The Prevention Of Tardive Dyskinesia with High Dosage Vitamins:

A Study of 58,000 Patients

David R, Hawkins, M.D.

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Tardive Dyskinesia is a critical clinical problem in psychiatry today and almost every issue of every professional journal carries at least one article devoted to the subject. In general, the incidence is reported to be on the average of between 10 and 25% of patients on neuroleptics, and the recovery rate is reported to be about 50% patients who develop this neurological disorder.

T.D. has presented the profession with whole variety of practical as well as theoretical problems. It also presents an ethical as well as a medico-legal dilemma for the practitioner. If he withholds neuroleptic medication the patient's psychosis may progress or re-emerge, and psychotic behavior and self-destruction in all its forms may occur. If the patient commits a crime, or suicide, or is overtly destructive, the physician may be sued for malpractice for failing to institute proper treatment. If he places the patient on medication and T.D. develops, he may be sued for causing the T.D. Many private clinicians are currently solving the problem by refusing to treat patients who require antipsychotic drugs, but physicians such those who work in hospitals and state institutions are caught in an insoluble conflict situation. Even if a truly effective treatment eventually is found, the illness will still have already been present with all its risks, Until recently, knowledge about T.D, was limited primarily to the profession and the unfortunate victims of the disorders. Recently, however, in November of 1983, there was a three day nation-wide documentary program devoted to T.D. aired on CBS television and the public was exposed to viewing some severe cases plus the news that one million dollar malpractice awards were being won by T.D. victims.

The program included a moralistic denunciation of the profession which "should have known better than to prescribe anti-psychotic drugs" by a Monday morning quarterback critic. The program deliberately promoted emotionalism and sympathy in the viewer and indignation at the guilty culprit, the practicing physician, together with the strong suggestion to sue for a million dollars. The full impact of this widely televised program is yet to be felt by the profession, but numerous lawsuits are currently in preparation as an immediate aftermath, Once the legal precedent has been set, the door is open to a mass of lawsuits, The TV documentary estimated, based on incidence and prevalence, and the number of patients who need anti-psychotic drugs, that within a year one million Americans will have developed T.D. The medico-legal potentiality of this is awe inspiring, to say the least.

Over the past 20 years there has been much work done to clinically investigate the value of high dosage vitamins as an adjunct in the treatment of schizophrenics and other perceptually disordered psychotic conditions. There was much discussion, argument and political dissension about this approach, which first arose at a time in the 1950s and '60s when psychiatry was previously psychoanalytically oriented and there was little knowledge about the relationship between nutrition and brain chemistry. Orthomolecular psychiatry developed out of the inquiry as to whether therapeutic nutrition favourably affected psychotic disorders or not, There were conflicting reports in all the literature and the Issue was never settled to general satisfaction. The end result was that those who believed that nutrition helped their patients continued to use high dosage vitamins in treating their schizophrenic patients,

During the late 1960s, the 1970s and early 1980s, well over a hundred thousand psychotic patients were on high dosages of vitamins as well as the standard treatment of anti-psychotic drugs. These were primarily long term patients who were on neuroleptics and on mega-vitamins for years, many for as long as 20 years and more, There is thus a very large patient population group that has been treated by a large number of physicians over a period of many years distributed throughout the entire country under very diverse family, ecological and socio-economic conditions.

By the late 1970s it was clear from the psychiatric literature and professional meetings that T.D. was becoming an increasingly frequent clinical development in patients who were solely on neuroleptic drugs, At the North Nassau Mental Health Center in Manhasset Long Island, New York, we had been treating large numbers of schizophrenics since the mid-1960s with anti-psychotics, plus megavitamins and sugar free diets. (We reported our results and techniques primarily in the book Orthomolecular Psychiatry published with Prof. Linus Pauling as Co-editor.) We noticed that none of our patients either in private practice, the hospital or the clinic had developed overt T.D. We searched through our case loads over the years and there was not a single case of clinically apparent T.D. amongst the 15,000 schizophrenic patients we had treated over the past 15 years. Together with Dr. Charles Tkacz we presented a report at the Academy of Orthomolecular Psychiatry Meeting in May, 1981, and published it in the Journal of Orthomolecular Psychiatry in 1981.1 We thought that it would be overlooked in a sub-speciality journal of limited circulation so notices were placed in Psychiatric News to bring it to the attention of the profession at large. Perhaps the fact that we had NO cases of T. D. in 15,000 patients presented a credibility problem, as many clinicians probably thought that we ought to have some, at least! It was decided to enlarge the study to include a much wider patient population so as to include the clinical observations of many more physicians and Institutions. This was done in December, 1983.

One hundred clinicians were contacted who were known to have large practices which included prescribing megavitamins along with neuroleptics in the treatment of schizophrenic patients. They were scattered throughout the United States and Canada and had been using megavitamins in their practice for an average of at least 10 years or more, Twenty physicians stated that they did not use neuroleptics; and the remaining 80 physicians reported on the number of cases they had treated over the last 10 years and the incidence of overt T.D. in their practices.

The average dose of megavitamins was 3 grams daily of Vitamin B3 (of either Niacin or Niacinamide) plus 3 grams of Vitamin C, plus 600 mg of B6 and often Vitamin E 600 IU was included. Nutramega was the brand formulation most often prescribed which contained the megadoses in capsule form). This was divided into 1/3 the daily dose at each meat (3 capsules 3 times daily of the most frequently used formulation.)

The results of the study were as follows: 69 physicians treated a total of 41,972 patients without a single case of T.D. 11 physicians treated a total of 16,070 patients and reported collectively 26 cases Thus, 80 clinicians treated a total of 58,042 patients with an incidence of 0.045% T.D. (In this reporting, only cases of overt clinically observable T.D. are reported).

The 26 cases of T.D. who were reported among the 58,000 patients have as yet not been studied and so it is still unknown whether they were bona-fide T.D. or not. (As one clinician put it "Everything that shakes is now called T.D. - but we saw
movement disorders years before the antipsychotic drugs".) Also, it is not known whether those 26 patients actually took the prescribed megavitamins or not. It could also be argued that the cases of T.D. were under reported. This would mean that the symptoms were not noticed by the patient or his family nor by the treating physician or his assistants (many of the reporting physicians practice in groups and clinics with large staff and patients are seen by a multiplicity of professionals). To help clarify this problem, there is amongst this large patient population a sub-group of 1,000 patients whom I personally treated over a 10 year period in the hospital and all of whom had a neurological examination by an attending neurologist on the staff of the Brunswick Hospital. All of these patients were on neuroleptics, all were markedly psychotic and the majority were consequently on high doses of antipsychotics. All of these patients had a neurological work-up, including EEG and psychological testing, and were examined by an internist as well as at least one other psychiatrist, Over the ten year period no patient developed clinical T.D.,

With evidences of T.D. being reported of 10% to 50%, we should have expected between 6,000 to 20,000 cases of TD. in this study of 58,000 patients. Even if there were a 100% error in the reporting of cases (i.e. 52 cases instead of 26), there would still only be a remarkably low incidence of 0.1%!

Summary
A study of the practices of 80 physicians over a 10 year caseload of 58,000 patients treated with antipsychotic drugs plus high dosage vitamins, reveals a total of only 26 patients developing Tardive Dyskinesia, This Is an incidence of less than 0.05%. This is a remarkable finding in view of currently reported rates of 10% to as high as 60%. The data are strongly suggestive that the prescribing of high dosage Vitamins B3, C and B6, along with neuroleptic drugs, provides almost 100% protection against the development of this dread neurological disorder which is reportedly irreversible in 50% of those patients in whom it develops.

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