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From the June 4th, 1997 issue of Smart Drug News [v5n9]. Copyright (c) 1997. All rights reserved.

The Fiona Study

The Fiona study compared two groups of 26 children between the ages of 3 months and 12 years. The first group received only Dromia (5-hydroxytryptophan plus “pyriglutine”) during a two year period between 1972 and 1974. The second group received Dromia plus Noostan (a brand of piracetam) for a two year period between 1974 and 1976. There was no no-treatment group, presumably because the Dromia-only therapy (described as “very encouraging” and a “considerable success”) was considered a standard of care by the clinical team.

The Dromia was administered at 1 mg/kg/day for periods of 3 months, with breaks between periods. The Noostan was administered at 30 mg/kg/day on a continuous basis.

Improvement in all subjects was evaluated as modest (pink), marked (dark pink), or dramatic (red) in each of six categories. Scholastic evaluation was possible only in the 12 patients older than 5 years of age.

Net Improvement was calculated by scoring 1 for modest, 2 for marked and 3 for dramatic improvement, subtracting the Dromia-only total from the Dromia-plus-Noostan total in each category, and then dividing by the number of subjects. A Net Improvement score of 100% is equivalent to all children advancing to the next better evaluation (i.e., from modest to marked, or marked to dramatic). The Speech Net Improvement score of 142% indicates the equivalent of 100% jumping one level of improvement plus 42% jumping two levels.

A positive Net Improvement score does not imply that all children achieved that positive improvement. It means that children with less-than-indicated improvement would be balanced by children with greater-than-indicated improvement.