Seasonal Allergic RhinitisACUSARNCT00610584
Acupuncture for Seasonal Allergic Rhinitis
A study testing acupuncture and cetirizine dihydrochloride (rescue medication) in people with Seasonal Allergic Rhinitis, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Acupuncture is widely use by patients with seasonal allergic rhinitis (SAR), although there is only limited evidence of its effectiveness. The aim of this three armed randomised controlled multicentre trial is to investigate the efficacy of acupuncture plus rescue medication vs. Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- acupuncture and cetirizine dihydrochloride (rescue medication)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 422 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2008to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female or male patients (aged 16-45 years) with seasonal allergic rhinitis, clinically positive and test positive (skin-prick test and/or RAST) to grass and birch pollen
- Patients with >2 years of moderate to severe SAR
- Positive skin-prick test and/or RAST (at least class 2) results
- Visual analogue scale >40mm and <80 mm for SAR symptoms during the past year
- Patients must be able to complete a diary for self-evaluation of symptoms and recording use of anti-symptomatic medication
- Use of, or indication for, oral antihistamines as anti-allergic medication
- Written informed consent
Who cannot join
- Perennial SAR or other types of chronic rhinitis
- Allergic asthma and/or moderate to severe atopic dermatitis
- Active tuberculosis
- Autoimmune disorders
- Severe chronic inflammatory diseases
- History of anaphylactic reactions
Show all 15Show fewer
- Hypersensitivity to Rescue medication or related drugs used in study related drugs
- Specific immunotherapy >3 years
- Simultaneous participation in other clinical trials
- Serious acute or chronic organic disease or mental disorder
- Pregnancy or breast feeding
- Allergy desensitisation therapy (current, during the past two years, or planned in the next two years)
- Blood coagulation disorder and/or current use of anticoagulants
- Previous acupuncture treatment for SAR
- Any Complementary and alternative medicine treatment at the moment, in the last three months or planned in the next two years
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité - Institute for Social Medicine
Berlin, State of Berlin, 10098
About this study
Official title: Acupuncture for Seasonal Allergic Rhinitis (ACUSAR) - A Randomised Controlled Trial
Acupuncture is widely use by patients with seasonal allergic rhinitis (SAR), although there is only limited evidence of its effectiveness. The aim of this three armed randomised controlled multicentre trial is to investigate the efficacy of acupuncture plus rescue medication vs. minimal (sham) acupuncture plus rescue medication vs. (b) rescue medication alone in the treatment of seasonal allergic rhinitis.
Read the detailed description
Acupuncture is widely use by patients with seasonal allergic rhinitis (SAR), although there is only limited evidence of its effectiveness. The aims of this 3-armed, randomised controlled trial are to investigate whether acupuncture plus rescue medication is non-inferior (closed testing procedure: in case of success in non-inferiority: test of superiority) to minimal acupuncture plus rescue medication in the treatment of SAR (closed testing procedure: closed testing procedure: in case of success in non-inferiority: test of superiority), and whether acupuncture plus rescue medication is non-inferior to rescue medication alone consisting only of oral antihistamines for this indication. The trial interventions will be performed in approximately 40 outpatient centres in Germany. In total, 400 patients with SAR will be randomised to one of three groups: acupuncture plus rescue medication, minimal acupuncture (i.e. superficial needling at non-acupuncture points) plus rescue medication, or rescue medication only. Rescue medication will consist of oral antihistamines. Acupuncture and minimal acupuncture will be administered by physicians specialised in acupuncture and will consist of 12 sessions per patient in the first 8 weeks. Patients in the rescue medication group will receive 12 sessions of acupuncture after 8 weeks. The primary outcome measures will be the mean of Rhinitis Quality of Life Questionnaire score (RQLQ scores between weeks 6 and 8 of the first year (adjusted for baseline values) and the Rescue Medication Score (RMS) between weeks 6 and 8 of the first year (adjusted for baseline values).
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- acupuncture, minimal (sham)acupuncture, cetirizine dihydrochloride (rescue medication)
- Keywords
- seasonal allergic rhinitis, acupuncture, RCT, CAM
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureProcedure or surgery
arm 1: verum acupuncture group: 12 interventions (semi-standardised): 8 in the first 4 weeks and 4 in the next 4 weeks + rescue medication (up to 2 doses of second-generation oral antihistamines daily (e.g. 2 x 1 cetirizine dihydrochloride/daily))
minimal (sham)acupunctureProcedure or surgery
arm 2: minimal (sham) acupuncture group: 12 interventions (standardised): 8 in the first 4 weeks and 4 in the next 4 weeks + rescue medication (up to 2 doses of second-generation oral antihistamines daily (e.g. 2 x 1 cetirizine dihydrochloride/daily))
cetirizine dihydrochloride (rescue medication)Drug
arm 3: rescue medication (up to 2 doses of second-generation oral antihistamines daily (e.g. 2 x 1 cetirizine dihydrochloride/daily)) alone
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | verum acupuncture plus rescue medication (up to 2 doses of second-generation oral antihistamines daily (e.g. 2 x 1 cetirizine dihydrochloride/daily)) Receives: Procedure: acupuncture |
| 2 | Placebo comparator | minimal (sham) acupuncture plus rescue medication (up to 2 doses of second-generation oral antihistamines daily (e.g. 2 x 1 cetirizine dihydrochloride/daily)) Receives: Procedure: minimal (sham)acupuncture |
| 3 | Active comparator | rescue medication (up to 2 doses of second-generation oral antihistamines daily (e.g. 2 x 1 cetirizine dihydrochloride/daily))alone Receives: Drug: cetirizine dihydrochloride (rescue medication) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rhinitis Quality of Life Questionnaire score (RQLQ scores between weeks 6 and 8 of the first year (adjusted for baseline values) and the Rescue Medication Score between weeks 6 and 8 of the first year (adjusted for baseline values).
Measured: Weeks 6 and 8 of the first year (adjusted for baseline values).
Secondary outcomes (1)
Quality of life (SF-36), responder rate (RQLQ score of 0.5 or more), global evaluation of treatment success, VAS (0-100 mm) overall symptom severity and nasal, eye, pharyngeal and common symptoms, safety, patients constitution, health economic analyses.
Measured: Baseline, 8 weeks and 16 weeks in the first year and baseline and week 8 in the second year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 422 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Principal investigator, Benno Brinkhaus, Charite University, Berlin, Germany
- Investigators
- Stefan N Willich, MD, MBA, Principal investigator, Epidemiology, and Health Economics, Charité University Medical Center, 10098 Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610584
- Sponsor's protocol ID
- EA1/214/07
- Other IDs
- DFG
- Acronym
- ACUSAR
- Status last verified
- Oct 2012
- First submitted
- 28 Jan 2008
- Last updated
- 23 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Adam D, Grabenhenrich L, Ortiz M, Binting S, Reinhold T, Brinkhaus B. Impact of acupuncture on antihistamine use in patients suffering seasonal allergic rhinitis: secondary analysis of results from a randomised controlled trial. Acupunct Med. 2018 Jun;36(3):139-145. doi: 10.1136/acupmed-2017-011382. Epub 2018 Feb 10.
PubMed 29440045Ortiz M, Witt CM, Binting S, Helmreich C, Hummelsberger J, Pfab F, Wullinger M, Irnich D, Linde K, Niggemann B, Willich SN, Brinkhaus B. A randomised multicentre trial of acupuncture in patients with seasonal allergic rhinitis--trial intervention including physician and treatment characteristics. BMC Complement Altern Med. 2014 Apr 6;14:128. doi: 10.1186/1472-6882-14-128.
PubMed 24708643Reinhold T, Roll S, Willich SN, Ortiz M, Witt CM, Brinkhaus B. Cost-effectiveness for acupuncture in seasonal allergic rhinitis: economic results of the ACUSAR trial. Ann Allergy Asthma Immunol. 2013 Jul;111(1):56-63. doi: 10.1016/j.anai.2013.04.008. Epub 2013 May 3.
PubMed 23806461Brinkhaus B, Ortiz M, Witt CM, Roll S, Linde K, Pfab F, Niggemann B, Hummelsberger J, Treszl A, Ring J, Zuberbier T, Wegscheider K, Willich SN. Acupuncture in patients with seasonal allergic rhinitis: a randomized trial. Ann Intern Med. 2013 Feb 19;158(4):225-34. doi: 10.7326/0003-4819-158-4-201302190-00002.
PubMed 23420231
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Seasonal Allergic Rhinitis (ACUSAR) - A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00610584
- Acronym / sponsor ID
- ACUSAR / EA1/214/07
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- seasonal allergic rhinitis, acupuncture, RCT, CAM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 422 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Apr 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 8 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acupuncture is widely use by patients with seasonal allergic rhinitis (SAR), although there is only limited evidence of its effectiveness. The aim of this three armed randomised controlled multicentre trial is to investigate the efficacy of acupuncture plus rescue medication vs. minimal (sham) acupuncture plus rescue medication vs. (b) rescue medication alone in the treatment of seasonal allergic rhinitis.
Detailed description
Acupuncture is widely use by patients with seasonal allergic rhinitis (SAR), although there is only limited evidence of its effectiveness. The aims of this 3-armed, randomised controlled trial are to investigate whether acupuncture plus rescue medication is non-inferior (closed testing procedure: in case of success in non-inferiority: test of superiority) to minimal acupuncture plus rescue medication in the treatment of SAR (closed testing procedure: closed testing procedure: in case of success in non-inferiority: test of superiority), and whether acupuncture plus rescue medication is non-inferior to rescue medication alone consisting only of oral antihistamines for this indication. The trial interventions will be performed in approximately 40 outpatient centres in Germany. In total, 400 patients with SAR will be randomised to one of three groups: acupuncture plus rescue medication, minimal acupuncture (i.e. superficial needling at non-acupuncture points) plus rescue medication, or rescue medication only. Rescue medication will consist of oral antihistamines. Acupuncture and minimal acupuncture will be administered by physicians specialised in acupuncture and will consist of 12 sessions per patient in the first 8 weeks. Patients in the rescue medication group will receive 12 sessions of acupuncture after 8 weeks. The primary outcome measures will be the mean of Rhinitis Quality of Life Questionnaire score (RQLQ scores between weeks 6 and 8 of the first year (adjusted for baseline values) and the Rescue Medication Score (RMS) between weeks 6 and 8 of the first year (adjusted for baseline values).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: acupunctureverum acupuncture plus rescue medication (up to 2 doses of second-generation oral antihistamines daily (e.g. 2 x 1 cetirizine dihydrochloride/daily)) |
| 2 | Placebo comparator | Procedure: minimal (sham)acupunctureminimal (sham) acupuncture plus rescue medication (up to 2 doses of second-generation oral antihistamines daily (e.g. 2 x 1 cetirizine dihydrochloride/daily)) |
| 3 | Active comparator | Drug: cetirizine dihydrochloride (rescue medication)rescue medication (up to 2 doses of second-generation oral antihistamines daily (e.g. 2 x 1 cetirizine dihydrochloride/daily))alone |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Female or male patients (aged 16-45 years) with seasonal allergic rhinitis, clinically positive and test positive (skin-prick test and/or RAST) to grass and birch pollen
- Patients with >2 years of moderate to severe SAR
- Positive skin-prick test and/or RAST (at least class 2) results
- Visual analogue scale >40mm and <80 mm for SAR symptoms during the past year
- Patients must be able to complete a diary for self-evaluation of symptoms and recording use of anti-symptomatic medication
Key exclusion criteria (15 listed)
- Perennial SAR or other types of chronic rhinitis
- Allergic asthma and/or moderate to severe atopic dermatitis
- Active tuberculosis
- Autoimmune disorders
- Severe chronic inflammatory diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupuncturearm 1: verum acupuncture group: 12 interventions (semi-standardised): 8 in the first 4 weeks and 4 in the next 4 weeks + rescue medication (up to 2 doses of second-generation oral antihistamines daily (e.g. 2 x 1 cetirizine dihydrochloride/daily)) | Procedure or surgery | 1 |
| minimal (sham)acupuncturearm 2: minimal (sham) acupuncture group: 12 interventions (standardised): 8 in the first 4 weeks and 4 in the next 4 weeks + rescue medication (up to 2 doses of second-generation oral antihistamines daily (e.g. 2 x 1 cetirizine dihydrochloride/daily)) | Procedure or surgery | 2 |
| cetirizine dihydrochloride (rescue medication)arm 3: rescue medication (up to 2 doses of second-generation oral antihistamines daily (e.g. 2 x 1 cetirizine dihydrochloride/daily)) alone | Drug | 3 |
Primary outcome
Rhinitis Quality of Life Questionnaire score (RQLQ scores between weeks 6 and 8 of the first year (adjusted for baseline values) and the Rescue Medication Score between weeks 6 and 8 of the first year (adjusted for baseline values).
Time frame: Weeks 6 and 8 of the first year (adjusted for baseline values).
1 secondary outcome
Quality of life (SF-36), responder rate (RQLQ score of 0.5 or more), global evaluation of treatment success, VAS (0-100 mm) overall symptom severity and nasal, eye, pharyngeal and common symptoms, safety, patients constitution, health economic analyses.
Time frame: Baseline, 8 weeks and 16 weeks in the first year and baseline and week 8 in the second year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2012.
- Derived from this study: PubMed 29440045Adam D, Grabenhenrich L, Ortiz M, Binting S, Reinhold T, Brinkhaus B. Impact of acupuncture on antihistamine use in patients suffering seasonal allergic rhinitis: secondary analysis of results from a randomised controlled trial. Acupunct Med. 2018 Jun;36(3):139-145. doi: 10.1136/acupmed-2017-011382. Epub 2018 Feb 10.
- Derived from this study: PubMed 24708643Ortiz M, Witt CM, Binting S, Helmreich C, Hummelsberger J, Pfab F, Wullinger M, Irnich D, Linde K, Niggemann B, Willich SN, Brinkhaus B. A randomised multicentre trial of acupuncture in patients with seasonal allergic rhinitis--trial intervention including physician and treatment characteristics. BMC Complement Altern Med. 2014 Apr 6;14:128. doi: 10.1186/1472-6882-14-128.
- Derived from this study: PubMed 23806461Reinhold T, Roll S, Willich SN, Ortiz M, Witt CM, Brinkhaus B. Cost-effectiveness for acupuncture in seasonal allergic rhinitis: economic results of the ACUSAR trial. Ann Allergy Asthma Immunol. 2013 Jul;111(1):56-63. doi: 10.1016/j.anai.2013.04.008. Epub 2013 May 3.
- Derived from this study: PubMed 23420231Brinkhaus B, Ortiz M, Witt CM, Roll S, Linde K, Pfab F, Niggemann B, Hummelsberger J, Treszl A, Ring J, Zuberbier T, Wegscheider K, Willich SN. Acupuncture in patients with seasonal allergic rhinitis: a randomized trial. Ann Intern Med. 2013 Feb 19;158(4):225-34. doi: 10.7326/0003-4819-158-4-201302190-00002.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan N Willich, MD, MBA principal investigator
Epidemiology, and Health Economics, Charité University Medical Center, 10098 Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture and cetirizine dihydrochloride (rescue medication) in people with Seasonal Allergic Rhinitis, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rhinitis Quality of Life Questionnaire score (RQLQ scores between weeks 6 and 8 of the first year (adjusted for baseline values) and the Rescue Medication Score between weeks 6 and 8 of the first year (adjusted for baseline values). (time frame: Weeks 6 and 8 of the first year (adjusted for baseline values).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00610584, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2012.