Joerg Gruenwald

Publications

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

  Joerg Gruenwald, Ellen Petzold, Regina Busch, Heinz-Peter Petzold, Hans-Joachim Graubaum

  Advances in therapy. 09/2009;

  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 polyuns... [more] 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 >/=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 >/=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 (>/=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.
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  Therapeutic effect of 1,5-pentanediol for herpes simplex labialis: a randomized, double-blind, placebo-controlled clinical trial.

  Regina Busch, Hans-Joachim Graubaum, Joerg Gruenwald, Jan Faergemann

  Advances in therapy. 08/2009; 26(7):719-27.

  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 effe... [more] 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.

  Joerg Gruenwald, Regina Busch, Christine Bentley

  Clinical and experimental gastroenterology. 01/2009; 2:95-100.

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

  Ralf Uebelhack, Jens-Uwe Blohmer, Hans-Joachim Graubaum, Regina Busch, Joerg Gruenwald, Klaus-Dieter Wernecke

  Obstetrics and gynecology. 02/2006; 107(2 Pt 1):247-55.

  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... [more] 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.

• Devil's Claw (Harpagophytum procumbens DC): an evidence-based systematic review by the Natural Standard Research Collaboration.

  Thomas Brendler, Joerg Gruenwald, Catherine Ulbricht, Ethan Basch

  Journal of herbal pharmacotherapy. 02/2006; 6(1):89-126.

  An evidence-based systematic review including written and statistical analysis of scientific literature, expert opinion, folkloric precedent, history, pharmacology, kinetics/dynamics, interaction, adverse effects, toxicology, and dosing.... [more] An evidence-based systematic review including written and statistical analysis of scientific literature, expert opinion, folkloric precedent, history, pharmacology, kinetics/dynamics, interaction, adverse effects, toxicology, and dosing.
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  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.

  Joerg Gruenwald, Hans-Joachim Graubaum, Regina Busch

  Arzneimittel-Forschung. 01/2006; 56(8):574-81.

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

  Lars H Høie, Eve C A Morgenstern, Joerg Gruenwald, Hans-Joachim Graubaum, Regina Busch, Wolfgang Lüder, Hans-Joachim F Zunft

  European journal of nutrition. 04/2005; 44(2):65-71.

  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 level... [more] 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.
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  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.

  Joerg Gruenwald, Hans-Joachim Graubaum, Regina Busch

  Arzneimittel-Forschung. 02/2005; 55(11):669-76.

  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 o... [more] 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.

• Lemon balm (Melissa officinalis L.): an evidence-based systematic review by the Natural Standard Research Collaboration.

  Catherine Ulbricht, Thomas Brendler, Joerg Gruenwald, Benjamin Kligler, David Keifer, Tracee Rae Abrams, Jen Woods, Heather Boon, Catherine DeFranco Kirkwood, Dana A Hackman, Ethan Basch, Heather J Lafferty

  Journal of herbal pharmacotherapy. 02/2005; 5(4):71-114.

  An evidence-based systematic review including written and statistical analysis of scientific analysis of scientific literature, expert opinion, folkloric precedent, history, pharmacology, kinetic/dynamics, interactions, adverse effect, toxicology, and dosing.... [more] An evidence-based systematic review including written and statistical analysis of scientific analysis of scientific literature, expert opinion, folkloric precedent, history, pharmacology, kinetic/dynamics, interactions, adverse effect, toxicology, and dosing.
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  Safety and tolerance of ester-C compared with regular ascorbic acid.

  Joerg Gruenwald, Hans-Joachim Graubaum, Regina Busch, Christine Bentley

  Advances in therapy. 23(1):171-8.

  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 g... [more] 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.
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  Lipid-lowering effect of 2 dosages of a soy protein supplement in hypercholesterolemia.

  Lars H Høie, Hans-Joachim Graubaum, Andrea Harde, Joerg Gruenwald, Klaus D Wernecke

  Advances in therapy. 22(2):175-86.

  The lipid-lowering effect of a soy-based protein supplement was evaluated in an 8-week randomized, placebo-controlled trial in patients with hypercholesterolemia. A total of 117 patients (63 men and 54 women) received soy protein, either 15 or 25 g/d or placebo. In the active treatment groups low-de... [more] The lipid-lowering effect of a soy-based protein supplement was evaluated in an 8-week randomized, placebo-controlled trial in patients with hypercholesterolemia. A total of 117 patients (63 men and 54 women) received soy protein, either 15 or 25 g/d or placebo. In the active treatment groups low-density lipoprotein cholesterol levels decreased significantly by 5.9% and 1.1% respectively, but increased by 3.6% with placebo. Total serum cholesterol and apolipoprotein B levels changed significantly in a similar manner. High-density lipoprotein cholesterol, triglycerides, homocysteine, folic acid, and vitamin B12 levels did not change significantly compared with baseline in any of the study groups. All preparations were well tolerated. Soy protein 25 g/d was twice as effective as 15 g/d. In conclusion, soy protein supplementation may effectively reduce serum cholesterol levels and therefore is likely to diminish the risk for cardiovascular disease.
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  Efficacy and tolerability of Hypericum extract STW 3-VI in patients with moderate depression: a double-blind, randomized, placebo-controlled clinical trial.

  Ralf Uebelhack, Joerg Gruenwald, Hans-Joachim Graubaum, Regina Busch

  Advances in therapy. 21(4):265-75.

  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-ite... [more] 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.
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  Efficacy and tolerability of a combination of Lyprinol and high concentrations of EPA and DHA in inflammatory rheumatoid disorders.

  Joerg Gruenwald, Hans-Joachim Graubaum, Knuth Hansen, Barbara Grube

  Advances in therapy. 21(3):197-201.

  This 12-week drug-monitoring study was conducted to evaluate the efficacy of Sanhelios Mussel Lyprinol Lipid Complex on 50 adult men and women with inflammatory rheumatoid arthritis. A total of 34 patients required drug therapy before and during the study. By the end of the study, 21 (62%) patients ... [more] This 12-week drug-monitoring study was conducted to evaluate the efficacy of Sanhelios Mussel Lyprinol Lipid Complex on 50 adult men and women with inflammatory rheumatoid arthritis. A total of 34 patients required drug therapy before and during the study. By the end of the study, 21 (62%) patients were able to reduce their dosage and 13 were able to terminate drug therapy. At the end of the treatment period, 38% were regarded symptom free, and the number of patients with severe pain decreased significantly from 60% at baseline to 25% at the completion of the trial. A significant effect was observed for each investigated parameter. The special combination of Lyprinol and omega-3 fatty acids was generally very well tolerated, with only one, nonserious adverse event (mild nausea) reported. This dietary supplement may therefore be considered an effective and well-tolerated component of treatment regimens for inflammatory rheumatoid arthritis.
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  Effect of a probiotic multivitamin compound on stress and exhaustion.

  Joerg Gruenwald, Hans-Joachim Graubaum, Andrea Harde

  Advances in therapy. 19(3):141-50.

  This 6-month study evaluated a probiotic multivitamin preparation in 42 adult men and women suffering from stress or exhaustion. The preparation was taken daily with breakfast. A psychological-neurologic questionnaire assessed psycho-organic, central vegetative, and somatic discomforts, and a valida... [more] This 6-month study evaluated a probiotic multivitamin preparation in 42 adult men and women suffering from stress or exhaustion. The preparation was taken daily with breakfast. A psychological-neurologic questionnaire assessed psycho-organic, central vegetative, and somatic discomforts, and a validated list of adjectives was used to indicate the effect of therapy. At the end of the study, an overall 40.7% improvement in stress was noted, representing significant improvements of 17.4% in positive conditions and of 23.3% in negative conditions (both P<.001). In addition, decreases of 29% in the frequency of infections and of 91% in gastrointestinal discomforts, both established indicators of stress, were recorded. The preparation was well tolerated. This probiotic multivitamin is suitable for reducing stress or exhaustion, or both, as well as for improving the immune system, specifically gastrointestinal health.
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  Effect of cod liver oil on symptoms of rheumatoid arthritis.

  Joerg Gruenwald, Hans-Joachim Graubaum, Andrea Harde

  Advances in therapy. 19(2):101-7.

  In this pilot study, 43 patients with rheumatoid arthritis ingested 1 g of cod liver oil (one capsule) daily for 3 months. Decreases occurred in morning stiffness (52.4%; P<10(-3)), painful (42.7%) and swollen (40%) joints (P= 10(-3) each), and pain intensity (67.5%). Ratings of "good" ... [more] In this pilot study, 43 patients with rheumatoid arthritis ingested 1 g of cod liver oil (one capsule) daily for 3 months. Decreases occurred in morning stiffness (52.4%; P<10(-3)), painful (42.7%) and swollen (40%) joints (P= 10(-3) each), and pain intensity (67.5%). Ratings of "good" or "very good" were awarded by 68% of the patients for efficacy and by 95% for tolerability. Eleven patients reported nonsevere adverse effects that in 3 cases may have been related to the study preparation. Cod liver oil can be recommended for the treatment of rheumatoid arthritis.
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  Efficacy and tolerability of a Rhodiola rosea extract in adults with physical and cognitive deficiencies.

  Volker Fintelmann, Joerg Gruenwald

  Advances in therapy. 24(4):929-39.

  During a 12-wk drug monitoring study, the efficacy and safety of a Rhodiola rosea extract given in combination with vitamins and minerals (vigodana(R)) were tested in 120 adults (83 women and 37 men, ages 50-89 y) with physical and cognitive deficiencies. Two different dosage regimens were chosen. O... [more] During a 12-wk drug monitoring study, the efficacy and safety of a Rhodiola rosea extract given in combination with vitamins and minerals (vigodana(R)) were tested in 120 adults (83 women and 37 men, ages 50-89 y) with physical and cognitive deficiencies. Two different dosage regimens were chosen. One group of 60 patients (group 1) took 2 capsules orally in the morning after breakfast, and the other group (group 2) took 1 capsule after breakfast and 1 after lunch. Three medical examinations were performed during the course of the study (at baseline, after 6 wk, and after 12 wk). The evaluated symptoms were divided into physical disturbances such as exhaustion, decreased motivation, daytime sleepiness, decreased libido, sleep disturbances, and cognitive complaints (eg, concentration deficiencies, forgetfulness, decreased memory, susceptibility to stress, irritability). A statistically highly significant improvement (P<.001) in physical and cognitive deficiencies was observed in the overall group, as well as in the separately evaluated groups 1 and 2. In addition, the time needed to complete a digit connection test decreased significantly in all groups (P<.001). Improvements in group 1 were more pronounced than in group 2, however, indicating that the intake of 2 capsules after breakfast is more effective than the intake of 1 capsule after breakfast and 1 after lunch. Global assessment of efficacy revealed that treatment was "very good" or "good" for 81% of patients, as reported by physicians, and for 80%, as reported by patients. Ninety-nine percent of patients and physicians rated safety as "good" or "very good." No adverse events occurred during the course of the study. The results of this drug monitoring study are very promising, but they still need to be corroborated by future placebo-controlled clinical trials.
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  Ultra heat treatment destroys cholesterol-lowering effect of soy protein.

  Lars H Hoie, Ake Sjoholm, Marie Guldstrand, Hans-Joachim F Zunft, Wolfgang Lueder, Hans-Joachim Graubaum, Joerg Gruenwald

  International journal of food sciences and nutrition. 57(7-8):512-9.

  A randomized, placebo-controlled, double-blind clinical study was performed to investigate the dose-dependent response of serum cholesterol after consuming an ultra-heat-treated milk containing a soy protein preparation. Eighty hypercholesterolemic subjects were assigned to one of four study groups ... [more] A randomized, placebo-controlled, double-blind clinical study was performed to investigate the dose-dependent response of serum cholesterol after consuming an ultra-heat-treated milk containing a soy protein preparation. Eighty hypercholesterolemic subjects were assigned to one of four study groups receiving 12.5 or 25 g soy protein (active treatment) or casein (placebo) daily over a period of 4 weeks. The trial substances were provided as ready-made, ultra-heated milk preparations. Before and after the treatment, serum concentrations of total, low-density lipoprotein, and high-density lipoprotein cholesterol were determined. Unexpectedly, at the end of the study, low-density lipoprotein cholesterol concentrations were significantly increased compared with baseline in all study groups. The magnitude of this increase (17-19%) was similar in all active and placebo study groups. Soy protein supplements previously shown to be effective in reducing serum cholesterol had in this study no such lipid-lowering effect after ultra heat treatment.
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  Effects of soy and other natural products on LDL:HDL ratio and other lipid parameters: a literature review.

  Kjeld Hermansen, Bo Dinesen, Lars H Hoie, Eve Morgenstern, Joerg Gruenwald

  Advances in therapy. 20(1):50-78.

  Abnormal lipid levels contribute significantly to the risk of coronary heart disease, a major cardiovascular disease and a serious health problem. Various dietary and pharmacologic treatments have been devised to reduce elevated blood cholesterol levels. Soy protein, soluble fiber, and plant sterol/... [more] Abnormal lipid levels contribute significantly to the risk of coronary heart disease, a major cardiovascular disease and a serious health problem. Various dietary and pharmacologic treatments have been devised to reduce elevated blood cholesterol levels. Soy protein, soluble fiber, and plant sterol/ester-containing margarines are promising new food-component candidates that may help to realize this goal. Of particular interest in this context is the LDL:HDL ratio, a strong predictor of cardiac events. This report is a review of more than 50 recent trials to determine how such dietary components and garlic affect the LDL:HDL ratio and other lipid parameters. Consumption of new soy products containing high, fixed levels of isoflavones, cotyledon soy fiber, and soy phospholipids (Abaco and Abalon) significantly reduced the LDL:HDL ratio by up to 27%. Soluble dietary fibers such as psyllium and beta glucan from oat bran had a variable effect on LDL-cholesterol levels in the studies analyzed. Plant sterol esters, when consumed in margarines, lowered the LDL:HDL ratio by up to 22%. On average, Abacor and Abalon reduced the LDL:HDL ratio by 20%, LDL cholesterol by 15%, total cholesterol by 10%, and triglycerides by 6%, and increased HDL cholesterol by 5%. The new soy-based supplements may therefore play a valuable role in reducing cardiovascular risk.
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  Nutritional supplementation: is it necessary for everybody?

  Elmar Wienecke, Joerg Gruenwald

  Advances in therapy. 24(5):1126-35.

  Mineral nutrients, vitamins, and trace elements are essential for the growth and development of a multicellular organism. Today, an adequate supply of nutrients is often unattainable solely through a well-balanced diet, so a targeted, individually designed dietary supplement regime is necessary. Nut... [more] Mineral nutrients, vitamins, and trace elements are essential for the growth and development of a multicellular organism. Today, an adequate supply of nutrients is often unattainable solely through a well-balanced diet, so a targeted, individually designed dietary supplement regime is necessary. Nutrient deficiency, which is impossible to detect through plasma levels alone, is reliably detected through the intracellular measurement of the nutrient levels in the blood. Two case studies presented here indicate the need for supplementation as improvement in nutritional behavior could not replenish already exhausted nutrient reservoirs. Only supplementation was able to significantly boost nutrient levels and confer beneficial effects on general welfare, physical performance, and resistance to infections. Therefore, it appears that nutritional supplements are advisable for everyone, but more research is needed, especially on an intracellular level, to corroborate these findings.
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  Hypericum perforatum versus fluoxetine in the treatment of mild to moderate depression.

  Kirsten Behnke, Gert Saaby Jensen, Hans-Joachim Graubaum, Joerg Gruenwald

  Advances in therapy. 19(1):43-52.

  In a randomized, controlled, double-blind trial, 70 patients (mean age, 49.7 years) suffering from mild to moderate depression received one tablet of either St. John's Wort (Hypericum perforatum) extract (Calmigen) or fluoxetine hydrochloride (Prozac) twice a day for 6 weeks. Efficacy was determ... [more] In a randomized, controlled, double-blind trial, 70 patients (mean age, 49.7 years) suffering from mild to moderate depression received one tablet of either St. John's Wort (Hypericum perforatum) extract (Calmigen) or fluoxetine hydrochloride (Prozac) twice a day for 6 weeks. Efficacy was determined according to the 17-item Hamilton Rating Scale for Depression (HAMD), the von Zerssen depression scale (DS), Clinical Global Impression (CGI), and patients' overall evaluation. Significant decreases (P<.001) of 50% in the Hypericum group and 58% in the fluoxetine group in the HAMD score and of 42% and 52% on the DS spoke to the efficacy of both medications. The Hypericum extract achieved 83% of the efficacy of fluoxetine on the HAMD and 78% on the DS. Assessments by physicians (CGI) and patients indicated considerable improvement with no between-treatment differences. Of the 9 dropouts (13%), 2 in the Hypericum group and 2 in the fluoxetine group were due to adverse reactions. Safety evaluations demonstrated only minor changes. The Hypericum preparation tested in this study is therapeutically equivalent to fluoxetine and is therefore a rational alternative to synthetic antidepressants.