A randomised controlled trial examining the effect of acupuncture at the EX-HN3 (Yintang) point on pre-operative anxiety levels in neurosurgical patients

Abstract

Pre-operative anxiety is an unpleasant state of psychological distress that occurs in up to 87% of patients awaiting neurosurgical procedures. Sedative medication is undesirable in this population due to the need for early postoperative neurological assessment. Acupuncture has previously been shown to reduce pre-operative anxiety, but studies involving neurosurgical patients are lacking. This single-centre, prospective, randomised controlled trial was designed to determine the effect of acupuncture at the EX-HN3 (Yintang point) on pre-operative anxiety levels in neurosurgical patients. The study was prospectively registered before participant recruitment. After measuring baseline anxiety levels, 128 patients were randomly allocated in a 1:1 ratio by a web-based computer program to receive either acupuncture at the EX-HN3 (Yintang) point (acupuncture group) or no intervention (control group). Participants were not blinded, but all analyses were performed by a member of the research team who was unaware of the group allocation. The primary outcome measure was anxiety level after 30 min, as measured by the six-item short form of the State-Trait Anxiety Inventory (possible score range 20-80). Sixty-two patients in each group were subsequently analysed. Median (IQR [range]) anxiety State-Trait Anxiety Inventory score reduced significantly in the acupuncture group (46.7 (36.7-53.3 [23.3-70.0]) to 40.0 (30.0-46.7) [20.0-53.3]), p < 0.001), with no change seen in the control group (41.7 (33.3-53.3 [20.0-76.7]) to 43.3 (36.7-50.0 [20.0-76.7]), p = 0.829). There were no adverse events in either group. Acupuncture at the EX-HN3 point reduces pre-operative anxiety levels in patients awaiting neurosurgery.

Psychological factors as predictors of early postoperative pain after open nephrectomy

“…As, at present, there is no consensus as to which of the existing tools is the most sensitive and specific in assessing preoperative anxiety, we used APAIS alongside HAM-A. 29 Moreover, other than HAM-A, APAIS was specifically designed for use in the perioperative setting. It has also the advantage of being quicker to complete compared with other tests.…”

Acupuncture or Acupressure on Yintang (EX-HN 3) for Anxiety: A Preliminary Review

“…One review article and 2 studies that used 2 or more acupoints to perform acupuncture or acupressure were excluded. Finally, 5 RCTs [12][13][14][15][16] were included in the current review (Table 1 and Fig. 2).…”

“…Wiles et al (2017), 12 in a RCT of preoperative participants, performed acupuncture using an acupuncture sticker on EX-HN 3 in an experimental group (EG; n = 62) and did not perform any intervention in a control group (CG; n = 62). As a result, anxiety scores measured by the 6-item short-form of the STAI (STAI-S6) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS) at 30 minutes postintervention were significantly decreased in the EG (P < 0.001 for STAI-S6; P < 0.001 for APAIS), but not in the CG (P = 0.829 for STAI-S6; P = 0.872 for APAIS).…”

Credible control groups and blinding

“…An alternative to treating patients with sham acupuncture is to have a ‘no‐intervention’ control group. That is, patients will be assigned to no treatment, or simply observed, as in a recent study looking at the anxiolytic effects of acupuncture pre‐surgery . Investigators in this study chose to incorporate a no‐intervention control into the study design rather than utilise sham acupuncture as sham techniques may not be as inert as has been previously believed.…”

“…In this scenario, the only person who is not blinded would be the acupuncturist. If patient numbers allow, allocating patients into one of three groups (true acupuncture, sham acupuncture using non‐acupoints, and a no‐intervention observation‐only group) would enable investigators to tease out the effects of true, as well as sham acupuncture . Investigators collecting information from patients, and conducting the statistical analyses should remain blinded to group assignment, as is the case in any placebo‐controlled, double‐blind trial.…”