Original Research19 February 2013
A Randomized Trial
    Author, Article, and Disclosure Information


    Chinese translation


    Acupuncture is frequently used to treat seasonal allergic rhinitis (SAR) despite limited scientific evidence.


    To evaluate the effects of acupuncture in patients with SAR.


    Randomized, controlled multicenter trial. (ClinicalTrials.gov: NCT00610584)


    46 specialized physicians in 6 hospital clinics and 32 private outpatient clinics.


    422 persons with SAR and IgE sensitization to birch and grass pollen.


    Acupuncture plus rescue medication (RM) (cetirizine) (n = 212), sham acupuncture plus RM (n = 102), or RM alone (n = 108). Twelve treatments were provided over 8 weeks in the first year.


    Changes in the Rhinitis Quality of Life Questionnaire (RQLQ) overall score and the RM score (RMS) from baseline to weeks 7 and 8 and week 16 in the first year and week 8 in the second year after randomization, with predefined noninferiority margins of −0.5 point (RQLQ) and −1.5 points (RMS).


    Compared with sham acupuncture and with RM, acupuncture was associated with improvement in RQLQ score (sham vs. acupuncture mean difference, 0.5 point [97.5% CI, 0.2 to 0.8 point; P < 0.001]; RM vs. acupuncture mean difference, 0.7 point [97.5% CI, 0.4 to 1.0 point; P < 0.001]) and RMS (sham vs. acupuncture mean difference, 1.1 points [97.5% CI, 0.4 to 1.9 points; P < 0.001]; RM vs. acupuncture mean difference, 1.5 points [97.5% CI, 0.8 to 2.2 points; P < 0.001]). There were no differences after 16 weeks in the first year. After the 8-week follow-up phase in the second year, small improvements favoring real acupuncture over the sham procedure were noted (RQLQ mean difference, 0.3 point [95% CI, 0.03 to 0.6 point; P = 0.032]; RMS mean difference, 1.0 point [95% CI, 0.2 to 1.9 points; P = 0.018]).


    The study was not powered to detect rare adverse events, and the RQLQ and RMS values were low at baseline.


    Acupuncture led to statistically significant improvements in disease-specific quality of life and antihistamine use measures after 8 weeks of treatment compared with sham acupuncture and with RM alone, but the improvements may not be clinically significant.

    Primary Funding Source:

    German Research Foundation.


    • 1. Worldwide variation in prevalence of symptoms of asthma, allergic rhinoconjunctivitis, and atopic eczema: ISAACThe International Study of Asthma and Allergies in Childhood (ISAAC) Steering Committee. Lancet1998;351:1225-32. [PMID: 9643741] MedlineGoogle Scholar
    • 2. Weiss KBSullivan SDThe health economics of asthma and rhinitis. I. Assessing the economic impact. J Allergy Clin Immunol2001;107:3-8. [PMID: 11149982] CrossrefMedlineGoogle Scholar
    • 3. van Cauwenberge PBachert CPassalacqua GBousquet JCanonica GWDurham SRet alConsensus statement on the treatment of allergic rhinitis. European Academy of Allergology and Clinical Immunology. Allergy2000;55:116-34. [PMID: 10726726] CrossrefMedlineGoogle Scholar
    • 4. Krouse JHKrouse HJPatient use of traditional and complementary therapies in treating rhinosinusitis before consulting an otolaryngologist. Laryngoscope1999;109:1223-7. [PMID: 10443823] CrossrefMedlineGoogle Scholar
    • 5. Schäfer TRiehle AWichmann HERing JAlternative medicine in allergies-prevalence, patterns of use, and costs. Allergy2002;57:694-700. [PMID: 12121187] CrossrefMedlineGoogle Scholar
    • 6. Brinkhaus BHummelsberger JKohnen RSeufert JHempen CHLeonhardy Het alAcupuncture and Chinese herbal medicine in the treatment of patients with seasonal allergic rhinitis: a randomized-controlled clinical trial. Allergy2004;59:953-60. [PMID: 15291903] CrossrefMedlineGoogle Scholar
    • 7. Brinkhaus BWitt CMJena SLiecker BWegscheider KWillich SNAcupuncture in patients with allergic rhinitis: a pragmatic randomized trial. Ann Allergy Asthma Immunol2008;101:535-43. [PMID: 19055209] CrossrefMedlineGoogle Scholar
    • 8. Lee MSPittler MHShin BCKim JIErnst EAcupuncture for allergic rhinitis: a systematic review. Ann Allergy Asthma Immunol2009;102:269-79. [PMID: 19441597] CrossrefMedlineGoogle Scholar
    • 9. Roberts JHuissoon ADretzke JWang DHyde CA systematic review of the clinical effectiveness of acupuncture for allergic rhinitis. BMC Complement Altern Med2008;8:13. [PMID: 18430229] CrossrefMedlineGoogle Scholar
    • 10. Brinkhaus BWitt CMOrtiz MRoll SReinhold TLinde Ket alAcupuncture in seasonal allergic rhinitis (ACUSAR)—design and protocol of a randomised controlled multi-centre trial. Forsch Komplementmed2010;17:95-102. [PMID: 20484917] CrossrefMedlineGoogle Scholar
    • 11. Hou WXu GWang HGould JTreating Autoimmune Disease With Chinese Medicine. Edinburgh, Scotland: Churchill Livingstone; 2011. Google Scholar
    • 12. Juniper EFGuyatt GHGriffith LEFerrie PJInterpretation of rhinoconjunctivitis quality of life questionnaire data. J Allergy Clin Immunol1996;98:843-5. [PMID: 8876562] CrossrefMedlineGoogle Scholar
    • 13. Kuehr JBrauburger JZielen SSchauer UKamin WVon Berg Aet alEfficacy of combination treatment with anti-IgE plus specific immunotherapy in polysensitized children and adolescents with seasonal allergic rhinitis. J Allergy Clin Immunol2002;109:274-80. [PMID: 11842297] CrossrefMedlineGoogle Scholar
    • 14. Bousquet JBullinger MFayol CMarquis PValentin BBurtin BAssessment of quality of life in patients with perennial allergic rhinitis with the French version of the SF-36 Health Status Questionnaire. J Allergy Clin Immunol1994;94:182-8. [PMID: 8064070] CrossrefMedlineGoogle Scholar
    • 15. Bullinger MKirchberger ISF-36 Fragebogen zum Gesundheitszustand. Göttingen, Germany: Hogrefe; 1998. Google Scholar
    • 16. Elashoff JDNQuery Advisor Version 4.0 User's Guide. Cork, Ireland: Statistical Solutions; 2000. Google Scholar
    • 17. Maurer WHothorn LALehmacher WMultiple comparisons in drug clinical trials and preclinical assays: a priori ordered hypotheses. In: Vollmar J, ed. Biometrie in der chemisch-pharmazeutischen Industrie, Band 6. Stuttgart, Germany: Fischer Verlag; 1995:13-8. Google Scholar
    • 18. Dmitrienko AWiens BLTamhane ACWang XTree-structured gatekeeping tests in clinical trials with hierarchically ordered multiple objectives. Stat Med2007;26:2465-78. [PMID: 17054103] CrossrefMedlineGoogle Scholar
    • 19. Magnusson ALSvensson RELeirvik CGunnarsson RKThe effect of acupuncture on allergic rhinitis: a randomized controlled clinical trial. Am J Chin Med2004;32:105-15. [PMID: 15154290] CrossrefMedlineGoogle Scholar
    • 20. Williamson LYudkin PLivingstone RPrasad KFuller ALawrence MHay fever treatment in general practice: a randomised controlled trial comparing standardised Western acupuncture with sham acupuncture. Acupunct Med1996;14:6-10. CrossrefGoogle Scholar
    • 21. Xue CCEnglish RZhang JJDa Costa CLi CGEffect of acupuncture in the treatment of seasonal allergic rhinitis: a randomized controlled clinical trial. Am J Chin Med2002;30:1-11. [PMID: 12067084] CrossrefMedlineGoogle Scholar
    • 22. Witt CMReinhold TJena SBrinkhaus BWillich SNCost-effectiveness of acupuncture in women and men with allergic rhinitis: a randomized controlled study in usual care. Am J Epidemiol2009;169:562-71. [PMID: 19126587] CrossrefMedlineGoogle Scholar
    • 23. Melchart DWeidenhammer WStreng AReitmayr SHoppe AErnst Eet alProspective investigation of adverse effects of acupuncture in 97 733 patients. Arch Intern Med2004;164:104-5. [PMID: 14718331] CrossrefMedlineGoogle Scholar
    • 24. Niggemann BGrüber CSide-effects of complementary and alternative medicine. Allergy2003;58:707-16. [PMID: 12859546] CrossrefMedlineGoogle Scholar
    • 25. Witt CMPach DBrinkhaus BWruck KTag BMank Set alSafety of acupuncture: results of a prospective observational study with 229,230 patients and introduction of a medical information and consent form. Forsch Komplementmed2009;16:91-7. [PMID: 19420954] MedlineGoogle Scholar
    • 26. Pfab FHammes MBäcker MHuss-Marp JAthanasiadis GITölle TRet alPreventive effect of acupuncture on histamine-induced itch: a blinded, randomized, placebo-controlled, crossover trial [Letter]. J Allergy Clin Immunol2005;116:1386-8. [PMID: 16337477] CrossrefMedlineGoogle Scholar
    • 27. Pfab FHuss-Marp JGatti AFuqin JAthanasiadis GIIrnich Det alInfluence of acupuncture on type I hypersensitivity itch and the wheal and flare response in adults with atopic eczema-a blinded, randomized, placebo-controlled, crossover trial. Allergy2010;65:903-10. [PMID: 20002660] CrossrefMedlineGoogle Scholar
    • 28. Lundeberg TBondesson LThomas MEffect of acupuncture on experimentally induced itch. Br J Dermatol1987;117:771-7. [PMID: 3426954] CrossrefMedlineGoogle Scholar
    • 29. Belgrade MJSolomon LMLichter EAEffect of acupuncture on experimentally induced itch. Acta Derm Venereol1984;64:129-33. [PMID: 6203300] MedlineGoogle Scholar
    • 30. Pfab FKirchner MTHuss-Marp JSchuster TSchalock PCFuqin Jet alAcupuncture compared with oral antihistamine for type I hypersensitivity itch and skin response in adults with atopic dermatitis: a patient- and examiner-blinded, randomized, placebo-controlled, crossover trial. Allergy2012;67:566-73. [PMID: 22313287] CrossrefMedlineGoogle Scholar
    • 31. Carlsson CPWallengren JTherapeutic and experimental therapeutic studies on acupuncture and itch: review of the literature. J Eur Acad Dermatol Venereol2010;24:1013-6. [PMID: 20337812] MedlineGoogle Scholar
    • 32. Pfab FAthanasiadis GIHuss-Marp JFuqin JHeuser BCifuentes Let alEffect of acupuncture on allergen-induced basophil activation in patients with atopic eczema:a pilot trial. J Altern Complement Med2011;17:309-14. [PMID: 21443446] CrossrefMedlineGoogle Scholar
    • 33. Birch SControlling for non-specific effects of acupuncture in clinical trials. Clinical Acupuncture and Oriental Medicine2003;4:59-70. CrossrefGoogle Scholar
    • 34. Brinkhaus BWitt CMJena SLinde KStreng AWagenpfeil Set alAcupuncture in patients with chronic low back pain: a randomized controlled trial. Arch Intern Med2006;166:450-7. [PMID: 16505266] MedlineGoogle Scholar
    • 35. Linde KStreng AJürgens SHoppe ABrinkhaus BWitt Cet alAcupuncture for patients with migraine: a randomized controlled trial. JAMA2005;293:2118-25. [PMID: 15870415] CrossrefMedlineGoogle Scholar
    • 36. Melchart DStreng AHoppe ABrinkhaus BWitt CWagenpfeil Set alAcupuncture in patients with tension-type headache: randomised controlled trial. BMJ2005;331:376-82. [PMID: 16055451] CrossrefMedlineGoogle Scholar
    • 37. Witt CBrinkhaus BJena SLinde KStreng AWagenpfeil Set alAcupuncture in patients with osteoarthritis of the knee: a randomised trial. Lancet2005;366:136-43. [PMID: 16005336] CrossrefMedlineGoogle Scholar
    • 38. Linde KDincer FHow informed is consent in sham-controlled trials of acupuncture? J Altern Complement Med2004;10:379-85. [PMID: 15165419] CrossrefMedlineGoogle Scholar
    • 39. Lund INäslund JLundeberg TMinimal acupuncture is not a valid placebo control in randomised controlled trials of acupuncture: a physiologist's perspective. Chin Med2009;4:1. [PMID: 19183454] CrossrefMedlineGoogle Scholar
    • 40. Dincer FLinde KSham interventions in randomized clinical trials of acupuncture—a review. Complement Ther Med2003;11:235-42. [PMID: 15022656] CrossrefMedlineGoogle Scholar
    • 41. Linde KWitt CMStreng AWeidenhammer WWagenpfeil SBrinkhaus Bet alThe impact of patient expectations on outcomes in four randomized controlled trials of acupuncture in patients with chronic pain. Pain2007;128:264-71. [PMID: 17257756] CrossrefMedlineGoogle Scholar
    • 42. Vincent CCredibility assessments in trials of acupuncture. Complementary Medical Research1990;4:8-11. Google Scholar
    • 43. Wang RLagakos SWWare JHHunter DJDrazen JMStatistics in medicine—reporting of subgroup analyses in clinical trials. N Engl J Med2007;357:2189-94. [PMID: 18032770] CrossrefMedlineGoogle Scholar
    • 44. Liu GFLu KMogg RMallick MMehrotra DVShould baseline be a covariate or dependent variable in analyses of change from baseline in clinical trials? Stat Med2009;28:2509-30. [PMID: 19610129] CrossrefMedlineGoogle Scholar
    • 45. Liang K-YZeger SLLongitudinal data analysis of continuous and discrete responses for pre-post designs. Sankhya Ser B2000;62:134-48. Google Scholar
    • 46. Carpenter JRKenward MGMissing Data in Randomised Controlled Trials—A Practical Guide. Publication RM03/JH17/MK. Birmingham, United Kingdom: National Institute for Health Research; 2008. Google Scholar