Padma28 and the effect on MS
Experience of Padma 28 in
PHYTOTHERAPY RESEARCH, VOL. 6,133-136 (1992)
T. Korwin-Piotrowska, D. Nocon, A. Stankowska-Chomicz, A. Starkiewicz, J.
Wojcicki and L. Samochowiec
Clinic of Neurology, Institute of Pharmacology and Toxicology, Medical Academy,
Powstancow Wielkopolskich 72,
One hundred subjects suffering
from a chronic progressive form of multiple sclerosis were randomly divided
into two equal groups. Group 1 received Padma 28, two tablets three times a
day, and group 2, the control, were treated only symptomatically. Treatment
and observation lasted for 1 year. Examinations performed directly prior to
the study and in the course of observation included- neurological state, visual
and auditory evoked potentials, basic laboratory tests. A positive effect of
Padma 28 was observed in 44% of patients with multiple sclerosis in the form
of improvement of general condition, increase of muscle strength, decrease or
disappearance of disorders affecting sphincters. In 41% of patients with initially
an abnormal tracing of visual evoked potentials, an improvement or normalization
was achieved. Of patients, who did not receive Padma 28 none felt better, moreover,
40% of them showed a deterioration. Tolerance of the drug was excellent
Keywords: multiple sclerosis; Padma 28; treatment in 100 patients.
Multiple sclerosis is a chronic, often progressive, demyelisation disease that
is characterized by gait disturbances, visual and coordination impairment, sensory
complaints and genitourinary dysfunction. Numerous studies show that abnormal
immunological processes occur in this illness, in the form of humoral and cellular
reactions directed to viral cerebral antigens. According to one of these hypotheses,
in multiple sclerosis lymphocytes become sensitized to unidentified cerebral
viral or miscellaneous antigens. Cytotoxic lymphocytes and activated macrophages
are formed, and soluble factors are released (Cendrowski, 1980; Halliday and
McDonald, 1977; Kuratowska et al., 1982; 1,owitzsch et al., 1976). Oligodendrocytes
and myelin sheaths of the brain become the target of the cytotoxic attack in
sclerosis (Cendrowski, 1986). Bach (1982) disclosed that in cerebrospinal fluid
and the peripheral blood there is a decrease in suppressory lymphocytes (T,)
and an increased index of helper lymphocytes (TH: T,) in the period 2 weeks
prior to the attack of the disease, and up to 2 weeks after the attack.
lt is reported in the literature that Padma 28 is likely to exert an effect
on immunoregulation by affecting suppressory lymphocytes (Badmajew et aL,
1982b; Brzosko et al., 1983). Considering the immunotropic properties
of Padma 28 and data that the preparation may induce in humans, synthesis of
endogenous interferon (Brzosko et al., 1984), we have attempted to estimate
its therapeutic activity in patients suffering from multiple sclerosis. Padma
28 is an herbal mixture of the lamaistic medical science, consisting of 22 ingredients
combined in a specific order, according to strict weight ratios and according
to the prescription of W. N. Badmajew (Badmajew et al., 1982a). The chemical
components of the preparation have been identified using gas chromatography
and thin-layer chromatography (Sarnochowiec, 1983). Padma 28 stimulates the ascorbate
system (Wöjcicki et al., 1989) and is able to decrease lipid peroxidation,
thus exhibiting antioxidant properties (Samochowiec and Wöjcicki, 1987).
One hundred subjects suffering from progressive (and
proceeding with attacks) multiple sclerosis were randomly divided into two equal
groups. Group 1, consisting of 33 women and 17 men, aged 26 to 56 years, mean
38.4 years, received Padma 28, two tablets three times a day (Table 1); Group
2, including 29 women and 21 men, aged 29 to 60 years, mean 40.1 years, was
treated only symptomatically, receiving drugs to reduce pain, spasticity and
cramps, and to inhibit detrusor contractions. Observation was conducted at the
Medical Outpatients Clinic for Multiple Sclerosis. The study and treatment was
spread over a period of 1 year for each patient.
Prior to the onset of therapy, in all patients investigations covered the general
neurological state, blood morphology with a smear, blood platelets, erythrocyte
sedimentation rate, biochemical studies of the blood serum (urea, creatinine,
glucose, aminotransferases, alkaline phosphatase), urine analysis. Moreover,
Padma 28 was administered and directly after the end of therapy, visual and
auditory evoked potentials were studied in the whole group. Visual evoked Potentials
were investigated by applying the stimulation with reversal standard of chequerboard
at 2 Hz frequency, by means of a monitor, repeated 200 times, successively exciting
the retina of each eye. The per- formed evaluation embraced the amplitude and
latency of cortical response originating from the occipital region. The established
norm for cortical visual potential P, is 90-1 10 ms.
The studies of auditory evoked Potentials consisted
of applying stimuli through headphones in the form of "clicks" lasting
0. 1 ms, frequency 30 Hz and intensity 60 dB, above the auditory threshold (electroneuronograph,
Neuramatic 2080, Disa, Skovlunde, Denmark). These stimuli were used to excite
the right and left ear, 2000 times consecutively. Then the bioelectric responses
from the brainstem were estimated. Attention was paid to the individual components
as responses from respective nuclei of the brainstem. The brainstem auditory
evoked responses comprise a series of potentials (1-1V). Wave 1 corresponds
to activation of the Vlllth nerve, waves 111111 of the cochlear and olivary
nuclei, wave IV corresponds to the nuclei of the lateral lemniscus, wave V to
the inferior colliculus. Latencies are often measured from wave 1. The evaluation
included the latent excitation (absolute latency) as well as intercomponent
latency (relative latency). The elongation of intercomponent latency 1-111 was
looked upon as pathological change, thus pathological changes in the pons were
accepted as values being 2.25 ms. But the elongation of latency 111-V evidencing
a pathological change in the mesencephalon was taken as over 2.05 ms.
the evaluation of the therapeutic efficacy, attention was focussed on the number
of attacks, the dynamic with which the symptoms regressed after a new attack,
the delay in the slowly intensifying course of multiple sclerosis as well as
a diminution in intensity of certain neurological symptoms according to a numerical
scale (Cendrowski, 1986). This numerical scale is used to estimate the intensity
of the individual neurological symptoms in points from 0 to 4. In this way there
were estimated pyramid symptoms, cerebellum symptoms, disorder of sensation,
sphincters and sight.
Characteristic of patients treated with Padma 28
The effect of Padma 28 on multiple sclerosis depending on the course of disease
is presented in the table.An objective estimation of the improvement or aggravation
in multiple sclerosis is difficult. We were estimating the patients' neurological
state according to the numerical scale in several trials.
An improvement was reported in 22 patients, i.e. in 44% (Table 2). In 18 of
them a diminution of paresis was observed, to the following degree: in 10 of
them moderate paresis changed into light paresis (according to the numerical
scale from 3 to 2 points); in 5 of them grave paresis reduced to moderate paresis
(according to the numerical scale from 4 to 3 points); in 3 of them tight paresis
disappeared (reduction from 2 to 1 point). Apart from this, in 3 patients the
disorder of sensation, and in 1 subject the ataxy, disappeared.
An assessment of the health of untreated subjects (control group), with the
course of the disease being taken into consideration, is depicted in Table 3.
lt is obvious from this Table, that among patients who did not receive Padma
28, none of them felt better, while 20 patients (40%) reported deterioration.
The results of treatment with Padma 28, including the age of patients, are shown
in Table 4. lt is seen from this Table, that among the subjects over 50 years
of age, no deterioration was observed. In other groups, the deterioration occurred
most frequently among patients 41-50 years old.
Before the onset of therapy, visual evoked potentials were found to be normal
in 26 patients, while 24 subjects demonstrated an elongated latency of the P,
wave from 118 to 150ms. At follow-up examination, after the end of therapy with
Padma 28, 8 patients showed an improvement expressed by the shortening of P,
Examination of the auditory evoked potentials in 30 patients exhibited an abnormal
tracing (60%). In 15 of them the intercomponental latency 1-111 was elongated
over 2.25 ms; in 10 persons the elongation of intercomponental latency 111-V
was over 2.05 ms and in 5 patients there was an elongation of latency 1-111
At control examination upon the termination of therapy the tracing, from 1 patient
had worsened, in others the tracings failed to indicate any significant changes.
No side effects were noted. The tolerance of the drug was excellent. Laboratory
tests were unchanged in the course of the trial.
Effect of Padma 28 on the course
Course of multiple sclerosis in
the control group
Results of the treatement with Padma 28 in relation to age
None of the therapeutic methods in current use has influenced the natural course
of multiple sclerosis. In treatment, 180 or so methods and drugs have hitherto
been used, and only a small number have overcome the test of time (Wender, 1990).
Several observations suggest that an immunological process is involved in the
pathogenesis of multiple sclerosis (Ross Russei and Woles 1985). Although the
CNS is normally immunologically projected by the blood-brain barrier, this structure
is easily damaged, allowing CNS invasion by systemic immune cells form which
the Ig-secreting cells in the brain of patients with multiple sclerosis are
derived. Because of the very incomplete understanding of the immunological basis
of multiple sclerosis it is not yet certain whether stimulatory or suppressive
immunological treatment should be given. Existing trials suggest that immunological
treatment can reduce the rate of disability and frequency of relapse even in
severely affected patients (Cendrowski, 1980; Halliday and McDonald, 1977; Lowitzsch
et al., 1976). Padma 28 is an immunoregulatory drug (Brzosko et al.,
1982) improving the function of T suppressor lymphocyte (T,) and thus the
function of the immune system. Although this drug has no lymphopoietic activity
like thymic hormones, it seems to influence differentiation and maturation of
T, lymphocyte lineage. Taking into account the immunoregulatory properties of
Padma 28 application of this drug in patients suffering from multiple sclerosis
seems to be fully justified.
Padma 28 was administered to 50 patients affected by multiple sclerosis. They
included 29 persons, in whom multiple sclerosis proceeded with attacks, and
21 subjects who had a slowly progressing course of the disease. In the first
group improvement was recorded in 52% of patients, deterioration occurred in
10% while in 38% the condition remained unchanged. In a similar control group
containing 31 persons with attacks of multiple sclerosis, who were not treated
with Padma 28, not a single patient experienced improvement, deterioration appeared
in about 35%, and in 65% of subjects the course of multiple sclerosis was unaltered.
Twenty-one patients with slowly progressing multiple sclerosis were given Padma
28. Seven of them (33%) revealed improvement, in 3 persons (14%) the state worsened,
and in 11 subjects (52%) no changes were observed in the course of treatment.
In the group of 19 persons with slowly progressing multiple sclerosis, who were
not receiving Padma 28, not a single case of improvement was detected, in 9
patients (47%) deterioration took place, and in 10 subjects there was no alteration.
It is worth mentioning that in only 3 patients taking
Padma 28, attacks of disease occurred and in 4 patients the attack had appeared
after the termination of therapy. Thus, it seems to be obvious that Padma 28
exerts a positive effect on the course of multiple sclerosis. In patients treated
with this drug, there was improvement as in many as 44% of subjects. Among the
50 control patients with multiple sclerosis, who were not treated with Padma
28, there was no improvement in any of the cases.
Since no publication on the activity of Padma 28 has been available, the results
of our studies may be com- pared exclusively with other immunomodulating agents,
such as levamisole or thymopentin (Bolla et al., 1984; Wender, 1990).
However, while applying Padma 28 no complications were observed. Also all the
biochemical tests done before, during the course and after Padma 28 administration,
demonstrated that the drug is harmless; no single ease involving internal organ
complications was revealed.
In all patients with multiple sclerosis treated with Padma 28, our studies dealt
with visual and auditory evoked potentials. The visual evoked potentials play
an important diagnostic part in detecting lesions of the visual pathway. They
were abnormal, before beginning therapy with Padma 28, in 24 patients. Final
examination displayed improvement in 8 subjects, while in 2 persons full normalization
of the tracing was noted. As reported by the authors (Lowitzsch et al., 1976;
Rossini et al., 1979), during the disease remission period a reduction
in previously elongated latencies can be observed. There is a relationship between
worsening of the tracings and intensity of the existing or newly forming plaques.
Studies of auditory evoked potentials permit us, to a certain degree, to reach
a conclusion as to the state of the structures in the area of the pons and the
mesencephalon. In the first study, 60% of patients had an abnormal tracing.
Control examination after finishing Padma 28 administration failed to disclose
any differences as compared with the initial examination. This observation seems
to be consistent with results obtained by other authors (Cendrowski, 1980),
who emphasize that in patients with initially abnormal recordings of the auditory
evoked potentials, no more pronounced changes were observed during the disease
exacerbation or remission.
The results of our studies may be subjective to an extent in that it is known
that multiple sclerosis is characterized by irregular periods of disease activity
(relapses) lasting from a few days to several weeks, interspersed by intervals
of spontaneous remission which may last for a long time.
In conclusion a profitable influence of Padma 28 was observed in 44% of patients
with multiple sclerosis in the shape of a reduction of the pyramid symptoms,
diminution of the cerebellum symptoms, decrease or disappearance of disorder
of sphincters; there was no aggravation of the patients' state during treatment
with Padma 28; among patients with abnormal initial visual evoked potentials,
in 41% an improvement or normalization of the tracing was obtained, prolonged
application of Padma 28 caused no undesirable symptoms- tolerance of the drug
was excellent. We therefore believe that Padma 28 may be useful in slowing or
arresting the symptoms of chronic multiple sclerosis.
Bach, M. (1982). Deficit of suppressor T cells in active multiple sclerosis.
Symposium on Multiple Sclerosis, Copenhagen.
Badmajew, P., Jr, Badmajew, V., Jr, and Park, L. (1982a). Healing Herbs.
Lotus Press, Berkeley.
Badrnajew, V., Jr, Brzosko, W. J., Debrowski, M. P., and Dgbrowska-Bernstein,
B. K. (1982b). Padma 28: an irnmu- noregulatory substance in vitro. Abstract
of the Second International
Conference on lmmunopharmacology, Washington.
Bolla K., Duchateau, J., Delespesse, G., and Servais, G. (1984). Imn-lunomodulation
with thymopentin in humans. lnt. J. Pharm. Res. 4, 431-438.
Brzosko, W. J., Badmajew, V. Jr., Plachcihska, J., Dbrowska, M., Debrowska,
B., and Loch, T. (1982). Padma 28 a new drug for patients with HBsAg positive
or negative chronic aggressive hepatitis. Hepatology, Rapid Literature Review
Brzosko, W. J., Badrnajew, V. Jr, Plachci@ska, J., Beraud, M., Golonko, L.,
D4browa, A., Krzysztofik, R., and Matacz, D. (1983). Laboratory and clinical
studies on Padma 28 (in Polish). lmmunot. Pol. 8, 216.
Brzosko, W. J., Plachciriska, J., Krzysztofik, R., and Nawrocka, E. (1984).
Padrna 28, a new drug for patients with ehronic active hepatitis. Hepatology,
Rapid Literature Review 14, Memo-zh-2166.
Cendrowski, W. (1980). Cortical and cervical somatosensoric potentials evoked
in patients with multiple sclerosis. Neuroi. Neurochir. Pol. 14, 553-557.
Cendrowski, W. (1986). Demyelimating Diseases (in Polish). PZWL, Warsaw.
Halliday, A., and MeDonald, J. (1977). Pathomorphology of demyelinating disease.
Br. Med. BulL 33,21-27.
Kuratowska, Z., Lutyhski, A., and Dwilejczyk-Trojanek, J. (1982). Selected
Problems of Clinical Immunology (in' Polish). PZWL, Warsavv.
Lowitzsch, K., Kuhnt, U., Sakman, Ch., Maurer, K., Hopf, H., Schott, D., and
Thater, K. (1976). Visual pattern evaked responses and blink reflexes in assessment
of MS diagno- sis. J. Neurol. 213,17-32.
Ross Russel, R. W., and Woles, C. M. (1985). Neurology. Year Bock, Chicago.
Rossini, P., Pirchio, M., Salluzzo, D., and Caltagirone, C. (1979). Foveal versus
peripheral retinal responses: a new analysis for early diagnosis of multiple
sclerosis. EEG. Clin. Neurophysiol. 47, 515-531.
Sarnochowiec, L. (1983). Theoretieal, chernical and pharrnaco- dynamical examinations
of Padma 28. First International Convention on Tibetan Medicine, Venice,
Padma, AG. Zürich.
Samochowiec, L., and W6jcicki, J. (1987). Effect of Padma 28 on lipid endoperoxides
forrnation. Herbe Polon. 33, 219-222.
Wender, M. (1990). Demyelinating diseases. In, Treatment of Nervous System
Diseases (in Polish), ed. by 1. Hausmanowa-Petrusewicz. PZWL, Warsavv.
Wöjcicki, J., Gonet, B., Samochowiec, L., Gnacitiska, K., and Juiwiak, S. (1989).
Effect of Padma 28 on ascorbate system in rats receiving a high-fat diet. Phytother,
Res. 3, 54-56.