Impact of acupuncture for allergic rhinitis on the activity of the hypothalamus-pituitary-adrenal axis: study protocol for a randomized controlled trial

BACKGROUND: Patients with moderate and severe persistent allergic rhinitis (AR) have long-term physical and mental stress, leading to dysfunction of the hypothalamus-pituitary-adrenal (HPA) axis, which results in recurrence of AR. Previous research has proved acupuncture can regulate the function of the neuron-endocrine-immune system and contribute to improving the quality of life of patients with AR. This research aims to investigate the mechanism of acupuncture on the HPA axis in patients with moderate or severe persistent AR. METHODS/DESIGN: This randomized controlled trial aims to study the impact of acupuncture on the HPA axis of patients with moderate and severe AR. This research also aims to compare the curative effects of different treatments in three groups of patients: those receiving western medicine, western medicine and conventional acupuncture, or western medicine and mind-regulating acupuncture. We will study the therapeutic effect of acupuncture and the correlation between the changes of therapeutic indexes and experimental indexes after the treatments. Therapeutic indexes include the Visual Analog Scale (VAS) of nasal symptoms and the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) for AR patients; experimental indexes include corticotropin releasing hormone (CRH), adreno-corticotropic hormone (ACTH), cortisol (CORT), interleukin 4 (IL-4), and interferon-γ (IFN-γ). DISCUSSION: The results of this trial will provide evidence for the influence of chronic, long-term, repeated stimulation in patients with moderate and severe persistent AR and the impact of acupuncture on the HPA axis of these patients. TRIAL REGISTRATION: Acupuncture-Moxibustion Clinical Trial Registry, AMCTR-IOR-16000009. Registered on 22 August 2016.