a Medical Director Emeritus, Department of Pneumology , University Hospital at Freiburg University , Freiburg , Germany.
b Clinical Research Department, Dr. Willmar Schwabe GmbH & Co. KG , Karlsruhe , Germany.
Curr Med Res Opin. 2018 Jul;34(7):1245-1251. doi: 10.1080/03007995.2017.1416344. Epub 2018 Jan 18.
Patient-reported outcomes (PRO) such as health-related quality-of-life (HRQoL) belong to the most important criteria for the evaluation of medical therapies in clinical trials or practice-based benefit assessments. This study, therefore, revisited results of an earlier published clinical trial investigating the effects of the herbal drug preparation from the roots of Pelargonium sidoides EPs 7630, administered as add-on therapy in patients suffering from chronic obstructive pulmonary disease (COPD), with respect to HRQoL and other PRO.
A total of 199 adults diagnosed with COPD stages II/III and receiving standard treatment according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) were randomly assigned to add-on therapy with EPs 7630 or placebo for 24 weeks. HRQoL (disease-specific St. George's Respiratory Questionnaire, SGRQ; current HRQoL state according to the EuroQuol visual analog scale, EQ VAS) and PRO (Integrative Medicine Outcomes Scale, IMOS; Integrative Medicine Patient Satisfaction Scale, IMPSS; symptom severity score of cough, sputum production and sternal pain while coughing; duration of inability to work) were assessed at each study visit or documented daily by the patient in a patient diary, respectively.
At week 24, all HRQoL and PRO measures showed a more pronounced improvement under EPs 7630 than under placebo (EQ VAS, p < .001; SGRQ total score, p < .001; symptom severity score of cough, sputum production, and sternal pain while coughing, p = .021; duration of inability to work, p = .004; two-sided t-test each; IMOS, p < .001, IMPSS, p < .001, two-sided Mantel-Haenszel test each). Moreover, the difference seen for the SGRQ exceeded the SGRQ minimal clinically important difference (MCID) threshold of 4 points.
Add-on therapy with EPs 7630 led to an improvement in HRQoL and other PRO in adult patients with COPD compared to placebo while showing a good long-term tolerability.
患者报告的结局（PRO），如健康相关生活质量（HRQoL），是临床试验或基于实践的获益评估中评估医疗疗法的最重要标准之一。因此，本研究重新审视了早期发表的一项临床试验的结果，该试验调查了Pelargonium sidoides EPs 7630 根制剂作为附加疗法在慢性阻塞性肺疾病（COPD）患者中的疗效，该试验涉及 HRQoL 和其他 PRO。
共有 199 名被诊断为 COPD II/III 期的成年人接受了根据全球慢性阻塞性肺疾病倡议（GOLD）的标准治疗，他们被随机分配接受 EPs 7630 或安慰剂附加治疗 24 周。HRQoL（特定于疾病的圣乔治呼吸问卷，SGRQ；根据 EuroQuol 视觉模拟量表评估的当前 HRQoL 状态，EQ VAS）和 PRO（综合医学结局量表，IMOS；综合医学患者满意度量表，IMPS；咳嗽时的咳嗽、咳痰和胸骨疼痛严重程度评分；无法工作的持续时间）分别在每次研究就诊时进行评估，或由患者在患者日记中每天记录。
在第 24 周时，与安慰剂相比，所有 HRQoL 和 PRO 测量指标在 EPs 7630 治疗下均有更显著的改善（EQ VAS，p<0.001；SGRQ 总分，p<0.001；咳嗽、咳痰和胸骨疼痛时的症状严重程度评分，p=0.021；无法工作的持续时间，p=0.004；双侧 t 检验，各指标；IMOS，p<0.001，IMPSS，p<0.001，双侧 Mantel-Haenszel 检验，各指标）。此外，SGRQ 评分的改善超过了 SGRQ 最小临床重要差异（MCID）阈值 4 分。
与安慰剂相比，在 COPD 成年患者中，EPs 7630 的附加治疗可改善 HRQoL 和其他 PRO，同时表现出良好的长期耐受性。
