 45 minutes per day for 3 weeks. All 3 CES devices were equally effective based on Duncan's Range test in significantly (P<.001) reducing depression as measured on the IPAT depression scale (mean of 19.38 8.44 pretest to 13.19 7.00 post test), state and trait anxiety scales of the STAI (mean state anxiety was reduced from 39.95 11.78 pretest to 29.76 6.99 post test, and the mean trait anxiety was reduced from 43.90 11.31 pretest to 32.19 7.50 post test), and in increasing the Verbal pretest (mean of 99.38 13.20 to post test of 107.50 14.13), Performance (mean of 107.4 15.05 to 126.6 14.2 ), and Full Scale I.Q. scores on the WISC-R or WAIS-R IQ tests (mean of 103.2 13.7 to 117.6 14.28). The authors concluded that in the unlikely event that our findings are the results of placebo effect alone, a CES device, retailing at approximately $795, would still be a relatively inexpensive and apparently reliable treatment for such a debilitating disorder as stress related ADD. On 18 month follow up, the pts performed as well or better than in the original study, the Full Scale IQ had not moved significantly from where it was after the first 3 weeks of treatment, the Performance IQ fell back slightly, while the Verbal IQ continued to increase. There did not seem to be any pattern of addiction to or over dependence on the CES device. There was no side effects except for 1 pt who cried during treatments, and 1 who was sore behind the ears when the electrode gel began drying out.

61. Smith, Ray B., O'Neill, Lois. Electrosleep in the management of alcoholism. Biological Psychiatry. l0(6):675680, 1975.

Device: Neurotone 101, 100 Hz, 2mS, <1.5 mA, frontal and occipital electrodes

72 male alcoholic inpatients (average age of 42.4, average drinking of 22 years with an average of 5 years of heavy drinking) were given either CES (N = 24 at end of study) or simulated CES (N = 23 at end of study), 40 minutes a day for 15 days. All pts were also receiving medication and psychotherapy. Norms were derived from 342 inpatient alcoholics. The CES group improved significantly (beyond the 0.001 level of confidence) on all 5 negative subscales of the Profile of Mood States while the control group improved on only 2 subscales: Tension-Anxiety and Depression-Dejection. The mean scores were: Tension-Anxiety (pretest active CES mean of 12.61 1.39 to 6.30 0.79 post, control pretest 12.22 1.37 to 6.43 0.95 post), Depression-Dejection (pretest active CES mean of 12.32 1.73 to 4.52 0.87 post, control pretest 12.80 1.79 to 6.80 1.56 post), Anger-Hostility (pretest active CES mean of 6.75 1.41 to 1.21 0.42 post, control pretest 6.63 1.34 to 5.92 1.50 post), Vigor-Activity, a positive score where higher numbers are better (pretest active CES mean of 14.76 1.21 to 15.08 1.02 post, control pretest 14.76 1.25 to 13.00 1.40 post), Fatigue-Inertia-Confusion (pretest active CES mean of 6.18 1.12 to 1.91 0.53 post, control pretest 6.45 1.29 to 4.05 1.32 post), and Confusion-Bewilderment (pretest active CES mean of 8.08 0.99 to 3.92 0.49 post, control pretest 8.00 0.96 to 6.08 0.67 post). The CES group also improved significantly on Total Mood Disturbance while the controls did not (pretest active CES mean of 65.29 6.62 to 40.33 4.69 post, control pretest 63.96 6.56 to 47.29 6.12 post). The groups had to be matched following the study prior to statistical analysis, since a majority of the most seriously stressed controls (N = 13) had left the hospital against medical advice, along with 12 CES pts. No side effects were reported.

62. Smith, Ray B., Shiromoto, Frank N. The use of cranial electrotherapy stimulation to block fear perception in phobic patients. Journal of Current Therapeutic Research. 51(2):249-253, 1992.

Device: Alpha-Stim CS, 0.5 Hz, 50% duty cysle, <600 µA, biphasic rectangular waves, ear clip electrodes

After gaining IRB approval, 31 persons responded to public media announcements requesting subjects who had been medically diagnosed as having 1 or more phobias. 25 were females (81%). All gave informed consent The age ranged from 26 - 66 (average 48.69) with an average length of time since their phobia was diagnosed as 16.33 years (range 1 - 44 years). 65% (N = 20) were on medications, and of these, 60% (N = 12) were taking alprazolam. The authors cited an earlier study that reported internally elicited phobic thoughts produced as much and, at times, greater subjective anxiety, fear, and physiological activity than similar thoughts triggered externally by pictures or verbal statements about phobic objects. Each subject served as his/her own control. The subjects were asked to imagine themselves in their phobic stimulus situation and rate their fear on a 7 point scale. Following 30 minutes of Alpha-Stim CES stimulation, and while the stimulation was still on, they were asked to frighten themselves as before. I subject left the study before the program began citing increased situational anxiety as the reason. 4 subjects, appearing to be elated, rated their end-of-study fear as 0, which was not on the scale. That left a useable N of 26. While 77% (N = 20) rated their fear as moderate to extreme going into the study, 85% (N = 22) rated their fear from very low to none following the CES stimulation (mean of 3.33 1.22 pretest to 1.96 0.76 post test). The results reached significance beyond a probability of .0001. The authors concluded that, from their data, it appears that CES may be successfully instituted while pts are on medication. By the same measure, CES appears to be equally as effective without supportive medication and might be a useful tool with which to withdraw from such medication, should the physician desire. Since CES devices are portable, its use by the pt in most phobic stimulus situations would appear feasible. No side effects were reported.

63. Smith, Ray B., Tiberi, Arleine, Marshall, John. The use of cranial electrotherapy stimulation in the treatment of closed-head-injured patients. Brain Injury, 8(4):357-361, 1994.

Device: CES Labs, 100 Hz, 20% duty cycle, <1.5 mA

21 closed head injured pts with an average age of 30, and time since injury ranging from 6 months to 32 years (mean = 11) completed informed consent. The statistician was also blinded, being given the data in 3 unidentified groups, making this a triple-blind study. They were randomly assigned to CES treatment (N = 10), sham treatment (N = 5) or control "wait-in-line" (N = 6) groups. The CES and sham groups had 12 treatments, daily over a period of 3 weeks. They were pre- and post-tested on the Profile of Mood States which contains subscales for anxiety, depression, hostility, fatigue and mental confusion. The CES treated subjects, but not the sham treated subjects or controls, improved significantly on every POMS subscale. Tension/anxiety was reduced from a mean of 12.33 7.36 to 8.78 5.09 in the CES treated group, while it rose from 13.00 6.21 pretest to 14.36 8.25 post test in the sham group, and barely changed from 12.33 8.07 to 12.50 5.87 in the control group. Depression/dejection changed from 17.11 12.35 to 12.06 8.71 in the CES treated group, and from 20.91 17.79 pretest to 18.18 12.47 post test in the sham group, and from 20.00 14.45 to 16.17 9.48 in the control group. Anger/hostility changed from 13.67 11.20 to 10.39 7.49 in the CES treated group, and from 16.73 8.27 pretest to 17.55 12.22 post test in the sham group, and from 14.83 11.50 to 14.83 6.18 in the control group. Fatigue/inertia changed from 7.44 6.75 to 5.33 3.96 in the CES treated group, and from 9.46 7.83 pretest to 8.09 6.63 post test in the sham group, and from 8.17 7.41 to 6.50 5.82 in the control group. Confusion/bewilderment changed from 8.50 6.75 to 6.22 3.96 in the CES treated group, and from 10.55 5.87 pretest to 10.27 5.10 post test in the sham group, and from 9.67 6.15 to 10.50 5.01 in the control group. Total Mood Disturbance was reduced from a mean of 45.11 41.95 to 31.89 23.84 in the CES treated group, and from 52.73 41.95 pretest to 52.33 36.64 post test in the sham group, and from 47.83 43.25 to 45.67 24.16 in the control group. 1 pt on sham CES was seen to have a seizure. No negative effects from CES treatments was seen. The authors concluded that therapists of CHI pts may well try adding CES therapy, a prescription, but non-medication treatment, to the treatment of this currently heavily medicated pt population.

64. Smith, Ray B., and Tyson, R. The use of transcranial electrical stimulation in the treatment of cocaine and/or polysubstance abuse. Unpublished, 1991.

No stimulation parameters of CES were given.

146 inpatients were selected in the order of their admission to the hospital. 25% were primary alcohol abusers, while 47% were abusing cocaine. 39 pts were given CES daily for 45 minutes for from 1 to 3 weeks (31 males, 8 females, 14 - 46 years old plus 1, 69 year old, mean = 29.50). 107 pts served as controls (90 males, 27 females, 17 - 49 years old, mean = 29.20). All were pre and posttested on the Profile of Mood States (POMS). Pts treated for 1 week with CES did not differ statistically from the controls on the six POMS subtests. Pts receiving CES for 7 days to 3 weeks improved significantly on all of the 6 POMS subscales. On the Tension-Anxiety subscale the CES group had a mean of 9.00 5.05, while the controls mean was 10.94 7.17 (P<.03). On the Depression-Dejection subscale, the CES group was 10.22 5.48, while the control mean was 15.09 12.28 (P<.0001). On the Anger-Hostility subscale, the CES group was 9.00 5.05, while the control mean was 10.97 7.17 (P<.03). On the Lack of Vigor subscale, the CES group was 13.48 8.82, while the control mean was 14.77 6.50 (P<.03). On the Fatigue-Inertia subscale, the CES group was 5.09 3.91, while the control mean was 8.30 9.25 (P<.0001). On the Confusion-Bewilderment subscale, the CES group was 6.39 3.04, while the control mean was 8.84 5.73 (P<.001). When cocaine pts were analyzed separately, those receiving 7 days to 3 weeks of CES stimulation improved significantly on 4 of the 6 POMS subscales. When cocaine patients were compared with persons with other addictions, no differences in response to CES were found. The authors concluded that CES, which has earlier been shown to be an effective treatment for alcoholic pts, is also effective for pts who have abused drugs in the cocaine family. It can be inferred that CES could function well as a core program element in addiction treatment programs. No side effects were reported.

71. Taylor, Douglas, N. Effects of cranial transcutaneous electrical nerve stimulation in normal subjects at rest and during stress. Doctoral dissertation, Brooklyn College of the City University of New York, Pages 1-96, 1991.

Device: Neurometer, sinusoidal waveform of 5, 100, or 2,000 Hz, 0 - 10 mA (mean of 260 µA was used), ear clip electrodes

This IRB approved dissertation is comprised of 3 studies evaluating the physiological and psychological effects of CES. All subjects signed informed consent forms. In a pilot study 30 normal, healthy subjects (13 males, 17 females, 18 - 33 years old) were divided into treatment-blind active and placebo CES, and no treatment groups. They were given 1, 30 minute 100 Hz CES treatment. One-way multivariate analysis of variance confirmed by Duncan's test revealed significant (P<.05) reductions in systolic (post treatment mean of 90.29 6.18 as a percentage of pre-treatment means in the active group, 97.01 7.22 in the placebo, and 97.03 7.38 in control) and diastolic blood pressure (post treatment mean percentage of 91.07 4.94 in the active group, 97.84 3.48 in the placebo, and 98.82 7.51 in control) and anxiety based on the State-Trait Anxiety Inventory (post treatment mean percentage of 79.44 14.44 in the active group, 94.6 9.1 in the placebo, and 91.88 9.3 in control), but was not significant in pulse rate, peripheral vascular tension, or skeletal muscle activity.

A second study, using double-blind procedures to test 5, 100, or 2,000 Hz on 90 healthy volunteers (20 males, 70 females, 18 - 25 years old), found significant reductions among the active 100 Hz CES group only in systolic blood pressure (post treatment mean percentage of 96.4 6.14 in the active 5 Hz group, 90.57 7.58 in the active 100 Hz group, 100.05 4.16 in the active 2,000 Hz group, 97.19 4.26 in the placebo, and 98.53 4.38 in control) and diastolic blood pressure (post treatment mean percentage of 96.46 6.91 in the active 5 Hz group, 90.40 4.75 in the active 100 Hz group, 99.4 5.67 in the active 2,000 Hz group, 99.06 7.74 in the placebo, and 99.8 4.75 in control), and pulse rate (post treatment mean percentage of 97.3 4.24 in the active 5 Hz group, 89.22 6.13 in the active 100 Hz group, 97.88 5.87 in the active 2,000 Hz group, 101.71 7.92 in the placebo, and 99.07 5.17 in control), but was not significant for peripheral vascular tension or anxiety, and not when using 5 Hz or 2,000 Hz sine-wave CES. In the second study, anxiety scores did change in the active groups, but it also changed in the placebo group (post treatment mean percentage of 84.8 18.49 in the active 5 Hz group, 79.18 12.93 in the active 100 Hz group, 84.4 11.11 in the active 2,000 Hz group, 89.54 14.77 in the placebo, and 93.16 20.28 in control).

A third double-blind study of 90 subjects (26 males, 64 females, 18 - 25 years old) was designed to answer the following questions: 1) Can CES attenuate the physiological and psychological response of normal subjects to 3 minutes of standardized stress (mental arithmetic)?, 2) Are the effects of CES immediate? 3) Do the effects of CES last after the current is turned off? 4 different CES groups were compared to a no treatment control group. Group 1 received an active 30 minute CES treatment, and another active treatment during a 3 minute stress phase immediately following, Group 2 received an active 30 minute CES treatment, and a placebo treatment during the 3 minute stress phase, Group 3 received placebo CES both times, and Group 4 received a placebo 30 minute CES treatment and an active CES treatment during stress. Significant effects were reductions in systolic blood pressure (post treatment means as a percentage of pretreatment 93.33 5.99 in Group 1, 90.83 5.08 in group 2, 97.39 6.32 in group 3, 96.06 5.45 in Group 4, and 97.72 4.03 in the control group), pulse rate (post treatment means of 92.89 8.72 in Group 1, 92.83 8.95 in group 2, 97.22 13.23 in group 3, 97.89 5.78 in Group 4, and 100.61 5.78 in the control group), and anxiety (post treatment of 80.28 12.51 in Group 1, 84.11 12.19 in group 2, 96.11 8.74 in group 3, 94.72 11.31 in Group 4, and 93.22 8.27 in the control group), but not in diastolic blood pressure or peripheral vascular tension. The author concluded that only the first question can be answered from this study. MANOVA revealed no significant group differences in physiological or psychological response to mental stress. No significant placebo effect was observed in any of the 3 studies. The overall conclusion of the 3 studies was that CES can bring about reductions in anxiety, blood pressure, and pulse rates and that these effects are not due to placebo. The findings of this study also suggest that CES is not able to alter the physiological and psychological response to mental stress. No side effects were reported.

72. Von Richthofen, C.L., and Mellor, C.S. Electrosleep therapy: a controlled study of its effects in anxiety neurosis. Canadian Journal of Psychiatry. 25(3):213229, 1980.

Device: Neurotone 101, 100 Hz, 2 mS, <1.5 mA, anodes on forehead, cathodes on mastoid

10 pts with anxiety neurosis (6 males, 4 females, 17 - 52 years old) on medication, were given 5, 30 minute sessions of CES or simulated CES in a double-blind, cross over design. Results were made by psychiatric clinical assessment using a 0 - 7 scale, Eysenck Personality Inventory, State-Trait Anxiety Inventory, and Complaint Checklist. Both groups improved significantly and were not different from each other either before or following the study. It should be noted that the placebo group received actual current across their foreheads, which may have accounted for their results. No side effects were reported.

73. Voris, Marshall, D. An investigation of the effectiveness of cranial electrotherapy stimulation in the treatment of anxiety disorders among outpatient psychiatric patients, impulse control parolees and pedophiles, submitted for publication, 1995.

Device: Alpha-Stim 100, 0.5 Hz, 50% duty cycle, 200 µA, biphasic rectangular wave, ear clip

electrodes

IRB approved, informed consent. 105 parolees and psychiatric pts diagnosed with anxiety (STAI>40, EMG>6µV, Temp 75 - 95) were randomly assigned by assigning conditions to chairs, during group sessions conducted over a 10 day period, and allowing the subjects to sit wherever they would like in a group setting to either group A: Alpha-Stim CES (N = 40), group B: sham CES (N = 35), or group C, controls (N = 30). The study was triple-blind which was accomplished by the use of identical double-blinding boxes, with either of 2 options selected, and by the statistician being blinded to all conditions. All subjects were tested on the State Trait Anxiety Inventory, EMG, and peripheral temperature before and after a single 20 minute application of CES treatment, except the control group, which sat in the same room but was not connected to any device. All CES subjects, but not placebo or controls had significant effects. Analyses was by group medians. STAI in the active CES group had a pretest median of 50 8.12 to post test median of 34 7.39. STAI in the sham group had a pretest median of 51 8.58 to post test median of 50 8.46. STAI in the control group had a pretest median of 48 5.96 to post test median of 48 8.81. EMG in the active CES group had a pretest median of 10.40 7.12 to post test median of 3.80 4.98. EMG in the sham group had a pretest median of 12.55 10.45 to post test median of 12.95 10.65. EMG in the control group had a pretest median of 8.00 9.11 to post test median of 9.95 9.69. Temp in the active CES group had a pretest median of 90.0 5.63 to post test median of 93.60 3.36. Temp in the sham group had a pretest median of 90.5 4.90 to post test median of 91.65 4.81. Temp in the control group had a pretest median of 92.2 5.59 to post test median of 92.45 5.89. The probability of achieving these results by chance on the STAI is P<.0001 for CES vs sham or controls, and P<.3902 for sham vs controls, on the EMG is P<.0001 for CES vs sham or controls, and P<.6693 for sham vs controls, and on peripheral temperature is P<.0141 for CES vs sham, P<.0011 for CES vs. controls, and P<.3109 for sham vs controls. The author stated that when they began the research, several members of the team, had significant doubts as to the effectiveness of this technology. In addition, the concerns of FDA caused further concern and suspicion regarding this technology. But after this project, they concluded that they are completely convinced as to the value of this treatment methodology for many of their patients. No side effects were reported.

74. Weingarten Eric, the effect of cerebral electrostimulation on the frontalis electromyogram. Biological Psychiatry 16(1):61-63, 1981.

Device: Neurotone 101

This study of 24 alcoholic inpatients tested the idea that if the effects of CES can be attributed to general relaxation, reduction of arousal, or parasympathetic shift, then the effects of CES treatment should find a close correlation with the frontalis electromyographic score, since this measure also purports to reduce the central state of arousal, or sympathetic activity, by lowering the tension level of the frontalis muscle group in the forehead. The treatment was single blind, subsensation treatment for 40 minutes per day, Monday through Friday for 3 weeks. The EMG means were 8.03 8.01 µV pretreatment and 8.01 2.71 post treatment for the active CES group, and 8.65 2.31 pretreatment to 8.83 1.86 post for the control group. While CES treated subjects (N = 12) improved significantly on the Tension/Anxiety (P<.05), Depression/Dejection, (P<.02) Fatigue/Inertia (P<.01), and Confusion/Bewilderment (P<.05) factors on the Profile Of Mood States, the controls (N = 12) improved insignificantly on only the Confusion/Bewilderment factor (P<.10). 8 (33%) of the subjects left the study early, 6 (75%) of these being controls. As a group the initial EMG scores of those who left early were numerically higher than the initial scores of those who remained. It was concluded that while CES was an effective means of lowering stress levels, the EMG, alone, without biofeedback training did not show a correlated reduction. No side effects were reported.

76. Wharton, G.W. et al. The use of cranial electrotherapy stimulation in spinal cord injury patients. A poster study presented at the American Spinal Injury Association Meeting, New York, 1982, and at the Texas ASIA meeting in Houston, 1983.

16 inpatients on the Spinal Cord Injury Ward were measured on the POMS, the STAI, and the IPAT Depression Scale. Five were paraplegic and 11 were quadriplegic. They averaged 3.7 months post trauma. 11 were given CES, 40 minutes per day for 10 days. 5 served as hospital routine controls. The CES treated pts improved significantly on the Tension/Anxiety, Depression/Dejection, Fatigue/Inertia, and Confusion/Bewilderment factors on the POMS, on both the state and trait factors on the STAI, and on the IPAT Depression Scale. The control group did not improve on any of the measures. Abstract courtesy of Ray B. Smith, Ph.D., M.P.A.

78. Winick, Reid L. Cranial electrotherapy stimulation (CES): a safe and effective alternative to nitrous oxide in a dental practice. Submitted to the Journal of the American Dental Association, 1995.

Device: Alpha-Stim 100, 0.5 Hz, 50% duty cycle, 300 µA, biphasic rectangular wave, ear clip electrodes

This is a double-blind study of situational anxiety of 33 dental pts (9 males and 24 females, 20 to >59 years old). All pts completed informed consent. Pts were randomly assigned to an active CES group (N = 16), or placebo CES (N = 17) in the order they arrived for various dental procedures. A double-blinding box was used so neither the pt nor the dentist was aware who was receiving actual stimulation. 100 mm Visual Analogue Scales (VAS) of "not anxious" on the left to "very anxious" on the right were employed before, and after various dental procedures by both the patient and dentist, and a 7 point Likert scale was used at the conclusion of each treatment. There was no significant difference in anxiety levels before the procedure between both groups (P=.27). However, the anxiety level after the procedure was significantly lower in the treatment group than the control group. On the VAS scale, pts reported .64 66 after CES, vs 1.42 .94 after placebo (P=.02). On the Likert scale, in which a higher number signifies an improvement, the CES group reported 5.00 1.1, vs 2.5 2.13 after placebo (P=.001). The dentist-observer reported .86 .73 for the CES group, vs 1.39 .69 after placebo (P=.027). On the Likert scale the dentist-observer reported 4.38 1.59 for the CES group, vs 2.27 .46 after placebo (P=.0003). There was no indication of adverse effects noted in any of the subjects. The author concluded that dental pts, who experience extreme levels of anxiety, are significantly comforted by using CES during the dental procedure. In many instances the treatment group requested the CES at subsequent visits. The low cost, safety, and ease of use of CES recommends its freer trial to enhance patient comfort during various routine dental procedures. In addition, the results show that the test method of using a 100 mm VAS scale was confirmed to be consistent in the patient and dentist-observer, and with the Likert scale.

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