Allergic rhinitis (AR) is a common allergic condition in the respiratory system. The disease is characterised by sneezing, itching, rhinorrhoea and nasal congestion. AR is not a life-threatening disease; however, it affects 10% to 30% of the worldwide population and approximately 20% of Australians and has a significant impact on patients’ quality of life as well as brings a heavy financial burden to both AR sufferers and the healthcare system. Current management of AR includes education, allergen avoidance, pharmacotherapy and allergen-specific immunotherapy. However, these treatments are unable to provide full symptomatic relief of AR and some of them are associated with undesirable side effects. Some patients seek complementary and alternative medicine such as acupressure (a subtype of acupuncture) for self-management. However, there has been insufficient scientific evidence on its efficacy and safety. This research project aimed to investigate the effects and safety of acupressure for the self-management of AR by conducting a systematic review and randomised controlled trials (RCTs) and explore patients’ opinions on participating in the RCTs through an interview study.
A systematic review of RCTs on acupressure for respiratory allergic diseases
The systematic review was conducted prior to the design of the clinical trial protocol. Since AR and asthma share the same allergens and are present on both nasal and bronchial mucosa due to anatomical and physiological similarities and functional complementarity, this review focused on respiratory allergic diseases covering both AR and asthma. It searched 13 databases however only identified four eligible RCTs. Acupressure seems safe for symptomatic relief of AR and asthma but no reliable conclusions regarding the effects of acupressure on AR and asthma could be drawn by this review due to the small number of available trials with significant heterogeneity of study design and high/unclear risk of bias. More rigorously designed RCTs were needed. Findings from this review contributed to the selection of acupressure points for RCTs.
Development of RCT protocol
Based on the findings from the systematic review, the trial protocol was developed. The study was designed as a randomised, single-blinded, non-specific controlled, two-arm, parallel clinical trial involving a two-week run-in period, a four-week intervention period and an eight-week follow-up period. The eligible participants were randomised into either specific acupressure (SA) or non-specific acupressure (NSA) group and required to perform self-administered acupressure on either five SA points or five NSA points, one minute for each point, twice a day for four weeks. Participants were asked to complete a few self-administered questionnaires for comparison of their AR symptom severity and quality of life, relief medication use, adverse events and participants’ opinion of this study between two groups at the different assessment points throughout the trial period. Data was analysed using Statistical Package for Social Science software. The RCT protocol was approved by RMIT University’s Human Research Ethics Committee (HREC20742) and registered at Australia and New Zealand Clinical Trial Registry (ANZCTR): ACTRN12617001106325.
Self-administered acupressure for AR RCT: Pilot study 1 (feasibility study)
In order to assess the feasibility of the protocol, the pilot study 1 was conducted between November 2017 and February 2018 at RMIT University’s Bundoora campus. Fourteen AR patients completed the study. There was no significant difference in AR symptom severity, quality of life, or medication usage between two groups. However, participants in the SA group believed that SA was useful for AR and recommended it for self-care. The credibility of the blinding method was successful. No adverse effects were considered to be related to the intervention. Experience from this pilot study has guided minor amendments to the protocol, including the reduction of run-in periods from two weeks to one week and the follow-up periods from eight weeks to four weeks.
Self-administered acupressure for AR RCT: Pilot study 2 (efficacy study)
The pilot 2 RCT was conducted in 2018-2019 according to the amended protocol. Thirty-six AR patients completed the study. The SA group showed statistically significant improvement in nasal congestion, some non-nasal symptoms and two domains of Rhinoconjunctivitis Quality of Life Questionnaire with Standardised Activities throughout the trial period. Moreover, the significance of a few sub-items lasted until the end of the follow-up period. However, medication usage was not changed in both groups. The SA group participants believed that acupressure was useful and could improve their AR symptoms. The blinding method was successful. Minor adverse events were reported that were associated with the intervention. Self-administration of acupressure has demonstrated its feasibility, safety and promising effects for AR sufferers. Limited significant results on nasal symptoms may be associated with the small sample size. These results need to be further validated by a large-scale RCT.
Patients’ attitudes and perceptions in participating in RCTs: A survey
Due to the suspension of RCTs caused by COVID-19, the scope of my project has been adjusted with consideration of the challenges regarding participant recruitment during the pilot trials. A survey was designed to use semi-structured online interviews to investigate patient’s attitudes and perceptions in participating in previous RCTs. The ethics application for the survey was approved by RMIT University’s College Human Ethics Advisory Network (CHEAN23053). All the AR patients who expressed their interests in previous two pilot trials were invited and 23 patients completed online interviews. Each interview consisted of 8-15 questions and lasted for 20-30 minutes. Participants noted that the pilot trials were well organised. They also recognised that acupressure was non-invasive, easy to learn, convenient, and safe to practice, and they expressed their willingness to take part in the future studies. The location of the study, time-consumption, safety and benefits of the intervention are the identified key factors impacting on patients’ decision-making on trial participation. These findings may contribute to the fine-tuning of the RCT protocol through promotion of participant recruitment in the future.
This project started with a systematic review that addressed the current evidence of acupressure for AR and methodological issues of RCTs, followed by two pilot RCTs that investigated the feasibility, safety and efficacy of self-administered acupressure for AR. Subsequently the interview study further explored patients’ opinions on the pilot trials and the factors influencing their decision-making on trial participation. This cohesively designed project revealed that acupressure could be a feasible and safe technique for self-management of AR. Although the effects of acupressure for AR could not be determined in this project, strategies have been proposed to inform a fine-tuned trial protocol for conducting a large-scale RCT to confirm its effects in the near future.
History
Degree Type
Doctorate by Research
Imprint Date
2023-01-01
School name
School of Health and Biomedical Sciences, RMIT University