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Echinacea/sage or chlorhexidine/lidocaine for treating acute sore throats: a randomized double-blind trial.

ABSTRACT: BACKGROUND:The aim of this trial was to assess the relative efficacy of a sage/echinacea spray and a chlorhexidine/lidocaine spray in the treatment of acute sore throats. METHODS:This was a multicenter, randomized, double-blind, double-dummy controlled trial carried out in eleven general practices in Switzerland. A total of 154 patients (133 analyzed in per protocol collective) at least 12 years old with acute sore throat present for not more than 72 hours prior to inclusion and with a throat score >/=6 participated in the study. They used either an echinacea/sage spray or a chlorhexidine/ lidocaine spray with two puffs every 2 hours, in a double-dummy blinded manner, up to 10 times daily until they were symptom-free, for a maximum of 5 days. The main outcome measures was the comparison of response rates during the first three days. A response was defined as a decrease of at least 50% of the total symptoms compared to baseline. RESULTS:The echinacea/sage treatment exhibited similar efficacy to the chlorhexidine/lidocaine treatment in reducing sore throat symptoms during the first 3 days (P(x

SUBMITTER: Schapowal A

PROVIDER: S-EPMC3351972 | biostudies-literature | 2009 Sep

REPOSITORIES: biostudies-literature

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Echinacea/sage or chlorhexidine/lidocaine for treating acute sore throats: a randomized double-blind trial.

Schapowal Andreas A Berger D D Klein P P Suter A A

European journal of medical research 20090901 9

<h4>Background</h4>The aim of this trial was to assess the relative efficacy of a sage/echinacea spray and a chlorhexidine/lidocaine spray in the treatment of acute sore throats.<h4>Methods</h4>This was a multicenter, randomized, double-blind, double-dummy controlled trial carried out in eleven general practices in Switzerland. A total of 154 patients (133 analyzed in per protocol collective) at least 12 years old with acute sore throat present for not more than 72 hours prior to inclusion and w ...[more]

PMID: 19748859

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Project description:OBJECTIVE:To assess whether treatment with penicillin for three days and the traditional treatment for seven days were equally as effective at accelerating resolution of symptoms in patients with sore throat compared with placebo. DESIGN:Randomised double blind placebo controlled trial. SETTING:43 family practices in the Netherlands. PARTICIPANTS:561 patients, aged 15-60 years, with sore throat for less than seven days and at least three of the four Centor criteria-that is, history of fever, absence of cough, swollen tender anterior cervical lymph nodes, and tonsillar exudate. 142 patients were excluded for medical reasons and 73 needed penicillin. INTERVENTIONS:Patients were randomly assigned to penicillin V for seven days, penicillin V for three days followed by placebo for four days, or placebo for seven days. MAIN OUTCOME MEASURES:Resolution of symptoms in the first week, eradication of bacteria after two weeks, and recurrences of sore throat after two, four, and six months. RESULTS:Symptoms resolved 1.9 and 1.7 days earlier in patients taking penicillin for seven days than in those taking penicillin for three days or placebo respectively. Symptoms resolved 2.5 days earlier in patients with group A streptococci and 1.3 days earlier in patients with high colony counts of non-group A streptococci. 23 (13%) of the placebo group had to be given antibiotics later in the week because of clinical deterioration; three developed a peritonsillar abscess. The eradication rate for group A streptococci was 72% in the seven day penicillin group, 41% in the three day penicillin group, and 7% in the placebo group. Sore throat recurred more often in the three day penicillin group than in the seven day penicillin or placebo groups. CONCLUSION:Penicillin treatment for seven days was superior to treatment for three days or placebo in resolving symptoms of sore throat in patients with group A streptococcal pharyngitis and, possibly, in those with non-group A streptococcal pharyngitis.

Project description:BACKGROUND:Lozenges containing lidocaine and cetylpyridinium chloride (CPC) are commonly used for the treatment of sore throat. The lidocaine acts locally to provide pain relief and the CPC has an antiseptic effect. Mebucaine CL, a well-established fixed-combination sore throat lozenge, contains 1?mg lidocaine and 2?mg CPC. Single-agent lozenges containing 8?mg lidocaine have also been demonstrated to be significantly superior to placebo in confirmatory pain intensity assessments. This study compared a new lozenge formulation, containing 8?mg lidocaine and 2?mg CPC, with the currently marketed lozenge for the treatment and relief of sore throat symptoms in subjects diagnosed with a sore throat due to an upper respiratory tract infection (URTI). METHODS:In this double-blind parallel-group study, 250 adults with a sore throat due to an URTI were randomized to receive a single lozenge containing either 8?mg lidocaine +?2?mg CPC (n?=?125) or 1?mg lidocaine +?2?mg CPC (n?=?125). The primary efficacy endpoint of the study was the change in sore throat pain intensity (STPI) between baseline (immediately pre-treatment) and the 2-h post-dose assessment, measured on a 100?mm visual analog scale. STPI was measured at baseline and regular intervals up to 240?min after the lozenge was administered (evaluated in clinic). Any difficulty in swallowing and time to onset and duration of the analgesic effect were also assessed. RESULTS:No increase in efficacy was demonstrated with the higher dose of lidocaine. The difference in the 2-h post-dose change in STPI was not statistically significant between the treatments. There was only one statistically significant difference between the treatments in all of the efficacy outcomes assessed: pain relief scores at 4?h post-dose were higher with 1?mg lidocaine +?2?mg CPC than with 8?mg lidocaine +?2?mg CPC (P?=?0.0461). The most commonly reported adverse event (AE) was a headache; the only other AE experienced by more than one subject was throat irritation. No severe adverse events were reported during the assessment period. CONCLUSIONS:The modest difference in the pattern of effectiveness between the two treatments observed in this study does not support use of the 8?mg lidocaine +?2?mg CPC lozenge. TRIAL REGISTRATION:ClinicalTrials.gov, NCT01265446 . Registered on 20 December 2010.

Project description:BackgroundEchinacea has antiviral activity against influenza viruses in vitro and has traditionally been used for treatment of colds and flu.ObjectivesThis randomized, double-blind, double-dummy, multicenter, controlled clinical trial compared a new echinacea formulation with the neuraminidase inhibitor oseltamivir, the gold standard treatment for influenza.MethodsFollowing informed consent, 473 patients with early influenza symptoms (≤48 hours) were recruited in primary care in the Czech Republic and randomized to either 5 days of oseltamivir followed by 5 days of placebo, or 10 days of an Echinacea purpurea-based formulation called Echinaforce Hotdrink (A. Vogel Bioforce AG, Roggwil, Switzerland). The proportion of recovered patients (influenza symptoms rated as absent or mild in the evening) was analyzed for noninferiority between treatment groups using a generalized Wilcoxon test with significance level α = 0.05 (2-sided) and using a CI approach in the per-protocol sample.ResultsRecovery from illness was comparable in the 2 treatment groups at 1.5% versus 4.1% after 1 day, 50.2% versus 48.8% after 5 days, and 90.1% versus 84.8% after 10 days of treatment with Echinaforce Hotdrink and oseltamivir, respectively. Noninferiority was demonstrated for each day and overall (95% CI, 0.487-0.5265 by generalized Wilcoxon test). Very similar results were obtained in the group with virologically confirmed influenza virus infections and in a retrospective analysis during the peak influenza period. The incidence of complications was lower with Echinaforce Hotdrink than with oseltamivir (2.46% vs 6.45%; P = 0.076) and fewer adverse events (particularly nausea and vomiting) were observed with Echinaforce Hotdrink.ConclusionsEchinaforce Hotdrink is as effective as oseltamivir in the early treatment of clinically diagnosed and virologically confirmed influenza virus infections with a reduced risk of complications and adverse events. It appears to be an attractive treatment option, particularly suitable for self-care. Clinical trial identifier: Eudra-CT: 2010-021571-88. (Curr Ther Res Clin Exp. 2015; 77:66-72).

Project description:ObjectiveTo determine the effect of clinical scores that predict streptococcal infection or rapid streptococcal antigen detection tests compared with delayed antibiotic prescribing.DesignOpen adaptive pragmatic parallel group randomised controlled trial.SettingPrimary care in United Kingdom.PatientsPatients aged ≥ 3 with acute sore throat.InterventionAn internet programme randomised patients to targeted antibiotic use according to: delayed antibiotics (the comparator group for analyses), clinical score, or antigen test used according to clinical score. During the trial a preliminary streptococcal score (score 1, n=1129) was replaced by a more consistent score (score 2, n=631; features: fever during previous 24 hours; purulence; attends rapidly (within three days after onset of symptoms); inflamed tonsils; no cough/coryza (acronym FeverPAIN).OutcomesSymptom severity reported by patients on a 7 point Likert scale (mean severity of sore throat/difficulty swallowing for days two to four after the consultation (primary outcome)), duration of symptoms, use of antibiotics.ResultsFor score 1 there were no significant differences between groups. For score 2, symptom severity was documented in 80% (168/207 (81%) in delayed antibiotics group; 168/211 (80%) in clinical score group; 166/213 (78%) in antigen test group). Reported severity of symptoms was lower in the clinical score group (-0.33, 95% confidence interval -0.64 to -0.02; P=0.04), equivalent to one in three rating sore throat a slight versus moderate problem, with a similar reduction for the antigen test group (-0.30, -0.61 to -0.00; P=0.05). Symptoms rated moderately bad or worse resolved significantly faster in the clinical score group (hazard ratio 1.30, 95% confidence interval 1.03 to 1.63) but not the antigen test group (1.11, 0.88 to 1.40). In the delayed antibiotics group, 75/164 (46%) used antibiotics. Use of antibiotics in the clinical score group (60/161) was 29% lower (adjusted risk ratio 0.71, 95% confidence interval 0.50 to 0.95; P=0.02) and in the antigen test group (58/164) was 27% lower (0.73, 0.52 to 0.98; P=0.03). There were no significant differences in complications or reconsultations.ConclusionTargeted use of antibiotics for acute sore throat with a clinical score improves reported symptoms and reduces antibiotic use. Antigen tests used according to a clinical score provide similar benefits but with no clear advantages over a clinical score alone.Trial registrationISRCTN32027234.

Project description:ObjectiveTo determine whether the probiotic Lactobacillus reuteri DSM 17938 reduces crying or fussing in a broad community based sample of breastfed infants and formula fed infants with colic aged less than 3 months.DesignDouble blind, placebo controlled randomised trial.SettingCommunity based sample (primary and secondary level care centres) in Melbourne, Australia.Participants167 breastfed infants or formula fed infants aged less than 3 months meeting Wessel's criteria for crying or fussing: 85 were randomised to receive probiotic and 82 to receive placebo.InterventionsOral daily L reuteri (1 × 10(8) colony forming units) versus placebo for one month.Main outcomes measuresThe primary outcome was daily duration of cry or fuss at 1 month. Secondary outcomes were duration of cry or fuss; number of cry or fuss episodes; sleep duration of infant at 7, 14, and 21 days, and 1 and 6 months; maternal mental health (Edinburgh postnatal depression subscale); family functioning (paediatric quality of life inventory), parent quality adjusted life years (assessment of quality of life) at 1 and 6 months; infant functioning (paediatric quality of life inventory) at 6 months; infant faecal microbiota (microbial diversity, colonisation with Escherichia coli), and calprotectin levels at 1 month. In intention to treat analyses the two groups were compared using regression models adjusted for potential confounders.ResultsOf 167 infants randomised from August 2011 to August 2012, 127 (76%) were retained to primary outcome; of these, a subset was analysed for faecal microbial diversity, E coli colonisation, and calprotectin levels. Adherence was high. Mean daily cry or fuss time fell steadily in both groups. At 1 month, the probiotic group cried or fussed 49 minutes more than the placebo group (95% confidence interval 8 to 90 minutes, P=0.02); this mainly reflected more fussing, especially for formula fed infants. The groups were similar on all secondary outcomes. No study related adverse events occurred.ConclusionsL reuteri DSM 17938 did not benefit a community sample of breastfed infants and formula fed infants with colic. These findings differ from previous smaller trials of selected populations and do not support a general recommendation for the use of probiotics to treat colic in infants.Trial registrationCurrent Controlled Trials ISRCTN95287767.

Dataset Information

Echinacea/sage or chlorhexidine/lidocaine for treating acute sore throats: a randomized double-blind trial.

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Echinacea/sage or chlorhexidine/lidocaine for treating acute sore throats: a randomized double-blind trial.

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