A randomized, placebo-controlled, cross-over study of ginger extracts and ibuprofen in osteoarthritis.

OBJECTIVE: Alternative medicine is used extensively by patients with chronic pain due to e.g., osteoarthritis. Only few of these drugs have be tested in a controlled setting and the present study was undertaken to examine the effect of ginger extract, one of the most popular herbal medications. DESIGN: Ginger extract was compared to placebo and Ibuprofen in patients with osteoarthritis of the hip or knee in a controlled, double blind, double dummy, cross-over study with a wash-out period of one week followed by three treatment periods in a randomized sequence, each of three weeks duration. Acetaminophen was used as rescue medication throughout the study. The study was conducted in accordance with Good Clinical Practice (European Guideline for GCP). RESULTS: A ranking of efficacy of the three treatment periods: Ibuprofen>ginger extract>placebo was found for visual analogue scale of pain (Friedman test: 24.65, P< 0.00001) and the Lequesne-index (Friedman test: 20.76, P< 0.00005). In the cross-over study, no significant difference between placebo and ginger extract could be demonstrated (Siegel-Castellan test), while explorative tests of differences in the first treatment period showed a better effect of both Ibuprofen and ginger extract than placebo (Chi-square, P< 0.05). There were no serious adverse events reported during the periods with active medications. CONCLUSION: In the present study a statistically significant effect of ginger extract could only be demonstrated by explorative statistical methods in the first period of treatment before cross-over, while a significant difference was not observed in the study as a whole.

The protective effect of inhaled levomepromazine (Nozinan) on histamine-induced bronchial constriction.

The effect of inhaled levomepromazine (Nozinan, Veractil) on bronchial responsiveness to inhaled histamine was investigated in asthmatics. In a double blind, randomized controlled study, 12 asthmatics (FEV1% pred 52-96%, and PC20 histamine 1.01 mg/ml (geometric mean)) were challenged before and after inhalation of levomepromazine in three different doses. Before and after each inhalation of levomepromazine, PC20, FEV1, the continuous reaction time (CRT) and the subjective sedation score (VAS) were determined. A dose-dependent increase in PC20 was observed after inhalation of levomepromazine. PC20 was increased by up to 4.02 two-fold concentration differences (doubling), i.e. up to a 38-fold increase from the basic values. Inhalation of the two higher doses of levomepromazine had a small sedative effect evaluated from an increase in CRT and the VAS-score and corresponding to the plasma concentrations. We conclude that inhaled levomepromazine has a dose-dependent protective effect on histamine-induced bronchial hyperresponsiveness in asthmatics and that inhalation of levomepromazine was well tolerated. The mechanism by which levomepromazine acts on histamine-induced bronchial hyperresponsiveness is not known but it could be partly explained by the antihistaminic effect. In this respect levomepromazine bears comparison with the most potent second generation antihistamines. The plasma concentrations of levomepromazine measured corresponded to those seen after oral intake of 5-10 mg levomepromazine.

Levomepromazine (Nozinan) reduces nonspecific bronchial hyperreactivity in asthmatics.

Ten patients with bronchial asthma were challenged with histamine before and after receiving saline and active drug (levomepromazine or antazoline) (a total of six challenges). The antihistaminic effect of levomepromazine (25 mg) was found to be comparable to that of antazoline (100 mg), evaluated from skin prick tests. Prechallenge forced expiratory volume in one second (FEV1) was found to be larger after levomepromazine than after antazoline (p less than 0.05), indicating a direct bronchodilating effect. This increased threshold airway calibre may have influenced the results of challenge, but change in provocative concentration producing 20% fall (PC20) was not statistically significantly correlated to change in FEV1. Levomepromazine increased PC20 2-doubling concentration compared to antazoline (p less than 0.05). Variation was observed in two minutes' ventilation during tidal volume breathing challenge. However, there was no statistically significant variation in two minutes' ventilation during challenge after receiving levomepromazine or antazoline. It was concluded that levomepromazine possesses a bronchodilating capacity and reduces bronchial hyperreactivity.

Metronidazole uptake in the cholesteatomatous membrane in chronic otitis media.

Previous investigations have demonstrated a good uptake of metronidazole in the middle ear mucosa. We have now presented a trial study in which there was also a significant uptake of metronidazole in the cholesteatomatous membranes of patients with chronic otitis media.

Single dose prophylaxis with metronidazole in infants during abdominal surgery: a pharmacokinetic study.

Plasma metronidazole was measured following a single intravenous dose of 20 mg/kg (Flagyl 5 mg/ml) in 12 infants less than 1 year of age undergoing abdominal surgery. In all patients sufficient plasma concentrations, well above the MIC values for anaerobic bacteria, were found for at least 16 h. A prolonged half-life was demonstrated in the group less than 8 weeks of age (t1/2/18.4 h). The group over 8 weeks of age demonstrated a t1/2 comparable to that seen in adults (t1/2 7 h).

A new H+ suppressor: RP 40 749 versus placebo and cimetidine. Ambulatory 48-hour intragastric pH monitoring in normal men.

Six normal male test persons had nasogastric glass electrodes placed in the antrum for four periods of 48 h each, separated by wash-out periods of 9 days. The electrodes were connected to a portable pH-monitoring system enabling continuous pH recording and storing during and after four different drug or placebo treatments arranged in a double-blind, cross-over experimental design. Data were read out and stored in a computer for later analysis. RP 40 749, a new gastric acid secretion inhibitor acting within the parital cell, raised the median 24-h intragastric pH significantly not only during medication but also during the day after its discontinuation. It also proved to be a significantly more potent H+ suppressor than cimetidine. The same was true for inhibition of nocturnal intragastric acidity, for which cimetidine seemed comparably ineffective. The efficacy of RP 40 749 is comparable to that of omeprazole.

Minimal walking distance following exercise treatment in patients with arterial occlusive disease.

79 patients with intermittent claudication were tested with peripheral blood pressure measurement and determination of minimal walking distance before and after a 3 months' period with scheduled walking exercises under supervision. No change in peripheral blood pressure was observed following the treatment whereas the minimum walking distance was increased with statistical significance. The gain was most pronounced in patients with an initial combination of high peripheral pressures and short walking distances. A graphic presentation allows for the estimation of the expected gain in individual patients with claudication.

Colles' fractures treated by plaster and polyurethane braces: a controlled clinical study.

In a prospective randomized controlled trial polyurethane casts and traditional plaster-of-Paris braces were compared in 46 cases of Colles' fractures of the forearm. Secondary fracture dislocation, subjective inconveniences, and the need for secondary adjustment of the cast were recorded. No significant difference was observed in the two groups. In comparison with plaster the synthetic bandage is lighter, water repellent, and hardens faster, and as far as circular bandages are concerned, they have zippers. It is concluded that polyurethane braces are a good supplement to plaster-of-Paris bandage in such fractures and recommended in selected cases.