Do acupuncture and nutritional therapy change the quality of life and symptoms of people with atrial fibrillation?
We don’t know – but we’d like to find out.
To do this, we aim to carry out a large-scale trial with hundreds of people who have atrial fibrillation (AF). But medical trials are expensive – funding often runs to millions of pounds. So first we need to find out if it’s actually feasible to carry out that large-scale trial. For instance, if people with AF don’t like acupuncture or nutritional therapy, they might not enrol in the trial, or they might not finish a course of treatment – which means a large-scale trial would waste time and money as it wouldn’t be able to reach reliable conclusions.
So at this stage, the Santé-AF project is a feasibility study, enrolling a small number of people with AF to keep costs low and to minimise any as-yet unknown risk to participants from the therapies we’re investigating. For this feasibility study, we will be collecting data from our participants, but we won’t be using this to work out whether acupuncture or nutritional therapy are helpful for people with atrial fibrillation. That’s because we will only enrol 30 people, and that isn’t enough to draw any meaningful conclusions.
So we’re only collecting this data to help us work out whether collecting the data is a feasible thing to do – strange though that sounds! To work this out, we’ll be asking questions about whether participants feel the assessments themselves are acceptable.
One of the reasons people take part in trials is to advance knowledge and improve treatments for the health conditions that have made life difficult for them – they do it to help others and turn the difficulties they’ve had to advantage. So sometimes recruitment to feasibility studies is low because potential participants feel they aren’t actually contributing to that knowledge. But it’s worth bearing in mind that if we don’t have the feasibility data, a large-scale trial is much less likely to be funded – and that means we’ll never know the answers to whether these particular therapies are helpful for people with atrial fibrillation. So participants in the Santé-AF feasibility study are still contributing very strongly to advancing knowledge and improving treatments for atrial fibrillation – because they will play a crucial role in helping us to work out whether it’s feasible to conduct a trial that IS big enough to draw meaningful conclusions.
If the data from the feasibility study support it, we aim to make an application for funding and carry out the large-scale trial… and the large-scale trial will test whether acupuncture and nutritional therapy can change quality of life and symptom levels in people with atrial fibrillation. This is the first step on a carefully-tested, thoroughly planned journey to produce a reliable answer to that question!
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What are acupuncture and nutritional therapy?