Download A Placebo-Controlled Trial on the Efficacy of Mentat in Managing

(Probe (1993): (XXXIII), 1, 26-31)
A Placebo-Controlled Trial on the Efficacy of Mentat
in Managing Depressive Disorders
K.P. Sharma, M.D.,
Scholar, Dept. of Shalya Tantra,
H.K. Kushwaha,
Asst. Professor, Dept. of Shalya Tantra
and
S.S. Sharma
Associate Professor and Head of Shalya Dept.,
National Institute of Ayurveda (NIA), Jaipur, India.
ABSTRACT
Mentat was used in 20 patients with mild to moderate symptoms of depressive disorders in this
placebo-controlled trial. They were divided into two groups for comparison. The trial lasted 8
weeks.
Mentat exerted a positively effective antidepressant activity and did not produce any side effects. It is
noteworthy that Mentat enabled the patients to regain self-confidence and look at things more
objectively than before treatment. A soothing effect on the mind was observed.
It is suggested that with the advent and use of Mentat no case of depression need be looked upon as
hopeless.
INTRODUCTION
The most characteristic symptom of a depressive disorder in a patient is his over-pessimistic view of
life. His mood is morose, swinging from sorrow to sadness and he has a completely dejected
countenance. Clinicians use different psychiatric terms to describe the variations in moods of
patients.
Besides psychotherapy and electroconvulsive therapy (ECT), a number of chemotherapeutic agents
have been tried to alleviate the symptoms of depressive disorders or to obtain a complete cure.
Monoamine oxidase (MAO) inhibitors and a number of antidepressants are frequently used to treat
depressive symptoms. But none of these can be said to have brought about satisfactory response in
the patients for various reasons. Monoamine oxidase inhibitors may give rise to tremors, dizziness
and oedema of the ankle. This drug is contraindicated in patients having liver diseases.
Psychotherapy in the form of psychoanalysis and counselling often fails in the absence of innate cooperation by the patient with the therapist. Electroconvulsive therapy has sometimes been accused of
causing memory impairment. The patient with respiratory infection cannot go in for ECT.
Antidepressants like imipramine and amitriptyline have unwanted effects upon the respiratory,
cardiovascular and central nervous systems, and may cause complications in pre-existing
constipation, retention of urine, muscular twitching or mild cholestatic jaundice.
Having experienced so many side-effects and toxic symptoms produced by MAO inhibitors and
antidepressant compounds, it was thought appropriate to give a clinical trial to Mentat (The
Himalaya Drug Co., Bangalore) for evaluating its clinical efficacy in treating the various symptoms
of depressive disorders.
Mentat is a herbal compound that contains a number of ingredients which have since long been
known to possess the property of soothing the nerves and having a desired effect on the brain. One of
its ingredients, Evolvulus alsinoides, has been used as a brain tonic.
MATERIAL AND METHODS
In this clinical study, 20 patients (15 males and 5 females), all brought by community social workers
to our OPD, were included. It was initially the insistence of social workers that prompted the hospital
staff to enter these patients for the present clinical study, though the gloom writ large on their faces
showed that they had psychic problems of one type or another. Each patient was, therefore,
individually interviewed to confirm or rule out the social worker’s version about the patient’s
ailments. To maintain a good rapport, all the patients were encouraged to talk freely. The complaints
volunteered by the patients and those revealed by questioning were noted separately.
First of all, the patients’ present problems were noted down. Their family history, social position and
atmosphere at home were elicited. The factors and periods that made them worse or better were also
noted down in detail. Enquiries were made about their sleep and diurnal pattern, their appetite and
bowel movements. Their particular aversions and desires and their past and present ideas concerning
their future were also elicited. The married patients were asked to how they were getting along with
their spouses, as also about their attitude to sex. It was also ascertained whether or not they had been
under any treatment for their ailments before coming to us at the NIA. If yes, the drug and duration
of treatment along with improvement, if any, under previous treatment were noted. Their blood
pressure, weight and pulse rates were also recorded.
DIAGNOSTIC CRITERIA
The criteria for including the patients in this clinical study were the presence of most of the clinical
features of the depressive syndrome — a pessimistic view of life, poor appetite, loss of weight and a
sleep pattern characterised by early morning waking and a changed diurnal pattern that usually
follows the depressive disorder. One of the patients had earlier been taking a hypotensive drug that
was the cause of his lethargy and low mood. He was asked to contact his previous physician for
further consultation and was, therefore, excluded from the study.
The 20 patients, diagnosed as having mild to moderate symptoms of depressive disorders, were
divided into two equal groups. The allocation of patients to different groups was done at random.
Eventually, the first group consisted of 7 male and 3 female patients, while the second group had 8
male and 2 female patients (Table I).
Table I : Showing random distribution of patients in the two groups
Males
Females
Group I (Mentat)
7
3
Group II (Placebo)
8
2
The patients of the first group (Mentat group) were given Mentat, 2 tablets b.i.d., while those of the
second group (placebo group) were put on placebo. The blood pressure, weight and pulse rates along
with any changes in their moods and facial expression were recorded regularly on a day-to-day basis
for one week and thereafter at an interval of one week for 8 weeks.
Patients’ self-rating of depression along with manifest changes in their facial expressions from
gloom to that of cheerfulness and an increase in self-confidence to cope with their problems
themselves and restoration of normalcy in sleep pattern were taken as parameters for measuring
improvement in patients’ depressive symptoms. The antidepressant activity of this clinical trial was
considered positive only if there was more than 80% reduction in severity of total symptoms score in
an individual patient. A reduction of 50% to 75% in symptoms was rated as moderate to marked and
81% to 100% as good as excellent. Patients scoring less than 50% improvement were regarded as
unchanged.
The findings observed in this study were properly analysed and compared between the two groups.
OBSERVATION, ANALYSIS AND DISCUSSION
In the present clinical study, it was found that males are more prone to develop depressive disorders
than females and the child is less prone to develop depressive symptoms and still less th female child
although such a one was absent in this study (Table II).
Table II : Showing age and sex incidence of patients
Age in years
Males
Females
10 to 20
1
—
21 to 40
10
3
41 to 60
4
2
15
5
Married persons seemed more sensitive to develop symptoms of depressive disorders than unmarried
ones (Table III).
Male
Female
Table III : Showing marital status of patients
Unmarried
Married
Divorced
5
10
—
4
1
—
9
11
—
This may be due to the presence of undesired interaction between couples. As depicted in Table IV, a
pessimistic view of life, troubled sleep, constipation, loss of appetite and weight and changed diurnal
pattern were prevalent symptoms that were exhibited by the patients in the study. Agitation was
found only in four male patients. Menstrual disturbance appeared a common symptom in 3 out of 5
female patients.
Table IV : Showing prevalence of symptoms of depressive orders
Symptoms
Males
Females
1. Pessimistic view of life
12
4
2. Poor appetite
10
4
3. Constipation
13
4
4. Troubled sleep
15
5
5. Loss of weight
10
4
6. Delusions
—
—
7. Hallucinations
—
—
8. Changed diurnal pattern
11
3
9. Agitation
4
—
10. Menstrual disturbance
—
3
After 8 weeks of trial with both regimens it was found that moderate to marked reduction in
symptoms was manifest in 2 patients in Group I (Mentat). Two patients in this group were able to
score good to excellent results. It was also observed that a maximum of six patients in the Mentat
group were able to achieve positive improvement. In contrast to this, neither good to excellent nor
positive results were obtained by any of the patients taking the placebo. However, 4 patients of the
placebo group could achieve a moderate to marked score, while depressive symptoms of six patients
in the same group remained unchanged. No toxic symptoms of any nature seemed to have developed
in patients taking Mentat.
It was observed that Mentat helped patients revive their faith in life and gain confidence to solve
their problems themselves. After treatment with Mentat, the patients were able to look at things more
objectively than before, whereas no such pleasant psychological change was found in patients who
were on placebo. It appears that some of the ingredients of Mentat have a soothing effect on the
mind.
RESULTS
The clinical efficacy of Mentat, an indigenous compound, was assessed and evaluated in 10 patients
of depressive disorders against an equal number of such patients who were on placebo. It was
observed that Mentat possesses a positively effective antidepressant activity and does not produce
any toxic symptoms. Mentat is useful in managing depressive disorders, and some of their pathetic
symptoms can be successfully controlled within a short duration by the use of Mentat (Table V).
Table V : Showing improvement in score in the two groups of patients after 8 weeks of trial
Improvement rating
Group
Unchanged
Moderate to Marked
Positive
Good to Excellent
Group I
—
2
6
2
(Mentat)
Group II
6
4
—
—
(Placebo)
SUMMARY
Life is full of joys and sorrows. Sorrows or problems are a natural part of life and have to be faced,
dealt with and solved. When one finds oneself unable to solve one’s problems, he or she becomes
confused, unhappy, bewildered, unsure and ultimately succumbs to a depressive disorder. Despite
intensive research, the treatment of depressive disorders was until recently limited primarily to a few
time-tested drugs which relieved the symptoms temporarily, while simultaneously producing various
side-effects. This sorry picture changed during the present clinical study, wherein a placebocontrolled trial was conducted to evaluate the efficacy of Mentat in the management of depressive
disorders. A few of the findings of the present study substantiate the earlier observations made by
Sharma, A.K. and others who have tried Mentat in cases of depression.
Obviously, while there is no `magic bullet’ for treating depressive disorders, yet with the advent and
use of Mentat no case of depression seems completely hopeless. Even if the depressive disorder
gallops out of control, most of its pathetic symptoms can be minimised by the use of Mentat. Mentat
is a “mood maker” and changes the mood from morose to mellow, from sullen to sweet.
ACKNOWLEDGEMENTS
Our grateful thanks are due to the Head of the NIA Hospital, Jaipur for according permission to
publish this report. We (KPS & HKK) are thankful also to the Head of Department (Shalya),
Dr. S.S. Sharma for his kind co-operation and supervision to conduct the study, as well as the
doctors, nursing staff at NIA and concerned social workers for their co-operation in handling the
patients. Thanks also to The Himalaya Drug Co., Bombay for a liberal supply of Mentat to conduct
the study.