In a medical research project, the safety of everyone concerned is an over-riding priority. We have paid very close attention to all aspects of safety on the study, supported by the Health Research Authority’s London (Surrey) Research Ethics Committee.
In general, the potential for harm or adverse events as a result of acupuncture or nutritional therapy is judged to be low compared with the safety record of conventional treatment for atrial fibrillation. Acupuncture has an excellent safety record [1, 2, 3, 4, 5]; harms or adverse reactions are usually mild and self-correcting, such as minor bruising around a needle site. Members of the British Acupuncture Council follow a rigorous protocol to manage any risks for anti-coagulated patients.
The risks associated with nutritional therapy are unknown, as there are no studies published that indicate the level of adverse events; however, it is a requirement of the nutritional therapists’ professional body, BANT, that members conduct individualised assessments of risk for each client in relation to the dietary strategies proposed by the therapist, and that risk includes an “understanding and application of the mechanism of action of common classes of drugs and common drug-nutrient and drug-food interactions” [6].
Measures we have taken to protect participant safety include:
- Employing only members of the British Acupuncture Council and the British Association of Nutritional Therapy and Lifestyle Medicine, to ensure the highest standards of treatment and safety for participants in these arms of the trial. Members of both associations hold a minimum first-degree level training and are required to comply with the highest standards of practice, including safety. For acupuncturists, who will carry out face-to-face treatments during the trial, this also includes a comprehensive Covid-19 safety protocol including thorough cleaning, PPE and checking Covid status of the patient;
- Thorough pre-study training for all therapists in the trial, to make sure trial processes are complied with, including safety;
- A comprehensive and timely reporting and recording system for any adverse events that occur during the trial. Reported adverse events are acted on accordingly, and may involve a range of responses from monitoring to withdrawal of a participant from the trial. We’ll report on these at the end of the trial;
- A Trial Steering Committee whose duties include monitoring literature and relevant professional alerts regarding any change in the safety of either the therapies, or any medications taken for AF, with responsive actions taken appropriately;
- A rigorous system of monitoring Covid-19 levels in the area where the trial is taking place, with the Trial Steering Committee having the authority to pause the appropriate aspects of the trial if numbers rise past a certain level.
The safety and ethical standing of the study have been thoroughly scrutinised and given approval by the London (Surrey) Research Ethics Committee of the Health Research Authority (ref. 20/LO/0598).
1. Melchart, D. et al. (2004). Prospective Investigation of Adverse Effects of Acupuncture in 97 733 Patients. Archives of Internal Medicine, 164, pp.104–105.
2. Yamashita, H. and Tsukayama, H. (2008). Safety of acupuncture practice in Japan: Patient reactions, therapist negligence and error reduction strategies. Evidence-based Complementary and Alternative Medicine, 5 (4), pp.391–398. [Online]. Available at: doi:10.1093/ecam/nem086.
3. Witt, C. M. et al. (2009). Safety of acupuncture: Results of a prospective observational study with 229,230 patients and introduction of a medical information and consent form. Forschende Komplementarmedizin, 16 (2), pp.91–97. [Online]. Available at: doi:10.1159/000209315 [Accessed 15 May 2020].
4. Kawakita, K. and Okada, K. (2014). Acupuncture therapy: Mechanism of action, efficacy, and safety: A potential intervention for psychogenic disorders? BioPsychoSocial Medicine, 8 (4), pp.1–7. [Online]. Available at: doi:10.1186/1751-0759-8-4.
5. Chan, M. W. C. et al. (2017). Safety of Acupuncture: Overview of Systematic Reviews. Scientific Reports, 7, pp.3369–3379. [Online]. Available at: doi:10.1038/s41598-017-03272-0 [Accessed 6 June 2019].
6. Complementary and Natural Healthcare Council. (2018). Core curriculum for Nutritional Therapy. [Online]. Available at: doi:10.7326/0003-4819-117-7-607.
Please use these links to find out more about:
What are acupuncture and nutritional therapy?