Azithromycin for acute bronchitis: a randomised, double-blind, controlled trial. The treatment of acute bronchitis with trimethoprim and sulfamethoxazole. Efficacy and tolerability of myrtol standardized in acute bronchitis. A multi-centre, randomised, double-blind, placebo-controlled parallel group clinical trial vs. cefuroxime and ambroxol. Effects of antibiotic treatment in the subset of common-cold patients who have bacteria in nasopharyngeal secretions. A randomized, controlled trial of doxycycline in the treatment of acute bronchitis. A placebo-controlled, double-blind trial of erythromycin in adults with acute bronchitis. Information leaflet and antibiotic prescribing strategies for acute lower respiratory tract infection: a randomized controlled trial. Effectiveness of erythromycin in the treatment of acute bronchitis. Placebo found equivalent to amoxicillin for treatment of acute bronchitis in Nairobi, Kenya: a triple blind, randomised, equivalence trial. Albuterol delivered by metered-dose inhaler to treat acute bronchitis. Doxycycline in acute bronchitis: a randomized double-blind trial. Erythromycin in the treatment of acute bronchitis in a community practice. Effects of doxycycline in patients with acute cough and purulent sputum: a double blind placebo controlled trial.
The value of azithromycin for treatment of acute bronchitis is unknown, even though this drug is commonly prescribed. We have investigated this question in a randomised, double-blind, controlled trial.
                Adults diagnosed with acute bronchitis, without evidence of underlying lung disease, were randomly assigned azithromycin (n=112) or vitamin C (n=108) for 5 days (total dose for each 1.5 g). All individuals were also given liquid dextromethorphan and albuterol inhaler with a spacer. The primary outcome was improvement in health-related quality of life at 7 days; an important difference was defined as 0.5 or greater. Analysis was by intention to treat.
                The study was stopped by the data-monitoring and safety committee when 220 patients had been recruited. On day 7, the adjusted difference in health-related quality of life was small and not significant (difference 0.03 [95% CI -0.20 to 0.26], p=0.8). 86 (89%) of 97 patients in the azithromycin group and 82 (89%) of 92 in the vitamin C group had returned to their usual activities by day 7 (difference 0.5% [-10% to 9%], p>0.9). There were no differences in the frequency of adverse effects; three patients in the vitamin C group discontinued the study medicine because of perceived adverse effects, compared with none in the azithromycin group. Most patients (81%) reported benefit from the albuterol inhaler.
                Azithromycin is no better than low-dose vitamin C for acute bronchitis. Further studies are needed to identify the best treatment for this disorder. Sixty-seven previously healthy patients with acute bronchitis were randomized and treated with either a fixed dose of trimethoprim and sulfamethoxazole or placebo for seven days. All outcomes examined showed a trend favoring the use of antibiotic, with statistically significant differences for cough, night cough, mean temperature, and use of antihistamines or decongestants. Night cough occurred on 84 percent of nights in the control group vs 56 percent in the antibiotic group (P = .003). Cough occurred on 99 percent of days for patients in the control group vs 93 percent of days for patients in the antibiotic group (P = .05). Mean temperature over the seven nights was 37.3 degrees C in the control group vs 36.9 degrees C in the antibiotic group (P = .004). The use of antihistamines and decongestants was reduced from 32 percent of days in the control group to 6 percent of days in the antibiotic group (P = .005). Patients in the antibiotic group worked 73 percent of days vs 55 percent of days for patients in the control group, which was significant when patients were stratified by the appearance of their sputum on Gram stain (P = .006). Smoking history was not found to help predict the response to antibiotic therapy. Myrtol standardized (Gelomyrtol forte) is a phytotherapeutic extract (distillate) consisting mainly of three monoterpenes: (+)alpha-pinene, d-limonene and 1,8-cineole.
                This study describes and compares the efficacy, safety and tolerability of a 2-week treatment with myrtol stand. (4 x 300 mg, day 1-14), cefuroxime (CAS 55268-75-2) (2 x 250 mg daily for day 1-6), ambroxol (CAS 18683-91-5) (3 x 30 mg for day 1-3, 2 x 30 mg for days 4-14) and matched placebo in acute bronchitis.
                676 male and female outpatients, aged > or = 18 years, with acute bronchitis of recent onset (within last 5 days), with an FEV1 > 75% of the normal EGKS-value and without evidence or suspicion of chronic pulmonary disease or any further confounding illness were included in the study.
                Patients were randomly assigned to a 2-week treatment course with either myrtol stand. (N = 170), cefuroxime (N = 171), ambroxol (N = 163) or placebo (N = 172) in a double-blind, placebo-matched, parallel-group fashion. Evaluations were at baseline (visit 1), after 1 and 2 weeks of treatment (visits 2 and 3) and at 2 weeks after conclusion of the treatments (visit 4). CRITERIA: Responder- and non-responder rates (primary), signs (abnormal auscultation), symptoms (daily diary data on nightly cough, coughing fits during the day, sputum consistence and general well-being; visit data on bronchial hyperreactivity and absence/presence of associated symptoms), FEV1, overall efficacy, absence of relapse, safety and tolerability (adverse events, laboratory screens, vital signs and physical examination). Criteria were evaluated for the intention-to-treat data-set (ITT) and the 'efficacy evaluable' sample (EAP), i.e. excluding patients with missing values (incl. discontinued non-responders and drop-outs for other reasons) at the time of assessment.
                The signs and symptoms of acute bronchitis regressed readily in all treatment groups, but regression was slower and less complete in the patients treated with placebo. In patients treated with placebo, the acute bronchitis was considered to have deteriorated to such an extent that discontinuation was indicated ('non-responder') in 36 patients (ITT: 20.9%, 95% CI: 15.1 to 27.8% and EAP: 21.3%, CI: 15.4 to 28.3%) after 1 week (visit 2) and in 19 further patients (ITT: 11.0%, CI: 6.8 to 16.7%; EAP: 14.8%, CI: 9.2 to 22.2%) after 1 further week (visit 3). In contrast, in the group of patients treated with myrtol stand. the non-responder rates at visits 2 and 3 were only 5.3% (ITT, CI: 2.4 to 9.8%; EAP: 5.4%, CI: 2.5 to 10.0%) and 1.2% (ITT, CI: 0.1 to 4.2%; EAP: 1.3%, CI: 0.2 to 4.7%); the responder rates at visit 2 were statistically significantly higher (p < 0.001) for myrtol stand. (ITT: 92.9%, CI: 88.0 to 96.3) compared to placebo (ITT: 77.3%, CI: 70.3 to 83.4), and similar to those for cefuroxime (ITT: 92.4%, CI: 87.4 to 95.9) and ambroxol (ITT: 89.6%, CI: 83.8 to 93.8%). The superiority of the active treatments vs. placebo with little difference among the treatments was confirmed for all further criteria of evaluation. There was no evidence of bronchoconstriction or relapse in any treatment group for the patients continuing treatment (i.e. for those who were not discontinued because of non-response). The treatments were safe and comparably well tolerated.
                Compared to placebo, treatment with myrtol stand. was well tolerated but evidently superior in terms of efficacy, resulting in a more rapid and more complete recovery; although well comparable with the other active treatments, myrtol stand. tended to be superior to cefuroxime and ambroxol for several ancillary criteria. Myrtol stand. is a well-evidenced alternative to antibiotics for acute bronchitis without specified infective agent, without the risk to promote the development of bacterial resistance. Upper-respiratory-tract infection is one of the main causes of overuse of antibiotics. We have found previously that bacteria such as Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae can be isolated from the nasopharyngeal secretions of a substantial proportion of adults with upper-respiratory-tract infections. We have assessed the efficacy of co-amoxiclav in patients with common colds but no clinical signs of sinusitis or other indications for antibiotics.
                Between January, 1992 and March, 1994, 314 patients who presented to our outpatient clinic with common colds were enrolled in the double-blind, placebo-controlled study. They were randomly assigned 5 days' treatment with co-amoxiclav (375 mg three times daily) or identical placebo. Clinical examinations were done at enrolment and on day 5-7 to assess outcome (cured, persistent symptoms, worse symptoms). Seven patients were excluded after randomisation, seven did not have nasopharyngeal aspiration, and 12 did not return for followup assessment.
                Of 300 patients with nasopharyngeal aspirates, 72 had negative bacterial cultures, 167 had cultures positive only for bacteria unrelated to respiratory infections, and 61 had cultures positive for H influenzae, M catarrhalis, or S pneumoniae. At 5-day follow-up of these culture-positive patients, the distribution of outcome was significantly better among co-amoxiclav-treated (n=30) than placebo-treated (n=28) patients (cured 27 vs 4%; persistent symptoms 70 vs 60%; worse symptoms 3 vs 36%; p=0.001). Patients on co-amoxiclav also scored their symptoms significantly lower than patients on placebo (p=0.008). Among culture-negative patients (n=230), the outcome distribution did not differ between the treatment groups (p=0.392).
                The majority of patients with upper-respiratory-tract infection do not benefit from antibiotics and side-effects are frequent. However, for the subgroup whose nasopharyngeal secretions contain H influenzae, M catarrhalis, or S pneumoniae, antibiotics are clinically beneficial. Acute bronchitis is a common reason for visits to primary care physicians and a commonly given reason for antibiotic treatment. However, evidence regarding the efficacy of antibiotics for this syndrome is lacking. In a randomized trial, a one-week course of a frequently used antibiotic, doxycycline, was compared with one week of placebo in 74 otherwise healthy adults with acute bronchitis. The doxycycline group fared no better than the placebo group for all 13 outcomes measured, including duration of cough, clinical improvement at one week, return visits for unresolved symptoms, days away from work, and subjective ratings of cough severity, sleep loss, diminished activity and overall well-being. Doxycycline is not beneficial in the treatment of acute bronchitis in otherwise healthy adults. Sixty-three otherwise healthy adults with acute productive cough and no clinical evidence of pneumonia were randomized to receive a ten-day course of erythromycin or placebo. Fifty-seven of these patients returned completed symptom diaries or returned for a two-week follow-up visit. Patients treated with erythromycin reported a more rapid improvement in subjective ratings of cold symptoms, general health, sputum production, and a mean symptom score. Fewer patients in the erythromycin group required cough or cold medications or were congested by day 10 (P less than .05). The treatment group was also less likely to have purulent sputum (9 percent vs 36 percent, P less than .05) and abnormal lung examinations (0 percent vs 29 percent, P less than .01) at a two-week follow-up visit. These results support the use of erythromycin in acute bronchitis. Acute lower respiratory tract infection is the most common condition treated in primary care. Many physicians still prescribe antibiotics; however, systematic reviews of the use of antibiotics are small and have diverse conclusions.
                To estimate the effectiveness of 3 prescribing strategies and an information leaflet for acute lower respiratory tract infection.
                A randomized controlled trial conducted from August 18, 1998, to July 30, 2003, of 807 patients presenting in a primary care setting with acute uncomplicated lower respiratory tract infection. Patients were assigned to 1 of 6 groups by a factorial design: leaflet or no leaflet and 1 of 3 antibiotic groups (immediate antibiotics, no offer of antibiotics, and delayed antibiotics).
                Three strategies, immediate antibiotics (n = 262), a delayed antibiotic prescription (n = 272), and no offer of antibiotics (n = 273), were prescribed. Approximately half of each group received an information leaflet (129 for immediate antibiotics, 136 for delayed antibiotic prescription, and 140 for no antibiotics).
                Symptom duration and severity.
                A total of 562 patients (70%) returned complete diaries and 78 (10%) provided information about both symptom duration and severity. Cough rated at least "a slight problem" lasted a mean of 11.7 days (25% of patients had a cough lasting > or =17 days). An information leaflet had no effect on the main outcomes. Compared with no offer of antibiotics, other strategies did not alter cough duration (delayed, 0.75 days; 95% confidence intervals [CI], -0.37 to 1.88; immediate, 0.11 days; 95% CI, -1.01 to 1.24) or other primary outcomes. Compared with the immediate antibiotic group, slightly fewer patients in the delayed and control groups used antibiotics (96%, 20%, and 16%, respectively; P<.001), fewer patients were "very satisfied" (86%, 77%, and 72%, respectively; P = .005), and fewer patients believed in the effectiveness of antibiotics (75%, 40%, and 47%, respectively; P<.001). There were lower reattendances within a month with antibiotics (mean attendances for no antibiotics, 0.19; delayed, 0.12; and immediate, 0.11; P = .04) and higher attendance with a leaflet (mean attendances for no leaflet, 0.11; and leaflet, 0.17; P = .02).
                No offer or a delayed offer of antibiotics for acute uncomplicated lower respiratory tract infection is acceptable, associated with little difference in symptom resolution, and is likely to considerably reduce antibiotic use and beliefs in the effectiveness of antibiotics. Clinical trials have not shown a consistent benefit of treating bronchitis with antibiotics. Many physicians, however, treat acute bronchitis with antibiotics because of the possibility of Mycoplasma pneumoniae or other pathogens. The objectives of this study were to determine the effectiveness of erythromycin treatment in patients with acute bronchitis and to determine whether a newly developed rapid M pneumoniae antibody test is useful in predicting which patients will respond to therapy.
                We conducted a randomized, double-blind, placebo-controlled clinical trial at three primary care centers in North Carolina. A convenience sample of 140 patients presenting with acute bronchitis were tested for M pneumoniae, 91 of whom were treated with either erythromycin 250 mg four times daily for 10 days or an identical-appearing placebo.
                Patients treated with erythromycin missed an average of only 0.81 +/- 1.1 days of work compared with 2.16 +/- 3.2 days for placebo-treated patients (P < .02). There were no significant differences in cough, use of cough medicine, general feeling of well-being, or chest congestion between the erythromycin and placebo groups. Twenty-five percent of the patients tested positive for M pneumoniae. There were no differences in response to erythromycin based on whether the patient had a positive test for M pneumoniae.
                Erythromycin is effective in significantly reducing lost time from work, but it is not effective in reducing cough or other symptoms in patients with acute bronchitis, regardless of the outcome of the M pneumoniae antibody test. Antibiotic treatment is not recommended for acute bronchitis in immunocompetent patients in industrialised countries. Whether these recommendations are relevant to the developing world and to immunocompromised patients is unknown. Design,
                Randomised, triple blind, placebo controlled equivalence trial of amoxicillin compared with placebo in 660 adults presenting to two outpatient clinics in Nairobi, Kenya, with acute bronchitis but without evidence of chronic lung disease.
                The primary study end point was clinical cure, as defined by a >or=75% reduction in a validated Acute Bronchitis Severity Score by 14 days; analysis was by intention to treat with equivalence defined as <or=8% difference between study arms.
                Clinical cure rates in the amoxicillin and placebo arms were 81.7% and 84.0%, respectively (difference 2.3%, 95% CI -8.6% to 4.0%). Of 131 HIV infected subjects (19.8%), cure rates for those randomised to amoxicillin (77.2%) and placebo (83.8%) differed by 6.6% (95% CI -21.7% to 8.6%). Among HIV uninfected subjects, the difference in cure rates was 1.6% (95% CI -8.5% to 5.3%). Potential drug side effects were similar in the two arms. No subjects required hospitalisation or died.
                Antibiotic treatment of acute bronchitis is unhelpful, even in populations with a high prevalence of HIV infection. Previous research has suggested that cough associated with acute bronchitis is more likely to subside within 7 days when treated with albuterol than with an antibiotic. This study examines the effectiveness of aerosolized albuterol for the treatment of acute bronchitis in patients treated with erythromycin or placebo.
                A double-blind, randomized placebo-controlled trial of albuterol delivered by metered-dose inhaler (MDI) was conducted in a primary care setting with healthy adult patients who presented with a productive cough of fewer than 30 days' duration. In addition to randomization for albuterol, patients were also randomized to receive erythromycin or placebo. Outcomes were assessed at follow-up after 7 days.
                Patients treated with albuterol MDI were less likely to be coughing after 7 days of treatment than were patients using a placebo inhaler (61% still coughing vs 91%, P = .02). When analysis was stratified by cigarette smoking status and the use of erythromycin, the differences observed between albuterol MDI patients and controls persisted.
                Albuterol appears to reduce the likelihood that patients with acute bronchitis will be coughing after 7 days following initiation of treatment. This effect appears to be independent of cigarette smoking or the concomitant use of antibiotics. nan To assess the efficacy of erythromycin in treating acute bronchitis, 52 adults were enrolled in a randomized trial comparing a one-week course of erythromycin with placebo. Among smokers, no difference in outcome was noted. Among nonsmokers, trends favored more rapid resolution of key symptoms in the erythromycin group, but these trends did not generally achieve statistical significance. These results suggest a trial with a larger sample size. Acute cough with purulent sputum is a common complaint presented to general practitioners.
                A randomized, double blind, placebo controlled clinical trial was undertaken to determine the efficacy of doxycycline in persons aged 18 years and over presenting to 22 general practices in the Netherlands with acute cough and purulent sputum.
                Patients were excluded if they were pregnant, had an allergy or intolerance to tetracyclines, had severe dyspnoea and fine crackles on auscultation, purulent rhinitis together with maxillary tenderness, chronic airways disease, or had taken antibiotics in the previous two weeks. Patients entered in to the study were given oral doxycycline for 10 days, 200 mg on the first day, followed by 100 mg on the next nine days, or placebo.
                Duration of frequent daytime cough after entry was a mean of 1.5 days shorter in the group of 71 patients receiving doxycycline than in the group of 69 patients on placebo (4.7 days versus 6.2 days, respectively). In patients aged 55 years and over the mean duration of frequent day-time cough after entry was 4.1 days shorter in the group taking doxycycline than in the placebo group. Patients with a very frequent cough and who also felt ill at entry regained their normal daily activities 2.1 days earlier when using doxycycline than the control group.
                Doxycycline has small beneficial effects in patients with acute cough and purulent sputum. These beneficial effects are more prominent, and probably clinically relevant, in patients aged 55 years and over and in patients who cough very frequently and who also feel ill.
There is limited evidence to support the use of antibiotics in acute bronchitis. Antibiotics may have a modest beneficial effect in some patients with acute bronchitis though data on subsets of patients who may benefit more from treatment is lacking. However, the magnitude of this benefit needs to be considered in the broader context of potential side effects, medicalisation for a self limiting condition, increased resistance to respiratory pathogens and cost of antibiotic treatment.