Effects of cactus fiber on the excretion of dietary fat in healthy subjects: a double blind, randomized, placebo-controlled, crossover clinical investigation.

BACKGROUND: Cactus (Opuntia ficus-indica) fiber was shown to promote weight loss in a 3-month clinical investigation. As demonstrated by in vitro studies, cactus fiber binds to dietary fat and its use results in reduced absorption, which in turn leads to reduced energy absorption and ultimately the reduction of body weight. OBJECTIVE: The objective of our study was to elucidate the dietary fat binding capacity of cactus fiber through determination of fecal fat excretion in healthy volunteers. SUBJECTS AND METHODS: This clinical investigation was performed as a double-blind, randomized, placebo-controlled, crossover study in healthy subjects for a period of approximately 45 days. Twenty healthy volunteer subjects were randomized to receive cactus fiber or placebo, 2 tablets thrice daily with main meals. All subjects were provided with meals during the study period (except washout) according to a standardized meal plan, with 35% of daily energy need coming from fat. Two 24-hour feces samples were collected during both the baseline and treatment periods for analysis of the fat content. RESULTS: Cactus fiber showed an increased fecal fat excretion compared with placebo (mean [SD] = 15.79% [5.79%] vs 4.56% [3.09%]; P < 0.001). No adverse events were reported throughout the study period. CONCLUSIONS: Cactus fiber has been shown to significantly promote fecal fat excretion in healthy adults. The results of our study support the hypothesis that cactus fiber helps in reducing body weight by binding to dietary fat and increasing its excretion, thus reducing dietary fat available for absorption. ClinicalTrials.gov identifier: NCT01590667.

Yeast (1,3)-(1,6)-beta-glucan helps to maintain the body's defence against pathogens: a double-blind, randomized, placebo-controlled, multicentric study in healthy subjects.

PURPOSE: The effect of brewers' yeast (1,3)-(1,6)-beta-D-glucan consumption on the number of common cold episodes in healthy subject was investigated. METHODS: In a placebo-controlled, double-blind, randomized, multicentric clinical trial, 162 healthy participants with recurring infections received 900 mg of either placebo (n = 81) or an insoluble yeast (1,3)-(1,6)-beta-D-glucan preparation (n = 81) per day over a course of 16 weeks. Subjects were instructed to document each occurring common cold episode in a diary and to rate ten predefined infection symptoms during an infections period, resulting in a symptom score. The subjects were examined by the investigator during the episode visit on the 5th day of each cold episode. RESULTS: In the per protocol population, supplementation with insoluble yeast (1,3)-(1,6)-beta-glucan reduced the number of symptomatic common cold infections by 25% as compared to placebo (p = 0.041). The mean symptom score was 15% lower in the beta-glucan as opposed to the placebo group (p = 0.125). Beta-glucan significantly reduced sleep difficulties caused by cold episode as compared to placebo (p = 0.028). Efficacy of yeast beta-glucan was rated better than the placebo both by physicians (p = 0.004) participants (p = 0.012). CONCLUSION: The present study demonstrated that yeast beta-glucan preparation increased the body's potential to defend against invading pathogens.

Double-blind comparison of two types of benzocaine lozenges for the treatment of acute pharyngitis.

In a reference-controlled double-blind trial in patients with acute pharyngitis the effects of a newly developed lozenge containing 8 mg of benzocaine (p-aminobenzoic acid ethyl ester, CAS 94-09-7) were compared with those of an identically dosed commercial pastille. 246 patients were randomized to receive either the lozenges (group A, n = 123) or the pastilles (group B, n = 123). Each patient took a total of six doses within 12 h according to the double-dummy principle, with each single dose spaced by 2 h. The primary parameter was the assessment of the responder rate with = 50 % pain relief within 15 min post application. Further parameters included the relative relief of pain in the course of the study and the tolerability of the formulation. After application of the first unit the comparison of groups yielded very similar and statistically not differing results for efficacy in both groups, with responder rates of 25.2 % and 22.0 % in groups A and B, respectively. One adverse drug reaction was observed in group B (burning and tingling feeling on the tongue), which, however, did not lead to discontinuation of study participation. In all other cases tolerability was stated to be "good to very good". The application of the benzocaine lozenges was statistically non-inferior to the use of the pastilles.

Effect of glucosamine sulfate with or without omega-3 fatty acids in patients with osteoarthritis.

INTRODUCTION: A total of 177 patients with moderate-to-severe hip or knee osteoarthritis (OA) were tested over a period of 26 weeks in a two-center, two-armed, randomized, double-blind, comparison study. The aim was to see if a combination of glucosamine sulfate (1500 mg/day) and the omega-3 polyunsaturated fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (group A), showed equivalence (noninferiority) or superiority as opposed to glucosamine sulfate alone (group B). METHODS: The primary therapy evaluation was performed using the Western Ontario and McMaster Universities Arthrosis index (WOMAC) score. At the end of the study, a reduction in the pain score of > or =20% was required (primary target criterion) and the quantitative difference in the WOMAC subscores pain, stiffness, and function were analyzed (secondary target criteria). RESULTS AND CONCLUSION: When a minimal pain reduction of > or =20% was chosen, there was no statistically significant difference in the number of responders between the two groups (92.2% group A, 94.3% group B). A higher responder criterion (> or =80% reduction in the WOMAC pain score) was chosen. Therefore, the frequency of responders showed a therapeutic and statistical superiority for the combination product of glucosamine sulfate and the omega-3 polyunsaturated fatty acids in patients who complied with the study protocol (group A 44%, group B 32%; P=0.044). OA symptoms (morning stiffness, pain in hips and knees) were reduced at the end of the study: by 48.5%-55.6% in group A and by 41.7%-55.3% in group B. The reduction was greater in group A than in group B. There was a tendency toward superiority shown in the secondary target criteria and concurrent variables. In the global safety evaluation, both products have been demonstrated to be very safe in long-term treatment over 26 weeks. To our knowledge, this is the first clinical trial in which glucosamine was given in combination with omega-3 fatty acids to patients with OA.

Therapeutic effect of 1,5-pentanediol for herpes simplex labialis: a randomized, double-blind, placebo-controlled clinical trial.

INTRODUCTION: Most episodes of recurrent herpes labialis are self-limited and mild, but can be troublesome when they occur frequently with painful and unsightly lesions. Therefore, there has been much interest in developing agents that can suppress outbreaks in addition to being therapeutically effective. The objective of the present study was to examine the prophylactic and therapeutic efficacy of 1,5-pentanediol (PD) gel in patients with recurrent episodes of herpes labialis. METHODS: In this placebo-controlled, randomized, double-blind clinical trial, a total of 105 patients with frequent episodes of recurrent herpes were randomized to either PD or placebo. During the 26-week prophylactic phase of the study, the patients applied PD gel or placebo gel twice daily to both lips. Upon recurrence of an episode, a 5-day therapy phase started during which the gel was to be applied eight times daily. After the therapy phase, the patient resumed prophylactic treatment twice daily until the next herpes episode. The main outcome measures were number of herpes episodes during the prophylactic phase of 26 weeks, and successful therapy of occurring herpes episodes with a 5-day treatment. RESULTS: There was no significant difference in recurrence rate between the two groups (P>0.05). During recurrence there was a statistically significant improvement regarding the therapeutic effect of the symptoms "blistering," "swelling," and "pain" in the PD group. The global evaluation of efficacy by the investigators and patients showed a statistically significant superiority for PD as opposed to placebo (P<0.001). CONCLUSION: Under the conditions used in the present study, PD did not show any prophylactic effect against recurrence of herpes episodes. A significantly better therapeutic effect of PD over placebo could be demonstrated on the symptoms "blistering," "swelling," and "pain." PD was very safe as no side effects were observed during the course of the study.

Efficacy and tolerability of Laxatan Granulat in patients with chronic constipation.

BACKGROUND: On average 12% of the population worldwide suffer from acute or chronic constipation. Pathological intestine alterations, an unhealthy diet with reduced liquid intake, and little exercise are potential reasons. Often the motility of the intestine is disturbed. Changing nutrition habits or lifestyle is not always successful. In such cases, laxatives containing macrogol and inulin are highly effective. METHODOLOGY: The efficacy and tolerability of Laxatan(®) Granulat, a laxative containing macrogol, inulin, and mineral salts, was assessed in a drug-monitoring study of 105 patients for four weeks. RESULTS: At the end of this study, a highly significant reduction of the constipation symptoms in 98.1% of the patients was observed. No adverse events were reported during this drug-monitoring study. The overall efficacy was rated as being "very good" or "good" for 96% and the overall tolerability was rated as being "very good" or "good" for 99% of patients. CONCLUSION: The combination of macrogol, inulin, and mineral salts is highly effective in the treatment of chronic constipation. Due to its prebiotic activity, inulin probably leads to proliferation of lactic acid-producing bacteria. The lowered pH and increased water content probably increases the peristaltic action and therefore reduces constipation.

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.

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.

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.

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.

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.

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.