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Published on: February 26, 2013
Sessions of acupuncture and nutritional therapy evaluation for atrial fibrillation (Santé-AF): a randomised
Karen Charlesworth1,2, David J Torgerson3, Judith M Watson3
1Department of Health Sciences, University of York, Heslington, York, YO10 5DD, UK. karencharlesworth@nca.ac.uk.
Insights
A feasibility study found a large-scale trial for atrial fibrillation complementary therapies is possible. Adjustments to eligibility and assessments are recommended for future research on acupuncture and nutritional therapy.
Area of Science:
- Cardiology
- Complementary Medicine
- Health Services Research
Background:
- Atrial fibrillation (AF) significantly impacts quality of life, with current treatments having limitations.
- Investigating complementary therapies for AF symptoms and quality of life is warranted.
- A feasibility study was conducted to inform a larger trial.
Purpose of the Study:
- To assess the feasibility of a large-scale randomised controlled trial (RCT) for complementary therapies in AF.
- To evaluate participant recruitment, retention, and intervention acceptability.
- To gather data for refining the design of a future definitive trial.
Main Methods:
- A three-arm, parallel-group, pragmatic randomised controlled feasibility study.
- 30 participants with paroxysmal AF (aged 45-70) were randomised to acupuncture + usual care, nutritional therapy + usual care, or usual care alone.
- Feasibility objectives included willingness to participate, eligibility criteria appropriateness, retention, and acceptability of interventions and assessments, analysed using descriptive statistics and thematic analysis.
Main Results:
- Five of seven feasibility objectives met progression criteria; one did not meet its threshold.
- Recommendations for a future trial include adjusting eligibility criteria and assessment methods to reduce participant burden.
- Uncertainty remains regarding the impact of pre-COVID therapy reversion and assessment delivery, suggesting a longer follow-up.
Conclusions:
- A future large-scale trial investigating complementary therapies for AF is feasible with modifications.
- Adjustments to eligibility criteria and assessment methods are recommended.
- Further research is needed to address remaining uncertainties, particularly regarding follow-up duration.
Background:
Atrial fibrillation is a common cardiac arrhythmia, associated with debilitating symptoms and a decrease in health-related quality of life. Current treatments for atrial fibrillation may not provide symptomatic relief and are associated with risks and adverse responses. Large-scale trials are justified to investigate whether complementary therapies may improve symptoms and/or health-related quality of life in atrial fibrillation. To reduce the uncertainty of a future trial, a feasibility study was carried out.
Design And Methods:
A three-arm, parallel-group, pragmatic randomised controlled feasibility study recruited 30 participants with paroxysmal AF aged 45-70 from NHS primary care, randomising to Group A (acupuncture + usual care), Group B (nutritional therapy + usual care) or Group C (usual care alone) using a 2:2:1 allocation ratio in favour of the interventions. Interventions were delivered by private practitioners. Seven feasibility objectives were investigated, including participants' willingness to take part, appropriateness of eligibility criteria, participant retention and acceptability of interventions and study assessments. Additional exploratory feasibility objectives were investigated, including the effect of the COVID-19 pandemic and the safety of interventions. Data was analysed using descriptive statistics and reflexive thematic analysis, and the study used a sequential convergent mixed methods design to understand whether, and why, objectives were feasible and to make recommendations for a future trial.
Results:
Five feasibility objectives' progression criteria were met, one did not meet its progression threshold and one was abandoned as infeasible to analyse but did not affect feasibility. Recommendations for a future trial include changes in eligibility criteria to reflect real-world populations and changes to assessment methods to reduce participant burden. Uncertainty remains around the effect on the feasibility of reversion to pre-COVID therapy and study assessment delivery, including a recommended longer follow-up.
Conclusion:
A future large-scale trial was found to be feasible with adjustments, but some uncertainty remains.
Trial Registration:
ISRCTN13671984. Registered on June 04, 2020.
