Zhang Cui-hong (張翠紅), Hong Jue (洪玨), Wu Ling-xiang (吳凌翔), Liu Jie (劉婕), Ma Xiao-peng (馬曉芃),Hou Su-yi (侯蘇尹), Xie Chen (謝晨)

1 Shanghai Research Institute of Acupuncture and Meridian, Shanghai 200030, China

2 Shanghai Ci Hao Tang Chinese Medicine Clinic, Shanghai 200233, China

Abstract

Keywords: Acupuncture Therapy; Point, Tianrong (SI 17); Point, Lieque (LU 7); Rhinitis, Allergic; Quality of Life

Allergic rhinitis (AR) is a non-infectious inflammation of the nasal mucosa triggered by the contact with allergens, mainly mediated by IgE.It is a common clinical disease.The domestic prevalence rate is about 6.3%.The incidence rate is on the rise[1].The main clinical manifestations are sneezing, runny nose, nasal itching and nasal obstruction, which can cause dizziness,headache, low spirit and hypomnesia.In severe cases, it can induce life-threatening complications such as asthma, pulmonary heart disease and emphysema.Long-term recurrent AR will cause hyposmia and sinusitis.

Subjective and objective factors such as individual constitution, genetic, endocrine imbalance, mental and environmental factors are all related to the pathogenesis of AR[2].The main treatment of modern medicine is using antihistamines or steroids to relieve the symptoms of nasal mucosal congestion, or anticholinergic drugs to block local allergies.Most of these drugs are symptomatic treatments and unable to cure the disease.Long-term applications have different levels of adverse reactions.Surgical treatments such as vidian neurotomy and anterior ethmoid neurotomy are not recommended because of the uncertain effects and the hidden dangers of sequelae like dry eye and airborne nose[3].

AR belongs to Bi Qiu in traditional Chinese medicine.Its pathogenesis, syndrome differentiation and treatment methods have been discussed by physicians of each generation[4].Modern research believes that the indications of Zhen’ai needling method described in the 75th chapter ofLing Shu (Spiritual Pivot)are similar to allergic asthma and acute attack of asthmatic bronchitis in modern medicine[5].In patients with AR, symptoms such as runny nose and nasal congestion after inhaling allergens like dust and smoke, and allergic asthma manifested as dyspnea, being unable to lie down and aggravation by inhalation of smoke in severe cases, are very similar to indications described in Zhen’ai needling method.Therefore, some researchers use Zhen’ai needling method to treat wheezing and rhinitis caused by allergens such as dust[6-7].

In this study, we observed the effect of Zhen’ai needling method based on the conventional acupoint selection on the quality of life of patients with AR, to evaluate the efficacy of Zhen’ai needling method for the treatment of AR, in order to improve the existing acupuncture treatment for allergic rhinitis.

1 Clinical Materials

1.1 Diagnostic criteria

This study referred to the diagnostic criteria in theGuidelines for the Diagnosis and Treatment of AllergicRhinitis(2009, Wuyishan)[8]: at least two symptoms of sneezing, runny nose, nasal obstruction, and nasal itching, cumulative or lasting for more than 1 h per day;runny nose, nasal mucosa edema, pale nasal mucosa;may be accompanied by conjunctival congestion, itchy eyes and other symptoms.

1.2 Inclusion criteria

Those who met the above diagnostic criteria; aged between 10 and 70 years old; with duration more than 6 months; agreed to participate in this clinical trial and signed informed consent.

1.3 Exclusion criteria

Those who did not meet the above diagnostic criteria and inclusion criteria; who needed long-term use of aspirin or steroids; pregnancy; who was reluctant to accept interventions or cooperate; psychotic; coupled with nasal polyps or abnormally deflected nasal septum.

1.4 Elimination and dropout criteria

Those with poor compliance; those took medication out of the treatment protocol; those presenting with adverse reactions during treatment (record the adverse reactions and stop the treatment).

1.5 Statistical methods

All data were statistically analyzed by the SPSS version 18.0 statistical software.Measurement data in normal distribution were expressed as mean ± standard deviation ().Independent samplet-test was applied to the mean comparison of two samples.Pairedt-test was applied to the comparison of intra-group data before and after treatment.Measurement data in non-normal distribution were expressed as median(interquartile range) [M(IQR)], and Wilcoxon rank sum test was applied.Counting data were expressed as rate.Chi-square test was used for comparison between groups.P＜0.05 was considered to indicate a statistically significant difference.

1.6 General data

A total of 99 patients were enrolled, collected from the Clinic of the Shanghai Institute of Acupuncture and Meridian, between January 2016 and December 2017.All patients were randomly divided into two groups by the random number table according to the visiting sequence, with 51 cases in the conventional needling group and 48 cases in the Zhen’ai needling group.During the treatment, 7 cases dropped out in the Zhen’ai needling group and 8 cases in the conventional needling group.The research flow chart is shown in Figure 1.

There were no statistically significant differences in gender, age, or duration of disease between the two groups (allP＜0.05), indicating that the two groups were comparable (Table 1).

Figure 1.The flow chart

Table 1.Comparison of general data

2 Treatment Methods

2.1 Conventional needling group

Major points: Yintang (GV 29), Shangxing (GV 23),Baihui (GV 20); Zusanli (ST 36), Hegu (LI 4), Juliao (ST 3),and Yingxiang (LI 20) on both sides.

Methods: The patient took a supine position.The physician perpendicularly punctured Zusanli (ST 36),Hegu (LI 4) and Juliao (ST 3) using sterile acupuncture needles of 0.25 mm in diameter and 40 mm in length after routine disinfection; obliquely punctured Yingxiang(LI 20) upwards to Shangyingxiang (EX-HN 8);subcutaneously punctured Yintang (GV 29) with the tip of needle towards the nasal tip, so that the tip of the needle reached the nasion and the needle sensation would spread to the tip of the nose; subcutaneously punctured Shangxing (GV 23), Baihui (GV 20) with the tip of needles towards the occiput.The needles were retained for 30 min after qi arrival.After needle withdrawal, the patient took a prone position with back exposed.The physician applied flash-fire cupping method along the Bladder Meridian on the back.The skin was sucked into the cup for 5 to 8 mm, and the cups were removed 3-5 min later.

2.2 Zhen’ai needling group

Major points: Same as those in the conventional needling group.

Points of Zhen’ai needling method: Shanglianquan[Extra, located at 1 cun above Lianquan (CV 23)]; Lieque(LU 7) and Tianrong (SI 17) on both sides.

Methods: The acupuncture method for the major points was same as for the conventional needling group.Regarding the points of Zhen’ai needling method,Shanglianquan [Extra, located at 1 cun above Lianquan(CV 23)] and Tianrong (SI 17) were punctured with the tip of needle towards the throat; Lieque (LU 7) was subcutaneously punctured with the tip of needle towards the shoulder.After arrival of qi, the even reinforcing-reducing manipulation was performed, and the needles were retained for 30 min.The cupping method was applied in the same way as for the conventional needling group.

The treatment was performed twice a week for both groups, 5 times as a course of treatment, and the efficacy was evaluated after 3 courses of treatment.

3 Therapeutic Efficacy Observation

3.1 Observation items

The patients were asked to complete the evaluations of total nasal symptom score (TNSS), total ocular symptom score (TOSS) and sino-nasal outcome test-20(SNOT-20).

3.1.1 TNSS

Patients were scored 0 to 3 points according to the severity (0=none, 1=mild, 2=moderate, 3=severe) of 4 nasal symptoms (runny nose, nasal obstruction,sneezing, and nasal itching).

3.1.2 TOSS

Patients were scored 0 to 3 points according to the severity (0=none, 1=mild, 2=moderate, 3=severe) of 3 eye symptoms (itch/burning, tearing and redness).

3.1.3 SNOT-20

Patients were scored 0 to 3 points according to the severity (0=none, 1=mild, 2=moderate, 3=severe) of 20 symptoms closely related to rhinitis.

3.2 Criteria of curative efficacy

The score improvement rate was calculated according to the total scores of TNSS, TOSS and SNOT-20 before and after treatment, and the effect was evaluated by the integral improvement rate.

According to the relevant literature, the efficacy criteria of this study were established[8-9].

Integral improvement rate = (Total score before treatment – Total score after treatment) ÷ Total score before treatment × 100%.

Improved: The integral improvement rate ≥51%.

Effective: The integral improvement rate ≥21%, ＜51%.

Invalid: The integral improvement rate ＜21%.

3.3 Results

3.3.1 Comparison of clinical efficacy

The total effective rate of Zhen’ai needling group was 92.7%, and that of the conventional needling group was 88.4%.The Chi-square test showed that there was no significant difference in the total effective rate between the two groups (P＜0.05), (Table 2).

Table 2.Comparison of clinical efficacy between the two groups (case)

3.3.2 Comparison of TNSS score

There was no significant difference in TNSS score between the two groups before treatment (P＞0.05),indicating that the two groups were comparable.After treatment, the TNSS scores of the two groups both decreased, and the intra-group differences were statistically significant (bothP＜0.05), but there was no significant difference between the two groups (P＞0.05),indicating that both methods could improve the main symptoms of AR, with equal therapeutic effect (Table 3).

Table 3.Comparison of TNSS score between the two groups before and after treatment (, point)

Table 3.Comparison of TNSS score between the two groups before and after treatment (, point)

Note: Compared with the same group before treatment, 1) P＜0.05

Group n Before treatment After treatment Zhen’ai 41 8.31±2.64 3.94±1.271)Conventional 43 7.66±3.13 3.71±1.151)

3.3.3 Comparison of TOSS score

The Wilcoxon rank sum test showed that there was no significant difference in TOSS score between the two groups before treatment (P＞0.05).After treatment, the TOSS scores of both groups decreased, and the intra-group differences were statistically significant(bothP＜0.05), but there was no significant difference between the two groups (P＞0.05), indicating that both methods could improve the ocular symptoms of AR,with equal therapeutic effect (Table 4).

Table 4.Comparison of TOSS scores between the two groups before and after treatment [M (IQR), point]

3.3.4 Comparison of SNOT-20 score

There was no significant difference in SNOT-20 score between the two groups before treatment (P＞0.05).After treatment, the SNOT-20 scores of the two groups both decreased, and the intra-group differences were statistically significant (bothP＜0.05), and the difference between the two groups was also statistically significant(bothP＜0.05), indicating that both methods could improve the symptoms of sinus and nasal cavity in patients with AR, and the effect of Zhen’ai needling method was better than that of conventional acupuncture (Table 5).

Table 5.Comparison of SNOT-20 score between the two groups before and after treatment (, point)

Table 5.Comparison of SNOT-20 score between the two groups before and after treatment (, point)

Note: Compared with the same group before treatment, 1) P＜0.05;compared with the conventional group after treatment, 2) P＜0.05

Group n Before treatment After treatment Zhen’ai 41 20.64±7.99 5.43±2.961)2)Conventional 43 19.37±8.98 8.69±3.411)

3.3.5 Comparison of cough score

The highest score of cough symptom in the SNOT-20 scale before treatment was 3 points, and the lowest score was 0 point.There was no significant difference between the two groups before treatment (P＞0.05).After treatment, the intra-group difference in Zhen’ai needling group was statistically significant, and the difference between the two groups was statistically significant (P＜0.05), indicating that the improvement in cough symptom in the Zhen’ai needling group was more significant than that in the conventional needling group(Table 6).

Table 6.Comparison of cough symptom score before and after treatment (M (IQR), point)

3.3.6 Comparison of nasal reflux (to the throat) score

The highest scores of nasal reflux (to the throat)symptom in the SNOT-20 scale before treatment in both groups were 3 points, and the lowest scores were both 0 point.There was no significant difference between the two groups before treatment (P＞0.05).After treatment, the intra-group difference in Zhen’ai needling group was statistically significant, and the difference between the two groups was statistically significant (P＜0.05), indicating that the improvement in nasal reflux (to the throat) symptom in the Zhen’ai needling group was more significant than that in the conventional needling group (Table 7).

Table 7.Comparison of nasal reflux (to the throat) symptom score before and after treatment in both groups (M (IQR),point)

4 Discussion

Traditional Chinese medicine believes that the main pathogenesis of AR is the deficiency of the lung, spleen and kidney, the insecurity of defense-exterior, and the invading of external pathogens.Acupuncture treatment of nasal diseases has a long history and reliable efficacy,but the mechanism of the effect is complex, and there is no uniform acupoint selection standard[10-12].

In this study, we observed the effect of Zhen’ai needling method inNei Jing(Classic of Internal Medicine) on the basis of conventional acupoints in treating AR.In the conventional acupoints, Yintang(GV 29) is located on the outer edge of the nose, and the meridian qi is straight through the nose.It has a strong effect in dredging meridian and collateral, and clearing the nasal passage.It is the main point for treating various nasal diseases.Juliao (ST 3) is a crossing point of the Large Intestine Meridian, Stomach Meridian and Yang Heel Vessel, mainly for the treatment of nasal obstruction, runny nose and toothache.Yingxiang (LI 20), Shangxing (GV 23) and Baihui (GV 20) all belong to the Governor Vessel, and have a significant effect in clearing the nasal passage[4,13-14].Hegu (LI 4) is the Yuan-Primary point of the Large Intestine Meridian.The large intestine is exteriorly-interiorly related to the lung.Acupuncture at Hegu (LI 4) can disperse the nasal pathogen.Zusanli(ST 36) is the key acupoint for health care, having the effect of regulating the spleen and stomach, and unblocking the meridian and activating collaterals.Acupuncture at Zusanli (ST 36) can enhance the body immunity.The selection of the above acupoints was to combine the local points and distant points, for reinforcing the healthy qi and eliminating the pathogenic factors simultaneously.In addition, cupping along the Governor Vessel and the Bladder Meridian can fortify the spleen, lung, and kidney[15-16].Therefore,the TNSS, TOSS and SNOT-20 scores of the two groups were significantly improved after treatment.

The Zhen’ai needling group added acupoints on the basis of the conventional acupoints, in which Tianrong(SI 17) has the effect of opening orifices to eliminate stagnation, regulating qi and directing qi downward[17].ShangLianquan [Extra, located at 1 cun above Lianquan(CV 23)] has the effect of directing qi downward,benefiting throat and tongue, opening orifices and relieving swelling and pain.It is often used to treat cough, asthma, throat impediment, and language disorders[18].Lieque (LU 7) is the Luo-Connecting point of the Lung Meridian.It has the effect of dispersing wind to eliminate the exterior pathogens, diffusing the lung to regulate qi, and suppressing cough to calm panting.It was combined with Hegu (LI 4) to treat both exterior and interior meridians[19-20].

The results of this study indicated that the Zhen’ai needling had a better effect in improving cough and nasal reflux (to the throat) symptom scores in the SNOT-20 scale than the conventional needling,especially for AR children with adenoid hypertrophy.The symptoms like swollen throat and snoring were significantly improved.However, some of the patients without symptoms of throat reported pain with saliva swallowing when receiving acupuncture at Tianrong(SI 17) and Shanglianquan [Extra, located at 1 cun above Lianquan (CV 23)].Therefore, it is recommended that Zhen’ai needling acupoints can be used as the point combination for acupuncture in AR patients with throat symptoms, and not used in AR patients without throat symptoms.

In this study, the long-term efficacy was not observed,neither the objective tests such as serum IgE and allergen test.Therefore, further studies should have a follow-up to observe the long-term efficacy.Meanwhile,certain objective indicators should also be added to clarify the mechanism of acupuncture treatment of AR.