Close look at the experiences of patients enrolled in a clinical trial of acupuncture treatment for atrial fibrillation in Korea: a qualitative study nested within a randomised controlled trial

Abstract

ObjectiveTo explore the experiences of patients with atrial fibrillation (AF) in the context of a prospective, two-parallel-armed, participant-blinded and assessor-blinded sham-controlled randomised trial.DesignA nested qualitative study within an ongoing randomised controlled trial to explore acupuncture's antiarrhythmic effects on drug refractory acupuncture in persistent atrial fibrillation (AF) (ACU-AF trial).ParticipantsParticipants were recruited using purposeful sampling and a maximum variation strategy with regard to treatment allocation (treatment or control) and protocol completion (completion or non-completion).SettingThis was a single-centre in-depth interview qualitative study conducted at a tertiary-level university hospital in Seoul, Republic of Korea.ResultsData saturation was reached after 8 participants. Thematic analysis identified that most patients were not aware of their condition until medical check-up; physician referral was the main reason for trial participation, and patients had high expectations regardless of previous acupuncture experiences. Patients tended to depend on their physicians' opinions because they felt helpless of their condition. No one questioned their assigned treatment groups and generally believed acupuncture treatment was different for cardiovascular diseases. A few patients expressed disappointment in the strict and rigid protocols, in which most practitioners refrained from explaining their acupuncture procedures.ConclusionsFor cardiovascular patients their physician's advice was one of the biggest reasons for enrolling in the acupuncture trial therefore relying on standard recruitment methods may not be effective. Fortunately both real and sham acupuncture groups in our sample were receiving treatment as intended, but in the future, designing a more pragmatic trial (better reflecting clinical settings, expanding the inclusion criteria and using more treatment points) will allow researchers to better explore the comprehensive effects of acupuncture. The findings of this study will allow researchers to improve the currently ongoing ACU-AF trial and to further help interpretation of main trial outcomes once the trial is completed.Trial registration number:NCT02110537.

Effects of Acupuncture on Cardiac Remodeling in Patients with Persistent Atrial Fibrillation: Results of a Randomized, Placebo-Controlled, Patient- and Assessor-Blinded Pilot Trial and Its Implications for Future Research

“…In the future studies, transcutaneous stimulation of acupuncture points by patients as a home treatment between clinical visits might be a possible option to increase the dosage of acupuncture treatment. In our nested qualitative study [23], patients who reported having AF symptoms had a more positive response to acupuncture treatment than those who did not. Narrowing inclusion criteria to include patients with AF symptoms may also improve the results.…”

“…The type of sham control we selected allowed the control group to receive the same amount of attention and to minimize placebo effects. A qualitative study nested within our randomized trial revealed that blinding was successfully maintained [23].…”

Effectiveness and safety of traditional herbal medicine on cardiac arrhythmic condition: A systematic review and meta-analysis of randomized control clinical trial

“…In future studies, qualitative research methodologies should be considered to explain changes in the QoL and satisfaction of participants, which will promote an in-depth understanding of the effects and expectations of TEAM management. [ 118 ]…”

“…In future studies, qualitative research methodologies should be considered to explain changes in the QoL and satisfaction of participants, which will promote an in-depth understanding of the effects and expectations of TEAM management. [118] Several problems have been identified in disease diagnosis. In our meta-analysis, 20 studies defined arrhythmia without specific definitions or subtypes, such as AF and sinus bradycardia.…”

Research progress on central autonomic nervous mechanism of acupuncture at Neiguan point in the treatment of atrial fibrillation

“…Clinical study of acupuncture in the treatment of AF Many clinical studies have shown that acupuncture has a protective effect on AF [14][15][16][17] . In 2011, J Cardiovasc Electrophysiol published a randomized controlled trial (RCT) report [18] , which showed a statistically significant difference in the recurrence rate of AF during a 12-month follow-up period (recurrence rate was 27% in the amiodarone group, 35% in the acupuncture group, 69% in the sham acupuncture group, and 54% in the control group).…”