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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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 .

Current Primary Outcome: Change from baseline in Rhinitis Quality of Life Questionnaire (RQLQ) at the third week [ Time Frame: T0: before the first acupoint herbal plaster application, T3: the third week, 24 hours after the third acupoint herbal plaster application ]

Original Primary Outcome: Change from baseline in Rhinitis Quality of Life Questionnaire (RQLQ) at the third week [ Time Frame: T0: before the first acupoint herbal paster application, T3: the third week, 24 hours after the third acupoint herbal paster application ]

Current Secondary Outcome:

• Change from baseline in Rhinitis Quality of Life Questionnaire (RQLQ) at the fourth week [ Time Frame: T0: before the first acupoint herbal plaster application, T5: the fourth week, 24hours after the fourth acupoint herbal plaster applications ]
  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.
• Compare gene expression levels before and after a series of acupoint herbal plaster and Acupuncture treatment [ Time Frame: 6 times in four weeks ]
  GeneChip Human Genome U133 Plus2 array (Affymetrix, Santa Clara, CA, USA) containing approximately 54,675 probes. Patient peripheral blood samples were obtained in 5-ml volumes at the following 6 times (T0-T5) during the study: (1) before (T0) and 24 h after the 1st (T1) acupoint herbal plaster application; (2)the third week, before (T2) and 24 h after the 3rd (T3) acupoint herbal plaster application; and (3) the fourth week, before the 4th (T4) and 24 h after the 4th (T5) acupoint herbal plaster application.
• Detect serum allergen-specific IgE antibodies in patient [ Time Frame: When patient diagnoses were confirmed by otolaryngologists (baseline). Then the ImmunoCAP Phadiatop was performed. ]
  ImmunoCAP Phadiatop is a blood test widely used by ENT specialists in Taiwan to detect serum allergen-specific IgE antibodies. When patient provided written consent to enter the Chang Gung Memorial Hospital Institutional Review Board (IRB)-approved human trial, Patient diagnoses were confirmed by otolaryngologists. And the ImmunoCAP Phadiatop (InVitroSight, Phadia AB, Uppsala, Sweden) was performed.

Original Secondary Outcome:

• Change from baseline in Rhinitis Quality of Life Questionnaire (RQLQ) at the fourth week [ Time Frame: T0: before the first acupoint herbal paster application, T5: the fourth week, 24hours after the fourth acupoint herbal paster applications ]
  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.
• Compare gene expression levels before and after a series of acupoint herbal paster and Acupuncture treatment [ Time Frame: 6 times in four weeks ]
  GeneChip Human Genome U133 Plus2 array (Affymetrix, Santa Clara, CA, USA) containing approximately 54,675 probes. Patient peripheral blood samples were obtained in 5-ml volumes at the following 6 times (T0-T5) during the study: (1) before (T0) and 24 h after the 1st (T1) acupoint herbal paster application; (2)the third week, before (T2) and 24 h after the 3rd (T3) acupoint herbal paster application; and (3) the fourth week, before the 4th (T4) and 24 h after the 4th (T5) acupoint herbal paster application.
• Detect serum allergen-specific IgE antibodies in patient [ Time Frame: Before the first acupoint herbal paster application ]
  ImmunoCAP Phadiatop is a blood test widely used by ENT specialists in Taiwan to detect serum allergen-specific IgE antibodies. When patient provided written consent to enter the Chang Gung Memorial Hospital Institutional Review Board (IRB)-approved human trial, Patient diagnoses were confirmed by otolaryngologists. And the ImmunoCAP Phadiatop (InVitroSight, Phadia AB, Uppsala, Sweden) was performed.

Dates:
Date Received: June 16, 2015
Date Started: September 2009
Date Completion:
Last Updated: May 11, 2017
Last Verified: June 2015