Efficacy and Safety of a Fixed Combination Phytomedicine in the Treatment of the Common Cold (Acute Viral Respiratory Tract Infection): Results of a Randomised, Double Blind, Placebo Controlled, Multicentre Study

Zepelin, Hans-Heinrich Henneicke-von; Hentschel, C; Schnitker, J; Kohnen, Ralf; Köhler, G.; Wüstenberg, P W

doi:10.1185/03007999909114094

Cited by 60 publications

(37 citation statements)

References 14 publications

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“…Echinacea was selected as the active treatment because its popularity and name recognition provided reasonable potential of expectancyrelated placebo effects. At the time the current study was designed, several published trials of echinacea had reported benefi t, [37][38][39][40] whereas one, our own, 41 had not. The study design reported here provided the advantage of being able to test for specifi c effects of echinacea in addition to the main focus on effects related to placebo and expectancy.…”

Section: Methodsmentioning

confidence: 99%

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Placebo Effects and the Common Cold: A Randomized Controlled Trial

Barrett

Brown

Rakel

et al. 2011

The Annals of Family Medicine

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PURPOSE We wanted to determine whether the severity and duration of illness caused by the common cold are infl uenced by randomized assignment to openlabel pills, compared with conventional double-blind allocation to active and placebo pills, compared with no pills at all. METHODSWe undertook a randomized controlled trial among a population with new-onset common cold. Study participants were allocated to 4 parallel groups: (1) those receiving no pills, (2) those blinded to placebo, (3) those blinded to echinacea, and (4) those given open-label echinacea. Primary outcomes were illness duration and area-under-the-curve global severity. Secondary outcomes included neutrophil count and interleukin 8 levels from nasal wash at intake and 2 days later. RESULTSOf 719 randomized study participants, 2 were lost and 4 exited early. Participants were 64% female, 88% white, and aged 12 to 80 years. Mean illness duration for each group was 7.03 days for those in the no-pill group, 6.87 days for those blinded to placebo, 6.34 days for those blinded to echinacea, and 6.76 days for those in the open-label echinacea group. Mean global severity scores for the 4 groups were no pills, 286; blinded to placebo, 264; blinded to echinacea, 236; and open-label echinacea, 258. Between-group differences were not statistically signifi cant. Comparing the no-pill with blinded to placebo groups, differences (95% confi dence interval [CI]) were -0.16 days (95% CI, -0.90 to 0.58 days) for illness duration and -22 severity points (95% CI, -70 to 26 points) for global severity. Comparing the group blinded to echinacea with the open-label echinacea group, differences were 0.42 days (95% CI, -0.28 to 1.12 days) and 22 severity points (95% CI, -19 to 63 points). Median change in interleukin 8 concentration and neutrophil cell count, respectively by group, were 30 pg/mL and 1 cell for the no-pill group, 39 pg/mL and 1 cell for the group binded to placebo, 58 pg/mL and 2 cells for the group blinded to echinacea, and 70 pg/mL and 1 cell for the group with open-label echinacea, also not statistically signifi cant. Among the 120 participants who at intake rated echinacea's effectiveness as greater than 50 on a 100-point scale for which 100 is extremely effective, illness duration was 2.58 days shorter (95% CI, -4.47 to -0.68 days) in those blinded to placebo rather than no pill, and mean global severity score was 26% lower but not signifi cantly different 95% CI,. In this subgroup, neither duration nor severity differed signifi cantly between the group blinded to echinacea and the open-label echinacea group.CONCLUSIONS Participants randomized to the no-pill group tended to have longer and more severe illnesses than those who received pills. For the subgroup who believed in echinacea and received pills, illnesses were substantively shorter and less severe, regardless of whether the pills contained echinacea. These fi ndings support the general idea that beliefs and feelings about treatments may be important and perhaps should be taken into consid...

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Section: Methodsmentioning

confidence: 99%

“…In 2002, when we designed this trial, nearly all published echinacea trials had reported benefi t, [37][38][39][40] and societal expectations were high. Then came 4 highly publicized negative echinacea trials, our own in Medicine (2005).…”

Section: Pl Ac Eb O Ef Fec T S a Nd T He Co M M On Col Dmentioning

confidence: 99%

Placebo Effects and the Common Cold: A Randomized Controlled Trial

Barrett

Brown

Rakel

et al. 2011

The Annals of Family Medicine

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“…However, Schoneberger,33 in an 8-week trial, noted a shorter duration of illness and a trend toward fewer study participants with infection, indicating a possible preven- tive effect. In other placebo-controlled trials, Schmidt and colleagues 34 found a 15% lower frequency of infection in subjects given echinacea (P = .08), Forth and Beuscher 35 reported a relative risk reduction of 38% in nasal symptoms (P<.005), and Henneicke-von Zepelin et al 36 reported a superiority of echinacea preparation over placebo in the treatment of the common cold. On the other hand, Turner et al 37 found no significant difference in the occurrence of infection or severity of illness in a group of 92 volunteers challenged with rhinovirus type 23 and treated with echinacea for 5 days compared with control subjects.…”

Section: Commentmentioning

confidence: 99%

Effectiveness of an Herbal Preparation Containing Echinacea, Propolis, and Vitamin C in Preventing Respiratory Tract Infections in Children

Cohen¹,

Varsano²,

Kahan³

et al. 2004

Arch Pediatr Adolesc Med

119

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Objective: To evaluate the effectiveness and safety of a preparation containing echinacea, propolis, and vitamin C in the prevention of respiratory tract infections in children during a 12-week winter period.Design: Randomized, double-blind, placebo-controlled study.Subjects: Four hundred thirty children, aged 1 to 5 years, were randomized to an herbal extract preparation (n=215) or a placebo elixir (n = 215).Intervention: Administration of an herbal preparation (Chizukit) containing 50 mg/mL of echinacea, 50 mg/mL of propolis, and 10 mg/mL of vitamin C, or placebo (5.0 mL and 7.5 mL twice daily for ages 1 to 3 years and 4 to 5 years, respectively) for 12 weeks.Results: Significant mean ± SD reductions of illnesses were seen in the Chizukit group in the number of illness episodes, 138 vs 308 (55% reduction); number of episodes per child, 0.9±1.1 vs 1.8±1.3 (50% reduction, PϽ.001); and number of days with fever per child, 2.1 ± 2.9 vs 5.4 ± 4.4) (62% reduction, PϽ.001). The total number of illness days and duration of individual episodes were also significantly lower in the Chizukit group. Adverse drug reactions were rare, mild, and transient. Conclusion:A preventive effect of a product containing echinacea, propolis, and vitamin C on the incidence of respiratory tract infections was observed.

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“…data]. The most recent research focused on the efficacy of Esberitox N in the therapy of acute viral respiratory tract infection [22, 28]. Some papers on clinical studies are discussing the efficacy of the remedy as adjuvant drug in antibiotic therapy of bacterial infections [29, 30].…”

Section: Introductionmentioning

confidence: 99%

“…These considerations led to the idea of combining antibiotic treatment with an allopathic phyto-immunomodulator (Esberitox ® N), which is registered in Germany for several indications such as the supportive therapy of severe bacterial infections treated with antibiotics or treatment of the common cold and plays an important role in the treatment of patients in the general practice [20, 21, 22]. Esberitox N contains an extract of the herbal drugs, Echinacea, Baptisia and Thuja (cone flower, wild indigo and white cedar).…”

Section: Introductionmentioning

confidence: 99%

Esberitox<sup>®</sup> N as Supportive Therapy when Providing Standard Antibiotic Treatment in Subjects with a Severe Bacterial Infection (Acute Exacerbation of Chronic Bronchitis)

Hauke¹,

Köhler²,

Zepelin³

et al. 2002

Chemotherapy

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53 patients with planned antibiotic therapy for the treatment of acute exacerbation of chronic bronchitis as an example of a severe bacterial infection requiring antibiotics were included in a prospective, multicentre, double-blind, placebo-controlled study. The chronic bronchitis was staged by forced expiratory volume of the 1st second (FEV₁) measured in the infection-free interval prior to the current episode and had to be between 35 and 75% for the predicted value. Patients were randomly assigned to receive newer macrolide antibiotics plus either Esberitox^® N or placebo. Antibiotic therapy was administered according to generally accepted guidelines and Esberitox N or placebo was given for 28 days. The baseline-adjusted means for FEV₁ (%) on day 10 were 68.7 points for the Esberitox N group and 59.2 points for the placebo group (p = 0.0303). For FEV₁ the difference between the two treatment groups was 267 ml (p = 0.0499). The time to half maximal improvement was 5.7 days in the Esberitox N group compared to 12.8 days in the placebo group. The treatment was well tolerated; no serious adverse events were documented. In conclusion, comedication of antibiotics with Esberitox N in subjects with acute exacerbation of chronic bronchitis seems to be of benefit for the patient. Apparently, therapy with Esberitox N leads to a faster recovery from this severe bacterial infection, possibly via preventing an impairment of the host’s immune system which might otherwise occur as a consequence of aggressive antimicrobial therapeutics.

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Efficacy and Safety of a Fixed Combination Phytomedicine in the Treatment of the Common Cold (Acute Viral Respiratory Tract Infection): Results of a Randomised, Double Blind, Placebo Controlled, Multicentre Study

Cited by 60 publications

References 14 publications

Placebo Effects and the Common Cold: A Randomized Controlled Trial

Placebo Effects and the Common Cold: A Randomized Controlled Trial

Effectiveness of an Herbal Preparation Containing Echinacea, Propolis, and Vitamin C in Preventing Respiratory Tract Infections in Children

Esberitox<sup>®</sup> N as Supportive Therapy when Providing Standard Antibiotic Treatment in Subjects with a Severe Bacterial Infection (Acute Exacerbation of Chronic Bronchitis)

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