Acupuncture for persistent allergic rhinitis: a multi-centre, randomised, controlled trial protocol.
BACKGROUND
Allergic rhinitis is one of the most common health complaints worldwide. Complementary and alternative medical approaches have been employed to relieve allergic rhinitis symptoms and to avoid the side effects of conventional medication. Acupuncture has been widely used to treat patients with allergic rhinitis, but the available evidence of its effectiveness is insufficient. Our objective is to evaluate the effectiveness of acupuncture in patients in Korea and China with persistent allergic rhinitis compared to sham acupuncture treatment or waitlist control.


METHODS
This study consists of a multi-centre (two centres in Korea and two centres in China), randomised, controlled trial with three parallel arms (active acupuncture, sham acupuncture, and waitlist group). The active acupuncture and sham acupuncture groups will receive real or sham acupuncture treatment, respectively, three times per week for a total of 12 sessions over four weeks. Post-treatment follow-up will be performed a month later to complement these 12 acupuncture sessions. Participants in the waitlist group will not receive real or sham acupuncture treatments during this period but will only be required to keep recording their symptoms in a daily diary. After four weeks, the same treatment given to the active acupuncture group will be provided to the waitlist group.


CONCLUSIONS
This trial will provide evidence for the effectiveness of acupuncture as a treatment for persistent allergic rhinitis. The primary outcome between groups is a change in the self-reported total nasal symptom score (i.e., nasal obstruction, rhinorrhea, sneezing, and itching) from baseline at the fourth week. Secondary outcome measures include the Rhinitis Quality of Life Questionnaire score and total non-nasal symptom score (i.e., headache, itching, pain, eye-dropping). The quantity of conventional relief medication used during the follow-up period is another secondary outcome measure.


BACKGROUND
Current Controlled Trials ISRCTN90807007.
Kim
Jong-In
JI
Medical Research Centre, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea. hann8400@hanmail.net
Lee
Myeong Soo
MS
Jung
So-Young
SY
Choi
Jun-Yong
JY
Lee
Sanghoon
S
Ko
Jeong-Min
JM
Zhao
Hong
H
Zhao
Jiping
J
Kim
Ae-Ran
AR
Shin
Mi-Suk
MS
Kang
Kyung-Won
KW
Jung
Hee-Jung
HJ
Kim
Tae-Hun
TH
Liu
Baoyan
B
Choi
Sun-Mi
SM
D015670:Acupuncture Therapy; D002681:China; D006801:Humans; D007723:Korea; D011788:Quality of Life; D012107:Research Design; D012221:Rhinitis, Allergic, Perennial / Q000628:therapy*; D016896:Treatment Outcome