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Electronic letters published:
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Gastroesophageal reflux in children with asthma
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Tom N Hilliard, Research Fellow Royal Brompton Hospital, Jane Davies, Ian Balfour-Lynn, Nicola Wilson, and Andrew Bush.
Send letter to journal:
t.hilliard{at}imperial.ac.uk Tom N Hilliard, et al.
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We consider the study by Khoshoo et al(1) and the accompanying editorial(2) on therapy for gastroesophageal reflux (GER) in children with asthma to be seriously flawed. Our concerns relate to both the study design and the reporting and interpretation of the findings. In summary, the authors report that non-atopic children with asthma and documented GER respond to GER treatment, with a reduction in the requirement for asthma medications. The reader is provided with little clinical information on these children with ‘difficult-to-control asthma’; there are no asthma symptoms, GER symptoms or lung function data provided to allow an assessment of severity, or even information to determine whether they had asthma at all. 59% of the group had an abnormal pH study and all of these children were treated, although the nature of treatment (medical or surgical) was at the choice of the family. Those with normal pH studies could elect to start medical anti-GER therapy if wished. In neither group was there therefore any randomisation or placebo arm. The only outcome assessed and reported was asthma therapies given in the year following intervention, supervised by a single pulmonologist who was aware, as was the family, of the GER status and treatment. There is no information about how seriously a protocol driven reduction of treatment was attempted prior to GER therapy. Although there was a significant reduction in asthma treatment in the children with abnormal pH monitoring following GER therapy (with only 11% of children needing inhaled corticosteroids), no information is provided of how reduction was attempted or asthma symptoms or lung function. These data are equally compatible with the hypothesis that the children with GER never had asthma, and that when the correct diagnosis was made, they could be weaned off the wrong treatment. Of the 8 children who had normal pH monitoring and started GER therapy, 2 came off their asthma medication, compared to none of the children who had no GER therapy. Results from this group are interpreted as useful ‘control’ data, supporting treatment efficacy only in the group with GER; it is our view however, that as these patients knew they did not have GER any such interpretation is highly questionable. We also have some concerns regarding the ethics of the study. No mention is made of informed consent to participate, or whether the study was approved by a Review Board. We are surprised at the surgical management as first line treatment of GER in a subgroup of these children, which appears to be outside recently published guidelines3, and is not, in our experience, common clinical practice. The authors state that there were no ‘long-term complications’ of the Nissen fundoplication, but significant acute complications do occur with this procedure, with rates in large published series of 4 - 8%(4,5). The accompanying editorial(2) gives a very positive critique of this study. Many of the weaknesses of the design, whilst in some cases acknowledged are, in our view, played down. The authors of both the study and the editorial appear to subscribe to the view that the perfect study would be ‘placebo-controlled with pertinent clinical outcome parameters’. We wholeheartedly agree. In contrast to the view expressed in the editorial, we would argue that until that time, we are no wiser. References 1 Khoshoo V, Le T, Haydel RM, et al. Role of gastroesophageal reflux in older children with persistent asthma. Chest 2003;123:1008-1013 2 Richter JE. Not the perfect study, but helpful wisdom for treating asthma patients with gastroesophageal reflux disease. Chest 2003;123:973- 975 3 Rudolph CD, Mazur LJ, Liptak GS, et al. Guidelines for evaluation and treatment of gastroesophageal reflux in infants and children. Recommendations of the North American Society for Paediatric Gastroenterology and Nutrition. J Pediatr Gastroenterol Nutr 2001;32(S2):S1-31 4 Fonkalsrud EW, Ashcraft KW, Coran AG, et al. Surgical treatment of gastroesophageal reflux in children: a combined hospital study of 7467 patients. Pediatrics 1998;101:419-422 5 Esposito C, Montupet P, Amici G, et al. Complications of laparoscopic antireflux surgery in childhood. Surg Endosc 2000;14:622-624 |
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