Among nonantibiotic cough remedies, herbal preparations containing extracts from leaves of ivy Hedera helix enjoy great popularity. A systematic review to assess the effectiveness and tolerability of ivy for acute upper respiratory tract infections URTIs. We searched for randomized controlled trials RCTs , nonrandomized controlled clinical trials and observational studies evaluating the efficacy of ivy preparations for acute URTIs.
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Studies were heterogeneous in design and conduct; 2 were RCTs. Three studies evaluated a combination of ivy and thyme, 7 studies investigated monopreparations of ivy. All other studies lack a placebo control and show serious methodological flaws. They all conclude that ivy extracts are effective for reducing symptoms of URTI.
Although all studies report that ivy extracts are effective to reduce symptoms of URTI, there is no convincing evidence due to serious methodological flaws and lack of placebo controls. The combination of ivy and thyme might be more effective but needs confirmation. Cough is a highly prevalent condition and a common reason for consultations in general practice [ 1 — 4 ].
Most frequently, cough symptoms are caused by acute viral upper respiratory tract infections URTIs and the course is mostly benign and self-limiting, although bacterial superinfection may occur in acute bronchitis [ 5 , 6 ]. For chronic cough, important causes are chronic obstructive pulmonary disease COPD and asthma which are characterized by airway obstruction and hypersecretion of mucus, additionally causing symptoms like wheezing or dyspnoea.
Inappropriate use of antibiotics for viral respiratory tract infections is a significant problem causing both pathogen resistance and substantial health care expenditure without affecting the resolution of cough [ 7 ]. Therefore nonantibiotic alternative treatment options are needed. Commonly used over-the-counter drugs for acute cough in both children and adults are mucolytic agents and antitussives, which are also widely prescribed in primary care settings [ 8 ].
In the UK, cough liquids accounted for sales worth million pounds in [ 9 ]. Among these nonantibiotic cough remedies, herbal preparations containing extracts from the leaves of ivy Hedera helix L. Ivy leaf contains saponins which are considered to have mucolytic, spasmolytic, bronchodilatory and antibacterial effects [ 13 , 14 ]. Despite widespread use of ivy leaf extracts, the effectiveness for the treatment of acute cough is not well established.
Methodically strong clinical studies seem scarce despite the epidemiological and economic importance. To our knowledge, there is no comprehensive systematic review of the available clinical evidence. A Cochrane Review assessing over-the-counter cough medications does not cover herbal drugs [ 8 ]. Other reviews focus on effectiveness of ivy leaf extracts in asthma or COPD [ 12 , 15 — 17 ]. Therefore, we performed a systematic review of the effectiveness and tolerability of ivy preparations for the treatment of acute URTIs in children and adults.
We included studies published from the respective inception of the databases until December There was no language restriction. The complete search algorithm with the keywords and MeSH-terms used is available from the authors upon request. Additionally, we hand searched the bibliographies of the publications retrieved. Several manufacturer websites were also scanned manually for references. We did not exclude specific populations or age groups.
Studies investigating patients with a variety of other acute e.
However, we did not disregard studies where URTI patients represented the majority of investigated subjects or treatment results were reported separately. Ivy leaf extract could be the only ingredient in the respective drug preparation or could be combined with other herbal components.
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We restricted the search on studies evaluating oral or rectal administration forms. Outcome measures could be hard clinical endpoints e. The titles and abstracts of the citations identified were screened by two independent reviewers FH and JFC separately using a predesigned form. Titles and abstracts that clearly did not meet the inclusion criteria regarding indication respiratory symptoms or intervention drug containing ivy leaf extract were excluded. Duplicate titles were also eliminated. For publications fulfilling the inclusion criteria or for which inclusion or exclusion could not be ascertained, we reviewed the full text.
Disagreements were resolved by consensus. A list of references of excluded studies is available upon request from the authors. Figure 1 shows a detailed outline of the study selection process. For quality assessment of RCT, the Jadad scale score 0—5 was used [ 18 ]. The Jadad scale is not designed for assessment of nonrandomized or noncontrolled studies as it covers mainly the study characteristics of blinding and attrition [ 18 , 19 ]. Data was then extracted using a predesigned spreadsheet.
These steps of critical quality appraisal and data extraction were performed independently by the two reviewers. For controlled studies, the following comparisons were made: 1 ivy leaf extract versus placebo, 2 ivy leaf extract versus conventional therapy, 3 comparison of different formulations of Ivy leaf extract. For OSs findings before and after treatment are reported. Due to highly heterogeneous outcomes used by the included studies, we did not attempt to calculate pooled results.
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Our search identified potentially relevant citations. Of these, 27 publications were retrieved for evaluation of the full text. We retained 10 studies for inclusion into the review.
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The studies report on a total of subjects in treatment and control groups. Three of these studies included only children, 2 studies only adults and 5 studies included both. Of the 3 controlled studies, only one was placebo-controlled [ 22 ], one compared ivy leaf to a conventional expectorant acetylcysteine [ 23 ]. The third study compared two different syrup formulations containing ivy leaf extract [ 24 ]. Most studies investigated mono-preparations of ivy leaf extract, but 3 studies tested a mixture of ivy leaf and thyme extract [ 22 , 25 , 26 ].
One of these used a randomized controlled design [ 22 ]. The studies included patients with cough due to URTIs including acute bronchitis. Some studies included few patients with chronic bronchitis [ 26 , 27 ], or the authors did not differentiate distinctly between acute disease and acute exacerbations of chronic disease [ 27 , 28 ].
One study included COPD and pertussis patients, but reported the results separately [ 29 ]. The outcomes assessed by the studies were heterogeneous.
Studies reported assessment of URTI symptoms by the treating physician or results of physical examination. Symptoms assessed varied e. Symptom severity was measured by a variety of instruments. Two studies [ 22 , 26 ] used the BSS bronchitis severity score scale. Several studies mainly reported percentages of improvement or cure of symptoms after a certain treatment period. Two studies additionally reported a global self-assessment by patients [ 25 , 30 ]. One study measured and reported spirometric parameters [ 23 ].
An overview of the characteristics of the studies is given in Table 1. If information is missing e.