dextromethorphan and Respiratory-Tract-Infections

The purpose of the meta-analysis was to understand the antitussive effect of treatment with dextromethorphan hydrobromide, 30 mg, vs placebo over a 3-h treatment period in patients with cough due to uncomplicated upper respiratory tract infection (URTI), and to show that the computerized system for acquisition and analysis of cough sound was consistent and reproducible across the individual studies.. The six studies used for the meta-analysis were randomized, double-blind, parallel-group, single-dose, placebo-controlled studies with a 3-h postdose cough evaluation period.. One study was conducted in Durban, South Africa, and five studies were conducted in Bombay, India. Four studies took place in clinics, and two studies were in-home studies.. Seven hundred ten adult patients with cough due to uncomplicated URTI who were otherwise healthy and who satisfied the inclusion/exclusion criteria for the meta-analysis.. For each patient, a standard baseline was calculated pretreatment, then a 3-h continuous cough recording was made after treatment was initiated. Five efficacy variables were measured in 30-min intervals: cough bouts, cough components, cough effort, cough intensity, and cough latency. The meta-analysis showed consistent results across most of the studies for each of the efficacy variables. It demonstrated significantly greater overall reductions in cough bouts, cough components, and cough effort, and an increase in cough latency for patients treated with dextromethorphan hydrobromide, 30 mg, vs those treated with placebo.. The results of a meta-analysis of the six clinical studies show that the antitussive effect of a single dose of dextromethorphan hydrobromide, 30 mg, has been established. The consistent nature of the results shows that the computerized cough acquisition and analysis system is a valid and reproducible methodology for evaluating cough associated with URTI.

Topics: Adolescent; Adult; Aged; Antitussive Agents; Cough; Dextromethorphan; Diagnosis, Computer-Assisted; Double-Blind Method; Female; Humans; India; Male; Middle Aged; Monitoring, Ambulatory; Randomized Controlled Trials as Topic; Respiratory Tract Infections; Signal Processing, Computer-Assisted; Sound Spectrography

Available pediatric treatments for acute cough are limited by lack of demonstrated efficacy. The objective of this trial is to compare the effects of a polysaccharide-resin-honey based cough syrup, and carbocysteine syrups on nocturnal and daytime cough associated with childhood upper respiratory tract infections (URIs).. Using a single-blind randomization design, the study recruited children from 4 general pediatric community clinics. Participants included 150 children aged 2 to 5 years with an URI, nocturnal and daytime cough and illness duration of ≤7 days. To be eligible, children had to be free of medication on the day before presentation. A survey was administered to parents on 4 consecutive days beginning from the day of presentation in clinic. Children received the study preparation on the first evening and then 3 times per day for 3 further days. Main outcome measures were cough frequency, cough severity, bothersome nature of cough, and quality of sleep for both child and parent.. Both preparations were well tolerated and cough improved over the study period. After one night and on all survey days, there was a significantly better result for polysaccharide-resin-honey (P<0.05) for all the main outcome measures. The trend of improvement over the 4 days was steeper for polysaccharide-resin-honey (P<0.05) with regards to all cough parameters.. Both polysaccharide-resin-honey and carbocysteine cough syrups were well tolerated in children over 2 years of age. The polysaccharide-resin-honey syrup was associated with a more rapid and greater improvement in all clinical cough symptoms measured, beginning from the first night of therapy. Both nocturnal and daytime cough improved, as did sleep quality for both children and parents.

Topics: Antitussive Agents; Carbocysteine; Child; Child, Preschool; Common Cold; Cough; Dextromethorphan; Expectorants; Female; Follow-Up Studies; Humans; Israel; Male; Respiratory Tract Infections; Risk Assessment; Single-Blind Method; Sleep; Treatment Outcome

Currently available over-the-counter cough remedies historically have been criticized for lack of scientific evidence supporting their efficacy. Although the first-generation antihistamine diphenhydramine is classified as an antitussive by the United States Food and Drug Administration, to the authors' knowledge it has never been shown to inhibit cough reflex sensitivity in subjects with pathological cough.. To evaluate the effect of diphenhydramine on cough reflex sensitivity.. Montefiore Medical Center, an academic medical center in New York City.. Twenty two subjects with acute viral upper respiratory tract infection (common cold) underwent cough reflex sensitivity measurement employing capsaicin challenge on 3 separate days, 2 h after ingesting single doses of study drug (to coincide with peak blood concentrations), administered in randomized, double-blind manner: a multicomponent syrup containing diphenhydramine (25 mg), phenylephrine (10 mg), in a natural cocoa formulation; dextromethorphan (30 mg) syrup; and, placebo syrup. The standard endpoint of cough challenge was used: concentration of capsaicin inducing ≥5 coughs (C5).. Effect on cough reflex sensitivity (C5).. A significant difference (p = 0.0024) was established among groups, with pairwise analysis revealing a significant increase in mean log C5 (0.4 ± 0.55 (SD); p < 0.01) for the diphenhydramine-containing medication versus placebo, but not for dextromethorphan versus placebo.. Our results provide the initial evidence of the ability of diphenhydramine to inhibit cough reflex sensitivity in subjects with acute pathological cough. Timing of cough reflex sensitivity measurement may not have allowed demonstration of maximal antitussive effect of dextromethorphan.

Topics: Adult; Antitussive Agents; Capsaicin; Cough; Dextromethorphan; Diphenhydramine; Double-Blind Method; Female; Humans; Male; Reflex; Respiratory Tract Infections; Young Adult

Dextromethorphan hydrobromide (DM) is a widely used antitussive. This study determined, for the first time, the basic pharmacokinetic profile of DM and its active metabolite, dextrorphan (DP) in children and adolescents.. Thirty-eight male and female subjects at risk for developing an upper respiratory tract infection (URTI), or symptomatic with cough due to URTI, were enrolled in this single-dose, open-label study: ages 2-5 years (Group A, n = 8), 6-11 years (Group B, n = 17), 12-17 years (Group C, n = 13). Subjects were genotyped for cytochrome P450 (CYP) 2D6 polymorphisms and characterized as poor (PM) or non-poor metabolizers (non-PM). Groups A and B were dosed using an age-weight dosing schedule (DM range 7.5-24.75 mg); a 30-mg dose was used for Group C.. Average exposures to total DP increased as age group increased, and average exposure to DM was highest in the adolescent group. One subject in that group was a PM. The terminal half-life (t ½) values were longer in the adolescent group due in part to the single PM subject. No relationship between body weight and pharmacokinetic parameters was noted.. This is the first evaluation of the pharmacokinetic characteristics of DM in children and adolescents. A single dose of DM in this population was safe, and well tolerated at all doses tested. The data are used to model and compare pediatric DM exposures with those of adults.

Topics: Adolescent; Age Factors; Antitussive Agents; Child; Child, Preschool; Cough; Cytochrome P-450 CYP2D6; Dextromethorphan; Dose-Response Relationship, Drug; Female; Genotype; Half-Life; Humans; Male; Respiratory Tract Infections

To evaluate whether promethazine and dextromethorphan reduce nocturnal cough and improve sleep quality in children aged 1-12 y with upper respiratory tract infection (URI).. This randomised double-blinded placebo-controlled trial was conducted in Pediatric outpatient department of Lok Nayak Hospital, Delhi. After randomization into promethazine, dextromethorphan and placebo groups, parental assessment of 120 children with URI for nocturnal cough severity (child), post-tussive vomiting (child) and sleep quality (child and parent) on the night before enrolment and after 3 d of assigned medication was measured using an internally validated indigenously prepared ordinal scale.. Entire cohort improved in all the study parameters after 3 d. However, no superior benefit was noted when individual parameters were compared in the promethazine and dextromethorphan groups with the placebo group. Adverse effects were more frequent in the dextromethorphan and promethazine groups although the difference was not statistically significant.. Nocturnal cough in URI is self-resolving and dextromethorphan and promethazine prescribed for the same are not superior to placebo.

Topics: Antitussive Agents; Child; Child, Preschool; Cough; Dextromethorphan; Double-Blind Method; Female; Histamine Antagonists; Humans; Infant; Male; Promethazine; Respiratory Tract Infections

Coughing is a prevalent symptom of upper respiratory infections (URIs) that cause disturbance in the sleep of children and their parents. There is as yet no reliable treatment to control URIs and their related cough; however, drugs such as dextromethorphan (DM) and diphenhydramine (DPH) are now mainly used in the world. The aim of this study is to compare the effect of honey, DM, and DPH on the nightly cough and sleep quality of children and their parents.. This was a clinical trial study in which 139 children aged 24-60 months suffering from coughing due to URIs were selected and assigned randomly to 4 groups. The first group received honey (HG), the second one DM (DMG), the third DPH (DPHG), but the fourth group or control group (CG) was assigned to a supportive treatment.. After approximately a 24-hour intervention, the 4 groups were reexamined and their cough frequency, cough severity, and sleep quality in children and their parents were recorded by using the questionnaire with Likert-type questions.. The mean of cough frequency score HG is 4.09 +/- 0.72 and 1.93 +/- 0.65 before and after the intervention, respectively, while these figures for the CG are 4.11 +/- 0.78 and 3.11 +/- 0.57, respectively. After the intervention, the difference of the mean score of the variables in all groups became statistically significant. The mean score of all variables in HG has stood significantly higher than those in other groups. There is also a significant relationship between the DMG and CG groups, even though there is no statistically difference between DMG and DPHG groups.. The result of the study demonstrated that receiving a 2.5-mL dose of honey before sleep has a more alleviating effect on URIs-induced cough compared with DM and DPH doses.

Topics: Antitussive Agents; Apitherapy; Child, Preschool; Cough; Dextromethorphan; Diphenhydramine; Female; Honey; Humans; Male; Parents; Respiratory Tract Infections; Sleep; Time Factors

To compare the effects of a single nocturnal dose of buckwheat honey or honey-flavored dextromethorphan (DM) with no treatment on nocturnal cough and sleep difficulty associated with childhood upper respiratory tract infections.. A survey was administered to parents on 2 consecutive days, first on the day of presentation when no medication had been given the prior evening and then the next day when honey, honey-flavored DM, or no treatment had been given prior to bedtime according to a partially double-blinded randomization scheme.. A single, outpatient, general pediatric practice.. One hundred five children aged 2 to 18 years with upper respiratory tract infections, nocturnal symptoms, and illness duration of 7 days or less.. A single dose of buckwheat honey, honey-flavored DM, or no treatment administered 30 minutes prior to bedtime.. Cough frequency, cough severity, bothersome nature of cough, and child and parent sleep quality.. Significant differences in symptom improvement were detected between treatment groups, with honey consistently scoring the best and no treatment scoring the worst. In paired comparisons, honey was significantly superior to no treatment for cough frequency and the combined score, but DM was not better than no treatment for any outcome. Comparison of honey with DM revealed no significant differences.. In a comparison of honey, DM, and no treatment, parents rated honey most favorably for symptomatic relief of their child's nocturnal cough and sleep difficulty due to upper respiratory tract infection. Honey may be a preferable treatment for the cough and sleep difficulty associated with childhood upper respiratory tract infection.. clinicaltrials.gov Identifier: NCT00127686.

Topics: Adolescent; Antitussive Agents; Child; Child Welfare; Child, Preschool; Cough; Dextromethorphan; Female; Health Surveys; Honey; Humans; Male; Parents; Respiratory Tract Infections; Sleep; Sleep Wake Disorders

This study sought to investigate the efficacy of dextromethorphan (DM), diphenhydramine (DPH), and placebo (PL) for symptoms attributed to upper respiratory infections as determined by children, and to evaluate the concordance of perception of nocturnal symptoms between children and parents. A total of 37 children age 6 to 18 years of age were randomized in a double-masked fashion to receive a single bedtime dose of DM, DPH, or PL. Children found no significant difference in the effect of DM, DPH, or PL for any study outcome, and responses by parents and children were significantly correlated.

Topics: Adolescent; Antitussive Agents; Child; Cough; Dextromethorphan; Diphenhydramine; Female; Humans; Male; Placebos; Respiratory Tract Infections; Treatment Outcome

To determine whether the commonly used over-the-counter medications dextromethorphan and diphenhydramine are superior to placebo for the treatment of nocturnal cough and sleep difficulty associated with upper respiratory infections and to determine whether parents have improved sleep quality when their children receive the medications when compared with placebo.. Parents of 100 children with upper respiratory infections were questioned to assess the frequency, severity, and bothersome nature of the nocturnal cough. Their answers were recorded on 2 consecutive days, initially on the day of presentation, when no medication had been given the previous evening, and then again on the subsequent day, when either medication or placebo was given before bedtime. Sleep quality for both the child and the parent were also assessed for both nights.. For the entire cohort, all outcomes were significantly improved on the second night of the study when either medication or placebo was given. However, neither diphenhydramine nor dextromethorphan produced a superior benefit when compared with placebo for any of the outcomes studied. Insomnia was reported more frequently in those who were given dextromethorphan, and drowsiness was reported more commonly in those who were given diphenhydramine.. Diphenhydramine and dextromethorphan are not superior to placebo in providing nocturnal symptom relief for children with cough and sleep difficulty as a result of an upper respiratory infection. Furthermore, the medications given to children do not result in improved quality of sleep for their parents when compared with placebo. Each clinician should consider these findings, the potential for adverse effects, and the individual and cumulative costs of the drugs before recommending them to families.

Topics: Adolescent; Antitussive Agents; Child; Child, Preschool; Cough; Dextromethorphan; Diphenhydramine; Double-Blind Method; Female; Humans; Male; Respiratory Tract Infections; Sleep Initiation and Maintenance Disorders; Sleep Stages

The efficacy of dextromethorphan (DM) for treating acute cough is uncertain, and its use is not supported by the American Academy of Pediatrics. Nevertheless, DM is often administered to children as an antitussive. DM dosages are based on age rather than body weight, resulting in substantial variability in the relative amount of drug administered.. The aim of this work was to determine whether a dose-response relationship existed among a group of children administered a single nocturnal dose of DM for cough due to an upper respiratory tract infection.. As part of a larger double-blind, placebo-controlled trial of over-the-counter cough medications, children received DM. The administered doses (per manufacturer recommendations) were as follows: ages 2 to 5 years, 7.5 mg; ages 6 to 11 years, 15 mg; and ages 12 to 18 years, 30 mg. This resulted in a range of 0.35 to 0.94 mg/kg per dose. Subjective parental assessments of cough and sleep were obtained using a 7-point Likert-type scale that compared symptoms after medication with symptoms during the prior night (without medication). Three dose ranges were compared as a subset analysis of the group that received DM.. Thirty-three patients (19 girls, 14 boys; median [interquartile range] age, 4.90 [2.90-6.80] years; age range, 2.10-16.50 years) received DM and completed the study. No significant differences were found for any of the outcome measures when comparing the effects of different doses of DM, but our observations suggested somewhat more symptomatic relief for patients receiving medium-dose DM (0.45 to <0.60 mg/kg per dose) or high-dose (HD) DM (0.60-0.94 mg/kg per dose) compared with low-dose DM (0.35 to <0.45 mg/kg per dose). Adverse events occurred most often in the HD group.. Although no statistically significant differences were detectable for the outcomes studied, our observations suggest the potential for improved clinical symptom control with increasing doses of DM. Our findings may further suggest that a dose of 0.5 mg/kg should be considered in future assessments of the antitussive effect of DM in pediatric studies, to balance symptomatic relief with the avoidance of adverse events.

Topics: Adolescent; Antitussive Agents; Child; Child, Preschool; Cough; Data Collection; Dextromethorphan; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Male; Respiratory Tract Infections; Severity of Illness Index; Sleep; Treatment Outcome

Dextromethorphan is one of the most widely used antitussives for the treatment of cough associated with acute upper respiratory tract infection. However, there is very little data to support the efficacy of dextromethorphan in this disease state. This aim of this study was to obtain more information about the efficacy of a single dose of 30 mg dextromethorphan in the treatment of cough associated with acute upper respiratory tract infection. The study was a double-blind, stratified, randomized and parallel group design. Both objective and subjective measurements of cough were recorded over 10-min recording periods in a quiet room before (baseline) and at 90, 135 and 180 min after treatment. Forty-three patients (30 females and 13 males), mean age 22.9 years (range 18-46 years), with acute dry or slightly productive cough and otherwise healthy were included in the study. Patients were randomized to placebo treatment (n = 22) and dextromethorphan treatment (n=21). The results showed similar trends in both treatment groups with statistically significant reductions (P < 0.05) in cough sound pressure level (CSPL), cough frequency (CF) and subjective scores for cough severity within treatment groups but little difference between the treatment groups during the study period. The only statistically significant difference between treatment groups was for the mean CSPL changes from baseline to 90 min (P=0.019). There was a significant positive correlation between CSPL and CF (r = 0.752, P= 0.000) for changes in cough measurements from baseline to 90 min after treatment and this indicates that CSPL may be a useful measure of cough severity. This study provides very little if any support for clinically significant antitussive activity of a single 30 mg dose of dextromethorphan in patients with cough associated with acute upper respiratory tract infection.

Topics: Adolescent; Adult; Antitussive Agents; Cough; Dextromethorphan; Double-Blind Method; Humans; Middle Aged; Respiratory Tract Infections

Topics: Acute Disease; Albuterol; Child; Child, Preschool; Cough; Dextromethorphan; Double-Blind Method; Female; Humans; Infant; Male; Placebos; Respiratory Tract Infections; Time Factors

Dextromethorphan (DXM) is a common ingredient in several prescriptions and over-the-counter cough preparations. Its metabolism in humans includes hepatic O- and N-demethylation to form dextrorphan and 3-methoxymorphinan, respectively, followed by conjugation. The active metabolite dextrorphan is a noncompetitive N-methyl-D-aspartate receptor antagonist that has been linked with psychosis, especially in rapid metabolizers at cytochrome P450 (CYP) 2D6.. The patient was a 66-year-old married, retired Portuguese American male, with no prior psychiatric history. He presented to the emergency department following a brief psychotic episode leading to a near-fatal suicide attempt after ingesting an excessive quantity of DXM. The patient had started by ingesting 3 tablespoons (45 mL) of cough syrup per day (total, 1575 mg/d) instead of the prescribed 3 teaspoons (15 mL). In the days preceding the admission, his frequency of use had increased substantially (up to 6 times per day). During the treatment of this episode, he was initially started on sertraline 50 mg/d, which was discontinued within 48 hours, given the lack of depressive symptoms, and risperidone was initiated at 1 mg BID. The medication was discontinued after several months, and the patient completely recovered. Possible medical and psychiatric etiologies related to this brief psychotic episode in a geriatric patient are also discussed.. Caution should be exercised in prescribing DXM to geriatric patients, as they may be more susceptible to the drug's adverse effects because of increased clearance time. It appears that dose may play a greater role in causing psychosis, rather than the rate of metabolism, as evident in our patient who, contrary to the more often described scenario, was a slow metabolizer at CYP2D6.

Topics: Aged; Antitussive Agents; Cytochrome P-450 CYP2D6; Dextromethorphan; Humans; Kinetics; Male; Respiratory Tract Infections; Suicide, Attempted

Topics: Adolescent; Antitussive Agents; Child; Child, Preschool; Confounding Factors, Epidemiologic; Cough; Dextromethorphan; Diphenhydramine; Humans; Respiratory Tract Infections; Surveys and Questionnaires; Treatment Failure

Topics: Antitussive Agents; Child; Child, Preschool; Cough; Dextromethorphan; Dose-Response Relationship, Drug; Humans; Respiratory Tract Infections

Topics: Age Factors; Antitussive Agents; Child; Child, Preschool; Dextromethorphan; Guidelines as Topic; Humans; Infant; Nasal Decongestants; Pharmacy and Therapeutics Committee; Phenylephrine; Respiratory Tract Infections; Societies, Medical; Vasoconstrictor Agents