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Open Access Highly Accessed Research article

A randomised multicentre trial of acupuncture in patients with seasonal allergic rhinitis – trial intervention including physician and treatment characteristics

Miriam Ortiz1*, Claudia M Witt12, Sylvia Binting1, Cornelia Helmreich1, Josef Hummelsberger3, Florian Pfab45, Michael Wullinger3, Dominik Irnich6, Klaus Linde7, Bodo Niggemann8, Stefan N Willich1 and Benno Brinkhaus1

Author Affiliations

1 Institute of Social Medicine, Epidemiology and Health Economics, Charité-Universitätsmedizin Berlin, Berlin, Germany

2 Institute for Complementary and Integrative Medicine, University Hospital Zurich, Zurich, Germany

3 International Society for Chinese Medicine, Munich, Germany

4 Department of Dermatology and Allergy, Technische Universität München, Munich, Germany

5 Department of Prevention and Sports Medicine, Technische Universität München, Munich, Germany

6 Department of Anesthesiology, Technische Universität München, Munich, Germany

7 Institute of General Practice, Klinikum rechts der Isar, Ludwig Maximilians University, München, Germany

8 Department of Pediatrics, Division of Pneumonology and Immunology, Charité-Universitätsmedizin, Berlin, Germany

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BMC Complementary and Alternative Medicine 2014, 14:128  doi:10.1186/1472-6882-14-128

Published: 6 April 2014

Abstract

Background

In a large randomised trial in patients with seasonal allergic rhinitis (SAR), acupuncture was superior compared to sham acupuncture and rescue medication. The aim of this paper is to describe the characteristics of the trial’s participating physicians and to describe the trial intervention in accordance with the STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupuncture) guidelines, to make details of the trial intervention more transparent to researchers and physicians.

Methods

ACUSAR (ACUpuncture in Seasonal Allergic Rhinitis) was a three-armed, randomised, controlled multicentre trial. 422 SAR patients were randomised to semi-standardised acupuncture plus rescue medication (RM, cetirizine), sham acupuncture plus RM or RM alone. We sent a questionnaire to trial physicians in order to evaluate their characteristics regarding their education about and experience in providing acupuncture. During the trial, acupuncturists were asked to diagnose all of their patients according to Chinese Medicine (CM) as a basis for the semi-standardised, individualized intervention in the acupuncture group. Every acupuncture point used in this trial had to be documented after each session

Results

Acupuncture was administered in outpatient clinics by 46 (mean age 47 ± 10 years; 24 female/ 22 male) conventionally-trained medical doctors (67% with postgraduate specialization such as internal or family medicine) with additional extensive acupuncture training (median 500 hours (1st quartile 350, 3rd quartile 1000 hours with 73% presenting a B-diploma in acupuncture training (350 hours)) and experience (mean 14 years in practice). The most reported traditional CM diagnosis was ‘wind-cold invading the lung’ (37%) and ‘wind-heat invading the lung’ (37%), followed by ‘lung and spleen qi deficiency’ (9%). The total number of needles used was higher in the acupuncture group compared to the sham acupuncture group (15.7 ± 2.5 vs. 10.0 ± 1.6).

Conclusions

The trial interventions were provided by well educated and experienced acupuncturists. The different number of needles in both intervention groups could be possibly a reason for the better clinical effect in SAR patients. For future trials it might be more appropriate to ensure that acupuncture and sham acupuncture groups should each be treated by a similar number of needles.

Trial registration

ClinicalTrials.gov: NCT00610584.

Keywords:
Acupuncture; Randomised controlled trial; Seasonal allergic rhinitis; Trial intervention; Sham acupuncture