{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T15:24:30Z","timestamp":1789053870439,"version":"build-2803163510"},"reference-count":21,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2019,12,1]],"date-time":"2019-12-01T00:00:00Z","timestamp":1575158400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2019,12,30]],"date-time":"2019-12-30T00:00:00Z","timestamp":1577664000000},"content-version":"vor","delay-in-days":29,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004826","name":"Natural Science Foundation of Beijing Municipality","doi-asserted-by":"publisher","award":["7162081"],"award-info":[{"award-number":["7162081"]}],"id":[{"id":"10.13039\/501100004826","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["81674034"],"award-info":[{"award-number":["81674034"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"published-print":{"date-parts":[[2019,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      Allergic rhinitis (AR) is a common allergic disease. It affects people worldwide and traditional Chinese medicine is becoming popular among AR patients because it has a definite clinical effect and there are few adverse reactions. Lung\n                      <jats:italic>qi<\/jats:italic>\n                      deficiency and cold syndrome (LQDCS) is a frequent type of AR, and the Chinese herbal medicine\n                      <jats:italic>bimin<\/jats:italic>\n                      decoction (BMD) is prescribed for it. This study compared the clinical efficacy of BMD for AR patients with LQDCS to the conventional medicine loratadine and fluticasone nasal spray.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      The study was an open-label non-inferiority randomized controlled trial. A total of 108 AR patients with LQDCS aged 19 to 60 were randomly allocated in a 1:1 ratio to the BMD group or the control group by the central computer system in Beijing Hospital of Traditional Chinese Medicine from January 2017 to April 2018. In total, 98 participants completed the study (BMD group\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200951 and control group\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200947). Patients in the BMD group received BMD while those in the control group received fluticasone nasal spray and loratadine tablets for 4 weeks. The primary outcome was the change in the Total Nasal Symptom Score (TNSS) between the baseline and the end of treatment. Changes in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), nasal resistance, and acoustic rhinometry parameters were secondary outcomes. All side effects due to the treatments were recorded.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      After the 4-week treatment, the total TNSS was significantly reduced in both groups compared to the baseline (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u2009\u00a00.05). No significant between-groups differences were observed for changes in TNSS scores [\u2212\u20090.298 (95% confidence interval \u22120.640 to 0.140)], which was within the defined non-inferiority margin. RQLQ in both groups decreased significantly (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u2009\u00a00.001) from baseline, though a more obvious reduction was observed for the BMD group (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u2009\u00a00.001). There were no significant differences in nasal resistance, nasal volume, or nasal minimum cross-sectional area between groups after treatment (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&gt;\u20090.05).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>These findings indicate that BMD helps relieve the symptoms of perennial AR and improves rhinitis-related quality of life. Our study indicates that BMD is non-inferior to loratadine tablets and fluticasone nasal spray for AR patients with LQDCS.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      Chinese Clinical Trial Registry,\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.chictr.org.cn\/edit.aspx?pid=16492&amp;htm=4\">ChiCTR-INR-16010063<\/jats:ext-link>\n                      . Registered on 2 December 2016.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13063-019-3763-z","type":"journal-article","created":{"date-parts":[[2019,12,30]],"date-time":"2019-12-30T14:02:37Z","timestamp":1577714557000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Efficacy of Bimin decoction for patients with perennial allergic rhinitis: an open-label non-inferiority randomized controlled trial"],"prefix":"10.1186","volume":"20","author":[{"given":"Jingyi","family":"Zhao","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xinyu","family":"Yan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jianqing","family":"Gai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jinshuai","family":"Han","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hong","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hui","family":"Luo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shaoting","family":"Huang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Junge","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2019,12,30]]},"reference":[{"issue":"Suppl 86","key":"3763_CR1","doi-asserted-by":"publisher","first-page":"8","DOI":"10.1111\/j.1398-9995.2007.01620.x","volume":"63","author":"J Bousquet","year":"2008","unstructured":"Bousquet J, Khaltaev N, Cruz AA, Denburg J, Fokkens WJ, Togias A, et al. Allergic rhinitis andits impact on asthma (ARIA) 2008 update. Allergy. 2008;63(Suppl 86):8\u2013160.","journal-title":"Allergy"},{"issue":"1_suppl","key":"3763_CR2","doi-asserted-by":"publisher","first-page":"S1","DOI":"10.1177\/0194599814561600","volume":"152","author":"Michael D. Seidman","year":"2015","unstructured":"Seidman MD, Gurgel RK, Lin SY, Schwartz SR, Baroody FM, Bonner JR, et al. Clinical practice guideline: allergic rhinitis. Otolaryngol Head Neck Surg. 2015;152:S1\u201343.","journal-title":"Otolaryngology\u2013Head and Neck Surgery"},{"key":"3763_CR3","doi-asserted-by":"publisher","first-page":"6","DOI":"10.1186\/1939-4551-7-6","volume":"7","author":"GW Canonica","year":"2014","unstructured":"Canonica GW, Cox L, Pawankar R, Baena-Cagnani CE, Blaiss M, Bonini S, et al. Sublingual immunotherapy: World Allergy Organization position paper 2013 update. World Allergy Organ J. 2014;7:6.","journal-title":"World Allergy Organ J"},{"key":"3763_CR4","doi-asserted-by":"publisher","first-page":"851","DOI":"10.1016\/j.mcna.2016.03.010","volume":"100","author":"AG Ayars","year":"2016","unstructured":"Ayars AG, Altman MC. Pharmacologic therapies in pulmonology and allergy. Med Clin North Am. 2016;100:851\u201368.","journal-title":"Med Clin North Am"},{"key":"3763_CR5","doi-asserted-by":"publisher","first-page":"34","DOI":"10.4168\/aair.2018.10.1.34","volume":"10","author":"X Zhang","year":"2018","unstructured":"Zhang X, Lan F, Zhang Y, Zhang L. Chinese herbal medicine to treat allergic rhinitis: evidence from a meta-analysis. Allergy Asthma Immunol Res. 2018;10:34\u201342.","journal-title":"Allergy Asthma Immunol Res"},{"key":"3763_CR6","doi-asserted-by":"publisher","first-page":"219","DOI":"10.1016\/j.jpba.2017.03.049","volume":"145","author":"N Stefanie","year":"2017","unstructured":"Stefanie N, Marlene M, Huiqin Z, Yong L, Xiaojuan H, Danping F, et al. Metabolic profiling of the traditional Chinese medicine formulation Yu Ping Feng San for the identification of constituents relevant for effects on expression of TNF-\u03b1, IFN-\u03b3, IL-1\u03b2 and IL-4 in U937 cells. J Pharm Biomed Anal. 2017;145:219\u201329.","journal-title":"J Pharm Biomed Anal"},{"key":"3763_CR7","doi-asserted-by":"publisher","first-page":"2007","DOI":"10.1007\/s12272-012-1118-3","volume":"35","author":"H Lim","year":"2012","unstructured":"Lim H, Lee JH, Kim J, Kim YS, Kim HP. Effects of the rhizomes of Atractylodes japonica and atractylenolide I on allergic response and experimental atopic dermatitis. Arch Pharm Res. 2012;35:2007\u201312.","journal-title":"Arch Pharm Res"},{"key":"3763_CR8","doi-asserted-by":"publisher","first-page":"e0155930","DOI":"10.1371\/journal.pone.0155930","volume":"11","author":"H Fu","year":"2016","unstructured":"Fu H, Cheng H, Cao G, Zhang X, Tu J, Sun M, et al. The inhibition of mast cell activation of Radix Paeoniae alba extraction identified by TCRP based and conventional cell function assay systems. PLoS One. 2016;11:e0155930.","journal-title":"PLoS One"},{"key":"3763_CR9","doi-asserted-by":"publisher","first-page":"175","DOI":"10.1002\/ptr.3062","volume":"24","author":"Z Matkovic","year":"2010","unstructured":"Matkovic Z, Zivkovic V, Korica M, Plavec D, Pecanic S, Tudoric N. Efficacy and safety of Astragalus membranaceus in the treatment of patients with seasonal allergic rhinitis. Phytother Res. 2010;24:175\u201381.","journal-title":"Phytother Res"},{"key":"3763_CR10","doi-asserted-by":"publisher","first-page":"c332","DOI":"10.1136\/bmj.c332","volume":"340","author":"KF Schulz","year":"2010","unstructured":"Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332.","journal-title":"BMJ"},{"key":"3763_CR11","unstructured":"Subspecialty Group of Rhinology, Editorial Board of Chinese Journal of Otorhinolaryngology Head and Neck Surgery, Subspecialty Group of Rhinology, Society of Otorhinolaryngology Head and Neck Surgery, Chinese Medical Association. Chinese guidelines for diagnosis and treatment of allergic rhinitis. Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2016;51:6 [Article in Chinese]."},{"key":"3763_CR12","first-page":"124","volume-title":"Zhong Yi Er Bi Yan Hou Ke Xue (in Chinese)","author":"SZ Wang","year":"2003","unstructured":"Wang SZ, Xiong DJ, Liu SW, Liu P. Zhong Yi Er Bi Yan Hou Ke Xue (in Chinese). China: China Press of Traditional Chinese Medicine; 2003. p. 124. [Article in Chinese]"},{"key":"3763_CR13","doi-asserted-by":"publisher","first-page":"47","DOI":"10.1186\/s13601-016-0137-4","volume":"6","author":"J Bousquet","year":"2016","unstructured":"Bousquet J, Hellings PW, Agache I, Bedbrook A, Bachert C, Bergmann KC, et al. ARIA 2016: Care pathways implementing emerging technologies for predictive medicine in rhinitis and asthma across the life cycle. Clin Transl Allergy. 2016;6:47.","journal-title":"Clin Transl Allergy"},{"key":"3763_CR14","doi-asserted-by":"publisher","first-page":"310","DOI":"10.2500\/ajra.2017.31.4465","volume":"31","author":"T Schwanke","year":"2017","unstructured":"Schwanke T, Carragee E, Bremberg M, Reisacher WR. Quality-of-life outcomes in patients who underwent subcutaneous immunotherapy and sublingual immunotherapy in a real-world clinical setting. Am J Rhinol Allergy. 2017;31:310\u20136.","journal-title":"Am J Rhinol Allergy"},{"issue":"4","key":"3763_CR15","first-page":"247","volume":"51","author":"J Zhao","year":"2016","unstructured":"Zhao J, Gai J, Yan X, Han J, Huang S, Zhang H, Wang J. Effect of bimin decoction on allergic rhinitis and immune balance of Th1\/Th2 in lung qi weak and cold pattern patients. Chin Arch Otolaryngol Head Neck Surg. 2016;51(4):247\u201355 [Article in Chinese].","journal-title":"Chin Arch Otolaryngol Head Neck Surg"},{"key":"3763_CR16","first-page":"337","volume":"17","author":"MJ Welch","year":"2002","unstructured":"Welch MJ, Meltzer EO, Simons FE. H1-antihistamines and the central nervous system. Clin Allergy Immunol. 2002;17:337\u201388.","journal-title":"Clin Allergy Immunol"},{"key":"3763_CR17","first-page":"824","volume":"25","author":"RL Bian","year":"1990","unstructured":"Bian RL, Xie QM, Kobayashi M, Asai M, Ishiguro T, Kishi T. Antianaphylactic components of Asarum forbsii Maxin. Yao Xue Xue Bao. 1990;25:824\u20139 [Article in Chinese].","journal-title":"Yao Xue Xue Bao"},{"key":"3763_CR18","doi-asserted-by":"publisher","first-page":"361","DOI":"10.1016\/j.jep.2015.07.049","volume":"173","author":"KP Lee","year":"2015","unstructured":"Lee KP, Kang S, Park SJ, Kim JM, Lee JM, Lee AY, et al. Anti-allergic effect of alpha-cubebenoate isolated from Schisandra chinensis using in vivo and in vitro experiments. J Ethnopharmacol. 2015;173:361\u20139.","journal-title":"J Ethnopharmacol"},{"key":"3763_CR19","doi-asserted-by":"publisher","first-page":"257","DOI":"10.1016\/j.intimp.2016.03.037","volume":"35","author":"Z Chen","year":"2016","unstructured":"Chen Z, Guo M, Song G, Gao J, Zhang Y, Jing Z, et al. Schisandrin B inhibits Th1\/Th17 differentiation and promotes regulatory T cell expansion in mouse lymphocytes. Int Immunopharmacol. 2016;35:257\u201364.","journal-title":"Int Immunopharmacol"},{"key":"3763_CR20","first-page":"3166","volume":"39","author":"Y Li","year":"2014","unstructured":"Li Y, Fu CM, Ren B, Liu Y, Gao F, Yang H, et al. Study on attenuate and synergistic mechanism between aconiti lateralis praeparata radix and glycyrrhizae radix for toxicity reduction based on metabonomic of MI-RI mouse cardiomyocytes. Zhongguo Zhong Yao Za Zhi. 2014;39:3166\u201371 [Article in Chinese].","journal-title":"Zhongguo Zhong Yao Za Zhi"},{"issue":"3","key":"3763_CR21","doi-asserted-by":"publisher","first-page":"505","DOI":"10.1007\/s11418-014-0827-y","volume":"68","author":"Toshiaki Makino","year":"2014","unstructured":"Makino T, Shiraki Y, Mizukami H. Interaction of gypsum and the rhizome of Anemarrhena asphodeloides plays an important role in anti-allergic effects of byakkokakeishito in mice. J Nat Med. 2014;68:505\u201312.","journal-title":"Journal of Natural Medicines"}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-019-3763-z.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1186\/s13063-019-3763-z\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-019-3763-z.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,12,28]],"date-time":"2020-12-28T19:24:53Z","timestamp":1609183493000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-019-3763-z"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,12]]},"references-count":21,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2019,12]]}},"alternative-id":["3763"],"URL":"https:\/\/doi.org\/10.1186\/s13063-019-3763-z","relation":{"has-preprint":[{"id-type":"doi","id":"10.21203\/rs.2.173\/v4","asserted-by":"object"},{"id-type":"doi","id":"10.21203\/rs.2.173\/v3","asserted-by":"object"},{"id-type":"doi","id":"10.21203\/rs.2.173\/v2","asserted-by":"object"},{"id-type":"doi","id":"10.21203\/rs.2.173\/v1","asserted-by":"object"}]},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,12]]},"assertion":[{"value":"26 December 2018","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"28 September 2019","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"30 December 2019","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"The study design and protocol were approved by the ethics committee of BJHTCM, which is affiliated to Capital Medical University (code 2016BL-047). All subjects signed informed consent before enrollment. The study was conducted in accordance with the principles of the Declaration of Helsinki (2004) and in accordance with the Medical Research Involving Human Subjects Act. The study was registered in the China Clinical Trial Registry Center (ChiCTR-INR-16010063) on 2 December 2016.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"All subjects who participated in the\u00a0study signed informed consent forms. The patients agreed that information about them that was collected in this study could be published, however we would\u00a0anonymize the data before publishing. The informed consent forms signed by the participants of this study are kept in the author\u2019s institution and are available for review upon request from the editor-in-chief.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"802"}}