SCIENZA O CARTA STRACCIA ? Ma , chi decide ? Solo se ‘EVIDENCE BASED ?’ MA LE INNOVAZIONI sono spesso : - descrittive e qualitative non ancora un ‘ trial controllato’

CARTA STRACCIA ? Il doppio cieco ‘non è etico’ Proporre terapie senza un trial controllato Piccoli numeri fare sottogruppi Errore di II tipo Valutare solo ‘p’

Infliximab as a Novel Therapy for Ulcerative Colitis. J. P. G. Nutr Propone una nuova terapia 12 pazienti identificati Misura di outcome Risultato Complicanze ‘scarse’ Conclusioni : è ottimo ! We retrospectively collected data on children treated with Infliximab Risultati su 9 casi Severe, moderate, mild 7/9 o 7/12 migliorano 2 reazioni al farmaco, una ANA > 1280 ‘this study is too small to draw conclusions !!!!!’

Eur. J. Pediatrics 1993; 152:704-711 Working Group on Gastroesophageal reflux The drug of first choice is Cisapride Almost all studies have shown good short- and long-term control of GOR, with improved motility and almost complete absence of side effects This drug can certainly be administered to treat uncomplicated GOR disease in infants before performing complementary investigations

in Pediatric Gastroesophageal reflux J.P.G.Nutrition, 1997, 25:499-506 Scott RB, Ferreira C, Smith AB et al, Montreal Cisapride in Pediatric Gastroesophageal reflux Randomized, prospective, double blind, placebo controlled clinical trial risultati su 18 infanti a Cisapride e 15 a placebo, su 45 reclutati

CONCLUSIONI Cisapride is a safe agent that improves the esophageal clearance of refluxed acid in children under 2 years of age Supported by funding from Jassen Pharmaceutica Inc. (North York – Ontario – Canada )

J.P.G.Nutrition, 1996 ; 22:259-269 Invited Review S. Cucchiara Cisapride Therapy for Gastrointestinal Disease Review estesa e ‘stato dell’arte’ con raccolta degli studi

Conclusions Cisapride is the first-line prokinetic agent for treating the majority of gastrointestinal motility disorders in children. Unlike other traditional prokinetic agents, it has a favorable side-effect profile without antidopaminergic or direct cholinomimetic effetcts. Cisapride is devoid of extrapyramidal effects and has a very low incidence of central nervous system effects (fatigue, somnolence).

Arch Dis Childhood, 2002; 86:71-72 Leading Article Cochrane’s epitaph for cisapride in childhood gastro-oesophageal reflux La Cisapride non è mai stata efficace nel curare il Reflusso Patologico (metanalisi degli studi eseguiti)

125 infanti riferiti per Coliche Addominali J. Pediatrics 2002, 140:3-4 EDITORIAL GERD and crying : cause and effect or unhappy coexistence ? 125 infanti riferiti per Coliche Addominali 104/125 avevano ricevuto terapia per sospetto GERD prima della diagnosi Tutti indagati invasivamente 13% avevano ‘esofagite’ e pHmetria significativa 13% avevano esofagite senza pHmetria L’esofagite non correla ‘statistically!!) con i sintomi