Background Physiotherapy, and speech and language therapy are emerging non-pharmacological treatments for refractory chronic cough. We aimed to investigate the efficacy of a physiotherapy, and speech and language therapy intervention (PSALTI) to improve health-related quality of life (HRQoL) and to reduce cough frequency in patients with refractory chronic cough.
Methods In this multicentre randomised controlled trial, patients with refractory chronic cough were randomised to four weekly 1:1 sessions of either PSALTI consisting of education, laryngeal hygiene and hydration, cough suppression techniques, breathing exercises and psychoeducational counselling or control intervention consisting of healthy lifestyle advice. We assessed the change in HRQoL at week 4 with the Leicester Cough Questionnaire (LCQ). Secondary efficacy outcomes included 24-hour objective cough frequency (Leicester Cough Monitor) and cough reflex sensitivity. The primary analysis used an analysis of covariance adjusted for baseline measurements with the intention-to-treat population. This study was registered at UK Clinical Research Network (UKCRN ID 10678).
Findings Between December 2011 and April 2014, we randomly assigned 75 participants who underwent baseline assessment (34 PSALTI and 41 controls). In the observed case analysis, HRQoL (LCQ) improved on average by 1.53 (95% CI 0.21 to 2.85) points more in PSALTI group than with control (p=0.024). Cough frequency decreased by 41% (95% CI 36% to 95%) in PSALTI group relative to control (p=0.030). The improvements within the PSALTI group were sustained up to 3 months. There was no significant difference between groups in the concentration of capsaicin causing five or more coughs.
Interpretation Greater improvements in HRQoL and cough frequency were observed with PSALTI intervention. Our findings support the use of PSALTI for patients with refractory chronic cough.
Trial registration number UKCRN ID 10678 and ISRCTN 73039760; Results.
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Contributors Conception/design of work: RG, SSB, KKL and HB; Study recruitment: SAFCM, SSB, SMP, SJF, JHH and KFC; Assessments/treatment delivering in the trial: SAFCM, LC, JE and SL; Data analysis: SAFCM, AD, AP and SSB; Drafting manuscript: SAFCM, RG and SSB; Revised manuscript: All.
Funding This work was supported by a grant from the Chartered Society of Physiotherapy Charitable Trust, UK (Award PRF 10/4). Additional funding was obtained from NIHR-CRN. SSB was supported by King's College Hospital NHS Foundation Trust and London National Institute for Health Research (NIHR)/Wellcome Trust King's Clinical Research Facility and the NIHR Biomedical Research Centre and Dementia Unit at South London and Maudsley NHS Foundation Trust and King's College London. AD acknowledges financial support from the National Institute for Health Research Biomedical Research Centre at Guy's and St Thomas' National Health Service (NHS) Foundation Trust and King's College London. AD also acknowledges support from the NIHR Collaboration for Leadership in Applied Health Research and Care South London (CLAHRC South London). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.
Competing interests AP reports grants from NIHR, personal fees from Industry (Allergan, Merz and IPSEN), grants and non-financial support from Industry (Allergan and Biometrics), outside the submitted work. KFC has no disclosure for the work under consideration. Outside this work, he has received honoraria for participating in Advisory Board meetings regarding treatments for asthma and COPD for GSK, AZ, Novartis and J&J, and has received grant funding through his institution from Pfizer, GSK and Merck.
Ethics approval London-Chelsea National Research Ethics Service (NRES) Committee.
Provenance and peer review Not commissioned; externally peer reviewed.