Biomedical subjects

Regina Busch

Publications and source records attributed to Regina Busch.

6 recordsLinked to original sources

PubMed2006

Evaluation of the non-inferiority of a fixed combination of thyme fluid- and primrose root extract in comparison to a fixed combination of thyme fluid extract and primrose root tincture in patients with acute bronchitis. A single-blind, randomized, bi-centric clinical trial.

In a single-blind, randomized, bi-centric, prospective study, the non-inferiority of a fixed combination of thyme fluid extract and primrose root fluid extract (Bronchicum Elixir S, fluid test medication) was evaluated by comparison to a fixed combination of thyme fluid extract and primrose root tincture (Bronchcium Tropfen, drops test medication). The patients took either 6 x 5 ml of the fluid test medication (fluid group) or 5 x 1 ml of the drops test medication (drops group) daily. 189 outpatients (121 women, 68 men) suffering from acute, not previously treated bronchitis, lasting for less than 48 h, were randomized and treated with either fluid (94 patients: 66 women, 28 men) or drops (95 patients: 55 women, 40 men) over a time period of 7-9 days. 71 patients were excluded from the per-protocol (PP) collective because of violations regarding examination time points and/or intake of the study medication. The primary outcome criterion was to demonstrate the non-inferiority of the Score (BSS) at the end of the study compared to baseline. In the fluid group, the BSS decreased from 11.0 +/- 5.0 points at baseline to 2.6 +/- 4.6 (76%) at study end compared to a decrease from 11.0 +/- 4.8 points at baseline to 2.5 +/- 4.2 (77.1%) at study end in the drops group (Intention-to-treat (ITT) -analysis). The decrease of the BSS in both groups was highly significant (p < or = 10(-3)), but there was no difference between the two groups. Differences between the study sites were noticed regarding the baseline BSS, which were twice as high at study site 2 compared to study site 1 (probably due to the different way the patients were recruited). However, a statistically significant intergroup difference was not observed at any time point. At the end of the study, 52.1% of the patients of the fluid group were symptom free and 53.7% of the patients from the drops group were symptom free as compared by the ITT-analysis (secondary outcome criterion). For both parameters, the PP-analysis support the non-inferiority of the fluid compared to the drops. The global therapeutic efficacy of the fluid as well as of the drops was rated as being "very good" or "good" by 80% of the patients and clinical investigators. The tolerability was very good in both groups; neither serious adverse events nor clinically relevant findings in the safety parameters were observed. A total of 10 adverse events occurred, 5 in the fluid group and 5 in the drops group. Five of these adverse events (2 in the fluid group and 3 in the drops group) were considered to be possibly or probably related to the intake of the study medication. Neither serious nor unknown adverse drug reactions were observed. One drop-out occurred during the study, because of ineffectiveness of the study medication. In the global safety assessment, the tolerability of both medications was rated by about 90% of the patients and by clinical investigators as "good" or "very good". The study demonstrated that the fixed combination of thyme fluid extract and primrose root extract and the combination of thyme fluid extract and primrose root tincture were well tolerated and showed comparable results regarding their efficacy, e.g. decrease of the bronchitis symptoms (primary outcome criterion) and in relief of symptoms (secondary outcome criterion). The results of the study confirm the non-inferiority of the fluid, a combination of thyme fluid extract and primrose root extract when compared to the drops, a combination of thyme fluid extract and primrose root tincture.

Adult↗

PubMed2006

Black cohosh and St. John's wort for climacteric complaints: a randomized trial.

OBJECTIVE: To investigate the efficacy of the fixed combination of black cohosh (Cimicifuga racemosa) and St. John's wort (Hypericum perforatum) extracts in women with climacteric complaints with a pronounced psychological component. METHODS: In this double-blind randomized placebo-control study, 301 women experiencing climacteric complaints with psychological symptoms were treated with ethanolic St. John's wort extract and isopropanolic black cohosh extract or a matched placebo for 16 weeks. Climacteric complaints were evaluated by means of the Menopause Rating Scale mean score, and psychological complaints were evaluated using the Hamilton Depression Rating Scale sum score. RESULTS: The mean (+/- standard deviation) Menopause Rating Scale score decreased 50% (0.46 +/- 0.13 to 0.23 +/- 0.13) in the treatment group and 19.6% (0.46 +/- 0.14 to 0.37 +/- 0.15) in the placebo group. The Hamilton Depression Rating Scale total score decreased 41.8% in the treatment group (18.9 +/- 2.2 to 11.0 +/- 3.8 points), and 12.7% in the placebo group (18.9 +/- 2.1 to 16.5 +/- 4.3). The treatment was significantly (P < .001) superior to placebo in both measures. There were no relevant group differences regarding adverse events, laboratory values, or tolerability. CONCLUSION: This fixed combination of black cohosh and St. John's wort is superior to placebo in alleviating climacteric complaints, including the related psychological component. LEVEL OF EVIDENCE: I.

Adult↗

PubMed2005

Efficacy and tolerability of a fixed combination of thyme and primrose root in patients with acute bronchitis. A double-blind, randomized, placebo-controlled clinical trial.

In a double-blind, randomized, placebo-controlled, multicenter, prospective study, the clinical efficacy and tolerability of a fixed combination of thyme fluid extract and primose root tincture (Bronchicum Tropfen) was investigated at a dosage of 30 drops (1 ml), taken orally five times daily. 150 outpatients (97 women, 53 men) suffering from acute, not previously treated bronchitis, lasting for less than 48 h, were randomized and treated with either verum (75 patients: 45 women, 30 men) or placebo (75 patients: 52 women, 23 men) over a time period of 7-9 days. 17 patients were excluded from the per-protocol (PP) collective because of either withdrawal from the trial (n = 2) or violations regarding examination time points and/or intake of the study medication (n = 15). The primary outcome criterion for efficacy assessment was the decrease of the Bronchitis Severity Score (BSS) at the end of the study compared to baseline. In the verum group, the BSS decreased from 12.0 +/- 4.4 points at baseline to 1.0 +/- 2.1 at study end compared to a decrease from 11.7 +/- 4.3 points at baseline to 6.5 +/- 4.8 at study end in the placebo group. The inter-group difference of 5.8 points was highly significant (p < or = 10(-3)) in favour of the verum medication [Intention-to-treat (ITT) analysis]. At the end of the study, significantly more patients were symptom free in the verum group (58.7%) than in the placebo group (5.3%) as compared by the ITT analysis (secondary outcome criterion). For both parameters, the PP analysis showed comparable results. The results for the concomitant variables of efficacy support the high superiority of the verum medication compared to placebo. The therapeutic effect was more pronounced the stronger the severity of the acute bronchitis was (as proofed by a stratified evaluation based on severity grade). The tolerability was very good in both groups; neither serious adverse events nor clinically relevant findings in the safety parameters were observed. A total of 7 adverse events occurred, 2 in the verum group and 5 in the placebo group. One of the two adverse events in the verum group was considered to be possibly related to the intake of the study medication. Neither serious nor unknown adverse drug reactions were observed. Two drop-outs occurred during the study related to adverse events, both in the placebo group. In the global safety assessment, the tolerability of both medications was rated as "good" or "very good" by more than 90% of the patients and physicians. In the present study, the fixed combination of thyme fluid extract and primrose root tincture was well tolerated and resulted in a clinically relevant and more pronounced decrease of the bronchitis symptoms (primary outcome criterion) and in shortening the duration of acute bronchitis (secondary outcome criterion) when compared to placebo.

Acute Disease↗

PubMed2004

A double-blind placebo-controlled clinical trial compares the cholesterol-lowering effects of two different soy protein preparations in hypercholesterolemic subjects.

BACKGROUND: Soy protein is effective in lowering plasma cholesterol, LDL cholesterol and triglyceride concentrations. It has not been conclusively answered, whether and to what extent other soy constituents may also contribute to this effect. OBJECTIVE: To investigate the change in blood lipid levels after application of two soy-based supplements containing soy protein either without (SuproSoy) or with (Abacor) soy fiber and phospholipids in a randomized placebo-controlled triplearmed study. METHODS: 121 hypercholesterolemic adults (66 females, 55 males) were recruited and randomly assigned to one of three treatments. Over 8 weeks they received daily either 25 g soy protein (as a component of the supplements Abacor or SuproSoy) or 25 g milk protein (as a component of placebo). Serum lipids were measured at baseline and after 4, 6 and 8 weeks. RESULTS: After 8 weeks of supplementation total cholesterol levels were reduced by 8.0 +/- 9.6% (Abacor) and 3.4 +/- 8.3% (SuproSoy); LDL cholesterol levels by 9.7 +/- 11.7% (Abacor) and 5.4 +/- 11.6% (SuproSoy); and Apolipoprotein B levels by 6.9 +/- 14.6% (Abacor) and 4.0 +/- 12.4 % (SuproSoy). Serum levels of HDL cholesterol and triglycerides remained unchanged. CONCLUSIONS: A preparation combining isolated soy protein with soy fibers and phospholipids showed twice the lipid-lowering effect of a preparation containing isolated soy protein alone. Therefore, such soy-based supplements can be useful in reducing the cardiovascular risk.

Anticholesteremic Agents↗

PubMedDate not supplied

Efficacy and tolerability of Hypericum extract STW 3-VI in patients with moderate depression: a double-blind, randomized, placebo-controlled clinical trial.

In this double-blind, randomized, placebo-controlled, prospective study, the clinical efficacy and tolerability of oral Hypericum extract STW 3-VI (Laif) 900 mg once daily was compared with that of placebo. A total of 140 outpatients (94 women; 46 men) with moderate depressive disorders and a 17-item Hamilton Depression Scale (HAMD-17) score of 20 to 24 were enrolled in this study. Following a single-blind placebo run-in period of 7 days, the patients were randomized to Hypericum extract 900 mg or placebo for the 6-week treatment period. Nineteen patients have been excluded from the per protocol collective because of violations of protocol regarding the scheduling of study visits and intake of study medication. The primary endpoint for treatment efficacy was the change in total HAMD-17 score at the end of the 6-week treatment period. The HAMD-17 total score decreased significantly from baseline by approximately 11.1 +/- 4.5 points (from 22.8 +/- 1.1 to 11.8 +/- 4.4) in the Hypericum group and by approximately 3.4 +/- 3.9 points (from 22.6 +/- 1.2 to 19.2 +/- 3.8) in the placebo group (P < .001). Comparable group differences in favor of Hypericum were revealed by an additional responder analysis, the von Zerssen's Adjective Mood Scale, the Clinical Global Impressions scale, and a global efficacy assessment. Tolerability was very good in both groups; neither serious adverse events nor clinically relevant changes in safety parameters were observed, and only 2 cases demonstrated a possible connection between an adverse event and the study medication. The final safety assessment showed no differences between the Hypericum extract and placebo groups. The study provided evidence that Hypericum extract STW 3-VI in a once-daily dosing regimen may be an effective and well-tolerated option for patients with moderate depressive disorders.

Administration, Oral↗

PubMedDate not supplied

Safety and tolerance of ester-C compared with regular ascorbic acid.

The goal of this randomized, double-blind crossover clinical trial in 50 healthy volunteers sensitive to acidic foods was to evaluate whether Ester-C calcium ascorbate causes fewer epigastric adverse effects than are produced by regular ascorbic acid (AA). Volunteers were randomly separated into 2 groups of 25. The study comprised an observation period of 9 days (phase 1 medication for 3 consecutive days, washout phase for 3 consecutive days, phase 2 medication for 3 consecutive days). Participants took 1000 mg vitamin C as Ester-C during phase 1 of the study followed by 1000 mg of vitamin C as AA during phase 2, or vice versa. During the course of the study, 3 examinations for the evaluation of epigastric adverse effects were performed (on days 0, 3, and 9). Participants used a diary to record epigastric adverse effects on a daily basis. In total, 28 (56%) of 50 participants reported 88 epigastric adverse effects of mild to moderate intensity. Of these 88 adverse effects, 33 (37.5%) occurred after intake of Ester-C and 55 (62.5%) were noted after intake of AA. The tolerability of Ester-C was rated "very good" by 72% of participants, whereas AA was rated "very good" by only 54%. This difference is statistically significant (P<.05). Investigators concluded that Ester-C compared with AA caused significantly fewer epigastric adverse effects in participants sensitive to acidic foods and that Ester-C is much better tolerated.

Adult↗