SUMMARY: How to Treat Arthritis with Niacinamide (Vitamin B-3)
COMMON FORM OF JOINT DYSFUNCTION
METHOD OF TREATMENT OF JOINT DYSFUNCTION (pages 20-29)
After completion of his physical examination, the patient was apprised of the normal and abnormal findings revealed by the clinical study. Where problems other than joint dysfunction existed, these were discussed, and appropriate therapeutic recommendations were made. The subject of joint dysfunction was then presented. The meaning of the numerical value of the patient's Joint Range Index was explained to him in terms of the Clinical Classification of Joint Function (see page 21), and the dynamic nature of joint dysfunction was described. The patient was told that joint dysfunction was reversible in time when appropriate therapy was taken.
All patients with joint dysfunction who elected to accept treatment were given niacinamide in suitable doses, either alone or in combination with other vitamins. When indicated the appropriate vitamins were prescribed in addition to niacinamide. The water-soluble vitamins used were never prescribed in aqueous solution, but as tablets or as dry powders in capsule form. When vitamin A was used, it was usually given in conjunction with vitamin D. Vitamin D was always given in conjunction with vitamin A; when vitamin D was administered in this study, the daily dosage rarely exceeded 6,000 U.S.P.units per 24 hours (14) (10) (38) (56) (59) (95).
Participation in the therapeutic program was entirely voluntary on the part of the patient. Some patients at the outset declined to accept treatment for their joint dysfunction. When a patient accepted therapy for his joint dysfunction, with each succeeding visit after the initial one, improvement or lack of improvement in his joint dysfunction was frankly discussed with him. No patient was chided because he was unwilling or unable to carry out the program of therapy as it was originally scheduled. Thus, because there was no “loss of face," most patients cooperated well and gave an accurate account of their deviations, if any, from the suggested therapeutic program. Some patients at the end of the first or second month of treatment, or at a later time, felt so much improved physically that they discontinued therapy for their joint dysfunction, mistakenly believing, in spite of advice to the contrary, that they were "cured," and required no further therapy or medical supervision. Some of these persons, who experienced a recurrence of their original pattern of symptoms upon premature cessation of therapy, returned subsequently for re-evaluation of their therapeutic needs. Other patients, who felt that they had not benefited from therapy for their joint dysfunction, did not continue with treatment though objectively they responded satisfactorily to adequate therapy, as shown by increasing values of the Joint Range Index on serial re-measurements.
Therapy was always
individualized. In the therapeutic program introduced for the treatment of
joint dysfunction, each patient served as his test object in the bio-assay of
the dosage of niacinamide necessary to reverse his joint dysfunction. Therapy
with niacinamide (used
The clinical classification of joint function in terms of the numerical values of the Joint Range Index is listed below:
Classification of Joint Function
For each clinical grade of joint dysfunction, the initial dosage schedule of niacinamide suggested below effects in time such improvement in joint dysfunction as the writer has considered to be clinically satisfactory. (However, since April 1947, it was found that dosage schedules 50-100% greater than those recommended below (particularly in the moderate, severe and extremely severe grades of joint dysfunction) are therapeutically superior, as judged by the patient's clinical response.)
While the initial dosage may be increased as necessary during treatment, it is not decreased, even though the Joint Range Index increases in response to adequate therapy.
The vitamins were administered orally, usually in equal doses at equal intervals during the day, and, in severe and extremely severe joint dysfunction, during the night when the patient would spontaneously awaken from sleep. In slight grades of joint dysfunction, the daily continuous ingestion of 100 mg of niacinamide after meals and at bedtime sufficed for treatment (400 mg/24 hours). Usually adequate in moderate joint dysfunction was the continuous ingestion of 150 mg niacinamide administered every 3 hours for 6 daily doses (900 mg/24 hours). In extremely severe and severe grades of joint dysfunction, 100-150 mg niacinamide were prescribed every hour (1500-2250 mg/24 hours), every hour and a half (1110-1650 mg./24 hours), or every two hours (800-1200 mg/24 hours), depending on the severity of the joint dysfunction, the more frequent schedule being used in more severe cases (97) (51).
It has been found in the treatment of joint dysfunction that the manner in which the daily dosage of niacinamide is divided has an important bearing on the the therapeutic results achieved; e.g., 300 mg niacinamide given three times daily (900 mg/24 hours) is inferior in its therapeutic action to 150 mg niacinamide administered every 3 hours for 6 daily doses (900 mg/24 hours). Therefore, to define the type of therapy used, the writer routinely records the following data: (a) the number of milligrams or units administered per dose, and (b) the total number of milligrams or units administered per 24 hours.
No untoward effects or clinical signs of toxicity were noted when niacinamide (alone or in combination with other vitamins) was administered on the above dosage schedules to individuals for short or long periods of observation. Before 1943, mild hypoglycemia had been noted clinically in a few persons when niacinamide exceeded certain dosage levels (97) (135) (51) (62), but this phenomenon has not been observed since that time.
"ADEQUATE" AND "OPTIMAL” DOSAGE LEVELS OF NIACINAMIDE IN THE TREATMENT OF JOINT DYSFUNCTION
"Adequate" dosage of niacinamide is defined as that clinically safe dosage of niacinamide which, when ingested in divided doses throughout the day by a person with joint dysfunction whose ordinary diet is not inadequate in protein or calories, and whose joints are not subjected to excessive mechanical joint injury, will effect in time what the writer has considered to be a satisfactory pattern of increasing values of the Joint Range Index. The pattern of recovery from joint dysfunction in response to niacinamide therapy, and the numerical limits of increments in the value of the Joint Range Index which are considered to be satisfactory for the first month of therapy and for succeeding months, are described on page 24.
“Optimal” dosage of niacinamide is defined as that clinically safe dosage niacinamide which, when ingested in divided doses during the day by a person with joint dysfunction, would permit the most rapid recovery in joint function, as demonstrated by the largest possible increments in the values of the Joint Range Index in the shortest possible period of time. At present, the optimal dosage of niacinamide for the treatment of joint dysfunction has not been determined clinically, although it is hoped to approximate such a dosage level eventually. Since adequate dosages of niacinamide have given clinically satisfactory results without producing any untoward symptoms or signs of acute or chronic toxicity, no attempt has been made in this study to determine the optimal level of niacinamide therapy in the treatment of the various clinical grades of joint dysfunction.
However, as the higher dosage levels of niacinamide have been cautiously explored in the past 22 months, it has been found in severe and extremely severe joint dysfunction that divided doses of niacinamide totaling 4 or 5 grams (4,000-5,000 mg) per 24 hours are therapeutically superior to the lower dosage schedules which previously had been considered adequate. Even these higher dosage levels of niacinamide may not be optimal for the treatment of joint dysfunction.
The optimal dosage of niacinamide for the treatment of joint dysfunction, as well as the limit of human tolerance for niacinamide, can be established only in those medical centers equipped to provide careful clinical supervision, and to conduct such chemical, metabolic and clinical laboratory studies as would reveal the earliest signs of toxicity, should these occur with the administration of progressively higher dosage levels of niacinamide.
DESCRIPTION OF JOINT DYSFUNCTION AND ITS TREATMENT FOR THE PATIENT
Since the cooperation of the patient is a prerequisite for the successful therapy of joint dysfunction, it was found desirable and necessary before treatment of joint dysfunction was instituted to discuss with the patient his various clinical problems (including the dynamic nature of joint dysfunction, and its response to niacinamide treatment, and the dynamic nature of certain complicating syndromes, and their appropriate treatment), and the therapeutic goals. During the course of therapy, it may become necessary to review and amplify this discussion for the benefit of the patient as various clinical problems arise.
is the articular aspect of a generalized, usually slowly progressive
metabolic disorder which is corrected in time by adequate niacinamide
therapy. Since the retrograde changes in tissue structure and function which
characterize this disorder occur insidiously over a period of years, many of
its symptoms and signs are incorrectly attributed by laymen and physicians
alike to the so-called "normal" aging process. But
Theoretically, optimal nutrition must be continuously available to bodily tissues to ensure the best possible structure and function of tissues (104) (108). While we do not know what constitutes optimal nutrition, it has been demonstrated empirically that even persons eating a good or excellent diet according to present-day standards exhibit measurable impairment in ranges of joint movement which tends to be more severe with increasing age (see page 153). It has also been demonstrated that when such persons supplement their good or excellent diets with adequate amounts of niacinamide, there is, in time, measurable improvement in ranges of joint movement, regardless of the patients' ages. In general, the extent of recovery from joint dysfunction of any given degree of severity depends largely on the duration of adequate niacinamide therapy (see pages 187 and 188).
With the ingestion of adequate amounts of niacinamide continuously for a sufficient period of time, a patient whose ordinary diet is not inadequate in protein or calories, whose joints are not subjected to excessive mechanical trauma, will recover from joint dysfunction at the satisfactory rate of 6.0 to 12.0 Joint Range Index units, or better, in the first month of therapy, and 0.5 to 1.0 Joint Range Index unit, or better, for each month of therapy thereafter, until a Joint Range Index of 96-100 is reached. (Rarely, when a patient has one or more ankylosed joints, he may have no appreciable active or passive movement of these ankylosed joints, even after two years of adequate niacinamide therapy, although his other joints recover the full ranges of movement in response to such therapy. In such cases, the Joint Range Index cannot reach 96-100; e.g., when one wrist is ankylosed and has not shown increased movement in response to niacinamide therapy, the maximum Joint Range Index attainable is 90.9; and when both wrists are ankylosed, the maximal Joint Range Index attainable is 81.8.)
In general, the more severe and more chronic the patient's joint dysfunction, the slower is the rate of recovery in response to adequate niacinamide therapy, and the slower his subjective appreciation of improvement. The rate of recovery for each patient must be established empirically from serial determinations of the Joint Range Index. In order to ensure a continuously satisfactory rate of recovery from joint dysfunction, the physician must re-examine the patient at intervals during the course of niacinamide therapy. Whenever a patient taking the amounts of niacinamide prescribed by the physician, and eating a good or excellent diet, fails to make satisfactory improvement in his Joint Range Index, in the absence of excessive mechanical joint injury the niacinamide schedule must be revised upward to that level which permits satisfactory improvement. Failure of the patient to take niacinamide as directed will result in failure to improve at a satisfactory rate.
When a patient has joint dysfunction associated with obvious arthritic deformities, he is told that the physician cannot predict whether or not in his case articular deformities will resolve with adequate niacinamide therapy. However, in response to adequate niacinamide therapy for a sufficient period of time, other patients have shown partial or complete resolution of their arthritic joint deformities. Some patients with arthritic deformities show resolution of some of their joint deformities, but not of others. Only careful observation of the patient's deformities on serial re-examinations will indicate whether or not his deformities are resolving in response toadequate niacinamide therapy. In most instances, the rate of resolution of the deformities will be slow, if it occurs at all.
It cannot be predicted whether or not a given joint that appears to be completely ankylosed clinically will recover any degree of movement. It has been observed many times that joints appearing to be clinically ankylosed prior to therapy tend to have partial or complete recovery of movement in response to adequate niacinamide therapy, although some ankylosed joints have not shown any degree of movement as a result of therapy during an observation period of several years. In response to adequate niacinamide therapy over a sufficient period of time some patients have partial or complete recovery of movement in some of their ankylosed joints, but not in others. Only careful observation of the ranges of joint movement on serial re-examinations will demonstrate whether or not a given ankylosed joint can recover any degree of movement in response to adequate niacinamide therapy.
In general, in the absence of complicating factors, the higher the patient's Joint Range Index rises in response to adequate niacinamide therapy, the fewer articular symptoms he will have; and the better he will feel. However, even though the Joint Range Index increases satisfactorily in response to adequate niacinamide therapy, the patient may not feel well because of complicating syndromes which are not on the basis of aniacinamidosis. Careful clinical study is necessary in order to establish the etiology of whatever complicating syndromes may be present and, with appropriate therapy, the patient is likely to become free from articular symptoms and to feel well. However, at any time symptoms of bodily discomfort may recur which must be studied and given appropriate treatment as promptly as possible, if the patient is to feel well again. While the patient may obtain temporary relief from articular and other symptoms through the use of analgesics, narcotics, sedatives, antihistaminics and local anesthetics, only adequate treatment of joint dysfunction and the complicating syndromes is likely to give more lasting benefits.
In order to assess the effects of niacinamide therapy on joint dysfunction and on the patient's general status, the patient is usually re-studied one month after continuous niacinamide therapy has been instituted. If good progress in recovery from joint dysfunction is noted at that time, he is reexamined in two months, and thereafter every three to six months. For the most part, this schedule of re-examination is found to be satisfactory for the supervision of the therapeutic program of patients presenting the chronic problems of joint dysfunction, although when the individual's problems are of unusual complexity, or when intercurrent problems arise, the time interval between visits is shortened.
When a patient with joint dysfunction fails to make the anticipated progress in response to niacinamide therapy, he is asked if he has taken the medication as prescribed; if not, he is urged to do so. (When a patient has taken multiple vitamin capsules as prescribed and has not made satisfactory improvement in his Joint Range Index in response to such therapy, the druggist is asked how the vitamin powders were compounded. The clinical effectiveness of niacinamide seems to be lessened when niacinamide is mixed with ascorbic acid by vigorous trituration, since this favors inter-molecular reactions between niacinamide and ascorbic acid in the dry powder state. The occurrence of such inter-molecular reactions between niacinamide and ascorbic acid is hindered by the preliminary admixture of each dry powder separately with a small amount of calcium stearate (0.2%) before the final admixture by sieving.)
It is always emphasized that the patient must take his medication continuously as prescribed until such time as the supervising physician may decide, on the basis of objective clinical evidence, that it is necessary to increase the level of niacinamide therapy in order to produce continuously satisfactory improvement in the Joint Range Index.
However, certain factors other than the ingestion of inadequate amounts of niacinamide may tend to depress the Joint Range Index. These include (a) transient or persistent mechanical joint injury resulting from unusual or physical exertion (see page 79) or from psychogenically sustained hypertonia of somatic muscle (see page 115), (b) rapid and excessive gain in weight to obesity levels, (c) excessive ingestion of alcohol, (d) inadequate dietary protein. When any of these factors is operative, it is of limited value to increase the amounts of niacinamide taken by the patient in an effort to effect satisfactory improvement in the Joint Range Index. Instead, treatment should be directed toward lessening the degree of mechanical joint injury, reducing the patient's weight to the normal range, interdicting alcohol, and increasing the protein intake to adequate levels, respectively.
When indicated, the physician describes for the patient four complicating syndromes frequently coexisting with joint dysfunction, and their treatment (see page 76). Most of the articular and non-articular symptoms of a patient with joint dysfunction which are not corrected by niacininide therapy usually originate as part of these four complicating syndromes. When the patient understands the etiologic basis of his symptoms, he will not have anxiety concerning the meaning of symptoms which would otherwise seem mysterious and alarming. The patient with joint dysfunction who has one or more of these complicating syndromes is told that he will not feel well unless joint dysfunction and these coexisting syndromes are correctly identified and successfully treated, and that in order to accomplish this, his active participation in the clinical investigation and therapeutic program is required.
TYPICAL IMPROVEMENT IN MOBILITY OF A SINGIE JOINT IN RESPONSE TO LEVELS OF NIACINAMIDE THERAPY USED PRIOR TO APRIL 1947
In serial determinations of the mobility of single joints in response to levels of niacinamide therapy used prior to April 1947, it was found that niacinamide-induced recovery of full joint mobility was an orderly process. (Since April 1947, when higher dosage schedules of niacinamide were introduced (see page 21), there has been a marked reduction in the incidence of articular pain and discomfort upon maximal passive movement of the moveable joints during various stages of recovery from joint dysfunction.)
There is described below typical improvement in joint mobility, as illustrated by several sequential stages occurring during niacinamide-induced recovery of full mobility of the metacarpophalangeal (knuckle) joint.
(Figure 14 is a schematic representation of maximal passive extension of the meta-carpophalangeal joint at four successive stages (a) (b) (c) (d), during the course of niacinamide-induced recovery of full joint mobility. The line touched by the head of the arrow in (a) (b) (c) (d) indicates the upper limit of painless extension. The shaded angle in (b) and (c) indicates the range of painful passive extension.)
Figure 14(a). On the initial examination before niacinamide therapy was instituted, the metacarpophalangeal joint of the forefinger of the right hand could be extended passively to 30% of the full range of extension for this joint. No pain or discomfort was experienced by the patient during this maneuver. The examiner noted the presence of palpatory resistance from the initiation of the movement of passive extension of this metacarpophalangeal joint, and this resistance progressively increased as the joint was extended from the range of 0% to 30% of the maximal extension; the palpatory resistance at the end of the movement was graded as firm. When at the 30% level of passive extension a small increase of force in the direction of extension caused no further extension of this joint, 30% of the full range of extension was taken as the upper limit of maximum passive extension of this metacarpophalangeal joint.
Figure 14 (b). At the end of one month of continuous, adequate niacinamide therapy, maximal passive extension of this metacarpophalangeal joint increased to 60% of the full range of extension. No pain or discomfort was experienced by the patient when the metacarpophalangeal joint was extended from 0% to 40% of the full range of extension. The patient experienced localized joint pain, often severe, as the joint was passively extended from 40% to 60% of the full range of extension. The examiner's palpatory sensation indicated that movement of the joint in passive extension was free from 0% to 40%, and that there was soft, yielding resistance which progressively increased as the finger was extended at the metacarpophalangeal joint from 40% to 60% of the full range of movement. When a further small increase of the extending force did not increase the degree of extension, 60% of the full range of extension was taken as the upper limit of passive extension of this metacarpophalangeal joint. The palpatory resistance at the end of the movement of extension was rubbery.
Figure 14 (c).After months of continuous, adequate therapy with niacinamide, maximal passive extension of the metacarpophalangeal joint reached 100%; i.e., the full range of movement. Passive extension of the metacarpophalangeal joint from 0% to 85% was without pain or discomfort; passive extension from 85% to 100% was painful. The examiner's palpatory sensation indicated that the movement of this joint was free from 0% to 85%, and that there was soft resistance, which increased progressively with increasing extension of the metacarpophalangeal joint from the level of 85% to 100%. A small additional force in the direction of extension when the 100% level was reached did not cause further extension of this joint. The palpatory resistance at the end of the full range of movement (100%) was rubbery.
Figure 14(d). With a longer period of continuous, adequate niacinamide therapy, it was possible to achieve full, free and painless extension of this metacarpophalangeal joint to the level of 100%. Slight additional palpatory force in the direction of extension with the joint fully extended did not increase the amount of movement beyond the full range of extension; i.e., the 100% level. The examiner's palpatory sensation indicated that the movement of extension was free from 0% to 100% of full extension, that the resistance met at the end of this movement was firm, and that the patient experienced no pain from this maneuver.
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