TY - JOUR
T1 - An External CAM Therapy (Tian Jiu) versus Placebo in Treatment of Allergic Rhinitis
T2 - A Pilot Single-Blinded, Three-Arm, Randomized Controlled Study
AU - Dai, Liang
AU - Zhong, Lidan
AU - Kun, Wai
AU - Lam, Wai Ching
AU - Yang, Zhen
AU - Huang, Tao
AU - Mu, Huaixue
AU - Bian, Zhaoxiang
N1 - Funding Information:
The study protocol was approved by the Hong Kong Baptist University Ethics Committee on the Use of Human Subjects for Teaching and Research (Approval no. HASC/13-14/0241). The protocol has been registered with the identifier NCT02470845 (17 May 2015) at ClinicalTrials.gov and published in Trials [22]. Every included patient signed the Informed Consent voluntarily. The checklists for items in CONSORT 2010 and STRICTOM 2010 were given in Supplement 1 and Supplement 2, respectively [23, 24]. The research was supported by the Marcoda Co. Ltd., which had no role in the protocol design, study implementation, data collection, and manuscript preparation.
Funding Information:
The research was financially supported by the Marcoda Co., Ltd.
PY - 2019/4/14
Y1 - 2019/4/14
N2 - Allergic rhinitis (AR) is one of the common allergic diseases in clinical practice and significantly impairs the quality of life (QoL) of patients. The conventional treatments are not satisfactory because of various reasons. Tian Jiu (TJ) therapy is a characteristic external intervention of complementary and alternative medicine (CAM) and has been widely utilized in the management of AR. However, the evidences resulted from current studies were generally poor due to high risk of bias. Therefore, we conducted this rigorous designed, single-blinded, three-arm, randomized controlled study to evaluate the efficacy and safety of TJ therapy on AR. Totally 138 AR patients were enrolled. The TJ group and placebo group received 4-week treatment with either TJ or placebo patches for 2 hours each time applied to Dazhui (GV 14), bilateral Feishu (UB 13), and bilateral Shenshu (UB 23) one session per week and then underwent a 4-week follow-up. The waitlist group received no treatment during the corresponding treatment period, but would be given compensatory TJ treatment in the next 4 weeks. The primary outcome was the change of the Total Nasal Symptom Score (TNSS) after treatment. The secondary outcomes included the changes of Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and rescue medication score (RMS). After treatment, the total TNSS in TJ group was significantly reduced compared with baseline, but showed no statistical meaning compared with placebo. Among the four domains of TNSS, the change of nasal obstruction exhibited statistical difference compared with placebo group. The total RQLQ score in TJ group was significantly reduced compared with both placebo and waitlist groups. The needs of rescue medications were no distinct difference between two groups. In summary, this study showed potential effectiveness of TJ therapy in improving nasal obstruction symptoms and QoL of AR patients.
AB - Allergic rhinitis (AR) is one of the common allergic diseases in clinical practice and significantly impairs the quality of life (QoL) of patients. The conventional treatments are not satisfactory because of various reasons. Tian Jiu (TJ) therapy is a characteristic external intervention of complementary and alternative medicine (CAM) and has been widely utilized in the management of AR. However, the evidences resulted from current studies were generally poor due to high risk of bias. Therefore, we conducted this rigorous designed, single-blinded, three-arm, randomized controlled study to evaluate the efficacy and safety of TJ therapy on AR. Totally 138 AR patients were enrolled. The TJ group and placebo group received 4-week treatment with either TJ or placebo patches for 2 hours each time applied to Dazhui (GV 14), bilateral Feishu (UB 13), and bilateral Shenshu (UB 23) one session per week and then underwent a 4-week follow-up. The waitlist group received no treatment during the corresponding treatment period, but would be given compensatory TJ treatment in the next 4 weeks. The primary outcome was the change of the Total Nasal Symptom Score (TNSS) after treatment. The secondary outcomes included the changes of Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and rescue medication score (RMS). After treatment, the total TNSS in TJ group was significantly reduced compared with baseline, but showed no statistical meaning compared with placebo. Among the four domains of TNSS, the change of nasal obstruction exhibited statistical difference compared with placebo group. The total RQLQ score in TJ group was significantly reduced compared with both placebo and waitlist groups. The needs of rescue medications were no distinct difference between two groups. In summary, this study showed potential effectiveness of TJ therapy in improving nasal obstruction symptoms and QoL of AR patients.
UR - http://www.scopus.com/inward/record.url?scp=85065134289&partnerID=8YFLogxK
U2 - 10.1155/2019/6369754
DO - 10.1155/2019/6369754
M3 - Article
AN - SCOPUS:85065134289
SN - 1741-427X
VL - 2019
JO - Evidence-based Complementary and Alternative Medicine
JF - Evidence-based Complementary and Alternative Medicine
M1 - 6369754
ER -