Acupuncture will be performed by certified acupuncture medical doctors at four centres. Qualified specialists of acupuncture in traditional Korean or Chinese medicine with at least three years of clinical experience will perform the acupuncture in this study. All treatment regimens will be standardised between Korean and Chinese practitioners
via video and international workshops. Participants will be randomly assigned to the active acupuncture group, the sham acupuncture group, or the waitlist group. The active acupuncture and sham acupuncture group participants will receive real and sham acupuncture treatments respectively, three times/week for a total of 12 sessions over four weeks. A 0.20 mm (diameter) × 30 mm (length) disposable needle (Dongbang Acupuncture Inc, Korea) will be used. For the active acupuncture group, 10 acupuncture points (bilateral LI4, LI20, ST2, and ST36, unilateral EX-1 and GV23) according to 'WHO Standard Acupuncture Point Location' [
18] were selected for use based on an expert discussion held in Beijing in December, 2008. These acupuncture points were selected according to traditional Chinese medicine (TCM) theory, which is quite different from that of conventional medicine. Briefly, the basic therapeutic strategies of acupuncture, based on a meridian system, is to correct the body's core imbalances in order to disperse blocked
Qi and blood in treating disease [
19]. According to the TCM theory, when an acupuncture point is stimulated, treatment effects tend to occur in specific parts of the body along the meridian that contains this specific acupuncture point. There are two categories of acupuncture points used to effectively regulate
Qi and blood for syndromes: local points and distal points. In establishing an acupuncture strategy for this study, we focused on the imbalance of the Large Intestine and/or Stomach meridian and/or Governor Vessel due to an invasion of pathogenic agents, such as cold, wind, and damp, as the key pathogenesis of PER. These three key meridians associated with PER flow together through the nose, and are therefore closely connected with respiratory function. In order to disperse pathologic
Qi and blood from these meridians and improve the function of the nose and sinuses, the local or adjacent points, including LI20 in the Large intestine meridian, ST2 in the Stomach meridian, GV23 in the Governor vessel and EX1, were selected. The remote points, including LI4 and ST36, were selected to correct the imbalance of the relevant meridians and organs. LI4 was selected for lung
Qi deficiency syndrome, and ST36 for spleen
Qi deficiency syndrome. These two syndromes represent the pathologic basis of PER in TCM theory.
As for treatment sessions, previous high quality trials [
14,
16] used a total of 16 acupuncture sessions, twice a week for eight weeks. But those trials allowed the concomitant use of conventional medication for symptomatic relief of AR, so interpretation of the efficacy of acupuncture is limited. In contrast to those studies, we added one additional session of acupuncture treatment per week (i.e., three times/week) without allowing PER symptom relievers; this addition was thought to compensate for the reduced effect of not using conventional medication. As with treatment duration, we considered four weeks to be a sufficient period of time to obtain clinically relevant improvement based on clinical experiences with PER patients. The needles will be inserted to a depth of 7–30 mm, depending on the points selected. In order to achieve
de-qi sensation for real acupuncture treatment, the needles will be manually manipulated and maintained for 20 minutes, with manual stimulations at the start and just before the withdrawal of needles. Additional interventions, such as infrared irradiation or electronic stimulation, will not be allowed during acupuncture treatment. For real acupuncture treatment, needles will be inserted into the aforementioned acupuncture points at an appropriate insertion angle and direction (Table
1). For example, at EX1, the needle will be inserted to a depth of 20 to 30 mm in an oblique direction towards the nose with respect to the skin. Each needle will be rotated until the participant and doctor feel de-qi sensations. For the sham acupuncture treatment, the needles (the same type used for the active acupuncture treatment) will be inserted at non-acupuncture point sites, 1 – 1.5 cm from the acupuncture points. However, they will be inserted to a depth of 3 – 5 mm perpendicularly to the skin, using a hollow pool and a shallow needling technique to avoid de-qi. The needle will then be rotated once in order to preserve patient blinding. The duration of this procedure will be the same as the real acupuncture treatment.
Table 1
Acupuncture points and needling procedure for real and sham acupuncture.
LI20 (Both) | Obliquely along the nasolabial sulcus towards the root of nose with respect to the skin | 20–30 | Lateral 1.5 cm and Downward 1 cm to LI20. |
ST2 (Both) | Transversely, upward to the centre of the pupil with respect to the skin | 7–10 | Lateral 1.5 cm to ST2 |
EX1 (unilateral) | Transversely, downward to the nose | 20–30 | Upward 1.5 cm, Rt. Lateral 1 cm to EX1 |
GV23 (unilateral) | Transversely, downward to the forehead with respect to the skin | 20–30 | Rt. Lateral 1 cm to GV23 |
LI4 (Both) | Perpendicular to the skin | 20–30 | Posterior to the web margin between the first and second phalanges |
ST36 (Both) | Perpendicular to the skin | 20–30 | Medial 1.5 cm to ST36 |
Needle sites in both active and sham acupuncture groups will be swabbed with 2% boric acid before insertion. On withdrawal of the needle, dry sterilised cotton balls will be firmly applied to the insertion points. Blood pressure will be measured before and after acupuncture treatment. Before acupuncture, each participant will be evaluated by an assessor blinded to participants' random allocation, and their symptoms and total non-nasal symptom scores will be recorded. The level of any discomfort in the acupuncture or sham acupuncture will also be monitored.