The effect of 6 months supplementation with conjugated linoleic acid on insulin resistance in overweight and obese.

BACKGROUND: Contradicting results have been published regarding the effect of conjugated linoleic acid (CLA) on insulin resistance. However, only a few studies have used the euglycemic hyperinsulinemic clamp method, which is considered the standard for measuring insulin resistance. OBJECTIVE: To evaluate if CLA as a mixture of the main isomers trans-10 cis-12 and cis-9 trans-11 affects the insulin resistance in healthy overweight and obese male and female adults. DESIGN: The main study was a randomized, double-blind, placebo-controlled trial with change in body composition as primary end point comprising 118 subjects receiving supplementation with either placebo (olive oil) or CLA (Clarinol) for 6 months. A sub-population of 49 subjects agreed additionally to participate in an euglycemic hyperinsulinemic clamp study at baseline and after 6 months of supplementation with study drug. The primary outcome was the change in glucose uptake (M) as measured by the hyperinsulinemic euglycemic glucose clamp method. Secondary outcomes were the correlates between insulin resistance and changes in body composition or blood chemistry parameters. Forty-one subjects completed the clamp test at both time points. RESULTS: The median M of the CLA group was 11.0 mg min(-1) lean body mass (lbm)(-1) (n=24) at baseline, 10.3 mg min(-1) lbm(-1) (n=24) after 6 months, and the median difference was +0.21 mg min(-1) lbm(-1) (n=24). The median M of placebo group was 8.4 mg min(-1) lbm(-1) at baseline and 9.3 mg min(-1) lbm(-1) after 6 months and the median difference was -0.22 mg min(-1) lbm(-1) (n=17). No significant (P<0.05) differences were found within groups or between groups. Likewise, the glucose uptake insulin concentration ratio during clamp (M/I) was independent of treatment and time. Homeostasis model assessment (HOMA) and quantitative insulin sensitivity check index derived from fasting glucose and insulin were also independent of treatment and time, and HOMA for the clamp population (n=49) corresponded well with HOMA for the per protocol population (n=83). Correlation analysis showed that changes in M were inversely correlated to changes in glucohemoglobin (P=0.002), but did not correlate with changes in either glucose, insulin, insulin c-peptide, leptin, adiponectin or percent body fat. CONCLUSIONS: CLA does not affect glucose metabolism or insulin sensitivity in a population of overweight or obese volunteers.

Azithromycin versus placebo in acute infectious rhinitis with clinical symptoms but without radiological signs of maxillary sinusitis.

In this double-blind, parallel-group, multicenter study, 169 patients with symptoms of maxillary sinusitis but without radiographically confirmed empyema (pus) were randomly assigned to receive either 500 mg azithromycin once daily for 3 days (87 patients) or placebo daily for 3 days (82 patients). Nasal secretion, maxillary tenderness and pain, nasal obstruction, general malaise, and hyposmia were assessed at the start of the study and on days 4, 11, and 25 of treatment. After 11 days 58% of the patients in the azithromycin group were cured versus 31% in the placebo group; after 25 days the cure rate was 79% versus 67%, respectively. When both cure and improvement were considered, the corresponding figures after day 25 were 90% and 88%, respectively. Adverse events, predominantly gastrointestinal, occurred in 24 (27%) of the azithromycin-treated patients and in 15 (18%) of those treated with placebo, but the difference was not statistically significant. There was a difference in efficacy in favor of azithromycin in the treatment of rhinitis with symptoms of maxillary sinusitis but without radiological signs of empyema (pus). Antibiotics should only be used to alleviate symptoms in patients with moderate to severe symptoms, as the results after 25 days for both improvement and cure are equal. In the treatment of acute rhinitis with symptoms and signs of maxillary sinusitis but without empyema, treatment with azithromycin seems to result in a better cure rate after 10-12 days when compared with placebo.

Efficacy and safety of azithromycin versus phenoxymethylpenicillin in the treatment of acute maxillary sinusitis.

In the treatment of acute maxillary sinusitis, azithromycin offers an advantage over phenoxymethylpenicillin in that a complete course of treatment requires drug administration once daily for only three days. In this double-blind, parallel-group, multicenter study, 438 patients with radiographically verified maxillary sinusitis were randomly assigned to receive either 500 mg azithromycin once daily for three days (221 patients) or 1.3 g phenoxymethylpenicillin three times daily for ten days (217 patients). Nasal secretion, maxillary tenderness and pain, nasal obstruction, general malaise, and hyposmia, were assessed at the start of the study and on days 4, 11, and 25 of treatment. After 11 days 58% of the patients in the azithromycin group were cured versus 51% in the penicillin group; after 25 days the cure rate was 79% versus 76%, respectively. When both cure and improvement were considered, the corresponding figures after 11 days were 97% (azithromycin) and 95% (penicillin); after 25 days they were 92% and 88%, respectively. Adverse events, predominantly gastrointestinal, occurred in 73 (33%) of the azithromycin-treated patients and in 87 (40.1%) of those treated with penicillin. No difference in efficacy was found between the two drugs in the treatment of acute maxillary sinusitis, and the adverse effects were comparable. The short duration of treatment with azithromycin offers a significant advantage over treatment with phenoxymethylpenicillin.

Effect of a combination of orphenadrine/paracetamol tablets ('Norgesic') on myalgia: a double-blind comparison with placebo in general practice.

The clinical efficacy and tolerability of a combination preparation ('Norgesic') of 35 mg orphenadrine plus 450 mg paracetamol was compared with that of placebo in a controlled double-blind, parallel group, 7-day study comprising 44 patients suffering from pain due to tension of the cervical and upper thoracic musculature. The patients were allocated at random into two homogeneous groups, stratified by sex and initial pain intensity. One group received the combination, the other placebo. The dosage used was 1 tablet 3-times daily. The effect of treatment of pain was assessed daily using a visual analogue scale. Despite the low dosage used, orphenadrine/paracetamol produced statistically significant pain relief from initial levels by and from the second day of the study. Comparison between the groups showed that the analgesic efficacy of the combination was significantly superior to that of placebo from the third day of treatment. These results confirm the efficacy of a combination of orphenadrine/paracetamol in patients suffering from myalgia nuchae.