Randomised, placebo-controlled, double-blind study to investigate the efficacy and safety of the acute use of sodium picosulphate in patients with chronic constipation.

There are few studies supporting the effective and safe use of laxatives for constipation. This study examined the short-term efficacy and safety of sodium picosulphate in patients with chronic constipation. Patients with a history of chronic constipation for at least 3 months were randomised to receive 7 mg sodium picosulphate or placebo for three consecutive nights. Patients recorded stool frequency and consistency, straining, bloating, and pain at baseline and during treatment. Vital signs, haematocrit, serum creatinine and electrolytes were monitored. Primary end-point for efficacy was the occurrence of a response to treatment, defined as improvement in stool frequency and occurrence of straining. All 57 randomised patients (sodium picosulphate n = 29, placebo n = 28; mean age 54.8 and 54.1 years) completed the study. Sodium picosulphate produced a treatment response (improved stool frequency and straining) in 82.8% compared with 50% in the placebo group (p = 0.010) and reduced bloating more often than placebo. There were no serious adverse events and one patient with diarrhoea and another with abdominal pain in each treatment group. There were no cardiovascular effects, changes in serum haematocrit, creatinine or electrolytes in either group. This study confirmed that sodium picosulphate is an effective, well-tolerated and safe laxative in the acute treatment of constipation.

[Effects of standardized Myrtol in therapy of acute sinusitis--results of a double-blind, randomized multicenter study compared with placebo]. / Wirkung von Myrtol standardisiert bei der Therapie der akuten Sinusitis--Ergebnisse einer doppelblinden, randomisierten Multicenterstudie gegen Plazebo.

BACKGROUND: In the management of non-purulent acute sinusitis, alpha adrenergic substances are administered topically and secretolytics systemically. Antibiotic therapy should be restricted to purulent forms. This study was designed to demonstrate the importance of the maintenance of permanent ventilation and drainage of the sinuses as a therapeutic concept. PATIENTS/METHODS: In a multicentric trial the efficacy and safety of myrtol standardized and another essential oil were investigated in 331 patients with acute sinusitis in comparison to placebo. Three hundred thirty patients were evaluated in an intent-to-treat-analysis and 291 patients remained for statistical analysis. The study was conducted in 16 centers in a double-blind, double-dummy, randomized design versus placebo. During an observation-period of 14 days the patients were treated for 6 +/- 2 days with the respective study medication. RESULTS: With respect to efficacy, both myrtol standardized and the other essential oil proved to be significantly superior to placebo. As to the tolerance, a slight advantage of myrtol standardized was demonstrated in comparison to the other verum substance. CONCLUSION: These results which do support the value of essential oils like myrtol as an effective treatment in acute, uncomplicated sinusitis instead of antibiotics as first choice, are confirmed by the existing literature.

N-acetylation and oxidative capacity in aged volunteers determined with sulfamethazine and antipyrine.

The elimination of antipyrine (AP 15 mg/kg) and sulfamethazine (SM 500 mg) was measured in healthy volunteers of rapid and slow acetylator phenotype. Nineteen males were 20-32 years of age, 11 males and 6 females between 62-86 years of age. Apparent volume of distribution of AP was reduced in advanced age independent of the acetylator status of the individuals. Total body clearance was significantly lower and half-time and mean residence time were higher only in slow but not in rapid acetylators. In the elderly of both phenotypes, the acetylation ratios of SM were significantly enhanced. Renal and metabolic clearance were decreased and AUC-values of SM and its acetylated metabolite were increased in slow but unchanged in rapid acetylators. Physiological peculiarities of distribution and renal excretion of SM and its acetylated metabolite in advanced age may have caused the contradictory results.

N-acetylation and debrisoquine hydroxylation polymorphisms in patients with Gilbert's syndrome.

1. N-acetylation and debrisoquine hydroxylation phenotypes were determined in 54 patients with Gilbert's syndrome and in 247 (sulphamethazine) and 76 (debrisoquine) non-related healthy volunteers. 2. Forty (74.1%) of the patients and 135 (54.7%) of the healthy volunteers were slow acetylators (chi 2 = 6.87). In the patients, the cumulative urinary excretion of sulphamethazine up to 6 h (Ae(0,6)) was significantly lower. No differences in the frequency of debrisoquine poor metabolizers were observed: Gilbert's syndrome 5/54 (9.3%), healthy volunteers 5/76 (6.6%). The metabolic ratios were similar in both groups as well as the urinary recoveries of debrisoquine and its 4-hydroxy metabolite. 3. Gilbert's syndrome seems to be related in some way to N-acetylation but not to the debrisoquine hydroxylation polymorphism.

[Thrombogenicity of prothrombin complex concentrates]. / Zur Thrombogenität von Prothrombinkomplexkonzentraten.

PCC's were isolated either by adsorption to DEAE-Sephadex A-50 (particle size 40-120 microns; Pharmacia Uppsala) or by adsorption to Molselect DEAE-50 (particle size 100-320 microns; Reanal Budapest) from human citrated plasma after separation of factor VIII by cryoprecipitation. The two products obtained (without heparin) were both compared by in vitro (NAPTT, TGt50) and in vivo (venous stasis) model in rats acc. to WESSLER) tests. The agent prepared by adsorption to DEAE-Sephadex A-50 showed a significantly higher thrombogenicity than that prepared by Molselect DEAE-50. ED50 values for thrombus formation to amounted 15 Factor IX U/kg for the first product and to 210 factor IX U/kg for the second.