Results of Alpha-Stim® postmarketing surveys Survey of Alpha-Stim® Warranty Cards2 Additional support for the efficacy and safety of Alpha-Stim®, and validation of the post-marketing clinical results achieved with this therapy, comes from an analysis of warranty cards completed in 2000. The analysis included 2,500 consecutive survey forms submitted by patients (72% female, 15 to 92 years old, mean age 50 years) with multiple symptoms who have used Alpha-Stim® MET or CES for at least 3 weeks. The length of treatment ranged from 3 weeks to 5 years (average 3.5 months). None of the patients reported any significant side effects of the therapy even though they were explicitly asked to list them on the warranty card. A level of improvement of at least 25% was considered clinically significant. See Smith (2001) for more information. Self-reported outcomes of Alpha-Stim® therapy (percent improvement; n = 2,500 patients)

Condition	N	Slight <24%	Fair 25-49%	Moderate 50-74%	Marked 75-100%	Clinically Significant >25%
Pain (all cases)	1,949	6.98	31.97	38.02	23.04	93.02
Back Pain	403	4.96	27.05	38.96	29.03	95.04
Cervical Pain	265	6.79	26.04	47.17	20.00	93.21
Hip/Leg/Foot Pain	160	3.75	26.88	33.13	36.25	96.25
Shoulder/Arm/Hand Pain	150	8.67	27.33	42.00	22.00	91.33
Carpal Tunnel	25	0.00	20.00	68.00	12.00	100.00
Arthritis Pain	188	5.85	27.13	46.81	20.21	94.15
TMJ Pain	158	10.76	37.97	37.97	13.29	89.24
Myofascial Pain	62	9.68	29.03	29.03	32.26	90.32
Reflex Sympathetic Dystrophy	55	18.18	29.09	34.55	18.18	81.82
Fibromyalgia (alone)	142	9.15	37.32	36.62	16.90	90.85
Fibromyalgia (with other)	363	9.09	36.09	41.87	12.95	90.91
Migraine	118	1.69	41.53	25.42	31.36	98.31
Headaches (all other)	112	17.86	26.79	21.43	33.93	82.14
Psychological (all cases)	723	8.44	24.20	32.78	34.58	91.56
Anxiety (alone)	128	10.16	22.66	32.81	34.38	89.84
Anxiety (with other)	370	8.92	22.97	32.97	35.14	91.08
Anxiety/Depression	58	5.17	32.76	32.76	29.31	94.83
Depression (alone)	53	13.21	20.75	43.40	22.64	86.79
Depression (with other)	265	10.94	23.02	35.09	30.94	89.06
Stress	123	4.88	24.39	31.71	39.02	95.12
Chronic Fatigue	50	6.00	60.00	20.00	14.00	94.00
Insomnia	163	6.13	28.83	28.83	36.20	93.87

Results of Alpha-Stim® warranty card survey

CES vs. Antidepressants: an analysis of treatment efficacy³

The following analysis compares the efficacy of leading selective serotonin reuptake inhibitors (Prozac, Paxil, Zoloft, Celexa) and serotonin-norepinephrine reuptake inhibitors (Effexor, Serzone) with that of cranial electrotherapy stimulation (CES). The cited drug efficacy information is based on the data reported to the FDA by the manufacturers of the respective brands as part of their new drug application process⁴. CES efficacy data come from studies^5-12 submitted to the FDA by the manufacturer of the Alpha-Stim®, Electromedical Products International, Inc. as part of a regulatory 515(i) reclassification process for CES³.

The results of this comparison suggest that CES may represent a stronger modality for the treatment of depression than antidepressants given its high average effect size (63%), which can be interpreted as the additional amount of clinical improvement beyond the benefits (effects) of placebo. The comparative average value for antidepressants appears to be only 21%³. See Gilula and Kirsch (2005) for more information.

Alpha-Stim® cost containment and treatment efficacy analysis

References:

¹Kirsch, Daniel L. (2002). The Science Behind Cranial Electrotherapy Stimulation, 2nd Edition, Medical Scope Publishing Corporation, Edmonton, Alberta, Canada, 224 pp.
²Smith, Ray B. (2001). Is microcurrent stimulation effective in pain management? An additional perspective. American Journal of Pain Management 11(2):62-66.
³Gilula, M. F. and D. L. Kirsch (2005). Cranial electrotherapy stimulation review: a safer alternative to psychopharmaceuticals in the treatment of depression. Journal of Neurotherapy 9(2): 7-26.
⁴Kirsch et al. (2002). The emperor's new drugs: an analysis of antidepressant medication data submitted to the FDA. Prevention and Treatment, 5:1-11.
⁵Bianco, F. (1994). The efficacy of cranial electrotherapy stimulation (CES) for the relief of anxiety and depression among polysubstance abusers in chemical dependency treatment. Ph.D. Dissertation. University of Tulsa.
⁶Krupitsky et al. (1991). The administration of transcranial electric treatment for affective disturbances therapy in alcoholic patients. Drug and Alcohol Dependence 27(1):1-6.
⁷Lichtbroun et al. (2001). The treatment of fibromyalgia with cranial electrotherapy stimulation. Journal of Clinical Rheumatology 7(2):72-78.
⁸Matteson, M. T., and J. M. Ivancevich (1986). An exploratory investigation of CES as an employee stress management technique. Journal of Health and Human Resource Administration 9:93-109.
⁹Rosenthal, S. H. (1972). Electrosleep: a double-blind clinical study. Biological Psychiatry 4(2):179-185.
¹⁰Rosenthal, S. H. and N. L. Wulfsohn (1970). Electrosleep: a preliminary communication. Journal of Nervous and Mental Disease 151:146-151.
¹¹Smith et al. (1994). The use of cranial electrotherapy stimulation in the treatment of closed-head-injured patients. Brain Injury 8(4):357-361.
¹²Smith, R. B., and L. O’Neil (1975). Electrosleep in the management of alcoholism. Biological Psychiatry 10(6):675-680.