A Multicenter Randomized Controlled Pilot Trial Testing the Efficacy and Safety of Pterygopalatine Fossa Puncture Using One Acupuncture Needle for Moderate‐to‐Severe Persistent Allergic Rhinitis

Abstract

Objective. To compare the efficacy and safety of pterygopalatine fossa puncture using one acupuncture needle inserted through the temporal fossa (intervention) and Chinese verum acupuncture (VA) in patients with moderate-to-severe persistent allergic rhinitis. Methods. The patients were randomized to an intervention group receiving pterygopalatine fossa puncture with one acupuncture needle for 4 weeks (once or twice weekly, 4–8 sessions in total, with a second course performed if required) or to a control group receiving individualized VA for 4 weeks (twice weekly, eight sessions in total). Patients were followed up 4 weeks later. Results. Ninety-six participants were assigned to intervention (n = 48) or VA (n = 48) groups. After treatment, differences in the total nasal symptom score (2004 Chinese version), total nonnasal symptom score, Rhinoconjunctivitis Quality of Life Questionnaire score, and symptomatic days were not significant between the groups (P>0.05 in all cases). Compared with the VA, the time to onset of effect in the intervention group was shorter and the duration of effectiveness was longer. The mean clinical waiting time was significantly shorter in the intervention group than in the control group (6.640 ± 3.035 min and 31.19 ± 10.216 min, respectively). The total number of sessions in the VA group was 384; 7 episodes of subcutaneous bleeding occurred but did not require treatment. The total number of sessions in the intervention group was 185. Two cases of subcutaneous bleeding (one of local hematoma during the intervention and the other one of bruising in the palpebra inferior on the day after intervention) resolved upon withdrawal from the study. Conclusions. Pterygopalatine fossa puncture using one acupuncture needle resulted in a shorter time to onset of effect, a longer duration of effectiveness, and less clinical waiting time when compared with VA. Though the significant differences for TNSS and TNNSS were shown within intervention and VA groups, there were no differences between the two groups. Although the rate of subcutaneous bleeding was low, these adverse events may influence patient compliance. This trial is registered with ISRCTN21980724.

Sphenopalatine ganglion stimulation: a comprehensive evaluation across diseases in randomized controlled trials

“…We assessed the quality assessment by the Cochrane Handbook for Systematic Reviews of Interventions. There were 10 high quality ( 34 , 40 , 42 – 47 , 53 , 58 ), 23 moderate quality, and three low quality ( 33 , 38 , 49 ). The ROB map is shown in Figure 2 .…”

“…ER was used as an outcome in 13 articles ( 23 , 25 , 26 , 28 , 29 , 31 , 32 , 34 , 36 – 38 , 40 , 41 ). IgE levels were assessed as an outcome in 4 articles ( 25 , 31 , 32 , 42 ).…”

“…RQLQ was utilized as an outcome measure in 13 articles (23, 24, 26, 28, 30, 33-36, 38, 41-43). TNSS was employed as an outcome measure in seven articles (27,30,33,36,(41)(42)(43). SSS was utilized as an outcome measure in eight articles (23,24,28,29,33,35,37,39).…”

“…ER was used as an outcome in 13 articles (23, 25, 26, 28, 29, 31, 32, 34, 36-38, 40, 41). IgE levels were assessed as an outcome in 4 articles (25,31,32,42) In terms of decreasing SSS scores, none of comparisons were statistically significant. Detailed information can be found in Table 2C.…”

Acupuncture and its effect on cytokine and chemokine profiles in seasonal allergic rhinitis: a preliminary three-armed, randomized, controlled trial

“…Despite a variety of high-quality trials confirming efficacy of acupuncture in AR [8][9][10][11][12], acupuncture is often Donata Gellrich, Florian Pfab, Benno Brinkhaus, and Moritz Gröger contributed equally. criticised as "unproven" [13], as strong evidence of the underlying mechanism is still missing.…”