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Commments On Side Effects & Safety From All CES Research Studies
First Author, N Subject Authors' Comments on Safety and Side Effects Year Description Achte, K.A. severe insomnia Complications were discovered in 5 cases, 2 1968 patients and drug complained of headaches, 3 felt aching in the eyes, 24 abusers 1 had hysterical convulsions during the treatment. Too strong currents caused headaches in healthy persons. The currents were too weak to cause convulsions and too weak to bring about neuro-vegetative side effects. England, migraine patients 1 subject in the placebo group developed a skin Ronald R. 18 irritation at the location of the electrode. She 1976 suggested that sensations felt during the treatment were responsible. Feighner, John long term 4 of 6 long term depressed patients were dropped P. psychiatric from the study because of massive worsening of 1973 23 patients, depressive symptoms. unresponsive to medications, ECT, psychotherapy Flemenbaum, A. anxiety, An insignificant trend towards worsening was seen by 1974 depression, the 24th week. 5 of 25 patients were not improved or 28 insomnia had become worse. The author added that side effects outpatients are virtually nonexistent. unresponsive to medications Forster, inducing sleep Although as current amplitude was increased to 20 Sigmund 23 volts a feeling of slight dizziness approaching a 1963 headache was noted, the authors concluded that the technic appears to be entirely safe. Frankel, insomniacs A commonly reported innocuous side effect was mild Bernard 17 blurring of vision lasting 15-30 minutes which 1973 resulted from sustained mechanical pressure of the electrodes on the eyeballs. Gomez, 14 heroin It was noted that with a higher current the patients Evaristo 28 patients, 7 felt uncomfortable, but there were no skin burns. 1979 placebo and 7 controls Hearst, E.D. psychotherapy No patient with primary affective disorder was 1974 28 outpatients adversely effected by CES. Hochman, dental patients From the results obtained during 1 year of treating Richard a variety of patients requiring a broad scope of 1988 600 dental treatments, CES was found to provide a safe, noninvasive, readily acceptable, adjunctive analgesic modality to maintain patient comfort through the majority of dental procedures for most patients. Koegler, R.R. insomnia patients The only side effects noted were blood pressure 1971 14 lowers during treatment, and a slight blurring of vision occurs due to eye electrodes, which stops within a few minutes. Krupitsky, alcoholic CES was not accompanied by side effects nor E.M. 20 patients with complications and was well tolerated by the 1991 affective patients. CES tends to avoid side effects and disorders complications sometimes observed in antidepressant therapy and tranquilizers. Levitt, Eugene psychiatric Subjects in both groups reported slight blurring of 1975 inpatients vision lasting 30 - 45 minutes following treatments. 13 This supports the findings of other researchers that the blurred vision effect is mechanically caused by pressure of eye electrodes, and not electrical current. McKenzie, 8 chronic Blurring of vision due to eye electrode pressure was Richard anxiety, fairly uniform over the small control sample and was 1971, 1976 12 depression and not especially uncomfortable. insomnia patients and 4 controls Magora, F. A: A: hospitalized No ill-effects were noted on prolonged and repeated 1967 20 polysubstance observations in dogs and in humans. B: abusers, and 9 B: asthmatic children Magora, F. inducing sleep No ill effects were observed after repeated 1965 31 experiments in the same and different individuals. Marshall, Alan depressive Although no patients were burned, the author and 1 1974 40 inpatients pilot subject suffered second degree burns behind 1 ear at the point of electrode contact. Matteson, graduate students 4 subjects left the study due to complaints of Michael 62 headaches. 1986 Miller, E.C. sleep induction There appears to be no disturbing side effects; 1965 27 however, 1 patient did undergo a brief dissociative episode after beginning his third treatment. Overcash, anxiety There were no reported side effects (short or long Stephen 1995 197 outpatients term). Philip, P. psychiatric In 2 cases, benodiazepine withdrawal induced 1991 21 depressive epilepatientic seizures in patients devoid of inpatients epileptic history. These seizures did not occur during CES. Rosenthal, psychiatric There was no side effects reported by any of the Saul H. 13 patients patients other than a transient blurring of vision 1970 unresponsive to reported by several of the patients, probably meds associated with the forced closure of the eyes by the eyepads for 1 hour, which cleared 15-30 minutes after treatment. Rosenthal, outpatients with The only side effect was the transient blurring of Saul H. chronic anxiety, vision reported by several of the patients, which 1970 18 depression & cleared within 15 minutes after treatment. It was insomnia probably due to the forced closure of the eyes and the pressure of the eye pads. It was seen less often with later patients, and this may be due to less tight placement of the electrodes. Rosenthal, 1 psychologist, 1 subject complained of mildly unpleasant Saul H. 3 medical experiences including visual disturbances lasting a 1972 7 students, maximum of 1 hour, tinnitus lasting several hours, 1 psychiatry hyperactivity, difficulty sleeping, and epigastric resident, sensations. His hyperactivity and sleeping 1 secretary difficulty were gone 48 hours after the final treatment and 1 week later he reported, "I don't feel anxious, I feel fine." His previous mild transient reactive depression had not occurred and he was sleeping soundly. 2 subjects reported a headache lasting 1 hour. Sing, K. anxiety patients The following side effects were noted: headache, 1967 30 with sleep giddiness, pain in tooth, heaviness around eyes, disturbances pain in eyes, pain behind the ears. Smith, Ray B. psychiatric There did not seem to be any pattern of addiction to 1993 outpatients with or over dependence on the CES device. There was no 23 anxiety, side effects except 1 patient who cried during depression, treatments, and 1 was sore behind the ears when the attention deficit electrode gel began drying out. disorder Smith, Ray B. closed head 1 patient on sham CES was seen to have a seizure. No 1994 21 injury inpatients negative effects from CES treatment was seen. Solomon, tension headache 6 of 7 in the active group, and 7 of 55 in the Seymour 112 patients placebo group had 1 or more adverse events. The 1989 incidence of adverse events was not significantly different between the active and placebo groups for any of the reported symptoms.
In addition, a search was conducted of United States Food and Drug Administration records through Freedom of Information Services. The search encompassed all complaints to FDA from May, 1976 through March, 1995 (latest available data). The search revealed only 3 entries. One was an implanted stimulator (which can hardly be considered a CES device) manufactured by Medtronic Neuro Division. The device apparently malfunctioned causing the need for it to be explanted. No death or serious injury occurred. The other two were both Pain Suppressor Model 112A malfunctions. Of these, one caused the patient to suffer extreme headache pain for about 10 hours, and lack of sleep for 48 hours. The patient discontinued use of the device, took a prescription sleeping pill and then felt better. The other was a patient who was two weeks pregnant and experienced the early signs of miscarriage. This patient was instructed not to use the device while pregnant and was referred to the instruction manual which expressly states "warning": the safety of the device during pregnancy has not been established. It should be noted that the output of the Pain Suppressor is up to 4 mA which is unusually high for a CES device.
Following recommendations of the National Research Council and over 25 years of medical experience with CES in America, the FDA considers CES to be a non-significant risk modality.
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