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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.
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