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.

UNLABELLED: Myrtol standardized (Gelomyrtol forte) is a phytotherapeutic extract (distillate) consisting mainly of three monoterpenes: (+)alpha-pinene, d-limonene and 1,8-cineole. OBJECTIVE: 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. PATIENTS: 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. INTERVENTION: 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. RESULTS: 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. CONCLUSION: 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.

"Angiodysgenetic necrotizing encephalopathy" and its different manifestations. Survey of age-related forms and clinico-pathological appearances.

Various observations of diffuse meningo-cerebral angiomatoses, which cannot be satisfactorily classified with the common phakomatoses, have been reported. They may occur at any age, with familial accumulation or sporadically. Divry and van Bogaert were the first to draw attention to such conditions in adults, where meningo-cerebral angiomatoses seemed to be combined with sudanophilic leukodystrophy. However, subsequently the latter was considered to be due to hypoxic damage to the white matter. In other observations, the severe damage to the grey matter was more evidently of hypoxic origin. Observations on two newborn individuals, sporadic examples of diffuse meningo-cerebral angiomatosis and with severe necrotic changes in the grey and white matter, are reported and discussed. Published reports on the various age-related forms are summarized and a general designation is suggested, which includes the various observations under a general heading. A parallel will be drawn between the meningo-cerebral angiomatosis and Foix-Alajouanin's disease.

Partial in vivo response to corticosteroid treatment in common variable immune deficiency.

The case of a 13-year-old girl with CVI is presented who required steroid treatment for myositis. After three weeks of treatment, the serum IgM level increased about ten-fold. Specific antibodies to vaccination antigens, which despite adequate vaccination were absent prior to any kind of treatment, could be synthesized following steroid treatment. The effects observed were only transient. Steroid influences on immunoregulatory T cell may have contributed to the improvement of humoral immunity in this patient.

CAT scan and immunohistochemical findings in a case of cerebral thromboangiitis obliterans (Buerger's disease).

Immunohistochemical examinations were carried out in a case of thromboangiitis obliterans. A 26-year-old man developed 4 brain infarctions which could be demonstrated by CAT scan. He suffered from a left-sided hemiparesis, major epileptic seizures, and an ischemic optic neuritis. Immunologic studies supported a diagnosis of cerebral thromboangiitis obliterans (CTAO). The serum anti-elastin titer as well as IgE were considerably increased and a biopsy of the temporal artery showed immunohistochemical signs of an acute inflammatory vessel disease. After the diagnosis of CTAO had been made, the patient was treated with azathioprine and dexamethasone. In cases of young stroke patients, a temporal biopsy is important in confirming the diagnosis.