Object:To evaluate the clinical efficacy and safety and explore the mechanism of warm needling therapy for Perennia Allergic Rhinitis (PAR).Methods:1. Using the randomized, single-blind, sham-controlled methods,60 patients with a history of PAR which were randomly assigned by computer-generated randomization listed into A group(warm needling therapy)and B group (acupuncture) and C(Acupuncture moxibustion), they received two course of treatments,each course 5 treatments,and have a follow-up phase of 8 weeks. The main outcome measures included the primary and secondary indicators. Primary indicators were subjective symptoms scores evaluated by visual analogue scales (VAS) and Rhinconjunctivitis Quality of Life Questionnaires (RQLQ). The secondary indicators were the results of endoscopic and laboratory examinations, such as the serum allergen-specific IgE and IL-4 and IL-10. With VAS and RQLQ before the treatment and after two course of the treatment, in the 4th and 8th week after the treatment;with nasal endoscopy, serum allergen-specific IgE,IL-4 and IL-10 before and after treatment. The datum were recorded and analysed to assess the efficacy and safety of warm needing in treatment of PAR, to evaluate differences of the three groups between the main and secondary indicators. The use of anti-allergic medication and adverse events were also recorded as one of the secondary indicators.Results:1.The baselines of the three groups showed no statistical differences.2.The VAS sores:The score of total symptom:Comparison among groups, group A and B,A and C are significantly difference in general(P<0.05). In inner group comparison,before the treatment and the end of treatment, before the treatment and the end of follow-up treatment, the difference of group A,B and C are significant(P<0.05). The score of every symptom:Compared with A and B,A and C,there was significant differences after the treatment and follow-up period(P<0.05) in nasal itching, sneezing,stuffy and running nose. In inner group comparison, after the end of treatment and the end of follow-up treatment,the scores of every symptom has significant differences in three groups(P<0.05).3.The RQLQ scores:Comparison among groups, there was no difference between A and C after the treatment and the first follow-up treatment (P> 0.05),while there was significant difference between A and B(P<0.05).Compared with A and B,A and C,there was significant differences the end of follow-up treatment(P<0.05). In inner group comparison, after the end of treatment and the end of follow-up treatment,the scores of RQLQ has significant differences of three groups(P<0.05).4.For endoscopic examination:Comparison among groups, before the treatment and after the treatment, there was no significant either between A and B or A and C (P>0.05). In inner group comparison, the scores of each group has significant differences(P<0.05).5.TCM score:The TCM score of three groups have significant differences after the treatment and t follow-up treatment (P<0.05).Comparison among groups, there was significant difference either between A and B or A and C (P<0.05). In inner group comparison, the TCM score of each group has significant differences(P<0.05).6.Cytokines detection:Comparison among groups, interleukin (IL-4) was compared in pairs,there was significant difference after treatment except group A and B.In inner group comparison, there was significant difference of group A after treatment and the end of follow-up treatment(P<0.05),while either B or C was no significant differences.As interleukin (IL-10),there was no significant difference either compared in pairs or inner group (P>0.05).The levels of serum specific IgE: Comparison among groups,there was significantly improved for group A and C after treatment(P<0.05), while for the group A and B was no significant differences (P>0.05). In inner group comparison, the differences of serum specific IgE were significant either A or B after the treatment (P<0.05),while there was no significant difference in group C (P>0.05).7.There is no patients out of experiment during the period of treatment and follow-up.No adverse events occurred in group A,B and C in the treatment.Conclusion:1.Group A,B and C group could relieve the symptoms of patients with perennial allergic rhinitis (VAS score) and improve quality of life (RQLQ score). The observational group had an obvious advantage than control group, VAS score, RQLQ score and the improvement of signs.2. Although group A,B and C could relieve the TCM symptoms of patients with perennial allergic rhinitis (TCM score), the observational group A had an obvious advantage than control group. Especially for follow-up treatment it has better control.3.No adverse events occurred in group A in the treatment.Warm needling is safe to deficient cold of Lung Qi syndrome persistent AR. |