PMID- 29441845
OWN - NLM
STAT- MEDLINE
DCOM- 20180312
LR  - 20180312
IS  - 0031-7144 (Print)
IS  - 0031-7144 (Linking)
VI  - 71
IP  - 9
DP  - 2016 Sep 1
TI  - A randomized, controlled, double-blind, multi-center trial to evaluate the 
      efficacy and safety of a liquid containing ivy leaves dry extract (EA 575((R))) vs. 
      placebo in the treatment of adults with acute cough.
PG  - 504-509
LID - 10.1691/ph.2016.6712 [doi]
AB  - This randomized, placebo-controlled, double-blind trial was conducted to assess 
      the efficacy and safety of ivy leaves cough liquid in the treatment of acute 
      cough. A total of 181 adult patients with acute cough were treated with either 
      ivy leaves cough liquid containing EA 575(R) or with placebo three times a day for 
      one week. The primary efficacy outcome was cough severity (CS) assessed by Visual 
      Analogue Scale (VAS) over the whole treatment period (area-under-the-curve 
      (AUC0-168 h) over 7 days (visit (V)1, V2, V3, V4, and V5). The secondary 
      endpoints were defined as the CS assessed by VAS over the whole observation 
      period (V1 - V6) and by Bronchitis Severity Score (BSS) and Verbal Category 
      Descriptive (VCD) score. The evaluation of the VAS, BSS and VCD score revealed 
      that subjects treated with ivy leaves cough liquid showed statistically 
      significant and clinically relevant reductions in CS, severity of symptoms 
      associated with cough and bronchitis compared to the placebo group. Furthermore, 
      a remarkable early onset of efficacy was observed as significant reductions of 
      cough severity were detected within 48 hours after the first drug intake. At all 
      following visits and even 7 days after the end of treatment (V6) this significant 
      treatment advantage was detected in comparison to placebo. All adverse events 
      (AEs) in this clinical trial were non-serious, mild or of moderate severity and 
      not drug-related. This clinical trial proved consistent superiority of the ivy 
      leaves cough liquid treatment versus placebo and confirmed the EA 575(R) 
      preparation to be a safe and efficacious option for the treatment of acute cough.
FAU - Schaefer, A
AU  - Schaefer A
FAU - Kehr, M S
AU  - Kehr MS
FAU - Giannetti, B M
AU  - Giannetti BM
FAU - Bulitta, M
AU  - Bulitta M
FAU - Staiger, C
AU  - Staiger C
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - Germany
TA  - Pharmazie
JT  - Die Pharmazie
JID - 9800766
RN  - 0 (EA 575 extract)
RN  - 0 (Plant Extracts)
SB  - IM
MH  - Acute Disease
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Area Under Curve
MH  - Bronchitis/drug therapy
MH  - Cough/*drug therapy
MH  - Double-Blind Method
MH  - Female
MH  - Hedera/*chemistry
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Plant Extracts/adverse effects/*therapeutic use
MH  - Plant Leaves
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2016/09/01 00:00
MHDA- 2018/03/13 06:00
CRDT- 2018/02/15 06:00
PHST- 2018/02/15 06:00 [entrez]
PHST- 2016/09/01 00:00 [pubmed]
PHST- 2018/03/13 06:00 [medline]
AID - 10.1691/ph.2016.6712 [doi]
PST - ppublish
SO  - Pharmazie. 2016 Sep 1;71(9):504-509. doi: 10.1691/ph.2016.6712.