(Antiseptic (1993): (90), 12, 538.) 

Double-Blind Trial of Mentat in Enuresis 

Annie J. Mani, M.B.,B.S., D.P.M., M.D.,
Prof. & Head of Psychiatry,
K. Indirabai, M.B.,B.S., D.C.H., M.D.,
Prof. of Paediatrics,
S. Ramesh, M.B.,B.S., D.C.H., M.D.,
Reader in Paediatrics,
Rajah Muthiah Medical College and Hospital, Annamalainagar,
K.E.S. Unni, M.B.,B.S., D.P.M., DIP.N.B.
Asst. Prof., Division of Psychiatry,
JIPMER, Pondicherry. 

Forty children with enuresis and aged between 5-13 years were given Mentat for 6 weeks and graded on a rating scale once a week. After stopping the treatment they were followed up for four weeks. An identical-looking placebo was given to an age-and sex-matched group of 30 enuretic patients for a similar period and followed up for 4 week. The investigation were unaware as to which group received the drug till the results were formulated. The results indicated that Mentat is superior to placebo in the treatment of enuresis. 

Enuresis has been defined by Graham as involuntary emptying of the bladder in the absence of an organic cause in a child over the age of five years. Using this definition, patients presenting at the peadiatric and psychiatry divisions of Rajah Muthiah Medical College and Hospital (RMMC*H) were selected for a trail with Mentat, an Ayurvedic compound, which is said to act on the central nervous systems. A diagnosis of enuresis comprised about 1% of all psychiatric disorders presenting to the OPD services of the psychiatry department, while childhood disorders were about 2.2% and mental sub-normality 6.1%. 

Our interest was stimulated by published reports on the usefulness of Mentat in enuresis and by virtue of its having no known side or toxic effects. Mentat contains important plant ingredients such as Jal brahmi (Bacopa monnieri), Madukaparni (Centella asiatica), Jatamansi (Nardostachys jatamansi), Malkangni (Celastrus paniculatus) etc., besides numberous others which are reputed in Ayurveda, the ancient system of medicine, to be of great value in the management of nervous disorders. 

Patients presenting at the Paediatric and Psychiatric OPD with a history of enuresis, but without any clinical evidence of mental subnormality of organ deficit were taken up for study. They were in the age grup of 5-13 years. The first 10 patients were given tablet A and were designated as Group A patients and the next 10, who received Tablet B, were in Group B. This schedule was followed throughout the course of study which started in March 1992 and ended in December 1992. None of the investigators was aware which tablet had the active ingredients and which was the placebo. All the tablets were identical in colour size, shape and weight. 

Every patient had a detailed history and physical examination done. Special emphasis was placed on consanguinity, birth trauma, perinatal infections, home atmosphere, schooling, hyperactivity, neurotic tendencies and aggressiveness. Each one was assessed independently by two fully qualified observers on a modified version of the Yale inventory scale (Please see Table 1.). Behavioural disorder, when present, was graded as mild, moderate or severe and enuresis, if present daily or 5-7 times/week was graded as 3; 3-4 times/week as 2; 1-2 times/week as 1. 

Each patient in Group A was given tablet A, 2 tablets b.d. for 6 weeks with weekly assessments and followed up for 4 weeks after stopping medication and the results were tabulated. A similar schedule was followed for Group B patients. 

Initially there were 50 patients in each group but there were some drop outs at the end of the 2nd or 3rd week; two were found to be having urinary infection and hence were not included in the study. Thus, forty patients in Group (20 F, 20 M) and 30 patients in Group B (19F, 11 M) completed the study. 

The duration of symptoms varied from 6 months to 8 years and none had attained bladder control at night. All were instances of noctural enuresis only; except for two, all had a grading of 3 for enuresis. None had encopresis (faecal incontinence). Four children in Group A and two in Group B had an attention deficit disorder. None of the patients was mentally subnormal. A positive family history of enuresis was present in only 6 patients. 

Neither the patients nor the parents were given counselling were just told to take the tablets and report at weekly intervals. 

The Results are shown in Table 2 (Enuretic score of 1-much improved; 2-improved; 3-not improved. No enuresis 0 or totally dry).  

In Group A (Mentat), 15 out of 40 children were totally dry at the end of 6 weeks and continued to remain dry. One child in the 8-10 age group, who was much improved, became totally dry. Sixteen out of 40 (40%) were symptom-free and 3 out of 40 (7.5%) were much improved. Thus 47.5% showed remarkable response to Mentat. Only 10 out of 40 (25%) remained out without any improvement. Of the 4 children with hyperkinesis two improved slightly.

On the other hand in Group B (placebo), none achieved total relief from symptoms and only 4 (13.3%) had mild improvement.

There was no correlation between response to treatment and age or sex & family history of enuresis consanguinity. But it is worthy mention that in the 11-13 age group, only one of the eleven patients was totally dry, while in the remaining 10 (eight of who were boys) there was only mild improvement. Whether this was because of the duration of illness or whether they needed a larges dose is open to question.

Children are incontinent of urine at birth because they do not have the necessary physiological maturity and understanding to know what is required of them or the motivation to achieve continence. Continence will occur if the nervous system has matured sufficiently. Noctural enuresis commonly produced by an inherited dealy in maturation of the relevant nervous structures or less commonly by an interaction between delay in maturation and environmental circumstance which, for some reason or other, fails to promote the acquisition of bladder control. None of the patients in the study had an organic lesion and there was no history of stress or antecedent "Psychic trauma". But all were from middle class agricultrual families where parental attitudes were such that wetting the bed at night was not seen as an abnormality. Patients come to the hospital only because they learnt of talks regarding enuresis etc., delivered in schools. The slightly extra preponderance of females is probably due to the fact that more girl's schools were visited by us.

Tricyclic drugs are said to work either by altering sleep rhythms or by an adrenergic mechanism. Earlier reports by Rajiv Sharan et al showed Mentat to be effective not only in enuresis but in other behavioural problems as well. In enuresis, marked improvement was noticed by them in 59% of cases, whereas our study showed full remission in 40% and marked improvement in 7.5% a total of 47.5% with good results. These results compare favourably with the use of tricyclics and because Mentat has no known toxic or side effects it can be said to be superior.

This double-blind, placebo-controlled trial with mentat clearly establishes Mentat as an useful compound in the treatment of enuresis. 47.5% of patients of mentat showed extremely good results as compared to those on placebo where none achieved total freedom from symptoms.

We are grateful to the Himalaya Drug Co. for their generosity in supplying Mental and Placebo tablets for the study.

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