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Oxatomide for stable asthma in adults and childrenHayashi K, Yanagi M, Wood-Baker R, Takamatsu IIT, Anami KKA
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SummaryOxatomide for stable asthma in adults and childrenOxatomide, an anti-histamine agent, cannot be recommended for the treatment of chronic asthma as there is no consistent data to support a beneficial effect on asthma control. Six randomised controlled studies of the effect of oxatomide were identified. Some studies suggested a subjective benefit with oxatomide treatment. There was no consistent evidence of efficacy using objective outcomes. Adverse effects were the only outcome able to be combined in a meta-analysis, and these were significantly more likely with oxatomide than with placebo treatment.
This is a Cochrane review abstract and plain language summary, prepared and maintained by The Cochrane Collaboration, currently published in The Cochrane Database of Systematic Reviews 2010 Issue 1, Copyright © 2010 The Cochrane Collaboration. Published by John Wiley and Sons, Ltd.. The full text of the review is available in The Cochrane Library (ISSN 1464-780X).
This version first published online:
April 22. 2003 AbstractBackgroundOxatomide is a histamine H1-receptor antagonist. As an oral agent, oxatomide may be useful in managing asthma. Some guidelines recommend oxatomide for long-term prophylaxis of asthma in children. There is no clear evidence whether children or adults with asthma benefit from oxatomide. ObjectivesTo determine whether oxatomide alone, or in combination with other interventions, results in better disease control in people with asthma. Search strategyThe Collaborative Airway Group register and Collaborations trial register CENTRAL were searched using terms: oxatomide* OR Celtect OR Pinset OR KW-4354 OR Tincet. Reference lists of all relevant trials or review articles were checked. Enquiries were made of authors of included studies and relevant pharmaceutical companies. A search of 'Igaku Chuo Zasshi' and 'J-Medicine' were made using the following terms: oxatomide (also in Japanese) or Celtect (also in Japanese) or KW-4354. Searches are current as of September 2008. Selection criteriaStudies were randomised, placebo-controlled trials and the interventions were oxatomide or matched placebo given alone or in combination with other asthma-medication for at least 4 weeks. Data collection and analysisFour independent reviewers performed assessments of methodological quality and extracted relevant data. Main resultsSix studies are included in this review. Three studies were mainly conducted in adults, two were conducted in older children (5-16 years) and one in infants (18-25 months). Trial duration was 4 to 52 weeks. Doses of oxatomide varied between studies, ranging from 1 mg/kg/day for infants to 180 mg/day for adults. Only data on adverse events was suitable for meta-analysis. Although PEF did not change significantly in any of the studies, the FVC and FEV1 improved significantly in two. There was no uniform change in symptom scores. There was no significant difference between oxatomide and placebo treatment in use of inhaled corticosteroid or bronchodilator. Two studies showed significant improvement with oxatomide as judged subjectively by physicians. Adverse events, analysed using data from 4 parallel and one cross over study, showed oxatomide to be associated with a significantly higher risk of any adverse event (OR: 2.97, 95%CI: 1.69 to 5.22) and drowsiness (OR: 5.22,95%CI: 2.53 to 10.74). Authors' conclusionsThere is no evidence to show that oxatomide has a significant effect on the control of stable asthma. Some studies reported significant benefits in subjective parameters. There was improvement in some lung function outcomes reported, but this were not consistent across measures or studies and may represent reporting bias. Adverse events, including drowsiness, were significantly greater with oxatomide than placebo. |