Effects of Abexol® (beeswax alcohols) in patients with gastric symptoms

Experimental and clinical studies have demonstrated that oral treatment with beeswax alcohols (Abexol®) (formerly D-002), a mixture of six high molecular weight aliphatic alcohols, produces gastroprotective and antioxidant effects. Low plasma levels of vitamin C have been reported in subjects suffering of chronic gastritis as compared to healthy subjects. This randomized, double-blinded, placebo-controlled study was undertaken to investigate the effects of Abexol® in subjects with habitual gastrointestinal symptoms and its effects, if any, on plasma vitamin C levels. At visit 2 (baseline), 45 eligible men and women (mean age: 67 years old) were randomised to Abexol® (50 mg) or placebo tablets twice a day for six weeks. After three weeks on treatment, the dose was titrated to three daily tablets in subjects without symptom improvement. Symptoms were assessed by using the Gastrointestinal Symptom Rating Scale (GSRS). Patients? health perception was assessed with a three scores system. The primary efficacy variable was to obtain a significant reduction of the mean total GSRS score as compared to placebo, while decreases on distinct domains of the GSRS and improvement of health perception were secondary variables, and increased plasma vitamin C levels were a collateral variable. No significant changes occurred with placebo. At trial completion Abexol® reduced significantly the mean total GSRS score as compared to baseline and placebo (80.2 % reduction), such reduction being significant fromthe interim check-up (three weeks on treatment). At trial completion, the rate of Abexol®-treated patients who reported improved health perception (21/21, 100 %) was significantly greater than in placebo (0/24, 0 %). No Abexol®-treated subject (0/21, 0 %), in comparison with 24/24 (100 %) and 23/24 placebo subjects (95.8 %) required dose titration or consumed antacids (p 0.0001 for both comparisons), respectively. Abexol® did not affect physical or laboratory indicators, with the exception of a significant increase of plasma levels of Vitamin C as compared to placebo. Abexol® was well tolerated, no subject withdrew from the study, and only three placebo-treated subjects experienced moderate AE during the trial. In conclusion, this study demonstrates that Abexol® (100 mg/d) administered for six weeks improved the symptoms in subjects with habitual gastrointestinal complaints, since it reduced the mean total GSRS score, improved the health perception and reduced the intake of antacids as compared to placebo. In addition, it also produced a significant increase of plasma vitamin C levels.