Dromia and Piracetam. A useful association in the treatment of Down's syndrome (A comparative study)

J. Fialho, M.D.
Specialist in Pediatrics and Puericulture, University of Barcelona and School of Puericulture, Spain; Medical Society of Portugal.
Tempo Medico 30:944 (1977)

Introduction

In accordance with the methods followed at the Barcelona Faculty of Pediatrics, with whom we have studied and cooperated since 1966 when the product combining 5-hydroxytryptophan with pyriglutine was marketed under the trade name of Dromia, and within standards, advice and guidelines set the Professor Cruz, we have started to treat our Mongol children with this new drug, which has since then given very encouraging results.
Between 1972 and 1974 we used Dromia alone, with considerable success, and the results were all the better as the treatment was started earlier and earlier.
In 1974 we had the idea of associating Dromia with piracetam (Noostan), and this combination has been used systematically ever since. In this report we shall therefore always speak of Dromia and Noostan, as given together.

Materials and Methods

Twenty-six patients with Down's syndrome and treated with Dromia between 1972 and 1974 were selected together with another 26 treated with Dromia and Noostan between 1974 and 1976. The total number of patients considered is thus 52. In both groups the ages varied from 3 months to 12 years. The comparative study of the results was carried out on an age-equivalent basis in both groups. For brevity, we will not indicate the number of children in each age group among the two comparative groups, but only the numbers of school-age children (between 5 and 12 years old), being 12 in each group studied (Table 1).

Table 1 — Down's syndrome
Period	Treatment		No. of patients
1972-74	Dromia	3 months - 5 years old: 5 - 12 years old: Subtotal:	14 12 26
1974-76	Dromia + Noostan	3 months - 5 years old: 5 - 12 years old: Subtotal:	14 12 26
		Total:	52

In this comparative study we were concerned with the selection of cases free from pathological factors unconnected with the disease itself and free from severe cardiovascular, neurologic and endocrinologic complications, etc.
Dromia was always used at a dose rate of 1mg/kg/day and, in both groups, with treatment periods of 3 months alternating with treatment-free periods. Noostan was used at dose rate of 30 mg/kg/day administered continuously without interruption.
The comparative evaluation of the results in each group was based on the following parameters: muscular tone, motor development, mental development, speech, affective-social development, scholastic achievement and EEG trace.

Results

Table 2 shows the degrees of improvement according to the following scale:

+	= modest improvement
++	= marked improvement
+++	= dramatic improvement

Discussion

A simple analysis of Table 2 reveals the positive and very valuable effects in patients given the combined treatment of Dromia and Noostan as compared with the results obtained with Dromia alone and even though the latter itself produced notable improvements in the mongol children.

Table 2 — Down's syndrome
Parameter assessed			No. of patients			No. of patients
Muscular tone	++	26	26	++	26	26
Motor development	+ ++ +++	15 11 0	26	+ ++ +++	6 16 4	26
Mental development	+ ++ +++	10 8 8	26	+ ++ +++	0 19 0	26
Speech	+ ++ +++	14 12 0	26	+ ++ +++	0 3 23	26
Affective-social development	+ ++ +++	17 9 0	26	+ ++ +++	1 17 8	26
Scholastic achievement	+ ++ +++	8 4 0	12	+ ++ +++	2 8 2	12
EEG	+ ++ +++	15 11 0	26	+ ++ +++	3 20 3	26
Total number of patients			26			26

However, there is a special need to indicate and emphasize the appreciable differences with particularly affect the motor development, mental development, social development and, in a spectacular manner, the scholastic achievement and speech disorders. In a general way there was also a clearer improvement in bioelectric maturity in a greater number of cases.
The good results obtained with the association of 5-hydroxytryptophan and piracetam can be attributed to a joint action in which the increases in blood serotonin levels produced by Dromia are added to the relevant action of activation of the integrative cortical mechanisms by piracetam with clear improvement of the interhemispheric bioelectric synchronization.

Conclusions

A comparative study was carried out between patients with Down's syndrome treated with Dromia alone and those treated with this drug plus Noostan at the same time.
In no case were incompatibilities or side-effects observed with this association.
In all cases there was a faster and more intensive improvement in the psychomotor, sensory, social and bioelectric disturbances when 5-hydroxytryptophan was associated with piracetam.

References

Boissier, J.B., and Simon, P.: Preliminary pharmacologic study of a psychotropic substance [in French]. Thérapie 21, 799-811, 1996.
Bures, J., and Buresova, O.: Cortical spreading depression as a memory-disturbing factor. J. Comp. Physiol.-Psychol., 56, 268-272, 1965.
Cruz, M., Torralba, A., Rodriguez-Hierro, A.F., and Muñoz-Lopex, F.: The treatment of Mongol children with a new derivative of 5-hydroxytryptophan [In Spanish]. XIII International Congress of Paediatrics, Vienna, 1971.
Cruz, M., Torralba, A., Muñoz-Lopex, F., and Rodriguez-Hierro, F.: New perspectives in the treatment of Down's syndrome [in Spanish]. VIII Meeting of the Spanish Paediatrics Association, Sevilla, 1970.
Narikasvili, S.P.: Direct and indirect cortical influences on thalamic nuclei, 287-298. 1970.
Mendiguchia Quijada, J.: Pyridoxine ketoglutarate in mental deficiency [in Spanish]. II Congress of Child Neuropsychiatry, Madrid, 1971.
Martinez Roldan, C., Zeledon Pochet, F., and Vila-Coro, A.: Pharmacology of Dromia [in Spanish]. XI National Congress of Neuropsychiatry, Torremolinos, 1971.