Abstract
Yokukansan (YKS) is a traditional Japanese herbal (Kampo) medicine prescribed for anxiety. In this randomized controlled trial, we compared the subjective assessment of anxiety using questionnaires and its objective assessment using salivary alpha-amylase concentrations in YKS and control (CNT) groups of women undergoing breast surgery. The trial was registered at the University Hospital Medical Information Network Clinical Trials Registry (registration number: UMIN000028998), and the investigators were blinded to drug administration. One hundred patients who underwent breast cancer surgery were allocated to either the YKS or the CNT group. Finally, 35 and 42 patients in the YKS and CNT groups were analyzed, respectively. The YKS group received two 2.5 g doses of the medication before sleeping on the night before surgery and 2 h before inducing anesthesia, while the CNT group did not receive medication preoperatively. Patients answered two questionnaires, the Hospital Anxiety and Depression Scale and the State-Trait Anxiety Inventory, pre-and postoperatively as subjective anxiety assessments. As an objective anxiety indicator, salivary alpha-amylase levels were measured the day before, directly before, and the day after surgery (T3). In the YKS group, salivary alpha-amylase scores directly before operation were significantly lower than those on the day before surgery and at one day postoperatively (F [2,150] = 3.76, p = 0.03). Moreover, the Hospital Anxiety and Depression Scale-Anxiety and State-Trait Anxiety Inventory-Trait scores were significantly more improved postoperatively in the YKS group than in the CNT group (difference in Hospital Anxiety and Depression Scale-Anxiety: YKS, mean -2.77, 95% confidence interval [-1.48 --4.06], p <0.001, and CNT, -1.43 [-0.25--2.61], p = 0.011; and difference in State-Trait Anxiety Inventory: YKS group, -4.23 [-6.95--1.51], p = 0.0004; and CNT group, 0.12 [-2.36-2.60], p = 0.92). No side effects were associated with YKS. YKS may reduce perioperative anxiety in patients undergoing surface surgery.
Highlights
Perioperative anxiety is associated with unfavorable physiological responses, such as tachycardia and hypertension [1]; it has been shown to prolong postoperative pain [2] and increase the risk of postoperative delirium [3]
The trial was registered at the University Hospital Medical Information Network Clinical Trials Registry, and Japan Registry of Clinical Trials with some modifications: the objective parameter of perioperative anxiety was set as the primary outcome and questionnaire-assessed anxiety and perioperative pain (HADS, State-Trait Anxiety Inventory (STAI), quality of recovery (QoR)-15, and visual analog scale (VAS)) were set as secondary outcomes
There were no significant differences in age, body mass index (BMI), ASA, implementing facilities, and surgical procedure between both groups
Summary
Perioperative anxiety is associated with unfavorable physiological responses, such as tachycardia and hypertension [1]; it has been shown to prolong postoperative pain [2] and increase the risk of postoperative delirium [3]. Previous studies have shown that preventing preoperative anxiety improves surgical outcomes, including postoperative pain management [4] and recovery from anesthesia [5]. Benzodiazepines effectively reduce perioperative anxiety; they are associated with undesirable sedative effects [6]. Postoperative pain is among the most unpleasant symptoms associated with surgery. Perioperative pain management is considerably important for both patient satisfaction and CPSP prevention. Since postoperative pain is exacerbated by perioperative anxiety, improving anxiety may improve CPSP
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