The Oligonucleotide Chip Analysis for Allergic Rhinitis Treatment in Herbal Plaster and Acupuncture
NCT ID: NCT02486159
Last Updated: 2017-05-12
Study Results
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Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2009-09-30
2011-08-31
Brief Summary
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In the first year, Twenty-three participants with persistent allergic rhinitis each received four acupoint herbal plaster treatments, applied using the moxibustion technique, and clinical outcomes were evaluated using the Rhinitis Quality of Life Questionnaire (RQLQ). Peripheral blood samples were analyzed using an ImmunoCAP Phadiatop test, and patients were classified as phadiatop (Ph)-positive or -negative. Microarray results were examined for genes that were differentially expressed between (1) Ph-positive and -negative patients treated with herbal paste; and (2) before and after herbal paste treatment in the Ph-positive patient group.
In the second year, Twenty-seven participants with persistent allergic rhinitis each received four acupoint herbal plaster treatments and 8 courses of acupuncture treatment over 4 weeks in the same time.
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Detailed Description
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Many allergic rhinitis patients accept TCM treatment here in Taiwan. According to recent journal reports, Traditional Chinese medicine performed in accordance with the principles of TCM would show significant immune-modulating effects, herbal plaster is an effective, safe and convenient treatment for allergic rhinitis. The mechanism of its efficacy needs further study. This project plan to combine the experience of clinical doctor and GMRCL Microarray for the mechanism of herbal plaster on allergic rhinitis.
Investigators study the effects of herbal plaster treatment for allergic rhinitis in the first year. And study the combine effect of herbal plaster and Acupuncture treatment in the second year. All patients during 18-45 years old were treated over a time period of 4 weeks. Patients' general well-being and several peripheral blood parameters were determined before and after the herbal plaster treatment. RNA was extracted from the blood and pooled into patient pool. Oligonucleotide chips were used to analysis the pooled RNA each year. The microarray analysis for the genomic change before and after the herbal plaster treatment or herbal plaster with Acupuncture treatment was studied .
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Herbal plaster and Acupuncture
In the first year: Acupoint herbal plaster applications every one week over a 4-week period for a total of 4 applications.
In the second year: Acupoint herbal plaster used as the same method as first year, and combined with Acupuncture treatment in the same time.
Herbal plaster (Sanfujiu)
The Acupoint herbal plaster consisted of mustard seed, fumarate, asarum, angelica, cinnamon, and ginger at a ratio of 3:3:2:2:0.5:4, respectively. The treatment was prepared by dissolving the ginger in water and adding the powder to form a plaster. Mixtures were formed into cakes of approximately 1.5 × 1.5 × 0.5 cm3 and were held in position using plastic sheets.
Acupuncture
Eight (8) acupuncture treatment sessions over 4 weeks were performed for each volunteer. The standard protocol for acupuncture treatment covered the most commonly treated acupoints for allergic rhinitis: LI4, ST36, LI20 in both sides, and EX-HN3. After insertion of needles at each acupoint, manual stimulation of needles on LI20 and EX-HN3 was repeated 3 times at 5-minute intervals. Electrostimulation was applied to the needles inserted in ST36 and LI4 with a frequency of 3-5 Hz, and the intensity was adjusted according to each volunteer's tolerance. All needles were removed 20 minutes later in each treatment session.
Interventions
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Herbal plaster (Sanfujiu)
The Acupoint herbal plaster consisted of mustard seed, fumarate, asarum, angelica, cinnamon, and ginger at a ratio of 3:3:2:2:0.5:4, respectively. The treatment was prepared by dissolving the ginger in water and adding the powder to form a plaster. Mixtures were formed into cakes of approximately 1.5 × 1.5 × 0.5 cm3 and were held in position using plastic sheets.
Acupuncture
Eight (8) acupuncture treatment sessions over 4 weeks were performed for each volunteer. The standard protocol for acupuncture treatment covered the most commonly treated acupoints for allergic rhinitis: LI4, ST36, LI20 in both sides, and EX-HN3. After insertion of needles at each acupoint, manual stimulation of needles on LI20 and EX-HN3 was repeated 3 times at 5-minute intervals. Electrostimulation was applied to the needles inserted in ST36 and LI4 with a frequency of 3-5 Hz, and the intensity was adjusted according to each volunteer's tolerance. All needles were removed 20 minutes later in each treatment session.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Did not take medication in the previous month
* Provided written consent to enter a Chang Gung Memorial Hospital Institutional Review Board (IRB)
Exclusion Criteria
* Nasal polyps
* unwilling or unable to complete the full course of treatment
18 Years
45 Years
ALL
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Principal Investigators
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Hen-Hong Chang, M.D., PHD
Role: PRINCIPAL_INVESTIGATOR
Department of Chinese Medicine, Chang Gung Memorial Hospital
References
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Tai CJ, Chien LY. The treatment of allergies using Sanfujiu: A method of applying Chinese herbal medicine paste to acupoints on three peak summer days. Am J Chin Med. 2004;32(6):967-76. doi: 10.1142/S0192415X04002569.
Tai CJ, Chang CP, Huang CY, Chien LY. Efficacy of Sanfujiu to treat allergies: patient outcomes at 1 year after treatment. Evid Based Complement Alternat Med. 2007 Jun;4(2):241-6. doi: 10.1093/ecam/nel082. Epub 2006 Nov 24.
Juniper EF, Guyatt GH. Development and testing of a new measure of health status for clinical trials in rhinoconjunctivitis. Clin Exp Allergy. 1991 Jan;21(1):77-83. doi: 10.1111/j.1365-2222.1991.tb00807.x.
Benson M, Svensson PA, Carlsson B, Jernas M, Reinholdt J, Cardell LO, Carlsson L. DNA microarrays to study gene expression in allergic airways. Clin Exp Allergy. 2002 Feb;32(2):301-8. doi: 10.1046/j.1365-2222.2002.01300.x.
Shiue HS, Lee YS, Tsai CN, Hsueh YM, Sheu JR, Chang HH. Gene expression profile of patients with phadiatop-positive and -negative allergic rhinitis treated with acupuncture. J Altern Complement Med. 2010 Jan;16(1):59-68. doi: 10.1089/acm.2009.0024.
Petti FB, Liguori A, Ippoliti F. Study on cytokines IL-2, IL-6, IL-10 in patients of chronic allergic rhinitis treated with acupuncture. J Tradit Chin Med. 2002 Jun;22(2):104-11.
Shiue HS, Lee YS, Tsai CN, Chang HH. Treatment of allergic rhinitis with acupoint herbal plaster: an oligonucleotide chip analysis. BMC Complement Altern Med. 2016 Nov 4;16(1):436. doi: 10.1186/s12906-016-1418-0.
Other Identifiers
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98-0938B
Identifier Type: -
Identifier Source: org_study_id
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