Department of General Internal Medicine, Akashi Medical Center, Hyogo, Japan.
Department of General Medicine, Tone Chuo Hospital, Numata, Japan.
J Integr Complement Med. 2022 Sep;28(9):768-774. doi: 10.1089/jicm.2021.0433. Epub 2022 May 31.
(Kt), a herbal medicine composed of glycyrrhiza root (Chinese licorice) and Platycodon root extracts (Chinese bellflower), is commonly used in Japan for relief of throat symptoms related to acute upper respiratory tract infection (URTI). Its effectiveness on URTI-associated sore throat pain over 30 min is examined here in comparison with a placebo. Randomized double-blinded multicenter trial. Two local Japanese medical centers with primary care. Patients aged 20-65 years with URTI-related sore throat. Patients were randomized to receive either 2500 mg of Kt, or 2500 mg of placebo (lactose). Randomization was stratified by age (< 45 vs. ≥ 45 years) and baseline sore throat score according to visual analogue scale (VAS) (< 50 vs. ≥ 50). Primary outcome was change to sore throat score according to VAS 30 min after administration of Kt. Perceived impact of the sore throat on daily life at 30 mins after administration was another outcome. Outcomes are analyzed in the intention-to-treat population. Among 70 participants, (Kt group: 36; placebo group: 34), each group contained 34 patients for analysis ( = 68, total). Difference between the groups in the mean change of sore throat score according to VAS at 30 min was without statistical significance (Kt 15.3, placebo 17.2; = 0.66). Patients reporting that their sore throat had a moderate or greater impact on daily life were also similar in proportion between the groups (Kt 61.8% vs. placebo 55.9%; = 0.80). Side effects were not reported. Kt did not relieve acute URTI-associated sore throats significantly more than a placebo. (UMIN trial ID: UMIN000035591).
甘甘乐（Kt）是一种草药，由甘草根和桔梗根提取物组成，在日本常用于缓解急性上呼吸道感染（URTI）相关的喉咙症状。在此，我们将其用于治疗 URTI 相关的咽痛超过 30 分钟的疗效与安慰剂进行了比较。 随机双盲多中心试验。 两家日本地方医疗机构，设有初级保健科。 年龄在 20-65 岁之间、患有 URTI 相关咽痛的患者。 患者随机分为 Kt 组（2500 mg）或安慰剂（乳糖）组（2500 mg）。根据视觉模拟量表（VAS）<50 与≥50 分层，按年龄（<45 岁与≥45 岁）和基线咽痛评分进行分层。 主要结局为 Kt 给药后 30 分钟时 VAS 咽痛评分的变化。给药后 30 分钟时的咽痛对日常生活的影响也是另一个结局。采用意向治疗人群进行分析。 在 70 名参与者中（Kt 组：36 例；安慰剂组：34 例），每组均有 34 例患者进行分析（ = 68，总计）。Kt 组和安慰剂组 VAS 评分在 30 分钟时的咽痛评分平均变化差异无统计学意义（Kt 组 15.3，安慰剂组 17.2； = 0.66）。报告咽痛对日常生活有中度或更大影响的患者在两组中的比例也相似（Kt 组 61.8%比安慰剂组 55.9%； = 0.80）。未报告不良反应。 Kt 并未显著优于安慰剂缓解急性 URTI 相关咽痛。（UMIN 试验 ID：UMIN000035591）。
