The Oligonucleotide Chip Analysis for Allergic Rhinitis Treatment in Herbal Plaster and Acupuncture

NCT02486159 | Completed DMC

• 1 other identifier: 98-0938B
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rhinitis, Allergic

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Rhinitis Quality of Life Questionnaire (RQLQ) at the third week

  RQLQ, includes 28 questions in 7 categories. The RQLQ was designed to measure the impact of rhinitis on quality of life. It considers that allergic rhinitis patients often are troubled by nasal symptoms, eye symptoms, sleep problems, emotional problems, social issues, and other symptoms.

  T0: before the first acupoint herbal plaster application, T3: the third week, 24 hours after the third acupoint herbal plaster application

Secondary Outcomes (3)

• Change from baseline in Rhinitis Quality of Life Questionnaire (RQLQ) at the fourth week

  T0: before the first acupoint herbal plaster application, T5: the fourth week, 24hours after the fourth acupoint herbal plaster applications

• Compare gene expression levels before and after a series of acupoint herbal plaster and Acupuncture treatment

  6 times in four weeks

• Detect serum allergen-specific IgE antibodies in patient

  When patient diagnoses were confirmed by otolaryngologists (baseline). Then the ImmunoCAP Phadiatop was performed.

Study Arms (1)

Herbal plaster and Acupuncture

EXPERIMENTAL

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.

Drug: Herbal plaster (Sanfujiu); Procedure: Acupuncture

Interventions

Herbal plaster (Sanfujiu) DRUG

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.

Also known as: Sanfujiu

Herbal plaster and Acupuncture

Acupuncture PROCEDURE

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.

Herbal plaster and Acupuncture

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Related Publications (7)

• 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.

  PMID: 15673201 BACKGROUND

• 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.

  PMID: 17549242 BACKGROUND

• 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.

  PMID: 2021881 BACKGROUND

• 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.

  PMID: 11929497 BACKGROUND

• 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.

  PMID: 20070140 BACKGROUND

• 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.

  PMID: 12125480 BACKGROUND

• 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.

  PMID: 27814709 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Hen-Hong Chang, M.D., PHD

  Department of Chinese Medicine, Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2015
• First Posted: July 1, 2015
• Study Start: September 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: August 1, 2011
• Last Updated: May 12, 2017

Record last verified: 2015-06

Data Sharing

• IPD Sharing: Will not share