Bronchial thermoplasty for asthma: evidence is lackingBMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g2724 (Published 14 April 2014) Cite this as: BMJ 2014;348:g2724
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We note with interest the concerns raised by Minerva, the Cochrane collaboration and Bhowmik about the efficacy of bronchial thermoplasty. The National Institute for Health and Care Excellence (NICE) Interventional Procedure Guidance agrees with their caution and states that the “evidence on the efficacy of bronchial thermoplasty for severe asthma shows some improvement in symptoms and quality of life, and reduced exacerbations and admission to hospital. Evidence on safety is adequate in the short and medium term. More evidence is required on the safety of the procedure in the long term. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research” .
By recommending “special arrangements” the guidance requires clinicians to tell their hospitals that they are using the procedure; to ensure that patients understand the uncertainty about the procedure’s safety and efficacy; and to audit clinical outcomes for all patients. As part of its guidance development activities, NICE has established a process to promote the generation of high quality evidence where gaps prevent the development of comprehensive recommendations . As part of this initiative, Newcastle and York External Assessment Centre was commissioned by NICE to work with the BritishThoracic Society UK Difficult Asthma Registry to develop a dataset for bronchial thermoplasty and to collect data on clinical outcomes for all patients undergoing the procedure in the UK.
The Cochrane review found that studies showed moderate improvement only in quality of life of patients treated with bronchial thermoplasty and in the number of asthma attacks (exacerbations) that they experienced. But confidence in the results was considered moderate because of inequalities between study groups and use of sham in only one study. It is too early for us to draw conclusions from UK registry data but early results from the registry were presented to the British Thoracic Society Winter Meeting in December 2013. Indications are that the national cohort of patients are marginally older and have worse mean pre-bronchodilator FEV1 % predicted values and AQLQ scores at baseline than patients in previous clinical trials. No serious issues relating to equipment or adverse outcomes have been observed.
The “special arrangements” put in place by NICE are also consistent with the recommendations in the International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma These joint guidelines reviewed the evidence for this procedure and recommended that bronchial thermoplasty “……is performed in adults with severe asthma only in the context of an Institutional Review Board approved independent systematic registry or a clinical study…..’. They comment that “…… this is a strong recommendation, because of the very low confidence in the currently available estimates of effects of bronchial thermoplasty in patients with severe asthma. Both potential benefits and harms may be large and the long-term consequences of this new approach to asthma therapy utilising an invasive physical intervention are unknown. Specifically designed studies are needed to define its effects on relevant objective primary outcomes, such as exacerbation rates, and on long-term effects on lung function. Studies are also needed to better understand the phenotypes of responding patients, its effects in patients with severe obstructive asthma (FEV1 ,60% of predicted value) or in whom systemic corticosteroids are used, and its long-term benefits and safety. Further research is likely to have an important impact on this recommendation…..”
We support Torrego A et al in seeking evidence development for this potentially important intervention . The evidence gaps were recognised by NICE and on-going work organised through collaboration between the British Thoracic Society, the Difficult Asthma Network and NICE could make a valuable contribution to discussion about the place of bronchial thermoplasty in the management of severe asthma. It is important that Specialist Commissioning arrangements support data collection by a requirement upon designated centers to submit data on all patients undergoing the procedure.
Bhowmik A. Bronchial thermoplasty for asthma: evidence is lacking. BMJ 2014;348:g2724
Pomfrett C, Campbell B, Pugh PJ, Campbell M, Marlow M. Medical Technologies Evaluation II: catalysing the development of primary clinical evidence for promising medical technologies. HTAi Bilbao 25-27 June 2012.
Burn J, Sims AJ, Bousfield DR, Patrick H, Welham S, Heaney LG. Efficacy and safety of bronchial thermoplasty in clinical practice: Early results from a national registry. Thorax 2013;68(Suppl 3):A152–A153 [P171]: doi: 10.1136/thoraxjnl-2013-204457.322
Chung KF, Wenzel SE, Brozek JL, Bush A, Castro M, Sterk P, Adcock I, et al. Eur Respir J 2014; 43: 343–373.
Torrego A, Solà I, Munoz A, Roqué i Figuls M, Yepes-Nuñez J, Alonso-Coello P, Plaza V - http://summaries.cochrane.org/CD009910/bronchial-thermoplasty-for-people...
Competing interests: No competing interests