Although comparison with a placebo is necessary to demonstrate the "true" effect of a drug, neonatologists are usually reluctant to use a placebo. The reason given is the lack of placebo effect in neonates. We studied heart and respiration rates and behaviour in normal neonates during heelstick for diagnosis of phenylketonuria. In this open randomized study we compared no treatment with an "analgesic" treatment consisting of water and sucrose. There was no difference in heart and respiration rates and behaviour between the two groups. These results do not demonstrate a "suggested" placebo effect and can in part be explained by the model and tools used to measure pain. The results do not support the non-use of placebo in drug evaluation trials in children.

Female↗

PubMedDate not supplied

[Children's participation in biomedical research. A planned survey of 541 parents].

BACKGROUND: We have interviewed the parents of children born at two maternity hospitals to evaluate the knowledge of parents concerning the French Huriet law and their consent to the participation of their child in a randomized therapeutic trial. METHODS: The inquiry was conducted between 15 February and 30 April 1991. Each couple of parents of whom the mother had given birth in one of the hospitals was sent an explanatory letter and a questionnaire on the second day after delivery. Parents who were unable to read adequately and those whose baby was ill were excluded from the study. The main questions were: age of parents, country of origin, education, profession, social insurance, frequency of medical consulting, their knowledge of the Huriet law, the source of that knowledge, their attitude to giving parental consent for their child to participate in a trial, the reasons for their consent or refusal. RESULTS: Five hundred and eighty two questionnaires were distributed but only 541 were used. 73% of the parents said they knew that drugs were tested on volunteers. 59% claimed to know of the Huriet law, through the media (75%), their practitionist (12%), their environment (8%). 21% of the parents would consent to one of their children participating in such trial; 74% would refuse. Both parents were in agreement in 79% of cases, 12% of them for consent. The main reasons for refusal were the risk for side-effects of the drug (75%), lack of proof for efficacy (49%), disagreement in principle (19%). The mothers who consented were older than those who refused. The members of the "consent" group were more highly educated. CONCLUSIONS: Law Huriet is still inadequately understood in France. Pediatricians should consider how best to provide parents and the media with better information before trying to obtain parental consent.

Adult↗

PubMedDate not supplied

[Ulcerative rectocolitis. Somatic aspects (author's transl)].

Regional enteritis (Crohn's disease) and ulcerative rectocolitis, both "non specific inflammatory diseases of the bowel", might be diseases with a common etiology but with clinical features corresponding to a different tissular response to a noxious factor. Both diseases are however characterized by distinct clinical, radiological, histological peculiarities; evolution also is different, as appears from the rarity of malignant degeneration in Crohn's disease and its frequence in ulcerative colitis; a psychological support seems to be classical in ulcerative colitis but is on the contrary unusual in regional ileitis. Besides the interference of psychological factors in the outbreak of an ulcerative colitis, besides the infectious and genetic theories, the immunological theory appears as one of the most interesting and promising. In a significant percentage of cases of ulcerative colitis, anticolon antibodies are evidenced, which exhibit a crossed reaction with bacterial antigens, especially with those of Escherichia coli 014. Besides this humoral immunity a cellular immunity exists also: lymphocytes of patients with ulcerative colitis behave as a toxic agent towards colic tissue cultures; this cytotoxicity parallels the course of the disease and provides an explanation for the sometimes dramatic therapeutic effects observed after administration of immunosuppressive drugs and antilymphocytic serum. Moreover, colic antigen can block this cytotoxicity; the immunologically active portion of this antigen may be isolated and its administration in patients with ulcerative colitis may perhaps induce a specific immunosuppression and influence the evolution of the disease.

Adrenal Cortex Hormones↗

PubMedDate not supplied

[Isolated granulomatous gastritis].

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Crohn Disease↗