OTC use of a topical nasal spray solution containing xylometazoline plus ipratropium in patients with common cold.

BACKGROUND: Combination of xylometazoline and ipratropium in a nasal spray provides fast, effective symptomatic relief of nasal congestion and rhinorrhea in adults with common cold. OBJECTIVES: To gather data in a non-prescription setting regarding the safety, pattern of use, patients' general assessment of treatment and suitability of making available without medical prescription of this topical combination nasal spray. DESIGN: Post-marketing, non-interventional, non-controlled study reflecting normal over-the-counter (OTC) use of the spray in adults with common cold (n = 1,019). Main outcome measures included pattern of use (patient-reported effectiveness, compliance with treatment) and safety (adverse drug reaction (ADR) reports). RESULTS: Over 92% of patients used the product for the intended indication, 81.4% used it 2 - 3 times/day and the median duration of treatment was 6 days. In total, 39.7% of patients reported 585 ADRs (mean 1.45 ADR/patient) while 60.3% reported no ADRs. Most common side effects were nasal dryness (12.4%), blood tinged mucus (9.3%), nasal discomfort (6.2%), epistaxis (4.2%), generally harmless and of mild severity. Patients who used the product outside the approved indication did not seem to have a higher risk of ADRs. Mean general impression score was 3.4, with 79% of patients rating treatment as "good" to "excellent". CONCLUSIONS: The topical combination nasal spray (xylometazoline plus ipratropium) for the symptomatic relief of nasal congestion and rhinorrhea in adults with common cold has a good safety profile and results in high patient satisfaction in an OTC setting. No reasons could be found to oppose the assertion that the combination spray is suitable for classification as a product not subject to medical prescription.

Airborne Compositae dermatitis: monoterpenes and no parthenolide are released from flowering Tanacetum parthenium (feverfew) plants.

The air around intact feverfew (Tanacetum parthenium) plants was examined for the presence of airborne parthenolide and other potential allergens using a high-volume air sampler and a dynamic headspace technique. No particle-bound parthenolide was detected in the former. Among volatiles emitted from the aerial parts of feverfew plants and collected by the dynamic headspace technique a total of 41 compounds, mainly monoterpenes, were identified and quantified by GC and GC-MS. Alpha-Pinene, camphene, limonene, gamma-terpinene, (E)-beta-ocimene, linalool, p-cymene, (E)-chrysanthenol, camphor and (E)-chrysanthenyl acetate were the predominant monoterpenes accounting for nearly 88% of the total volatiles emitted. The average total yield of volatiles emitted over 24 h was 18,160 ng/g fresh weight of leaves and flowers, corresponding to the emission of approximately 8 mg volatiles per day from one full-grown feverfew plant. No parthenolide or other sesquiterpene lactones were detected. The present investigation does not support the theory of airborne sesquiterpene lactone-containing plant parts or of direct release of sesquiterpene lactones from living plants as the only explanations for airborne Compositae dermatitis. Potential allergens were found among the emitted monoterpenes and their importance in airborne Compositae dermatitis is discussed.

Once daily treatment of psoriasis with tacalcitol compared with twice daily treatment with calcipotriol. A double-blind trial.

Once daily topical treatment of psoriasis with tacalcitol ointment (4 micrograms/g) was compared with twice daily treatment with calcipotriol ointment (50 micrograms/g) in a double-blind, randomized study over a treatment period of 8 weeks. The severity of pruritus, erythema, infiltration and scaling was scored on a scale from 0 to 4. These features were scored at the initiation of treatment, after 2, 4, 6 and 8 weeks of treatment, and at 4 weeks after discontinuation of treatment. The sum score was the total score for erythema, infiltration and scaling. Serum levels of calcium, phosphate, ionized calcium and intact parathyroid hormone were used as safety parameters. Two hundred and eighty-seven adults with stable plaque psoriasis participated and were treated at least once. Both tacalcitol and calcipotriol ointments effectively reduced the severity of psoriasis. The mean reduction in the sum score in the intention-to-treat population of 287 patients was 4.03 in the group treated with tacalcitol compared with 5.05 in the group treated with calcipotriol. The mean baseline sum scores were 7.64 and 7.15, respectively. The acceptability of both ointments was excellent, and none of the patients had adverse effects in terms of increased serum calcium or other alterations in calcium metabolism. Although less effective than calcipotriol ointment used twice daily, tacalcitol ointment is an effective and useful once daily treatment of chronic plaque psoriasis.

The effect of ephedrine plus caffeine on smoking cessation and postcessation weight gain.

OBJECTIVES: To evaluate the efficacy of a combination of ephedrine and caffeine on smoking cessation rates, postcessation weight gain, and withdrawal symptoms and to examine changes in glycosylated hemoglobin (HbA1c) after smoking cessation. METHODS: This randomized double-blind placebo-controlled study with a 1-year follow-up period was carried out at the Department of Pulmonary Medicine in Denmark. Study subjects were 225 heavy smokers who wanted to quit smoking without gaining weight. Two-thirds of the subjects were randomized to receive 20 mg ephedrine plus 200 mg caffeine three times a day; one-third of the subjects received placebo treatment. The dosage was gradually decreased from week 12 to discontinuation at week 39. Group support and control were performed at entry and after 1, 3, 6, 12, 26, 39, and 52 weeks. Main outcome measures were (1) self-reported abstinence with validation by carbon monoxide in expired air and serum cotinine and (2) weight gain. RESULTS: The success rates after 1 year were 17% in the group treated with ephedrine plus caffeine and 16% in the group treated with placebo; the success rates were not significantly different at any time. The success rates for the four counseling physicians varied between 7% and 27% after 1 year (p < 0.05). The weight gain was significantly lower in the ephedrine plus caffeine-treated group during the first 12 weeks, but weight gains were similar after 1 year. No differences in the smoking withdrawal symptoms could be observed between the treatment groups. HbA1c was lower 6 weeks and 1 year after smoking cessation (p < 0.05). CONCLUSIONS: We found an effect of this combination of ephedrine and caffeine on weight gain during the first 12 weeks, but we found no effect on the success rates or craving for cigarettes.

Can social bees be influenced to choose a specific feeding station by adding the scent of the station to the hive air?

The behavioral response of honeybees (Apis mellifera L.) and bumblebees (Bombus terrestris L.) to the flower volatiles 2-ethyl-1-hexanol and myrcene isolated in situ from white clover (Trifolium repens L.) and oil seed rape (Brassica napus oleifera), respectively, were investigated on a rotating arena with 12 visually identical, but differently scented, feeding stations. When locating a feeding station, neutral in both shape and color, foragers used scent as orientation cue. Introduction of 2-ethyl-1-hexanol to the honeybee hives induced significantly more visits to sites containing this compound. In contrast, introduction of myrcene to the hives did not influence the foraging choices of honeybees significantly. No effect of hive scent composition on the choices made by bumblebees could be detected. "Experienced" bumble bees, i.e., bees with more than five visits to the feeding stations, tended to visit a particular position on the arena without discriminating between the two volatiles. In contrast, honeybees showed no positioning behavior on the arena, using primarily odoriferous stimuli. The observed influences of addition of scents to the hives are discussed in relation to the general knowledge on foraging behavior of social bees and the emission of volatiles from leaves and flowers.

Topical meclocycline sulfosalicylate, benzoyl peroxide, and a combination of the two in the treatment of acne vulgaris.

One hundred and six patients with acne vulgaris of the face were treated for 10 weeks with either topical meclocycline sulfosalicylate, topical benzoyl peroxide or both preparations. A randomized, double-blind parallel group study was used. Benzoyl peroxide proved more effective than meclocycline in reducing acne lesion counts, while local side effects were more common in the benzoyl peroxide-treated patients. The combined treatment was of intermediate efficacy with fewer local side effects.

Water-based versus alcohol-based benzoyl peroxide preparations in the treatment of acne vulgaris.

Forty-eight patients with acne vulgaris in the face were treated with a water-based (Basiron) and an alcohol-based (Panoxyl) 5% benzoyl peroxide preparation. A randomized double-blind, contralateral study was used. No difference in clinical effect was found. Treatment for 8 weeks resulted in at least 50% reduction in the number of closed comedones, papules and pustules in over 80% of the patients. In more than 70% of the patients, the reduction exceeded 75%. The water-based Basiron caused significantly less skin irritation than the alcohol-based preparation of Panoxyl.