Moderate-severe perennial allergic rhinitis Respiratory Other allergic rhinitis
Conditions
Interventions
Participants are randomly allocated to one of two groups:
1. Sphenopalatine ganglion stimulation with acupuncture
2. Verum acupuncture
The study includ
the majority of patients need only one session a week, and the doctor decides whether a patient needs another session or not according to the physical signs and symptoms.
Verum acupun
Sponsors
Chinese Academy of Chinese Medical Sciences (China)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of moderate-severe or severe PER, according to the criteria of allergic rhinitis and its impact on asthma (ARIA) initiative 2. Have had PER for greater than 4 days/week, and greater than 4 consecutive weeks, and disease course is more than 1 year 3. Age range is from 18 to 60 years, either sex 4. Completed AR baseline questionnaire and provided written informed consent 5. The physical sign score is greater than or equal to 1 and the symptom score is greater than or equal to 4
Exclusion criteria
Exclusion criteria: 1. Acute sinusitis, active asthma, or diagnosed or suspicious pneumonia 2. Nasal abnormalities or rhinopolypus (polypoid lesion can be included) 3. Had applied antihistamines, anticholinergics, corticosteroids, decongestants or antibiotics within 2 weeks before enrollment 4. Received systemically administered corticosteroids within 6 months before enrolment or special immune therapy within 1 year 5. Received alternative and complementary modality, i.e. acupuncture or herbal medication for treating AR within 2 months 6. Pregnant woman or someone is planning for pregnancy 7. Suffering serious medical conditions such as uncontrolled hypertension, diabetes mellitus requiring insulin injection, past or current malignant tumour, severe dyslipidaemia or liver and kidney dysfunction, anaemia, active pulmonary tuberculosis, other infectious disease or systemic diseases insufficient for acupuncture treatment 8. Heavy smoker
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The onset time and duration of the effectiveness produced by each intervention in every session. Measured before and after each session: 1. The physical sign score (the degree of swelling of the inferior nasal concha) 2. The nasal congestion degree (visual analogue score) 3. The duration of the change in total nasal symptom score after each session (once the patient feels the symptoms alleviate, the duration time will measured and the result will be recorded in a PAR diary) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in nasal symptoms (between the run-in period and 4 weeks treatment) 2. The changes in the number of days with moderate-severe rhinitis (between run-in period and one-month follow-up) 3. The changes in the total IgE level, number of eosnophils in venous blood, and number of eosnophils in nasal mucus (between the run-in period and after treatment) 4. The change in quality of life (between the run-in period and 4 weeks treatment) 5. The clinic waiting time (between the two groups) Measured during the run-in period and 4 weeks treatment: 1. Total nasal symptom score (i.e., nasal itching, sneezing, rhinorrhea, nasal congestion) 2. Total non-nasal symptom score (i.e., postnasal drip, tear dropping, eye itching, pain in nose or palate, headache) 4. The IgE, eosnophil number 5. Rhinitis Quality of Life Questionnaire (RQLQ) score Measured in follow-up period: The number of days with moderate-severe rhinitis | — |
Countries
China
Outcome results
None listed