Abstract
This 20 year longitudinal study reports the incidence of tardive dyskinesia in 61,508 patients treated by 80 psychiatrists who used high dosage vitamins in addition to neuroleptics. During the period 19671987 only 34 patients (0.05%) developed tardive dyskinesia.

Previous Phases

Phase 1:
In 1978 the North Nassau Mental Health Center in Manhasset, L.I., N.Y. discovered that not a single case of tardive dyskinesia had developed in a consecutive series of 10,000 schizophrenic outpatients treated with high dosage vitamins in addition to the usual neuroleptics. These patients were treated by 15 different psychiatrists over a 12 year period. This observation was reported to a small group of biologically and nutritionally oriented psychiatrists in 1981.5

Phase II:
During the same 12 year period the author had personally treated 1000 inpatients in the Psychiatric Division of the Brunswick Hospital Center, Amityville, L.I., N.Y. with the same treatment regimen. These patients all had neurological work. ups and EEGs and were seen diagnostically by multiple clinicians as well as house staff. None of these patients developed dyskinesia.6

Phase III:
These observations led to a larger study in 1983 of patients similarly treated by 80 geographically widely distributed biologically oriented psychiatrists who routinely used high dose vitamins in their treatment of schizophrenics on neuroleptics (Phenothiazines and/or Haloperidol). The study period was from 1963-1983. During that time period 26 clinically diagnosed cases of tardive dyskinesia developed among a total population of 58,139 schizophrenic patients.7 In that study there were 69 psychiatrists (who collectively had treated 42,142 patients) who had never ha a single case of tardive dyskinesia over the 20 year period. The overall incidence (tardive dyskinesia in the total patients population studied was 0.045% or 1 case per 2,200 patients treated. 7

Current Study
Phase IV:
The psychiatrists in the previous stud who were on a referral list of physician who used vitamins in addition to neuroleptics in the treatment of their schizophrenic patients were re-contacted. The study period was for the years Jan. 1983 to Jan. 1986. The reporting data were limited to the reporting of tardive dyskinesia in patients who were receiving a combination of neuroleptics and high dosage vitamins. The average daily vitamin dosages consisted of 3 g ascorbic acid, 3 g niacin or niacinamide, 400 mg pyridoxine and 400 I.U. alpha tocopherol. Medications included all the commonly available phenthiazines or haloperidol, singly, or in combination.

Dosage of medications ranged from low maintenance to heroic high doses. The patients were from all geographic areas, all age ranges in both sexes and all socioeconomic levels. Their diagnoses included the whole gamut of schizophrenic and borderline disorders. These patients we also treated in the whole range of clinic settings including private practice, group practice, outpatient clinic and hospitalization in patients.

Results
The same group of 80 clinicians no reported an additional 8 cases of tardive dyskinesia during the years 1983-1986
amongst an additional 3,369 new patients seen during that period of time, or, an incidence of 0.3%. The total number of patients in the overall study was thus brought up to 61,508, Among this total population 34 patients had developed clinically observable tardive dyskinesia.

Of these 34 cases, 21 were men and 23 were women. Mean age of the men was 41 (range 24-59) and that of the women was 37 (range 20-67). 26 patients were diagnosed as chronic schizophrenia (DSM III diagnoses were 9 paranoid, 12 chronic undifferentiated and 5 were schizoaffective). 8 patients were diagnosed as acute schizophrenias (DSM III: 5 acute undifferentiated and 3 acute paranoid). Medications included the whole range of available phenothiazines and haloperidol alone or in combination. Almost all the patients had been on more than one antipsychotic and many had been on 4 or more. Doses ranged from customary standard recommended dosages to heroic high doses for prolonged periods of up to 20 years. The mean duration of treatment before symptoms developed was 4.6 years (range 1.3 to 10.1 years).

Comment
This is a large scale longitudinal study in that it includes the clinical experience of 80 psychiatrists in different treatment settings with a total of 61,508 consecutive patients over a 20 year time period. Collectively they report an incidence of tardive dyskinesia developing in only 0.05%, or 1 in 2000 of their patients treated with high dose vitamins in addition to the usual neuroleptics. The overall psychiatric literature reports an average incidence of 25-50% of tardive dyskinesia in patients with phenothiazines or haloperidol. For example, a recently reported study at the North Chicago Veterans Administration Medical Center reported a prevalence of 52% of tardive dyskinesia among the patients in their Community Care Placement Program.8 Despite improvements in pharmacologic expertise the problem continues to be a serious one.9 Research this far into the etiology and treatment of tardive dyskinesia has been inconclusive and no satisfactory means of prevention has been described, This study reports a successful clinical method of prevention that allows the patient to be adequately treated with medications. On the basis of this retrospective study a controlled prospective study appears to be warranted.

References