ABSTRACT
The objective of the present study was to determine the efficacy and tolerability of a new solid formulation (capsules) of Agnolyt®(*)) in a randomized, controlled trial versus pyridoxine in women with PMTS over a period of three treatment cycles (Vitex agnus castus (VAC): 1 capsule + 1 placebo capsule/day, n = 90; pyridoxine (B6): 2 capsules day, n = 85). The therapeutic response was assessed using the premenstrual tension syndrome scale (PMTS scale), the recording of six characteristic complaints of the syndrome, and the clinical global impression scale (CGI scale). Upon completion of the trial, efficacy of the treatment was assessed by the physician as well as by the patient. On the PMTS scale, treatment with VAC and B6 produced a reduction in score points from 15.2 to 5.1 (-47,4%) and from 11.9 to 5.1 (-48%)(*), respectively. In comparison with pyridoxine, VAC caused a considerably more marked alleviation of typical PMTS complaints, such as breast tenderness, edema, inner tension, headache, constipation, and depression. Analogous results were obtained with the CGI scale. In both treatment groups, efficacy was rated as at least adequate by more than 80% of the investigators; however, VAC treatment was rated as excellent by 24.5% and pyridoxine treatment by 12.1% of the investigators. According to the patients' assessment, 36.1% of the cases in the VAC group and 21.3% in the pyridoxine group were free from complaints. Adverse events (gastrointestinal and lower abdominal complaints, skin manifestations and transitory headache) occurred in 5 patients under B6 and in 12 patients under VAC. Serious adverse events were not observed. The results of the present study confirm the efficacy and safety of Agnolyt® capsules in the treatment of PMTS.
ABSTRACT
In this study on 60 adult subjects, the effective of Parodontax, a dentifrice containing herbal ingredients and sodium bicarbonate abrasive, was compared to a non-marketed new toothpaste containing herbal ingredients and calcium hydrogen phosphate as the abrasive. Plaque, gingivitis and gingival bleeding parameters were scored. The periodontal probe bleeding index of Ainamo and Bay was modified to score slight and moderate bleeding. In this first four-week period all subjects used the new toothpaste. After this period the new toothpaste produced a significant decrease (p<0.01) in gingivitis and bleeding on probing, but no effect on plaque was observed. During the second period of eight weeks the subjects were randomly divided into two groups, one using Parodontax and the other group continuing with the new toothpaste. The study design was a double-blind procedure. At the end of the 12-week study period the plaque index showed no changes in both groups. The gingivitis and bleeding indices decreased significantly (p<0.001) by 40% in both groups compared to the baseline examination.
