Acupuncture in Seasonal Allergic Rhinitis (ACUSAR) – Design and Protocol of a Randomised Controlled Multi-Centre Trial

Institute for Social Medicine, Epidemiology, and Health Economics, Charité - University Medical Center, Berlin, Germany.
Forschende Komplementärmedizin / Research in Complementary Medicine (Impact Factor: 1.65). 04/2010; 17(2):95-102. DOI: 10.1159/000303012
Source: PubMed

ABSTRACT We report on the study design and protocol of a randomised controlled trial (Acupuncture in Seasonal Allergic Rhinitis, ACUSAR) that investigates the efficacy of acupuncture in the treatment of seasonal allergic rhinitis (SAR).
To investigate whether acupuncture is non-inferior or superior to (a) penetrating sham acupuncture and (b) rescue medication in the treatment of SAR.
3-armed, randomised controlled multi-centre trial with a total follow-up time of 16 weeks in the 1st year and 8 weeks in the 2nd year.
41 physicians in 37 out-patient units in Germany specialised in acupuncture treatment.
400 seasonal allergic rhinitis patients with clinical symptoms and test-positive (skin-prick test and/or specific IgE) to both birch and grass pollen.
Patients will be randomised in a 2:1:1 ratio to one of three groups: (a) semi-standardised acupuncture plus rescue medication (cetirizine); (b) penetrating sham acupuncture at non-acupuncture points plus rescue medication; or (c) rescue medication alone for 8 weeks (standard treatment group). Acupuncture and sham acupuncture will consist of 12 treatments per patient over 8 weeks.
Average means of the Rhinitis Quality of Life Questionnaire (RQLQ) overall score and the Rescue Medication Score (RMS) between weeks 6 and 8 in the first year, adjusted for baseline values.
The results of this trial available in 2011 will have a major impact on the decision of whether acupuncture should be considered as a therapeutic option in the treatment of SAR.

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Available from: Claudia M Witt, Mar 10, 2014
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    • "The participating physicians were recruited in a manner designed to ensure that their qualifications were adequate to perform a treatment procedure which included a CM diagnosis before acupuncture. According to the trial protocol [3], trial physicians had to fulfil the following criteria: (1) acupuncture training of at least 140 hours (equals an ‘A-diploma’ from the major German acupuncture associations); (2) at least 3 years of practical experience with acupuncture; (3) 50% of participating physicians had to have at least 350 h of acupuncture training (equals ‘B-diploma’); (4) 50% of trial physicians had to have experience working in clinical studies; and (5) required participation in trial training sessions on trial methods, applied trial interventions, and standards for performing clinical trials (ICH-GCP). At the trial beginning of the trial we sent a questionnaire to all 46 trial physicians. "
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    ABSTRACT: 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. 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). 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: NCT00610584.
    BMC Complementary and Alternative Medicine 04/2014; 14(1):128. DOI:10.1186/1472-6882-14-128 · 2.02 Impact Factor
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    Forschende Komplementärmedizin / Research in Complementary Medicine 01/2011; 18(3):127-33. · 1.65 Impact Factor
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    ABSTRACT: ZusammenfassungHintergrund: Kunsttherapeutische Angebote werden mittlerweile in allen Bereichen der onkologischen Versorgung angewandt, um die Krankheitsverarbeitung durch kreative Techniken zu unterstützen. In vorangegangenen Arbeiten wurde die Wirkung der Kunsttherapie überwiegend anhand der Teilnehmereinschätzungen beschrieben. Diese Studie hat das Ziel, die Bedeutung einer kunsttherapeutischen Intervention für Krebspatienten aus der Sicht aller Beteiligten – Teilnehmer, Kursabbrecher, Kursleitung und Supervisorin – zu untersuchen. Patienten und Methoden: Eine für die ambulante Nachsorge entwickelte kunsttherapeutische Intervention wurde mit Krebspatienten durchgeführt. Die persönliche Sicht der Teilnehmer und Kursabbrecher wurde nach Beendigung der Intervention mittels offener und geschlossener Fragen erfasst. Kursleitung und Supervisorin beschrieben die Wirkung der Intervention aus ihrer persönlichen Sicht. Ergebnisse: Insgesamt haben 74 Patienten die Intervention begonnen, wobei 18 die Teilnahme vorzeitig beendeten. Für die Teilnehmer (55 von 56 Fragebögen liegen vor) hatte die Intervention mehrere Bedeutungen. Am häufigsten wurden genannt: Anregung von Phantasie (50/55), emotionale Stabilisierung (48/55), Erweiterung der Ausdrucksmöglichkeit (45/55) und der Austausch mit Betroffenen (42/55). Das vorzeitige Beenden der Intervention hatte ganz verschiedene Gründe. Die befragten Kursabbrecher (N = 8/18) schätzten die Intervention positiv ein (4/8) bzw. konnten keine Aussage hierüber treffen (3/8). Einzelne Kritikpunkte waren: zu starke Thematisierung der Erkrankung (N = 3), modernes Zeichnen (N = 1), zu viele Gespräche (N = 1) und zu viel Zeichnen (N = 1). Sowohl die Kursleitung als auch die Supervisorin beschrieben vor allem die Aktivierung der Betroffenen als Wirkung der Intervention. Schlussfolgerungen: Die als positiv erlebten Wirkungen der Intervention sprechen für deren Etablierung im ambulanten Bereich. Kunsttherapeutische Angebote erweitern hierbei das Spektrum der psychosozialen Versorgung und bieten Krebspatienten die Möglichkeit, sich künstlerisch mit der Erkrankung und deren Folgen auseinanderzusetzen.
    Forschende Komplementärmedizin / Research in Complementary Medicine 05/2011; 18(3):127-133. DOI:10.1159/000328222 · 1.65 Impact Factor
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