Clinical trial NCT02486159: The Oligonucleotide Chip Analysis for Allergic Rhinitis Treatment in Herbal Plaster and Acupuncture
Official title: The Oligonucleotide Chip Analysis for Allergic Rhinitis Treatment in Herbal Plaster and Acupuncture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rhinitis, Allergic
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2015-07-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Using Oligonucleotide Chip Analysis, investigators compared gene expression levels in allergic rhinitis patients before and after a series of acupoint herbal plaster and Acupuncture treatment.

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.

Detailed description: This project「The oligonucleotide chip analysis for allergic rhinitis treatment in herbal plaster and acupuncture」 will be performed at Genomic Medicine Research Core Laboratory- GMRCL in Chung Gang Memorial Hospital. Allergic rhinitis patient will receive herbal plaster treatment in the first year, blood sample was attained before and after therapy. Then investigators use oligonucleotide chip to analyze the immunomodulatory effects of TCM in the treatment of allergic rhinitis. In the second year, the patient received herbal plaster and Acupuncture treatment in the same time.

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 .

Eligibility criteria: Inclusion Criteria:

* Exhibited sneezing, runny nose, and congestion for more than 9 months of the year
* Did not take medication in the previous month
* Provided written consent to enter a Chang Gung Memorial Hospital Institutional Review Board (IRB)

Exclusion Criteria:

* Sinusitis
* Nasal polyps
* unwilling or unable to complete the full course of treatment

Primary outcomes:
measure: Change from baseline in Rhinitis Quality of Life Questionnaire (RQLQ) at the third week
timeFrame: T0: before the first acupoint herbal plaster application, T3: the third week, 24 hours after the third acupoint herbal plaster application
Secondary outcomes:
measure: Change from baseline in Rhinitis Quality of Life Questionnaire (RQLQ) at the fourth week
timeFrame: T0: before the first acupoint herbal plaster application, T5: the fourth week, 24hours after the fourth acupoint herbal plaster applications
measure: Compare gene expression levels before and after a series of acupoint herbal plaster and Acupuncture treatment
timeFrame: 6 times in four weeks
measure: Detect serum allergen-specific IgE antibodies in patient
timeFrame: When patient diagnoses were confirmed by otolaryngologists (baseline). Then the ImmunoCAP Phadiatop was performed.
Other outcomes:
Locations:
Study officials:
affiliation: Department of Chinese Medicine, Chang Gung Memorial Hospital
name: Hen-Hong Chang, M.D., PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.