ABSTRACT
BACKGROUND: ELOM-080 is a phytomedicine approved for the treatment of acute and chronic inflammatory diseases of the respiratory tract, sinusitis, and bronchitis in particular. This prospective, randomized, placebo-controlled, double-blind clinical trial was conducted to assess efficacy and safety of ELOM-080 in the treatment of acute viral rhinosinusitis (AVRS). METHODS: Patients with AVRS received oral treatment (4 × 1 capsule per day) with either ELOM-080 or matching placebo. Primary endpoints were the change in major symptom score (MSS) after 7 and 14 days of treatment assessed by the investigator (MSSINV ). Secondary endpoints were changes in MSS assessed by the patients (MSSPAT ), olfactory function (12-item Sniffin' Sticks), 20-Item Sino-Nasal Outcome Test (SNOT-20 GAV; German adapted version), influence of treatment on viral load, and safety. RESULTS: Four hundred and sixty-three patients were randomized. At day 4, subjective burden of disease (MSS) was significantly ameliorated compared to placebo (p = 0.012). During the first treatment week MSS scores improved about 1 day earlier, and 3 days earlier in the second week. Effect with ELOM-080 on mean MSSINV was statistically significantly superior to placebo at visit 3 (p = 0.016) and visit 4 (p = 0.014). In chemosensory testing identification scores improved comparably in both treatments. The improvement of the SNOT-20 GAV was more pronounced in ELOM-080 patients. Treatment with ELOM-080 indicated a potential for decreasing viral load. Both treatments were well tolerated. CONCLUSION: ELOM-080 improves the burden of AVRS significantly in comparison to placebo, remission of symptoms occurred 3 days earlier. The results confirm the efficacy and safety of ELOM-080 for treatment of AVRS. LEVEL OF EVIDENCE: 1 Laryngoscope, 133:1576-1583, 2023.
Subject(s)
Rhinitis , Sinusitis , Humans , Prospective Studies , Rhinitis/drug therapy , Chronic Disease , Acute Disease , Sinusitis/drug therapy , Treatment Outcome , Double-Blind MethodABSTRACT
At the beginning of this year, the new German guideline on rhinosinusitis was published as a joint guideline of the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery and the German College of General Practitioners and Family Physicians. The guideline was designed for the treatment of adult patients with inflammatory diseases of the paranasal sinuses and is addressed to all medical specialties involved in the management of these diseases. The current challenge is the implementation of this guideline in the clinical daily routine. For this purpose, an abbreviated version (miniature) was designed.
Subject(s)
Otolaryngology/organization & administration , Sinusitis/therapy , Adult , Germany , Humans , Practice Guidelines as TopicABSTRACT
Patients with unspecific symptoms were sometimes tested for Candida. In case of findings of this yeast-like fungus in their stools they often were labelled with the diagnosis of a "Candida-syndrome". This comprises headache, weakness, flatulence, ravenous appetite for sweets, itching skin and several more unspecific symptoms. All 500 randomly sampled patients in 12 mainly naturopathic practices were asked to take part. In case of participation, they received stool-tubes and questionnaires to be answered during the waiting-time by the patients themselves. We asked for details of lifestyle, diseases and a number of unspecific symptoms. The stool-tubes were sent to a microbiological lab within 24 h after being filled. About one-third of all 308 participants carried Candida albicans in their stools. This finding is regarded as normal. Smoking habits were highly associated to Candida: 45 of the 78 smokers (58%), but only 68 of the 230 (29%) non-smokers were Candida positive, P < 0.0001. Three more results were associated with Candida-positive stools: Candida-vaginitis, allergies against food and allergies in general. Hints of a Candida-syndrome could not be found. The relation with smoking cigarettes is a new result. Associations to Candida-vaginitis and allergies were described before.
Subject(s)
Candida/isolation & purification , Candidiasis/epidemiology , Adolescent , Adult , Aged , Aged, 80 and over , Candida/classification , Candidiasis/microbiology , Case-Control Studies , Child , Child, Preschool , Cross-Sectional Studies , Family Practice , Feces/microbiology , Female , Germany/epidemiology , Humans , Male , Middle Aged , Risk Factors , Smoking , Surveys and QuestionnairesABSTRACT
BACKGROUND: With the implementation of the last 'Arztliche Approbationsordnung' in 2003, complementary medicine (CAM) became a required subject for all German medical schools. CAM will be taught together with rehabilitation and physical treatment in a compound as a cross sectional subject. OBJECTIVES: As CAM has rarely been represented at German universities before,the question arose who would give the classes. Previously, CAM had often been taught within the curriculum of academic General Practice. METHODS AND RESULTS: According to the replies from 27 departments of general practice at German universities, we show effects of the required additional curriculum on academic General Practice, which faculties are involved beyond General Practice, what kind of contents are taught and what type of examinations are considered. Descriptive statistical results will be given.
