The Childhood Autism Rating Scale, Second Edition (CARS-2), was administered as part of a routine evaluation of the child's severity prior to a change that is his academic placement. Prior to PEA, CARS-2 scoring placed the child at 43.5 total (82nd percentile) with a verbal communication subscale of 3 out 4. A speech assessment was performed including a mean length of utterance (MLU) measurement. MLU is based on the linguistic concept of morphemes as the smallest component of speech. Speech therapists use MLU as a routine assessment and, in this case, MLU was obtained prior to a change in school placement. MLU was observed to be 3.0 prior to PEA and this corresponded to an age equivalent of approximately 34-35 months (just under a 3-year-old level of speech).
After the practitioner reviewed the medical literature and the therapeutic rationale with his parents, they treated the child with Normast 600 mg tablets (Epitech Group Srl, Milano, Italy). Normast is available without prescription in Italy and Spain and is classified as "Food for Special Medical Purposes" by the Health Authorities of European Union member states according to standards set forth under European Commission Directive 1999/21/EC.
Initially, 1/2 tablet (300 mg) was given orally with water twice daily on an empty stomach to this boy (a child capable of swallowing tablets). After a week with no observable negative effects, the dose was increased to 1 (600 mg) tablet twice daily. Subject 1's parents returned for assessment after one month of oral supplementation with PEA. They reported "remarkable" changes in his behavior and his expressive language. Specifically, they noted he was spontaneously joining a conversation and commenting on various things happening in the home. The parents also reported the schoolteacher and speech therapist inquired about what had changed and noted similar positive changes at school. Equally noteworthy was the significant reduction in tantrums, outburst, self-talking, and stereotypies. Further, nose-picking, asthmatic cough, allergy stigmata (dark circles under eyes and nasal itching), nasal edema, and both skin eczema and urticaria diminished clinically after a month of PEA administration. No adverse effects were noted.
Following these comments, we readministered the CARS-2 test and noted a total score of 32 (representing the 28th percentile) whereas the starting score was 43.5 (net change 11.5 points and 54 percentiles less). The subscale for expressive language changed to 2 out 4 and represented significant and noticeable changes. Due to these observations, we suggested repeating the MLU assessment for further definition of the degree of language changes. Reassessment of MLU also changed significantly to 5.4 (approximately 58 month's age-equivalency). This represented a 2-year age gain in expressive language in only one month of supplementation with PEA.
Total serum IgE testing after PEA was introduced remained essentially unchanged at 567 IU/mL (nl < 200). Serum vitamin D-OH25 levels rose to 46 ng/mL after PEA was started (possibly due to better absorption). CD57+ natural killer (CD57+ NK) cell counts increased after PEA to 52 cells/muL (nl = 60-300 cells/muL), with a total white count remaining similar at 5.6 x 103/muL. Noticeably the percentage of lymphocytes reduced to 44%, and the other cell indices were also in the normal range.