Non-interventional observational study broadens positive benefit-risk assessment of an immunomodulating herbal remedy in the common cold

<b>Background:</b> The unique extract of a mixture of <i>Baptisiae tinctoriae</i> radix, <i>Echinaceae pallidae/purpureae</i> radix and <i>Thujae occidentalis</i> herba alleviates the typical symptoms of the common cold and shortens the duration of the disease. <b>Purpose:</b> The risk-benefit ratio of a concentrated formulation of this herbal extract was investigated under everyday conditions. <b>Study design:</b> Pharmacy-based, non-interventional, multicenter, open, uncontrolled study registered at DRKS00011068. <b>Methods:</b> For 10 days, patients completed a diary questionnaire rating the severity of each common cold symptom on a 10-point scale. For evaluation, symptoms were combined into the scores “overall severity”, “rhinitis”, “bronchitis” and “general symptoms”. Cox models were used to evaluate the influence of covariates on the time of stable improvement. <b>Results:</b> In total 955 patients (12 to 90 years) were analyzed; 85% assessed the efficacy as good or very good. Response (improvement of the overall severity by at least 50%) was reached at median day 5 (95% CI_median 5-5). General symptoms abated faster than the other complaints. The percentage of predominantly moderate or severe symptoms to predominantly mild or absent symptoms reversed on day 3.9 (interpolation). Results of adolescents and adults did not differ (<i>p =</i> .6013; HR = 0.918). Concomitant medication did not boost the effect of the herbal remedy. Early start of treatment of the cold accelerated the recovery (<i>p =</i> .0486; HR = 0.814). Thirty-four cases of adverse events were self-recorded in the diaries; none of them were serious. The tolerability was assessed as “good or very good” by 98% of the patients. <b>Conclusion:</b> The benefit–risk assessment of this herbal extract clearly remains positive. This non-interventional study accords with and shows transferability of the results of previous placebo-controlled studies with this extract in a real-life setting.

**背景：** 由菘蓝（*Baptisiae tinctoriae*）根、淡紫锥菊/紫锥菊（*Echinaceae pallidae/purpureae*）根以及北美崖柏（*Thujae occidentalis*）全草混合制成的独特提取物，可缓解普通感冒的典型临床症状并缩短病程。
**研究目的：** 本研究旨在日常临床场景下，考察该浓缩草本提取物的风险收益比。
**研究设计：** 本研究为基于药房开展的非干预性、多中心、开放、无对照研究，注册编号为DRKS00011068。
**研究方法：** 受试者需连续10天填写日记问卷，采用10分制对每一项普通感冒症状的严重程度进行评分。分析阶段将上述症状整合为「总体严重程度」「鼻炎症状」「支气管炎症状」与「全身症状」四类综合评分指标。采用Cox模型（Cox比例风险模型）评估协变量对症状稳定改善所需时间的影响。
**研究结果：** 本研究共纳入955名年龄介于12至90岁的受试者并完成数据分析，其中85%的受试者将该药物的疗效评价为「良好」或「极佳」。症状总体严重程度较基线改善≥50%的应答者，其中位应答时间为第5天（95%置信区间[CI]：5-5）。全身症状的缓解速度快于其他类型症状。症状严重程度谱从以中度至重度为主，转变为以轻度或无症状为主的拐点出现在第3.9天（经插值法计算所得）。青少年与成人的应答结果无显著统计学差异（*p*=0.6013；风险比[HR]=0.918）。合并用药未增强该草本制剂的治疗效果。感冒早期启动治疗可显著加速康复进程（*p*=0.0486；HR=0.814）。受试者在日记中共记录到34例不良事件，均未出现严重不良事件。98%的受试者将该制剂的耐受性评价为「良好」或「极佳」。
**研究结论：** 该草本提取物的风险收益评估结果整体仍呈积极态势。本项非干预性研究在真实世界临床场景中验证了此前该提取物相关安慰剂对照研究的结论，并证实其研究结果具有临床外推性。