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
Abstract
:1. Introduction
2. Materials and Methods
2.1. Trial Design
2.2. Randomization and Blinding
2.3. Participants
2.4. EC Protocol
2.5. Outcomes
2.5.1. Primary Outcome
2.5.2. Secondary Outcome
2.6. Intervention
2.6.1. Real Acupuncture Treatment
2.6.2. Sham Acupuncture Treatment
2.7. Sample Size
2.8. Statistical Analysis
2.9. Ethical Considerations
3. Results
3.1. Participant Flow and Recruitment
3.2. Baseline Characteristics
3.3. Primary Outcome
3.4. Secondary Outcomes
4. Discussion
4.1. Summary of Findings
4.2. Discussion
4.3. Strengths and Limitations
4.4. Implications for Future Study
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Abbreviations
References
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Sham Acupuncture (N = 15) | Acupuncture (N = 16) | p-Value | |
---|---|---|---|
Age (years) | 63.7 ± 6.5 | 69.6 ± 7.3 | 0.024 |
Male, n (%) | 12 (80.0%) | 13 (81.2%) | 1 |
Hypertension, n (%) | 10 (66.7%) | 14 (87.5%) | 0.339 |
Diabetes Mellitus, n (%) | 3 (20.0%) | 2 (12.5%) | 0.937 |
Stroke, n (%) | 0 (0.0%) | 3 (18.8%) | 0.247 |
Vascular disease, n (%) | 0 (0.0%) | 1 (6.2%) | 1 |
CHA2DS2VASC score | 1.6 ± 1.0 | 2.8 ± 1.5 | 0.02 |
BSA (kg/m2) | 1.8 ± 0.2 | 1.8 ± 0.2 | 0.961 |
TTE parameters | |||
LVEF (%) | 64.2 ± 5.3 | 61.0 ± 6.8 | 0.151 |
LAVI (mL/m2) | 38.1 ± 7.7 | 42.2 ± 13.9 | 0.31 |
E/E’ * | 11.5 [9.6–11.9] | 12.6 [10.4–14.7] | 0.455 |
Medications | |||
Beta blocker | 1 (6.7%) | 1 (6.2%) | 1.0 |
Calcium channel blocker | 3 (20%) | 5 (31.2%) | 0.685 |
ACEi | 0 | 2 (12.5%) | 0.484 |
ARB | 5 (33.3%) | 8 (50%) | 0.347 |
ACEi or ARB | 5 (33.3%) | 10 (66.6%) | 0.104 |
Loop diuretics | 2 (13.3%) | 1 (6.2%) | 0.6 |
Thiazide | 1 (6.7%) | 0 | 0.484 |
Spironolactone | 2 (13.3%) | 2 (12.5%) | 1.0 |
Any diuretics | 3 (20%) | 2 (12.5%) | 0.654 |
Nitrate | 1 (6.7%) | 1 (6.2%) | 1.0 |
Digitalis | 1 (6.7%) | 0 | 0.484 |
Anticoagulant | 0.461 | ||
Warfarin | 11 (73.3%) | 13 (81.2%) | |
DOACs | 4 (26.7%) | 3 (18.8%) | |
(Apixaban) | 0 | 1 (6.2%) | |
(Dabigatran) | 3 (20%) | 1 (6.2%) | |
(Edoxaban) | 1 (6.7%) | 0 | |
(Rivaroxaban) | 0 | 1 (6.2%) |
Sham Acupuncture (N = 15) | Acupuncture (N = 16) | p-Value | |
---|---|---|---|
Rhythm outcomes | 0.611 | ||
AF recurrence | 9 (60.0%) | 12 (75.0%) | |
Sinus rhythm | 6 (40.0%) | 4 (25.0%) | |
TTE parameters | |||
LVEF | 63.8 ± 4.6 | 63.6 ± 5.2 | 0.903 |
LAVI | 36.9 ± 14.1 | 36.1 ± 9.7 | 0.865 |
E/E’ | 11.9 ± 4.5 | 11.9 ± 3.9 | 0.984 |
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Lee, J.M.; Lee, S.M.K.; Leem, J.; Kim, J.-B.; Park, J.; Park, J.H.; Lee, S.; Kim, H.O.; Chung, H.; Woo, J.S.; et al. 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. Medicina 2022, 58, 41. https://doi.org/10.3390/medicina58010041
Lee JM, Lee SMK, Leem J, Kim J-B, Park J, Park JH, Lee S, Kim HO, Chung H, Woo JS, et al. 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. Medicina. 2022; 58(1):41. https://doi.org/10.3390/medicina58010041
Chicago/Turabian StyleLee, Jung Myung, Seung Min Kathy Lee, Jungtae Leem, Jin-Bae Kim, Jimin Park, Jun Hyeong Park, Suji Lee, Hyung Oh Kim, Hyemoon Chung, Jong Shin Woo, and et al. 2022. "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" Medicina 58, no. 1: 41. https://doi.org/10.3390/medicina58010041