PMID- 29231073
OWN - NLM
STAT- MEDLINE
DCOM- 20190923
LR  - 20220409
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 34
IP  - 7
DP  - 2018 Jul
TI  - Pelargonium sidoides preparation EPs 7630 in COPD: health-related quality-of-life 
      and other patient-reported outcomes in adults receiving add-on therapy.
PG  - 1245-1251
LID - 10.1080/03007995.2017.1416344 [doi]
AB  - OBJECTIVE: 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. 
      METHODS: 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. RESULTS: 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. 
      CONCLUSIONS: 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.
FAU - Matthys, Heinrich
AU  - Matthys H
AD  - a Medical Director Emeritus, Department of Pneumology , University Hospital at 
      Freiburg University , Freiburg , Germany.
FAU - Funk, Petra
AU  - Funk P
AD  - b Clinical Research Department, Dr. Willmar Schwabe GmbH & Co. KG , Karlsruhe , 
      Germany.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20180118
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (EPs 7630)
RN  - 0 (Plant Extracts)
RN  - 0 (Respiratory System Agents)
SB  - IM
MH  - Adult
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Patient Reported Outcome Measures
MH  - Patient Satisfaction
MH  - *Pelargonium
MH  - Phytotherapy/methods
MH  - *Plant Extracts/administration & dosage/adverse effects
MH  - *Pulmonary Disease, Chronic Obstructive/drug therapy/psychology
MH  - *Quality of Life
MH  - Respiratory System Agents/administration & dosage/adverse effects
MH  - Treatment Outcome
OTO - NOTNLM
OT  - COPD
OT  - Clinical trial
OT  - EPs 7630
OT  - health-related quality-of-life
EDAT- 2017/12/13 06:00
MHDA- 2019/09/24 06:00
CRDT- 2017/12/13 06:00
PHST- 2017/12/13 06:00 [pubmed]
PHST- 2019/09/24 06:00 [medline]
PHST- 2017/12/13 06:00 [entrez]
AID - 10.1080/03007995.2017.1416344 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2018 Jul;34(7):1245-1251. doi: 10.1080/03007995.2017.1416344. 
      Epub 2018 Jan 18.