Subject(s)
Anemia, Sickle Cell/drug therapy , Neuroprotective Agents/administration & dosage , Pain/drug therapy , Piracetam/administration & dosage , Adolescent , Adult , Anemia, Sickle Cell/complications , Child , Child, Preschool , Double-Blind Method , Female , Humans , Male , Pain/etiology , Pain Measurement/methods , Time FactorsABSTRACT
Analgesia and hydration remain the only safe treatment for painful crises of sickle cell disease; hydroxyurea is effective, but the toxicity is still a problem. Piracetam is a nootropic drug that has reportedly been effective and non-toxic in sickle cell patients, but most studies were not placebo-controlled and included a small number of patients. The present study evaluated the drug in a double-blind crossed placebo-controlled clinical trial in 73 children and adolescents suffering from moderate to severe painful crises for 13 months. Information regarding frequency and severity of pain was acquired through monthly clinical evaluation, visits and house calls, and 4,300 weekly questionnaires filled out by the patients in their domiciles. A monthly pain score was calculated for each patient. Pain was the most frequent adverse manifestation of the disease stressing its significant bio-psycho-social impact. Although nearly all patients and relatives reported a better clinical course throughout the whole study, the drug was ineffective in the prevention of painful crises. This placebo effect may be ascribed to an unplanned and unsystematic 'cognitive-behavioural' management of the children. The pain score in the second semester of the study - both in the experimental and in the control groups - was significantly smaller than that in the first semester. In conclusion, piracetam was found to be ineffective in the prevention of painful crises; a powerful placebo effect due to adequate patient care was demonstrated.
Subject(s)
Anemia, Sickle Cell/drug therapy , Pain/drug therapy , Piracetam/therapeutic use , Adolescent , Adult , Anemia, Sickle Cell/complications , Anemia, Sickle Cell/physiopathology , Child , Child, Preschool , Cross-Over Studies , Double-Blind Method , Female , Humans , Male , Pain/etiology , Placebos , Surveys and QuestionnairesABSTRACT
The influence of the nutritional status and other prognostic factors on the survival of 43 children with non-Hodgkins lymphoma was investigated in a retrospective study. The median age was 5.3 years. Most children had advanced abdominal disease and Rappaport's diffuse undifferentiated type. The median time of follow-up was 4.7 years (0.1 to 12.9 years). The estimated probability of 5 and 10-year survival was 69% -/+ 7%. The unfavorable prognostic factors were metabolic disturbances, treatment with the LSA(2)L(2) protocol, unresectable tumoral mass, age below 2 years and stage III or IV disease. The nutritional status did not influence the outcome. Eight children died within the first days of hospital admission; five had extensive abdominal Burkitt's type lymphoma with elevated uric acid concentration. All had been treated with nonfractionated high-dose cyclophosphamide in the first four years of the study and had metabolic complications which probably led to their death. The authors conclude that the overall survival is similar to that reported in the literature; the nutritional status did not influence the outcome; the high frequency of early death in the first days of treatment was probably due to the toxic-metabolic effects of nonfractionated high-dose cyclophosphamide, but other adverse factors were clearly associated.
