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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.

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.

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.

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.

This study was undertaken to compare the effects on plasma cholesterol concentration of a new isolated soy protein in which the protein structure is kept in its native, nondenaturated form (verum 1) versus a conventional isolated soy protein (verum 2) and milk protein (placebo). This prospective, randomized, double-blind, placebo-controlled study was conducted in an outpatient clinical study center in Berlin, Germany. Over 8 wk, 120 patients (total cholesterol, 5.2-7.8 mmol/L) were given verum 1, verum 2, or placebo at a dosage of 25 g protein daily. At the end of the treatment period, total cholesterol levels were significantly reduced by 10.7% in the verum 1 group compared with placebo (P<.001), and levels were reduced by 5.8% in the verum 2 group (P=.008). The difference between the 2 verum groups was statistically significant (P=.008). Low-density lipoprotein cholesterol levels were significantly reduced with nondenaturated isolated soy protein only: levels were reduced by 9.4% in the verum 1 group (P=.002) and by 4.9% in the verum 2 group (P=.107). Again, the difference between the verum groups was significant (P=.05). The results of this study confirm that supplementation with isolated soy protein can lead to significant reductions in plasma concentrations of total and low-density lipoprotein cholesterol. These reductions are significantly more pronounced with an isolated soy protein that maintains the native protein structure than with a commercially available reference isolated soy protein.

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.

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.

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.

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.

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.

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.

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.

This double-blind, placebo-controlled study assessed the efficacy of 3 weeks of impulse magnetic-field therapy for erectile dysfunction (ED). Twenty volunteers who suffered from ED or orgasmic disturbances were randomly assigned to either active treatment or placebo (n = 10 each). Efficacy was assessed in terms of intensity and duration of erection, general well-being, sexual activity, and warm sensation in the genital area. In the active-treatment group, all efficacy endpoints were significantly improved at study end (P < or = .01), with 80% reporting increases in intensity and duration of erection, frequency of genital warmth, and general well-being. The remaining 20%, who experienced minor improvements, were found to have an influenza-like infection after the study that may have influenced their results. Only 30% of the placebo group noted some improvement in their sexual activity; 70% had no change. No side effects were reported.

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.

The lipid-lowering effect of a carob pulp preparation rich in insoluble dietary fiber and polyphenols was investigated in a noncomparative, open-label pilot study. Over 8 weeks, 47 volunteers with moderate hypercholesterolemia (total cholesterol 232-302 mg/dL) consumed 15 g of carob per day in three products (breakfast cereal, fruit muesli bar, powdered drink) as a supplement to their regular diet. After 4 weeks, reductions of 7.1% in mean total cholesterol and 10.6% in LDL cholesterol were noted; respective decreases after 6 weeks were 7.8% and 12.2% (all P<.001). HDL cholesterol and triglyceride levels remained unchanged. Overall compliance was good. Only 3 volunteers (6%) reported a sensation of fullness, which led to 2 of the 3 dropouts. The carob preparation may have value in the dietary treatment of hypercholesterolemia.

This 4-week double-blind, placebo-controlled study assessed the efficacy of impulse magnetic-field therapy for insomnia. One hundred one patients were randomly assigned to either active treatment (n = 50) or placebo (n = 51) and allocated to one of three diagnostic groups: (1) sleep latency; (2) interrupted sleep; or (3) nightmares. Efficacy endpoints were intensity of sleep latency, frequency of interruptions, sleepiness after rising, daytime sleepiness, difficulty with concentration, and daytime headaches. In the active-treatment group, the values of all criteria were significantly lower at study end (P < .00001). The placebo group also showed significant symptomatic improvement (P < .05), but the differences between groups were highly significant (P < .00001). Seventy percent (n = 34) of the patients given active treatment experienced substantial or even complete relief of their complaints; 24% (n = 12) reported clear improvement; 6% (n = 3) noted a slight improvement. Only one placebo patient (2%) had very clear relief; 49% (n = 23) reported slight or clear improvement; and 49% (n = 23) saw no change in their symptoms. No adverse effects of treatment were reported.

This double-blind, placebo-controlled study assessed the efficacy of 4 weeks of impulse magnetic-field therapy (16 Hz, 5 microTs), delivered through a small device, for different types of headache and migraine. Eighty-two patients were randomly assigned to receive either active treatment or placebo (n = 41 each) and were characterized according to one of seven diagnoses (migraine, migraine combined with tension, tension, cluster, weather-related, posttraumatic, or other). Efficacy was assessed in terms of duration, severity, and frequency of migraine and headache attacks, as well as ability to concentrate. Data for 77 patients were analyzed. In the active-treatment group, all assessed criteria were significantly improved at the end of the study (P < .0001 vs baseline and placebo). Seventy-six percent of active-treatment patients experienced clear or very clear relief of their complaints. Only 1 placebo-patient (2.5%) felt some relief; 8% noted slight and 2% reported significant worsening of symptoms. No side effects were noted.

Ginger is well known in the form of ginger sticks or ginger ale. If these are consumed during travel, the traveler imbibes, albeit subconsciously, a healing plant for motion sickness. The efficacy of ginger rhizome for the prevention of nausea, dizziness, and vomiting as symptoms of motion sickness (kinetosis), as well as for postoperative vomiting and vomiting of pregnancy, has been well documented and proved beyond doubt in numerous high-quality clinical studies. The use of this ancient medicine for gastrointestinal problems (stimulation of digestion) has been given scientific approval. Today, medicinal ginger is used mainly for prevention of the symptoms of travel sickness.