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Alcoholism
2. Braverman, E, Smith, R., Smayda, R, and Blum, K. Modification of P300 amplitude and other electrophysiological parameters of drug abuse by cranial electrical stimulation. Current Therapeutic Research. 48(4):586596, 1990.
Device: HealthPax, 100 Hz, 20% duty cycle, 1.0 mA, no dc bias, square waves, electrodes at left wrist and forehead
Electrophysiological abnormalities are said to be hallmarks of the high risk individual for drug abuse and the drug abuser. P300 waves occur 300 mS after a cognitive auditory potential and have been shown to have a reduced amplitude in many alcoholics, which does not revert to normal even after continued abstinence. Earlier research has concluded that the need to modify these electrophysiological parameters could be of critical importance in the treatment and possibly the prevention of drug abuse. In this study 13 alcohol and/or drug abusers (9 - 81 years old, mean of 43.44) and 2 staff controls were selected as they entered the clinic for brain electrical activity mapping (BEAM, a computerized EEG). After providing informed consent, all were given 40 minutes of CES between preand postCES BEAM scans. There was no significant changes in the controls. Following CES the pts P300 amplitude increased significantly (P<.05) as analyzed by Fisher test of probability which compared the differences between the means and variances. The time went from a pretreatment of 308 24 to 317 26 msec post treatment. The amplitude (dV) went from pretreatment of 7.0 4.1 to 9.9 6.0 post treatment. Also, there were significant positive shifts in alpha, delta, theta and beta spectra in patients who were abnormal in one or more of these areas prior to CES treatment. It was concluded that CES might be a significant nondrug treatment for the underlying electrophysiological disorder of the drug abuser, because the normalization of these electrophysiological parameters are characteristic of pharmaceutical treatment. The authors concluded that they believe the future is bright for prescriptive electricity, and that the electrophysiological changes that occur as a result of CES have the greatest implication for American's # 1 health problem, drug abuse. No side effects were reported.
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.
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.
51. Schmitt, Richard, Capo, Thomas, Frazier, Hal, and Boren, Darrell. Cranial electrotherapy stimulation of cognitive brain dysfunction in chemical dependence. Journal of Clinical Psychiatry. 45(2):60-63, 1984.
Device: Neurotone 101, 100 Hz, 2 mS, <1 mA, electrodes behind each ear
This doubleblind study involved 60 alcohol and polydrug abuser inpatient volunteers with an average age of 33.9. Treatment effects were assessed pre- and post test on the Revised Beta Examination and 3 subscales of the WAIS that are clinical indicators of organic brain syndrome (digit span, digit symbol, and object-assembly). 88% of the pts were initially dysfunctional on 1 or more of the 3 WAIS scales, with 63% dysfunctional on 1 or more of the Beta subtests. 40 pts received CES or sham CES treatments, and a third, control group of 20 participated in the normal hospital program without access to CES devices. The study was completed by 87% of the CES treated pts (N = 26), 60% of the sham-treated pts (N = 6), and 85% of the controls (N = 17). It was noted that 80% of the sham-treated pts, but only 20% of the treated pts had complained about the ineffectiveness of CES treatment. Following the study, 2 of the complaining sham pts were given CES and they both said it was a highly effective treatment with WAIS testing supporting these claims. Using Fisher's t-tests (P<.01), CES treated pts made significant gains on all measures of brain function over and above the two control groups. No placebo effects were found. Significant gains were also made on the Revised Beta Examination I.Q. test among CES patients but not by the controls. The authors concluded by agreeing with Dr. Ray Smith's speculation that a treatment program in which patients are treated specifically for cognitive dysfunction is not only humane but can add to the effectiveness of the other treatment modalities in a treatment and rehabilitation setting. 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.
57. Smith, Ray B. Confirming evidence of an effective treatment for brain dysfunction in alcoholic patients. Journal of Nervous and Mental Disease. 170(5):275278, 1982.
Device: Neurotone 101, 100 Hz, 2 mS, <1.5 mA, electrodes below each ear
100 male alcoholic inpatient volunteers (drinking for an average of 21 years with an average age of 42.2) were randomly assigned to either active or sham CES treatments for this double-blind study, 40 minutes per day, 5 days a week, for 3 weeks on the basis of Revised Beta Examination IQ tests. Both groups had scored in the dysfunctional category on both tests before the study. 5 treatment and 10 controls left the study early and were not counted in the final tabulations. All were treated below sensation threshold. The CES group made significant gains on the Beta I.Q. test at or beyond the .05 level of confidence on subtest I (mazes) from a pretreatment mean for the active group of 8.53 to a post treatment mean of 10.74 with the sham group testing at 8.48 pretreatment to 8.37 post, and on subtest IV (spatial relations) from a pretreatment mean for the active group of 7.18 to a post treatment mean of 8.80 with the sham group testing at 7.21 pretreatment to 7.32 post. While the active group was completely back into the scoring pattern of published norms, the sham group did not improve. The author concluded that in addition to the obvious considerations for the pt such treatment and recovery denotes, as a treatment adjunct in a treatment center, it also appears to be a thoughtful thing to do for those involved in other areas of the treatment effort, and whose efforts usually depend heavily on the cognitive functioning of the pt. It should aid treatment immeasurably, for example, if the pt can remember from 1 treatment session to the next what transpired in the session just preceding. No side effects were reported.
58. Smith, Ray B., Burgess, A.E., Guinee, V.J., and Reifsnider, L.C. A curvilinear relationship between alcohol withdrawal tremor and personality. Journal of Clinical Psychology. 35(l):199203, 1979.
Device: Neurotone 101, 100 Hz, 2 mS, <1.5 mA, electrodes below each ear
53 male alcoholic pts (mean of 44 years old) who were withdrawing from heavy drinking (mean years' drinking 9.57) were monitored using the Lafayette Instrument Company's Steadiness Tester, hole type, Stop Clock, 1/100 second, and Tone Response hand tremor test along with the MMPI before and after 40 minutes of CES. All pts had been withdrawing for 96 hours or less, and were receiving Librium 25 mg t.i.d., and Dalmain 30 mg at bedtime. 5 pts whose tremor score did not vary more than 1 full second were discarded from the study because the reaction time of the experimenter who controlled the on/off switch on the tremor apparatus was found to vary within this limit. In keeping with an inverted Ucurve theory of responsiveness to CES, high stress pts who tremored very little initially, tremored more following CES, while low stress pts who tremored more initially, tremored less following CES. This could be a major source of confusion in the typical linear statistical analysis involved in CES research. The data fit the researchers' original hypothesis that withdrawing alcoholics would tremor less as their internal stress increased beyond a certain point, as indicated by MMPI score elevations. This may explain the somewhat disconcerting finding that sometimes as few as 80% of known alcoholics tremor during withdrawal, a response heretofore thought of as a diagnostic of the addiction process by many researchers. Drug therapy alone did not alter the stress-tremor relationships found. No side effects were reported.
59. Smith, Ray B., Day, Eleanor. The effects of cerebral electrotherapy on shortterm memory impairment in alcoholic patients. International Journal of the Addictions. 12(4):575562, 1977.
Device: Neurotone 101, 100 Hz, 2 mS, 100 - 710 µA, electrodes below each ear
227 alcoholic pts (average age of 42) were given CES (N = 198) or served as time controls (N = 29). CES was given 40 minutes a day, Monday through Friday, for 3 weeks. CES significantly (P<.001) reduced brain dysfunction in all active treatment patients when compared with the controls on the Beta nonverbal I.Q. Test and the Benton Visual Retention Test of short term memory loss. The dysfunctional process continued to deteriorate in many of the controls, with a mean loss of 55% over an average 21 day period. The matched CES treatment pts improved an average of 84% during the same period. The authors concluded that they again found that the more serious disabled alcoholic pts tend to leave early while the less seriously involved stay on for treatment and that CES treatment halts or reverses this trend. This would be helpful if only because it holds the pts for other kinds of therapy offered. However, they also found no other treatment that alters the short-term memory impairment of their pts making CES a valued adjunct to other treatment approaches. No side effects were reported.
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.
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.
65. Snodgrass, Ralph W. Cerebral electrostimulation (electrosleep), alcoholism, and personal discomfort. Ph.D. Dissertation, Loyola University of Chicago, January, 1977.
39 inpatient alcoholics were assigned to CES treatment, simulated CES treatment, or untreated controls. CES was given in 6, 40 minute sessions. All 3 groups improved significantly on 3 indices developed from the MMPI: Clinical Personal Discomfort, Experimental Personal Discomfort, and Personal Well Being. Note: When the non-sham treated controls improved significantly, the researcher had lost control of his study. Abstract courtesy of Ray B. Smith, Ph.D., M.P.A.
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.\
Cocaine
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.
5. Brovar, A. Cocaine Detoxification with cranial electrotherapy stimulation (CES): A preliminary appraisal. International Electromedicine Institute Newsletter. 1(4), July/Aug, 1984.
Device: Alpha-Stim 350, 0.5 Hz, 50% duty cycle, <500 µA, biphasic rectangular waves, ear clip electrodes
25 consecutive admissions to a drug abuse treatment hospital who qualified for DSM III diagnosis of cocaine abuse were included in the study. Pts were alternately assigned to a control group (N = 12), and Alpha-Stim CES treatment (N =13), of which only 5 accepted while 8 refused. CES was given for 20 minutes twice a day for the 5 day inpatient treatment program. All 5 (100%) of the CES patients completed detoxification, compared with 75% of the other 20. All five (100%) of the CES patients completed the treatment program, compared with 63% of the CES refusers and 67% of the other 12 controls. A follow up of the 3 groups from 6 to 8 months later showed that no CES patients had returned for treatment, while 50% of the CES refusers and 39% of the controls had recidivated. One of the latter had died of overdose. The authors concluded that CES facilitated patient retention in a hospital detoxification and rehabilitation program for cocaine dependent persons. No side effects were reported.
5. Brovar, A. Cocaine Detoxification with cranial electrotherapy stimulation (CES): A preliminary appraisal. International Electromedicine Institute Newsletter. 1(4), July/Aug, 1984.
Device: Alpha-Stim 350, 0.5 Hz, 50% duty cycle, <500 µA, biphasic rectangular waves, ear clip electrodes
25 consecutive admissions to a drug abuse treatment hospital who qualified for DSM III diagnosis of cocaine abuse were included in the study. Pts were alternately assigned to a control group (N = 12), and Alpha-Stim CES treatment (N =13), of which only 5 accepted while 8 refused. CES was given for 20 minutes twice a day for the 5 day inpatient treatment program. All 5 (100%) of the CES patients completed detoxification, compared with 75% of the other 20. All five (100%) of the CES patients completed the treatment program, compared with 63% of the CES refusers and 67% of the other 12 controls. A follow up of the 3 groups from 6 to 8 months later showed that no CES patients had returned for treatment, while 50% of the CES refusers and 39% of the controls had recidivated. One of the latter had died of overdose. The authors concluded that CES facilitated patient retention in a hospital detoxification and rehabilitation program for cocaine dependent persons. No side effects were reported.
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.
Marijuana
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.
Methadone
16. Gold, M.S., Pottash, A.L.C., Sternbach, H., Barbaban, J., and Annitto, W. Antiwithdrawal effects of alpha methyl dopa and cranial electrotherapy. Paper presented at Society for Neuroscience. 12th Annual Meeting, October, 1982.
Device not specified.
Chronic opiate user inpatients were randomized for this double-blind study and given either alpha methyl dopa (Aldomet) or placebo Aldomet 48 hours after abruptly removing methadone, or CES or placebo CES. Aldomet and CES were both effective in controlling the effects of acute withdrawal. CES was also effective in controlling the effects of protracted withdrawal. No placebo condition was effective. The authors theorized that CES was effective by stimulating -endorphin, which inhibited the noradrenaline activity at the locus ceruleus. 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.
Opiate Abuse
16. Gold, M.S., Pottash, A.L.C., Sternbach, H., Barbaban, J., and Annitto, W. Antiwithdrawal effects of alpha methyl dopa and cranial electrotherapy. Paper presented at Society for Neuroscience. 12th Annual Meeting, October, 1982.
Device not specified.
Chronic opiate user inpatients were randomized for this double-blind study and given either alpha methyl dopa (Aldomet) or placebo Aldomet 48 hours after abruptly removing methadone, or CES or placebo CES. Aldomet and CES were both effective in controlling the effects of acute withdrawal. CES was also effective in controlling the effects of protracted withdrawal. No placebo condition was effective. The authors theorized that CES was effective by stimulating -endorphin, which inhibited the noradrenaline activity at the locus ceruleus. No side effects were reported.
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.
Withdrawal
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.
2. Braverman, E, Smith, R., Smayda, R, and Blum, K. Modification of P300 amplitude and other electrophysiological parameters of drug abuse by cranial electrical stimulation. Current Therapeutic Research. 48(4):586596, 1990.
Device: HealthPax, 100 Hz, 20% duty cycle, 1.0 mA, no dc bias, square waves, electrodes at left wrist and forehead
Electrophysiological abnormalities are said to be hallmarks of the high risk individual for drug abuse and the drug abuser. P300 waves occur 300 mS after a cognitive auditory potential and have been shown to have a reduced amplitude in many alcoholics, which does not revert to normal even after continued abstinence. Earlier research has concluded that the need to modify these electrophysiological parameters could be of critical importance in the treatment and possibly the prevention of drug abuse. In this study 13 alcohol and/or drug abusers (9 - 81 years old, mean of 43.44) and 2 staff controls were selected as they entered the clinic for brain electrical activity mapping (BEAM, a computerized EEG). After providing informed consent, all were given 40 minutes of CES between preand postCES BEAM scans. There was no significant changes in the controls. Following CES the pts P300 amplitude increased significantly (P<.05) as analyzed by Fisher test of probability which compared the differences between the means and variances. The time went from a pretreatment of 308 24 to 317 26 msec post treatment. The amplitude (dV) went from pretreatment of 7.0 4.1 to 9.9 6.0 post treatment. Also, there were significant positive shifts in alpha, delta, theta and beta spectra in patients who were abnormal in one or more of these areas prior to CES treatment. It was concluded that CES might be a significant nondrug treatment for the underlying electrophysiological disorder of the drug abuser, because the normalization of these electrophysiological parameters are characteristic of pharmaceutical treatment. The authors concluded that they believe the future is bright for prescriptive electricity, and that the electrophysiological changes that occur as a result of CES have the greatest implication for American's # 1 health problem, drug abuse. No side effects were reported.
5. Brovar, A. Cocaine Detoxification with cranial electrotherapy stimulation (CES): A preliminary appraisal. International Electromedicine Institute Newsletter. 1(4), July/Aug, 1984.
Device: Alpha-Stim 350, 0.5 Hz, 50% duty cycle, <500 µA, biphasic rectangular waves, ear clip electrodes
25 consecutive admissions to a drug abuse treatment hospital who qualified for DSM III diagnosis of cocaine abuse were included in the study. Pts were alternately assigned to a control group (N = 12), and Alpha-Stim CES treatment (N =13), of which only 5 accepted while 8 refused. CES was given for 20 minutes twice a day for the 5 day inpatient treatment program. All 5 (100%) of the CES patients completed detoxification, compared with 75% of the other 20. All five (100%) of the CES patients completed the treatment program, compared with 63% of the CES refusers and 67% of the other 12 controls. A follow up of the 3 groups from 6 to 8 months later showed that no CES patients had returned for treatment, while 50% of the CES refusers and 39% of the controls had recidivated. One of the latter had died of overdose. The authors concluded that CES facilitated patient retention in a hospital detoxification and rehabilitation program for cocaine dependent persons. No side effects were reported.
16. Gold, M.S., Pottash, A.L.C., Sternbach, H., Barbaban, J., and Annitto, W. Antiwithdrawal effects of alpha methyl dopa and cranial electrotherapy. Paper presented at Society for Neuroscience. 12th Annual Meeting, October, 1982.
Device not specified.
Chronic opiate user inpatients were randomized for this double-blind study and given either alpha methyl dopa (Aldomet) or placebo Aldomet 48 hours after abruptly removing methadone, or CES or placebo CES. Aldomet and CES were both effective in controlling the effects of acute withdrawal. CES was also effective in controlling the effects of protracted withdrawal. No placebo condition was effective. The authors theorized that CES was effective by stimulating -endorphin, which inhibited the noradrenaline activity at the locus ceruleus. 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.
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.
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.
58. Smith, Ray B., Burgess, A.E., Guinee, V.J., and Reifsnider, L.C. A curvilinear relationship between alcohol withdrawal tremor and personality. Journal of Clinical Psychology. 35(l):199203, 1979.
Device: Neurotone 101, 100 Hz, 2 mS, <1.5 mA, electrodes below each ear
53 male alcoholic pts (mean of 44 years old) who were withdrawing from heavy drinking (mean years' drinking 9.57) were monitored using the Lafayette Instrument Company's Steadiness Tester, hole type, Stop Clock, 1/100 second, and Tone Response hand tremor test along with the MMPI before and after 40 minutes of CES. All pts had been withdrawing for 96 hours or less, and were receiving Librium 25 mg t.i.d., and Dalmain 30 mg at bedtime. 5 pts whose tremor score did not vary more than 1 full second were discarded from the study because the reaction time of the experimenter who controlled the on/off switch on the tremor apparatus was found to vary within this limit. In keeping with an inverted Ucurve theory of responsiveness to CES, high stress pts who tremored very little initially, tremored more following CES, while low stress pts who tremored more initially, tremored less following CES. This could be a major source of confusion in the typical linear statistical analysis involved in CES research. The data fit the researchers' original hypothesis that withdrawing alcoholics would tremor less as their internal stress increased beyond a certain point, as indicated by MMPI score elevations. This may explain the somewhat disconcerting finding that sometimes as few as 80% of known alcoholics tremor during withdrawal, a response heretofore thought of as a diagnostic of the addiction process by many researchers. Drug therapy alone did not alter the stress-tremor relationships found. No side effects were reported.
Polysubstance Abusers
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.
2. Braverman, E, Smith, R., Smayda, R, and Blum, K. Modification of P300 amplitude and other electrophysiological parameters of drug abuse by cranial electrical stimulation. Current Therapeutic Research. 48(4):586596, 1990.
Device: HealthPax, 100 Hz, 20% duty cycle, 1.0 mA, no dc bias, square waves, electrodes at left wrist and forehead
Electrophysiological abnormalities are said to be hallmarks of the high risk individual for drug abuse and the drug abuser. P300 waves occur 300 mS after a cognitive auditory potential and have been shown to have a reduced amplitude in many alcoholics, which does not revert to normal even after continued abstinence. Earlier research has concluded that the need to modify these electrophysiological parameters could be of critical importance in the treatment and possibly the prevention of drug abuse. In this study 13 alcohol and/or drug abusers (9 - 81 years old, mean of 43.44) and 2 staff controls were selected as they entered the clinic for brain electrical activity mapping (BEAM, a computerized EEG). After providing informed consent, all were given 40 minutes of CES between preand postCES BEAM scans. There was no significant changes in the controls. Following CES the pts P300 amplitude increased significantly (P<.05) as analyzed by Fisher test of probability which compared the differences between the means and variances. The time went from a pretreatment of 308 24 to 317 26 msec post treatment. The amplitude (dV) went from pretreatment of 7.0 4.1 to 9.9 6.0 post treatment. Also, there were significant positive shifts in alpha, delta, theta and beta spectra in patients who were abnormal in one or more of these areas prior to CES treatment. It was concluded that CES might be a significant nondrug treatment for the underlying electrophysiological disorder of the drug abuser, because the normalization of these electrophysiological parameters are characteristic of pharmaceutical treatment. The authors concluded that they believe the future is bright for prescriptive electricity, and that the electrophysiological changes that occur as a result of CES have the greatest implication for American's # 1 health problem, drug abuse. No side effects were reported.
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.
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.
51. Schmitt, Richard, Capo, Thomas, Frazier, Hal, and Boren, Darrell. Cranial electrotherapy stimulation of cognitive brain dysfunction in chemical dependence. Journal of Clinical Psychiatry. 45(2):60-63, 1984.
Device: Neurotone 101, 100 Hz, 2 mS, <1 mA, electrodes behind each ear
This doubleblind study involved 60 alcohol and polydrug abuser inpatient volunteers with an average age of 33.9. Treatment effects were assessed pre- and post test on the Revised Beta Examination and 3 subscales of the WAIS that are clinical indicators of organic brain syndrome (digit span, digit symbol, and object-assembly). 88% of the pts were initially dysfunctional on 1 or more of the 3 WAIS scales, with 63% dysfunctional on 1 or more of the Beta subtests. 40 pts received CES or sham CES treatments, and a third, control group of 20 participated in the normal hospital program without access to CES devices. The study was completed by 87% of the CES treated pts (N = 26), 60% of the sham-treated pts (N = 6), and 85% of the controls (N = 17). It was noted that 80% of the sham-treated pts, but only 20% of the treated pts had complained about the ineffectiveness of CES treatment. Following the study, 2 of the complaining sham pts were given CES and they both said it was a highly effective treatment with WAIS testing supporting these claims. Using Fisher's t-tests (P<.01), CES treated pts made significant gains on all measures of brain function over and above the two control groups. No placebo effects were found. Significant gains were also made on the Revised Beta Examination I.Q. test among CES patients but not by the controls. The authors concluded by agreeing with Dr. Ray Smith's speculation that a treatment program in which patients are treated specifically for cognitive dysfunction is not only humane but can add to the effectiveness of the other treatment modalities in a treatment and rehabilitation setting. 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.
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.