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  Journal of the National Integrated Medical Association (1979): 2, 74
Clinical trials with Bonnisan S.P. Palaniandi, M.B.,B.S., D.C.H., Tutor in Pediatrics and
J. Viswanathan, B.Sc., M.D., D.C.H., Professor and Head of the Dept. Of Pediatrics, M.G.M. Medical College and M.Y. Hospital, Indore, India.
 
 
 Introduction

Digestive disturbances (anorexia, flatulence, gripes, indigestion, trapped wind, constipation and diarrhea) constitute a significant segment of pediatric illnesses. This is more true of the newborn than infants and older children. It is particularly important that the digestive system should function normally for the metabolic processes of growth and development in the newborn. It has been estimated that as many as 60% of children in India suffer from digestive disturbances and delayed growth and development. A significant number also suffer from malnutrition due, probably, to non-availability of protein-rich food.

Though the digestive system of the newborn is normally adequate for this task, the rapid rate of growth and proportionately high requirements of nutrition at this stage of life coupled with the immaturity of digestive functions, enhance the proneness to digestive disturbances.

Many drugs (stomachics, gripe waters, carminative mixtures, sodium bicarbonate and such other remedies) have been used in the past for bringing about a quick amelioration from dyspepsia and flatulence. Though these drugs relieved dyspepsia and flatulence temporarily, they failed to produce a more marked and lasting relief.

It is in this particular context that Bonnisan scores a point over all others in not only correcting the indigestion, helping assimilation and utilization of food but also possessing the advantage of being an anabolic agent and a hepatic stimulant.

The results of our clinical trials in newborns tally with those of many workers in the field. Dhurandhar4 (1973) studied 100 cases and reported remarkable control of flatulence and distension and improvement in appetite, digestion and gain in weight, Indira Bai6 et al (1973) in a controlled study of 200 cases has reported similar findings. Koti and Mehta7 (1974) studied 138 cases which included 15 premature babies. They noted marked improvement in all the cases. Rangwala and Anjaneyulu9 (1974) studied 100 cases and reported significant and excellent improvement. Shirole10 et al (1974) in their study of 135 cases have reported excellent results with Bonnisan.

We have been particularly impressed by the effect of Bonnisan on chronic, non-specific (non-bacterial) and non-parasitic diarrheas in infants and children. In our trials therefore, we have two sections:

Section I - Trials with Bonnisan in newborn infants and

Section II - Bonnisan in chronic non-bacterial and non-parasitic diarrhea in infants and children.

Section I

Bonnisan in Newborns


 Criteria for Selection

Age: All newborns were included in the trial 2-4 days after birth. Parents were advised to start Bonnisan after 2 weeks and report in the 3rd week to the out-patient department for review. Parents were instructed to observe the baby for signs of distension, anorexia, flatulence and general well-being.

Sex Distribution:

Male — 18

Female — 20

All the cases were breast-fed babies.


 Material and Methods

Newborns and infants at age of 2-4 days delivered in R.M. Hospital, Thanjavur in Post-natal ward were selected (after excluding infants with congenital anomalies).

Each mother was handed over one bottle of Bonnisan at the time of her discharge with instructions to start Bonnisan from the 12-14th day of birth of the baby, and to report by the 20-21st day to the Pediatric out-patient for follow-up.

They were followed up for a period of 3 months at intervals of 2 weeks each.

The response to Bonnisan therapy was noted at the end of 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 12 weeks of age, i.e., 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks and 10 weeks after starting the drug.

Dose advised:

¼ tsp. t.i.d. up to 2 months.

½ tsp. t.i.d. after 2 months.


 Assessment

Appetite was assessed by the baby's satisfaction after feeds, duration of undisturbed sleep, time lag between feeds and the mother's observations.

Digestive function was rated by

— crying due to colic or restlessness

— belching

— flatulence

— consistency, color and frequency of stools

— cheerfulness of the infant

General Health was assessed by the well-being and cheerfulness of the infant as observed by the parents and the doctor.

Bowel Action: Number of motions was regular, as expected with breast-fed babies.

General Health: All babies were seen to thrive normally.

(Vomiting was noted in only 3 cases in 5-6th week).


 Results

At age

3 weeks

4 weeks

6 weeks

8 weeks

10 weeks

12 weeks

Appetite

Good

16

18

24

32

32

32

Fair

22

20

14

6

6

6

Poor

Digestion

Good

4

8

12

18

22

22

Fair

34

30

26

20

16

16

Poor

Flatulence

Absent

20

26

30

32

38

38

Present

18

12

8

6


Gain in Weight

 

3 weeks

4 weeks

6 weeks

8 weeks

10 weeks

12 weeks

.25 kg

36

32

8

     

.50 kg

2

6

24

2

   

.75 kg

   

6

22

20

 

1 kg

     

14

14

4

1.25 kg

       

4

16

1.50 kg

          

18

Weight gain was observed as shown in the Table above.


 Summary

Thirty-eight in-patient newborns who were on Bonnisan up to the end of 12 weeks were observed. Bonnisan was definitely helpful in these infants in promoting good appetite, maintaining a good level of digestion, normal bowel status and freedom from digestive disturbances. There was a uniform and sustained weight gain in the infants.


 Conclusion

Bonnisan maintains a status of good health especially in relevance to gastrointestinal system, promotes sustained weight gain and improves well-being because of good appetite and digestion.

Section II

Bonnisan in chronic Non-Bacterial and Non-Parasitic Diarrhea in infants and Children


 Criteria for Selection

Infants with diarrhea and digestive disturbances who after repeated stool examination, showed no positive findings were selected, as also those who were not improving with the routine O.P.D. symptomatic treatment.

The local people in this study are of poor socio-economic status having unfounded fears of offering supplementary feeds to infants. This often leads to malnutrition. These children are given only diluted milk even up to the age of 1-2 years. No cereal food is added to routine diet until the age of 1 year. No non-vegetarian food or curds or vegetables are given to infants below the age of 1-1½ years.

Those babies who are weaned from their mothers' milk usually go into clinical protein-calorie malnutrition status. The process of diarrhea starts and persists in these children. A vicious cycle is thus set up: diarrhea — malnutrition and more diarrhea. The total number of cases registered was 42.

Age distribution 0-6 months
6 months-1 year
1-2 years
2-4 years

6
6
16
14

 

42

Sex distribution

Male
22

Female
20



 Material and Methods

Out-patient infants attending the O.P. Department, R.M. Hospital and Thanjavur Medical College Hospital, Thanjavur were taken up for the study.

Cases were examined, weight checked and diet advice given on registration. Cases were instructed to continue to attend the O.P. Treatment was as usual and they were in addition asked to give Bonnisan.

Dose Schedule:

0 - 1 month

¼ tsp. t.i.d.

1 - 6 months

1 tsp. t.i.d.

6 months - 1 year

2 tsp. t.i.d.

2 years

2 tsp. t.i.d.

2 - 4 years

3 tsp. t.i.d.

The patients were reviewed once in 7-10 days for assessment.


 Assessment

1. Reduction in the number of motions; consistency, color and frequency of stools.

2. Disappearance of irritability.

3. Improvement in appetite.

4. Acceptance and tolerance of new foods hitherto not tolerated (e.g. cereals etc.).

5. Reduction in the size of abdomen (as seen by both mother and doctor).

6. Relief of abdominal pain.

7. General outlook and disposition.

8. Increase in weight.

9. Disappearance of flatulence.

10. Improvement in digestion.

The period of Bonnisan administration was for 3-4 weeks only, along with routine O.P. treatment (Supportive and symptomatic treatment).


 Results

Appetite

Good

26

Fair

12

18

16

Poor

30

24

nil

Digestion

Good

6

28

Fair

10

12

14

Poor

32

24

nil

Control of Diarrhea

Good

6

34

Fair

16

8

Poor

42

20

Weight Gain

Weight gain

26

26

42

No weight gain

16

26

Weight gain was variable (depending on the age of cases and the initial low weight).

0 - 6 months

½ — 1 lb

1 - 12 months

½ — 1 lb in 4 weeks

1 - 2 years

1 — 1½ lb in 4 weeks

Above 2 years

1 — 1½ lb in 4 weeks


 

1 week

2 weeks

4 weeks

Well-being

Good

6

6

Fair

22

22

36

Poor

20

14

nil

Progress

Seen

12

40

42

Not seen

30

2

nil

All cases showed positive improvement at the end of 4 weeks.


 Summary

Cases were drawn from the lower and middle income group. They were on insufficient diet and had chronic diarrheas off and on and low body weight.

Bonnisan was added as an adjuvant to symptomatic treatment of these cases receiving out-patient treatment. The response observed was significant with control of non-specific diarrhea in 34. The acceptance, toleration of new food (cereal etc.) was noteworthy. There was weight gain in all cases though the rate of weight gain was variable.

Most encouraging and gratifying results of improvement in appetite, digestion and control of loose motions were noted from the 2nd week after the commencement of Bonnisan.

Except in 8 cases, the control of diarrhea was nearly complete by the 4th week, along with general improvement in children. There were 9 babies among the 42 cases with protein caloric malnutrition and one case had congenital cyanotic heart disease and one case was receiving treatment for primary complex.


 Conclusion

The addition of Bonnisan to the routine treatment in cases of chronic diarrhea of nonspecific etiology associated with food taboos and insufficient food helps in controlling and arresting the diarrhea and also improving the status of general condition in these cases. The response to Bonnisan was remarkable because of the presence of Liv.52 ingredients in the formula which probably aids in correction of the digestive system and also helps as an anabolic agent.


 Acknowledgement

We thank The Himalaya Drug Company, Bombay for providing the opportunity for the trial and also for liberal supplies of Bonnisan. We thank Dr. M. Narayana, M.S., D.M.E., for permitting us to publish this article.

We are also thankful to Dr. D. Bhoopathy, M.D., Principal, Thanjavur Medical College Hospital and Dr. D.S. Desakavalan, M.S., D.L.O., and Dr. M.A. Mallick, M.D., the Superintendent, R.M. Hospital and TMC Hospital respectively for the use of hospital records


 References
  1. Athavale, V.B., "Mechanism of Anorexia and Effect of Liv.52 on Food Intake". Probe (1966) : 6, 12.

  2. Corblack, M. Et al, "Metabolic Adaptation in the Neonate". Israel J. Med. Sci. (1972) : 3, 453.

  3. Dayal, R.S., Kalra, K., Rajvanshi, V.S. and Baheti, P.C., "An Clinico-Pathological Study of Hepatomegaly with Special Reference to Liv.52 Therapy", J. Ind. Med. Prof. (1970) : 9, 7768.

  4. Dhurandhar, J., "Bonnisan — A Metabolic Corrective in Gastrointestinal Disorders of the Newborn (A Study of 100 Cases)", Probe (1973) : 2, 73.

  5. Indira Bai, K., Mallikarjuna Rao, V.P.R., Subbarao, K.V., "Therapy of Anorexia with Liv.52". Antiseptic (1970), 8, 615.

  6. Indira Bai, K., Subbarao, K.V., and Subramanyam, M.V.G., "Bonnisan — A Digestive Corrective and Anabolic Tonic for Newborns and Infants." Ped. Clin. Ind. (1973) : 1, 39.

  7. Koti, S.T., and Mehta, V.P., "Clinical assessment at Primary Health Centres of Bonnisan in Newborns, Infants and Children". Probe (1974): 2, 70.

  8. Kulkarni, S.D., Kulkarni, D.S., Vasantgadkar, P.S. and Joglekar, G.V., "Study of Liv.52 — An Indigenous Anabolic Compound.", Ind. Practit. (1971): 2, 145.

  9. Rangwala, Rukhsana, E. And Anjaneyulu, R., "Bonnisan in the Treatment of Newborn Babies and Infants". Antiseptic (1974): 10, 552.

  10. Shirole, D.B., Chandnani (Miss) Mohini, Ghaiye, Arun and Wagh, N.D., "Bonnisan—A Digestive Corrective and Anabolic Tonic for Newborns and Infants (An Observation on 135 Children)". Ind. Practit. (1974): 2, 213.