Sessions of Acupuncture and Nutritional Therapy Evaluation for Atrial Fibrillation (Santé-AF): a feasibility study

Atrial fibrillation (AF) is the most common arrhythmia globally, associated with increased risk of stroke, debilitating symptoms and a decrease in health-related quality of life (HRQoL). Current treatments for AF may not provide symptomatic relief, and are associated with risks and adverse responses that may decrease HRQoL. A systematic review was conducted, revealing a small amount of low-quality evidence demonstrating positive effects of complementary therapies for symptoms and HRQoL in AF. This suggests that a large-scale trial would be justified to investigate whether complementary therapies may improve symptoms and/or HRQoL in AF. To decrease the uncertainty associated with a future trial, a feasibility study was carried out.
Thirty participants were recruited to a three-arm parallel-group pragmatic randomised controlled trial of acupuncture and nutritional therapy compared with usual care. Seven feasibility objectives (comprising a total 10 domains) were investigated quantitatively and qualitatively, including participants’ willingness to take part, appropriateness of eligibility criteria, participant retention, and acceptability of interventions and study assessments. Additional parameters were investigated relating to practitioners, and the effect of the COVID-19 pandemic. The study used a convergent mixed methods design to understand not only whether, but why, objectives and domains were (in)feasible.
A future large-scale trial was found to be feasible. Of the 10 feasibility domains, six were feasible without modification, one required process-related modifications to achieve feasibility, and one was re-analysed to correct participant error, thus achieving feasibility. Two domains were abandoned as inappropriate/unviable but did not affect feasibility. Recommendations made to improve feasibility across all domains included changes in eligibility criteria to reflect real-world populations, and changes in study assessments to attenuate participant burden. The study also proposed an extension to pragmatic trials methodology – the inclusion of nested case studies/series – to give a fuller representation of the effects of complementary therapies.