Available online 6 August 2022

AbstractBackground

: Reflexology is commonly used as an adjunct to conventional treatment by patients with respiratory tract infections. The effect of reflexology needs to be tested in a full-scale randomized controlled study. Small early-phase trials can give an indication on whether full-size clinical trials are warranted. The objective of this study is to determine whether the study design is feasible in a full-scale study of reflexology as an add-on to usual care compared to usual care alone in acute rhinosinusitis, and further if there is a statistical indication of an effect of reflexology warranting a full-scale study.

Methods

: 20 patients with symptoms compatible with acute rhinosinusitis, and an illness duration of 28 days or less were randomized to additional reflexology treatment along with usual medical care, or usual care alone. The patients scored how much each of 16 sinus-related symptoms bothered them in the past few days on a six-point scale (zero = no problem to five = severe problem). To determine if there is a statistical indication of an effect of reflexology warranting a full-scale study, the separation test was used.

Results

: The methodology was considered feasible and could therefore be applied in a full-scale study of reflexology for acute rhinosinusitis. The mean reduction in symptom score from baseline to day two was 0.95 in the reflexology group and 0.78 in the control group. From baseline to day ten the mean reduction in symptom score was 2.12 in the reflexology group and 1.63 in the control group. A statistical indication of effect in a full-scale study in favor of reflexology was found from baseline to day ten but not from baseline to day two.

Conclusions

: The research methodology in this study could be used in a full-scale study of reflexology in acute sinusitis. The results from the separation test indicates an effect warranting a full-scale study of reflexology regarding effects in acute sinusitis ten days after treatment.

Section snippetsBackground

Respiratory tract infections constitute approximately 17.7% of all General Practitioner (GP) consultations in Norway1. A total of 96.8% of patients with acute rhinosinusitis in five Swedish counties who consulted a GP left with a prescription for antibiotics2, while the prescription of antibiotics for acute rhinosinusitis in Norway was 75.9%3. This prescription practice stands in contrast to the low documented efficacy of antibiotics in clinically diagnosed rhinosinusitis4,5, and Norwegian6

The patients

All patients, 16 years of age and above with symptoms compatible with acute rhinosinusitis, and an illness duration of 28 days or less seeking urgent care in three towns in southern Norway between September 2017 and March 2018 were invited to participate in the study. Enrollment continued until 20 patients were included according to pre-study sample size calculation. A total of 24 patients were asked to participate before 20 patients signed the informed consent form and were treated according

Feasibility of the study protocol

The study showed challenges in the recruiting process and willingness among patients to adhere to a study where a complementary therapist needed to be visited in addition to their general practitioner. On the other hand, patients that were randomized to reflexology as an add-on to conventional care expressed great satisfaction by being part of the study and receiving complementary treatment. The logistics in the medical center was excellent and the study did not add substantial extra work to

Discussion

The methodology in this study is shown to be feasible in a large-scale study in reflexology in acute rhinosinusitis with an extra focus of reducing dropouts in the control group and reduce the number of missing responses to single questions in the questionnaire. It is a concern that two out of nine patients (22.2%) in the control group were lost to follow up. This underscores the challenge of keeping patients in control groups in exploratory studies17.

In this study, it appears (by calculating

Further research

This paper has reaffirmed the critical role of early phase CAM research and can possibly encourage CAM researchers to value and conduct early phase studies for their proper purposes. The use of the separation test in small scale, early phase studies is valuable in assessing whether it is worthwhile to pursue research. This is particularly important in CAM research where both budgetary and safety considerations argue for research with small sample size before going forward with a full

Ethics approval and consent to participate

Approval of the study was received by the Regional Committee for Medical and Health Research Ethics (REK: 2017/445). The patients were informed about the study both through a pamphlet and verbally by a research assistant. Written informed consent was obtained from all participants. All participants were informed that there would be no disadvantage if they did not wish to participate, and that they could withdraw from the study at any time of the study.

Consent for publication

The manuscript does not contain sensitive data from any individual person. All participating patients has signed the informed consent for publication.

Availability of data and materials

The dataset this paper has been based on has not been deposited in any repository. All dataset and materials are available from the corresponding author upon reasonable request. The unified Delphi-based reflexological definition of diagnosis and treatment in acute rhinosinusitis is available upon request.

Funding

The study received a research grant from the National Research Centre of Complementary and Alternative Medicine (NAFKAM), Institute of Community Medicine, UiT - The Arctic University of Norway. The reflexology treatments were funded by Nøtterøy Naturmedisinske Senter (Nøtterøy Natural Medicine Center). The publication charges for this paper have been funded by a grant from the publication fund of UiT - The Arctic University of Norway.

Authors’ contributions

AJN, AEK, TS, JPL and VF conceived the study. AEK and VF performed the initial and final analyses. AJN and AEK drafted the initial version of the paper. CB, JPL and TV performed the clinical treatment in the study. All authors reviewed subsequent versions and read and approved the final manuscript.

Competing of Interests

The authors declare that they have no competing interests.

Acknowledgements

The authors are grateful to the Norwegian Association of Natural Medicine for the first initiative to do research in reflexology. Much appreciation also goes to all the staff at Vestskogen Medical Center and particularly research assistant Kjersti Tragethon for the most caring handling of the patients and follow-up during data collection. We acknowledge the support from the NAFKAMs Information Department in promoting the study in media and the recruitment of the patients.

References (23)AE Kristoffersen et al.Use of complementary and alternative medicine in Norway: a cross-sectional survey with a modified Norwegian version of the International Questionnaire to Measure Use of Complementary and Alternative Medicine (I-CAM-QN)

BMC Complementary therapies in Medicine

(2021)

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