INTRODUCTION
Allergic rhinitis (AR) is a disease with a prevalence rate of 20–30% worldwide.[1] Common symptoms of this disease include nasal congestion, sneezing, nasal itching, and runny nose. Moreover, asthma, sinusitis, inflammation, and fluid effusion in the middle ear can be mentioned as a number of its complications.[2] AR can be seasonal (mainly caused by pollen) or persistent (often caused by indoor allergens such as house dust mites, fungal spores, and animal dander). AR is seasonal, persistent, and mixed (persistent with seasonal recurrence) in almost 20%, 40%, and 40% of cases, respectively.[3] Allergy to the pollen of plants is found in 10–15% of individuals.[4]
AR is associated with significant health and psychological stresses in patients because of the complexity of its causes, the long duration of the disease, and its high prevalence.[1,5] AR has an evident impact on patient’s quality of life and interferes with recreational activities, sleep, and work.[6] In addition, it causes a considerable economic burden.[7] In Europe, the treatment of AR and its complications have direct costs of approximately 1.0–1.5 billion Euros and additional indirect costs of at least 1 billion Euros.[8]
Therefore, it is important to pay attention to its treatment and choose the best and most effective treatment protocol. Options for managing AR include allergen avoidance, medication, immunotherapy, and training. Medications include topical antihistamines, oral H1 antihistamines, systemic and topical glucorticosteroids, topical decongestants, chromones, topical anticholinergics, and anti-leukotrienes. The mentioned medications may lead to immediate control of symptoms. However, there is no long-term effect on the symptoms following the discontinuation of these medications.[9] Most of these medications have complications that can sometimes be serious.
Therefore, researchers have drawn attention to combination therapies with complementary and alternative medicine (CAM) as they improve clinical efficacy and reduce the incidence of complications.[10]
Acupuncture, having its basis in the meridian theory, can be regarded as one of the significant therapies employed in CAM. The aim of meridian medicine is targeting definite acupoints, as a result of which the body’s microenvironment improves, and thus certain diseases are effectively treated.[11]
A recent array of studies has proposed that acupuncture may enjoy anti-inflammatory effects, which can prevent AR through numerous immune and neuroendocrine network pathways.[12] A number of novel studies in the field of immunology and neuroscience have indicated the role of neural reflexes in regulating the immune system,[11] particularly in vagal nerve- and macrophage-related pathways.[13]
Though acupuncture has not been extensively suggested for treating AR in the past because of the insufficient clinical and laboratory evidence to support its efficacy. Since 2015, the evidence provided by many clinical trials has revealed the efficacy of acupuncture in the treatment of AR, especially in persistent AR (PAR).[1,14–16] However, although there is an extensive application of acupuncture for treating AR, the results obtained regarding its use in each type of AR have not been confirmed. Therefore, the present study aimed at evaluating the potential role of acupuncture along with conventional therapies in treating AR.
MATERIALS AND METHODS
The present study was a randomized single-blind clinical trial. The study population comprised all patients with AR who were referred to Kashani and Al-Zahra Hospitals of Isfahan from January 2010 to January 2019. The sample size was estimated to be 27 individuals in each group based on the sample size formula comparing the means at the 95% confidence level and power of 80% as well as considering the results of previous studies[16] indicating the standard deviation (SD) of 0.59 and 0.85 for the nasal symptom scores of the acupuncture and control groups, respectively, and an error level of 0.63 (µ1−µ2 = 1.28 − 0.65).
Inclusion criteria included having AR, having a positive skin allergy test determined using the skin prick test (SPT), and stating satisfaction to take part in the study. AR was diagnosed based on the patients’ symptoms and physical examinations (history of two or more nasal symptoms including rhinorrhea, nasal congestion, itching, and sneezing) performed by an otolaryngologist as well as the findings of the allergic rhinitis and its impact on asthma (ARIA) guidelines.
In addition, the patients were not included in the study in case of having a long-term use of corticosteroids, diabetes, nasal anatomical abnormalities such as septal abnormalities or nasal polyps, any previous rhinoplasty surgery, tuberculosis, any other chronic systemic diseases, and refractory asthma as well as being suspicious for malignancy. Moreover, patients were excluded from the study in case of patients’ dissatisfaction to continue their participation in the study or loss of follow-ups to perform re-evaluations.
The SPT was used to evaluate the sensitivity to allergens. In this test, FDA-approved standard antigens were applied to the skin and penetrated into the skin by a lancet puncturing the skin. After 15–20 min, the degree of a skin reaction at the site of scratch indicated by flare and wheal was measured using a ruler marked in mm. A wheel diameter of more than 3 mm was considered a criterion for a positive skin test.[17]
After obtaining a code of ethics from the Ethics Committee of Isfahan University of Medical Sciences (Approval code: IR.MUI.MED.REC.1398.716), a clinical trial code (IRCT20200825048515N8), and written consent from eligible patients, the patients were randomly divided into two groups using random allocation software.
The age and sex of patients were recorded at the baseline. In addition, the severity of symptoms, including runny nose and sneezing, was determined by patients using the Visual Analog Scale in terms of a score ranging from 0 (the lowest level) to 10 (the highest level). Nasal congestion, nasal itching, and tearing were also recorded in terms of self-reported total nasal symptom scores.
All patients underwent standard AR treatment including one 10-milligram (mg) dose of cetirizine per day, normal saline nasal spray, and one spray of Beconase Aqueous Nasal Spray into each nostril daily. The mentioned medications were prescribed by a specialist physician.
Patients in the first group were then treated with acupuncture twice a week for 3 weeks. Acupuncture was performed by a licensed acupuncturist having 15 years of professional acupuncture experience. Before starting the acupuncture treatment, patients were examined to specify traditional Chinese medicine (TCM) pattern recognition.
First, it is worth mentioning that cun is a standard unit of measurement in acupuncture. Basic points for acupuncture including Ermen (TE21, depth 0.5 cun), Tinggong (SI19, depth: 0.5 cun), Tinghui (GB2, depth 0.5 cun), and Yifeng (TE17, depth 0.5 cun) were selected according to the World Health Organization (WHO) guidelines. Other points were selected according to guidelines on Chinese medicine diagnosis (Wind cold, wind heat, Qi deficiency of the lungs, kidneys, spleen, and Du Mai).
The points mostly used are as follows: Houxi (SI-3, depth: 0.5 cun), Shenmai (BL-62, depth: 0.5 cun), Lieque (LU-7, depth: 0.5 cun), Zhaohai (KID -6, depth 0.5 cun), Feishu (BL-13, depth: 0.5 cun oblique), Taiyuan (LU-9, depth: 0.3 cun), Shenzhu (Du-12, depth: 0.5 cun), Shenshu (BL-23, depth: 0.5 cun), Taixi (KID-3, depth 0.5 cun), Zhongwan (Ren-12, depth: 1 cun), Zusanli (ST-36, depth: 1 cun), Pishu (BL-20, depth: 0.5 cun oblique), MIingmen (Du-4, depth: 1 cun), and Guanyuan (Ren-4, depth 1 cun).
The acupuncture needles were Dong Bang DB106 stainless steel needles with 25 mm length and 0.20 mm width. The needles were inserted and no more manual or electrical stimulations were applied after manual stimulation to elicit deqi (a composite of unique sensations after needle insertions). The needles were retained for about 30 min. Acupuncture treatment was performed twice a week for 3 weeks (six treatments were performed).
The second group was considered the control group and merely received the standard treatment. During the second and sixth weeks after the treatment, the improvement degree of AR symptoms including runny nose, sneezing, nasal congestion, nasal itching, and tearing was re-evaluated and recorded.
It is worth mentioning that although the researcher was aware of the type of treatment interventions, the evaluator did not have any information about the type of treatment in the groups. Moreover, the data analyst was unaware of the type of therapeutic intervention. Hence, the required conditions were set to establish a single-blind trial.
Finally, SPSS software (Ver. 23) was used to analyze the collected data. The data were presented as frequency (%), means ± SD, or median (interquartile range [IQR]). Fisher’s exact test and Chi-squared test were used to compare the qualitative data between the two groups. An independent samples t-test, Mann–Whitney U test, and Friedman test were employed for comparing the mean age of the two groups, the severity of runny nose and sneezing between the two groups, and the degree of improvement over time in each of the two groups, respectively. A significance level of less than 0.05 was considered in all analyses.
RESULTS
In this study, three patients in the acupuncture group were excluded due to incomplete treatment. Therefore, the study followed up on 24 patients in the acupuncture group and 27 patients in the control group [Figure 1].
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Figure 1: Consort flowchart of patients
The control group consisted of 10 male patients (37%) and 17 female patients (63%) with a mean age of 31.22 ± 10.62 years. The acupuncture group included 6 male patients (25%) and 18 female patients (75%) with a mean age of 34.85 ± 8.65 years (P value > 0.05). In addition, the results of the prick skin test indicated that most allergens were caused by pollen from trees, weeds, and grasses [Table 1].
Table 1: Determination and comparison of sex distribution and the mean age of patients between the two groups
At baseline, there was no significant difference in the patients’ runny nose and sneezing scores between the two groups (P value > 0.05); however, the severity of these symptoms was significantly lower in the acupuncture group as compared with the control group 2 and 6 weeks after the treatment (P value < 0.05) [Table 2]. In addition, the decrease in the severity of runny nose and sneezing in the acupuncture group with mean values of 4.59 ± 3.04 and 5.30 ± 2.92 was significantly higher than that of the control group with mean values of 2.85 ± 1.56 and 2.78 ± 1.28, respectively (P value < 0.05) [Figure 2].
Figure 2: Determination and comparison of the mean of patients’ runny nose and sneezing scores 6 weeks after the treatment between the two groups
Table 2: Determination and comparison of the severity of runny nose and sneezing between the two groups
Finally, the findings revealed no significant difference between the two groups in terms of nasal congestion, nasal itching, and tearing symptoms (P value > 0.05); however, in 2 and 6 weeks after the intervention, in the acupuncture group, the frequency of the mentioned three symptoms was significantly lower than in the control group (P value < 0.05) [Table 3].
Table 3: Determination and comparison of the frequency of nasal congestion, nasal itching, and tearing symptoms between the two groups
DISCUSSION
The results of this study indicated that although conventional therapies have a significant role in the improvement of AR patients’ outcomes, the concomitant use of acupuncture along with standard therapies can significantly control and improve symptoms of runny nose, sneezing, nasal congestion, nasal itching, and tearing. In addition, as compared with conventional treatment, it seems that this reduction in symptoms was accompanied by more stability in long-term follow-up.
In line with the findings of the present study, the effects of acupuncture on reducing allergic symptoms and improving quality of life have been addressed in several studies, the findings of which have revealed that acupuncture can reduce nasal and conjunctival symptoms and signs along with the improvement of the quality of life.[10,18–20] It seems that not only classical rhinoconjunctival complaints but also cutaneous symptoms such as itching in atopic dermatitis appear to be reduced by acupuncture.[21]
Mi et al. (2018), in a pilot study, revealed that the sphenopalatine acupoint (SPA) group had a significantly lower total nasal symptom score than the control group.[1] In addition, in line with the findings of the current study, the mentioned study found that acupuncture relieved symptoms of nasal congestion and runny nose. In this regard, a significant difference was observed between the improvement processes of these two symptoms. The relief of nasal congestion occurred earlier than that of a runny nose. This finding is probably due to different sensitivities to the neurotransmitters of the target organ. In comparison with glandular tissues, the sensitivity of blood vessels to nerve responses was higher, and the relief of nasal symptoms was significantly higher in the acupuncture group as compared with the control group.[1] However, our study investigated the effects of acupuncture by treating acupuncture points including TE17, TE21, SI19, and GB2. Acupuncture has been used frequently in previous studies and its effect on allergic symptoms has been demonstrated.[22,23]
A number of immunological neural mechanisms including decreasing plasma levels of vasoactive intestinal peptide and substance P[24] are involved in acupuncture. The mentioned mechanisms lead to the consideration of acupuncture as a modulator of anti-inflammatory cytokines in AR.[25]
Acupuncture may help improve blood rheology by generating large volumes of blood, may also regulate human immune function, and thus provide therapeutic effects for the treatment of AR.
In addition, according to the results of a meta-analysis study, the findings regarding the efficacy of acupuncture in the prevention of AR and its symptomatic treatment were inconsistent. Although findings on seasonal AR were not able to indicate the specific effect of acupuncture, the results on persistent AR provided promising evidence for the effectiveness of acupuncture.[6]
In contrast to the findings of the present study, another meta-analysis study found no strong evidence regarding the effect of acupuncture on the treatment of allergies. The author of this study expressed that the examined studies provided no effects that could not be attributed to chance. In addition, the author critically highlighted a number of methodological problems in the examined studies. Small sample sizes, lack of control group, and lack of sham acupuncture groups led to the exclusion of a major number of studies in the mentioned meta-analysis study. Hence, as a very small number of studies were included in the meta-analysis, the findings presented by this meta-analysis study cannot reasonably indicate the whole study situation on acupuncture in AR.[26]
Thus, although there is a widespread use of acupuncture for the treatment of AR, the results regarding its use vary due to differences in the accuracy of studies, lack of focus on specific acupuncture points, various duration of treatment and follow-up, or lack of attention to a specific type of AR.
In addition, there are many reports that present the effectiveness of various CAM for the treatment of AR such as acupuncture[16,26] herbal medicines,[27–29] homeopathy,[30] and physical techniques.[31]
In fact, acupuncture, yoga, massage, speleotherapy, and herbal therapy (HT) are therapeutic option considered as CAM[32] and has recently attracted the attention of researchers.
One of the shortcomings of studies in this regard may be the comparative evaluation of specific points of acupuncture, the comparison of electro-acupuncture and manual acupuncture, or a combination of CAM therapies to make treatment protocols as effective as possible.[33]
Although the small sample size and not using the sham acupuncture in the control group were the limitations of the present study, it can be stated that a definite diagnosis of AR confirmed using the skin prick test can be regarded as a strength of the current study as the mentioned issue has been attended to in few previous studies. In addition, the performance of acupuncture by trained and certified TCM practitioners can be considered a strength of the study.
CONCLUSION
According to the results of the present study, the use of acupuncture as a complementary therapy along with standard AR treatment can not only have a significant effect on the improvement of AR symptoms such as runny nose and sneezing scores but can significantly reduce nasal congestion, nasal itching, and tearing.
Declaration of patient consent
The authors certify that they have obtained all appropriate patient consent forms. In the form, the patients have given their consent for their images clinical information to be reported in the journal. The patients understand that their names and initials was not be published and due efforts was made to conceal their identity.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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