Contact information
Type
Scientific
Primary contact
Dr Jong-in Kim
ORCID ID
Contact details
483 Exporo Yuseng-gu
Daejeon
305-811
Korea
South
han8400@kiom.re.kr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
KW0901
Study information
Scientific title
Acupuncture for Persistent Allergic Rhinitis: a multicentre randomised sham acupuncture controlled trial
Acronym
Acupuncture for PER
Study hypothesis
The primary objective of the present protocol is to investigate the effectiveness of acupuncture in patients with moderate-severe persistent allergic rhinitis (PER) in Korea and China, compared to sham acupuncture and a no-acupuncture waitlist status.
Ethics approval
1. Kyung-Hee University Medical Center Ethics Committee gave approval on the 11th February 2009
2. Daegeon Oriental Hospital Ethics Committee gave approval on the 23rd January 2009
Study design
Multicentre randomised, subject and assessor blinded, sham acupuncture and waitlist controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Persistent allergic rhinitis
Intervention
The study includes the following periods in all groups: a run-in period of 1 week before randomisation, a treatment (acupuncture or sham) period of 4 weeks (3 sessions/week), and a follow-up period of 4 weeks.
Acupuncture group:
In the acupuncture treatment group, 10 acupuncture points (bilateral LI4, LI20, ST2 and ST36, unilateral EX-1 and GV23) will be inserted with 0.20 mm in diameter x 30 mm in length disposal needles. The needle will be inserted to a depth of 10 - 30 mm, according to the points selected. The participating acupuncture doctors will manually manipulate the acupuncture needles with de-qi sensation and maintain the needles for 10 minutes with two time manual stimulations, starting and ending point.
Sham acupuncture group:
The insertion sites will be 1 - 1.5 cm from the acupuncture points used for active acupuncture treatment and will be penetrated with the same type of acupuncture needles; the needle will be inserted to a depth of 3 - 5 mm with a perpendicular direction using hollow pool in a shallow needling technique to avoid de-qi. The needle is then rotated one time in order to preserve patient blinding.
Waitlist:
Participants who will be allocated to waitlist will receive no acupuncture or sham acupuncture treatments throughout the 4 weeks. After 4 weeks, if participants elect to try the acupuncture treatment, the active acupuncture treatment will be provided, acupuncture treatment period of 4 weeks (3 sessions/week).
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Changes in self-reported nasal symptoms during 7 days after 12 sessions/4 weeks acupuncture treatment and one-month follow-up.
Secondary outcome measures
Measured after 12 sessions/4 weeks acupuncture treatment:
1. Rhinitis Quality of Life Questionnaire (RQLQ) score
2. Total non-nasal symptom score (i.e. headache, itching, pain, eye dropping)
Measured during follow-up period:
3. Quantity of conventional relief medication use
Overall trial start date
01/03/2009
Overall trial end date
30/04/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Diagnosis of PER, with moderate-severe or severe degree, according to the criteria of Allergic Rhinitis and its Impact on Asthma (ARIA) initiative
2. Completed baseline AR diary and provided written informed consent
3. Aged greater than or equal to 18 years of age, either sex
4. Recruited from each centre by the use of local newspaper advertisements and posted notices at each site
5. Have had PER for greater than 4 days/week, and greater than 4 consecutive weeks
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
233 participants, allowing for a 20% withdrawal rate
Participant exclusion criteria
1. Suffering serious medical conditions such as uncontrolled hypertension, diabetes mellitus requiring insulin injection, past or current malignant tumour, severe dyslipidaemia or liver and kidney dysfunction, anaemia, active pulmonary tuberculosis, other infectious disease or systemic diseases insufficient for acupuncture treatment
2. Congenital nasal abnormalities
3. Sinusitis or active asthma
4. Operation history
5. Received systemically administered corticosteroids within 6 months before enrolment
6. Received alternative and complementary modality, i.e. acupuncture or herbal medication for treating AR within 6 months
Topical oral and nasal H1 blockers, or corticosteroid, or nasal anti-cholinergic medication will be stopped before 1 week before enrolment.
Recruitment start date
01/03/2009
Recruitment end date
30/04/2010
Locations
Countries of recruitment
China, Korea, South
Trial participating centre
483 Exporo Yuseng-gu
Daejeon
305-811
Korea, South
Sponsor information
Organisation
Korea Institute of Oriental Medicine (South Korea)
Sponsor details
483 Exporo Yuseng-gu
Daejeon
305-811
Korea
South
smchoi@kiom.re.kr
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Korea Institute of Oriental Medicine (South Korea) - The Acupuncture, Moxibustion and Meridian Research Project (ref: K09050)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19602250
2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23253122
Publication citations
-
Protocol
Kim JI, Lee MS, Jung SY, Choi JY, Lee S, Ko JM, Zhao H, Zhao J, Kim AR, Shin MS, Kang KW, Jung HJ, Kim TH, Liu B, Choi SM, Acupuncture for persistent allergic rhinitis: a multi-centre, randomised, controlled trial protocol., Trials, 2009, 10, 54, doi: 10.1186/1745-6215-10-54.
-
Results
Choi SM, Park JE, Li SS, Jung H, Zi M, Kim TH, Jung S, Kim A, Shin M, Sul JU, Hong Z, Jiping Z, Lee S, Liyun H, Kang K, Baoyan L, A multicenter, randomized, controlled trial testing the effects of acupuncture on allergic rhinitis., Allergy, 2013, 68, 3, 365-374, doi: 10.1111/all.12053.