The effectiveness of a standardized rose hip powder, containing seeds and shells of Rosa canina, on cell longevity, skin wrinkles, moisture, and elasticity.

OBJECTIVE: To evaluate the effects of a rose hip powder (Hyben Vital(®)) made from seeds and shells on cell senescence, skin wrinkling, and aging. METHODS: A total of 34 healthy subjects, aged 35-65 years, with wrinkles on the face (crow's-feet) were subjected to a randomized and double-blinded clinical study of the effects of the rose hip powder, as compared to astaxanthin, a well-known remedy against wrinkles. During the 8-week study, half of the participants ingested the standardized rose hip product, while the other half ingested astaxanthin. Objective measurements of facial wrinkles, skin moisture, and elasticity were made by using Visioscan, Corneometer, and Cutometer at the beginning of the study, after 4 weeks, and after 8 weeks. Evaluation of participant satisfaction of both supplements was assessed using questionnaires. In addition, the effect of the rose hip preparation on cell longevity was measured in terms of leakage of hemoglobin through red cell membranes (hemolytic index) in blood samples kept in a blood bank for 5 weeks. Significance of all values was attained with P≤0.05. RESULTS: In the double-blinded study, the rose hip group showed statistically significant improvements in crow's-feet wrinkles (P<0.05), skin moisture (P<0.05), and elasticity (P<0.05) after 8 weeks of treatment. A similar improvement was observed for astaxanthin, with P-values 0.05, 0.001, and 0.05. Likewise, both groups expressed equal satisfaction with the results obtained in their self-assessment. The rose hip powder further resulted in increased cell longevity of erythrocyte cells during storage for 5 weeks in a blood bank. CONCLUSION: Results suggest that intake of the standardized rose hip powder (Hyben Vital(®)) improves aging-induced skin conditions. The apparent stabilizing effects of the rose hip product on cell membranes of stored erythrocyte cells observed in this study may contribute to improve the cell longevity and obstructing skin aging.

Rose hip herbal remedy in patients with rheumatoid arthritis - a randomised controlled trial.

OBJECTIVE: To investigate if standardised powder made from rose-hip (Rosa canina) can reduce the symptom score in patients with rheumatoid arthritis. METHODS: In a double-blind placebo-controlled trial, patients with rheumatoid arthritis (RA) according to ARA/ACR criteria were randomised to treatment with capsulated rose-hip powder 5g daily or matching placebo for 6 months at two outpatient clinics in Berlin and Copenhagen. Primary outcome variable was Health Assessment Questionnaire (HAQ) at 6 months, secondary outcome included DAS-28, physician's global evaluation of disease activity, RAQoL, SF-12 and concomitant pain medication. RESULTS: In a total of 89 patients (90% female, mean age 56.6+11.3 years, mean disease duration 12.8+9.6 years) HAQ-DI in the rose-hip group improved by 0.105+/-0.346, whereas in the placebo group it worsened by 0.039+/-0.253 (p adjusted=0.032). In the HAQ Patient Pain Scale no significant differences were observed between both groups. In the HAQ Patient Global Scale a trend was seen favouring rose-hip (p=0.078). The DAS-28 score yielded improvement in the rose-hip group of 0.89+/-1.32 and in the placebo group of 0.34+/-1.27 (p=0.056) indicating moderate clinical relevance. The Physicians Global Scale demonstrated more improvement in the rose-hip compared to the placebo group (p=0.012). RAQoL and SF-12 physical score improved significantly in the rose-hip group compared to placebo, whereas SF-12 mental score remained unchanged. Intake of pain medication was not different between the groups. Per-protocol analysis confirmed these results. CONCLUSION: The results indicate that patients with RA may benefit from additional treatment with rose hip powder.

The efficacy of St. John's Wort in patients with minor depressive symptoms or dysthymia--a double-blind placebo-controlled study.

INTRODUCTION: We studied the efficacy of St. John's Wort compared with placebo in patients with minor depressive symptoms or dysthymia, with the main focus on which diagnostic entities are optimally amenable to treatment with two different doses of Hypericum, and which are not. METHODS: One hundred and fifty patients, 25-70 years old, meeting ICD-10 criteria for mild or moderately severe depressed episodes or with dysthymia, and having a 17-item Hamilton Depression Scale for Depression (HAM-D) total score between 7 and 17, were randomly assigned to an extract. The extract, PM235, manufactured by Cederroth International AB, Sweden, was given t.i.d. in a lower (0.12% hypericine) or a higher (0.18% hypericine) formulation, based on 270mg extractions or identical placebo. Clinical response was defined by HAM-D as a 50% reduction and/or a score 7. The Beck Depression Inventory (BDI) and Visual Analog Scales (VAS) were used as secondary efficacy parameters. Measures were conducted at screening, baseline, and after 3 and 6 weeks of treatment. RESULTS: We found a large discrepancy in response between dysthymic and non-dysthymics, the latter seemingly more sensitive to Hypericum. HAM-D showed tendency but no significance toward a more frequent improvement of the non-dysthymics treated with Hypericum (p=0.057). BDI criteria showed significance (p=0.045) for both doses of Hypericum compared to placebo. Pooling high- and low-dose groups together, a significant reduction for HAM-D7 and BDI criteria was found among non-dysthymic patients (p=0.03). Significant improvement in response to Hypericum was found in symptoms reflected by VAS - again only in non-dysthymic patients (p=0.041). DISCUSSION: We observed, a tendency toward a more frequent significant improvement of the non-dysthymic patient treated with PM235, though this did not reach the level of statistical significance. In a secondary analysis, pooling both hypericine-treated groups concluded that Hypericum has a clinical significant effect in minor depressed patients with HAM-D up to 17. This finding was significant only in non-dysthymic patients.

A powder made from seeds and shells of a rose-hip subspecies (Rosa canina) reduces symptoms of knee and hip osteoarthritis: a randomized, double-blind, placebo-controlled clinical trial.

OBJECTIVE: The aim of this study was to determine whether a herbal remedy made from a subspecies of rose-hip (Rosa canina) might reduce symptoms of osteoarthritis and consumption of rescue medication in patients suffering from osteoarthritis. METHODS: Ninety-four patients with osteoarthritis of the hip or knee were enrolled in a randomized, placebo-controlled, double-blind crossover trial. Forty-seven patients were given 5 g of the herbal remedy daily for a period of 3 months and the remaining patients were given a similar amount of placebo. The group initially treated with placebo was then changed to rose-hip and vice versa for another 3-month period. Upon inclusion and after 3 weeks and 3 months of each treatment period, pain, stiffness, disability, and global severity of the disease were scored on a Western Ontario and McMaster Universities (WOMAC) questionnaire. After 3 weeks of treatment, patients, if possible, were allowed to reduce their consumption of 'rescue medication'. Data were analysed on the basis of intention to treat. RESULTS: Rose-hip resulted in a significant reduction in WOMAC pain (p<0.014) as compared to placebo, when testing after 3 weeks of treatment. The consumption of 'rescue medication' significantly declined as a result of active treatment (p<0.027). WOMAC disability, stiffness, and global assessment of severity of the disease were not altered by 3 weeks but decreased significantly (p<0.018, p<0.038, and p<0.035, respectively) after 3 months of treatment. CONCLUSION: The data suggest that the present herbal remedy can alleviate symptoms of osteoarthritis and reduce the consumption of 'rescue medication'.

Femal, a herbal remedy made from pollen extracts, reduces hot flushes and improves quality of life in menopausal women: a randomized, placebo-controlled, parallel study.

BACKGROUND: The fact that hormone replacement therapy has been claimed to increase the risk of breast cancer has made it relevant to search for new non-hormonal treatments of menopausal symptoms. OBJECTIVES: This study aimed to evaluate whether Femal, a herbal remedy made from pollen extracts, alleviates the symptoms of the menopause, especially hot flushes. DESIGN: A randomized, double-blind, placebo-controlled, parallel trial of 64 menopausal women, of whom 54 completed the trial. After an initial run-in phase of 1 month, the women were randomly given either two Femal tablets each morning, or two identical placebo tablets, for 3 months of treatment. On inclusion, and then at 4-week intervals, the patients were asked to evaluate 16 symptoms of the menopause using Menopause Rating Scales (MRS). In addition, every day throughout the study, certain menopausal symptoms were recorded in a diary. RESULTS: The two treatment groups were identical regarding demographic data and the initial symptom scores. In the active-treatment group, 65% responded with a reduction in hot flushes compared with 38% in the placebo group (p<0.006) and, in this group, the number of hot flushes registered in diaries declined after 3 months by 27% as compared to the placebo group (p<0.026). MRS evaluation of hot flushes yielded similar results (p<0.031). There were 23% and 22% decreases in hot flushes after 2 and 3 months of treatment, respectively, and after both intervals of time the inter-group comparisons were significantly affected. An overall evaluation of the trend in 15 other 'quality-of-life' parameters showed likewise in favor of the pollen extract (p<0.031). CONCLUSION: The pollen extract Femal significantly reduces hot flushes and certain other menopausal symptoms when compared to placebo.

No effect of taurine on platelet aggregation in men with a predisposition to type 2 diabetes mellitus.

Any diet therapy that potentially could affect platelet function would also influence the initiation of atherosclerotic plaque formation which is an important complication of diabetes mellitus eventually resulting in myocardial infarction and stroke. Blood platelets are rich in taurine, and it has been shown that taurine inhibits platelet aggregation in healthy subjects. The purpose was to examine the effect of taurine supplementation on platelet aggregation in high-risk subjects with a positive family history of T2DM. Twenty healthy men were included in a double-blinded, randomized, crossover study, receiving daily supplementation of 1.5 g taurine or placebo for two 8-week periods. Subjects were overweight and first-degree relatives of T2DM patients. At the end of each treatment, fasting blood samples for assessment of platelet aggregation was drawn. Platelet aggregation was induced by ADP. Plasma taurine concentration was significantly greater after taurine intervention compared to placebo (131.4+/-61.7 vs. 38.9+/-6.7 micromol/l, P<0.0001). There was no difference in the threshold level for complete platelet aggregation induced by ADP in vivo between placebo and taurine intervention (placebo 3.86+/-2.21 vs. taurine 3.86+/-3.25 micromol/l). Supplementation with 1.5 g of taurine for 8 weeks had no effect on platelet aggregation in overweight prediabetic men.

A herbal remedy, Hyben Vital (stand. powder of a subspecies of Rosa canina fruits), reduces pain and improves general wellbeing in patients with osteoarthritis--a double-blind, placebo-controlled, randomised trial.

The treatment of osteoarthritis, a disease that eventually affects the majority of the older population, involves the alleviation of symptoms such as pain and stiffness, and the reduction of inflammation. The double-blind, placebo-controlled, crossover study reported here examined the effect of Hyben Vital, a herbal remedy made from a subtype of Rosa canina and recently reported to have anti-inflammatory properties, on the symptoms of osteoarthritis. One hundred and twelve patients with osteoarthritis were randomly allocated to treatment with either Hyben Vital 5 g daily or an identical placebo for 3 months, followed immediately by the alternative treatment. The patients assessed changes in joint pain and stiffness after each treatment period on a 5-point categorical scale. General wellbeing, including mood, sleep quality and energy were also assessed and recorded in a personal diary. The results in the two arms of the crossover differed markedly. Group A (placebo first) showed significantly more improvement from Hyben Vital than from placebo, p < 0.0078 for pain and < 0.0025 for stiffness. But Group B (Hyben Vital first) revealed a positive effect of the same order as for Hyben Vital in group A, not only from the active drug, but also from placebo (difference not significant). An identical pattern was observed when we evaluated general wellbeing from the diary records. When patients, on the basis of reduction in joint pain, were divided into responders and non-responders, the first 3 months of active treatment (group A) showed a response rate of 31/47 (66%) compared to that of placebo (group B) 18/50 (36%), p < 0.0185. No major side effects occurred in either group. The data indicate that Hyben Vital reduces the symptoms of osteoarthritis. We interpret the marked differences in the responses of the two groups as indicating a strong "carryover" effect of Hyben Vital.

Effects of a Ginkgo biloba extract on forearm haemodynamics in healthy volunteers.

The aim was to validate possible vasodilating effects of a Ginkgo biloba extract with a secondary aim of finding a pharmacodynamic signal relating to the active component of these extracts. We studied the effect of G. biloba extract on forearm haemodynamics in 16 healthy subjects (nine females, seven males) with a median age of 32 years (range: 21-47). The study was conducted as a randomized, double-blinded cross-over design using oral treatment with G. biloba extract (Gibidyl Forte(R) t.i.d. or placebo for 6 weeks. Forearm blood flow and venous capacity were measured by strain-gauge plethysmography. Blood pressure was measured by standard sphygmomanometry, and forearm vascular resistance (FVR) was derived. Measurements were made at baseline and after 3, 6, 9 and 12 weeks of treatment. Forearm blood flow was significantly higher during active treatment after 3 and 6 weeks as compared with placebo treatment for 3 and 6 weeks (P<0.05). Mean arterial blood pressure was unchanged, making the calculated FVR significantly lower during active treatment (P<0.02). It is concluded that oral treatment with a G. biloba extract (Gibidyl Forte(R)) is able to dilate forearm blood vessels causing increments in regional blood flow without changing blood pressure levels in healthy subjects. The increments in blood flow may be used as a biological signal for pharmacokinetic studies.

A botanical compound, Padma 28, increases walking distance in stable intermittent claudication.

Thirty-six patients with a median age of sixty-seven years and a median duration of intermittent claudication of five years were randomized to either active treatment with Padma 28 or placebo. The effect of treatment was quantified by measurements of systemic and peripheral systolic blood pressures and by measurements of the pain-free and the maximal walking distance on a treadmill. The ankle pressure index (ankle systolic pressure/arm systolic pressure) was calculated. The group randomized to active treatment received two tablets bid containing 340 mg of a dried herbal mixture composed according to an ancient lamaistic preparation (Padma 28). After active treatments, administered over a period of four months in a double-blinded, randomized design, the patients allocated to this group attained a significant increase in the pain-free walking distance from 52 m (20-106) to 86 m (24-164; P < 0.05) and in the maximal walking distance from 115 m (72-218) to 227 m (73- > 1,000; P < 0.05). The patient-group receiving placebo treatments did not show any significant changes in either the painfree or the maximal walking distance. The authors could not demonstrate any significant changes in the ankle pressure index either during active or during placebo treatment. In conclusion, this study has shown that treatment with Padma 28 over a period of four months significantly increased the walking distance in patients with stable, intermittent claudication of long duration.

[LongoVital in the prevention of recurrent aphthous stomatitis. 1]. / LongoVital i forebyggelsen af recidiverende aftøs stomatit. 1.

LongoVital (LV) (DK. reg. no. 5178/75) is a herbal based tablet enriched with recommended doses of vitamins. The present study was undertaken to investigate prevention of recurrent aphthous ulceration (RAU) during daily intake of LV for six months as compared with placebo in a double-blind, randomised clinical, cross-over 1-year study. The population comprised 29 otherwise healthy minor RAU patients (18F, 11M) mean age 36 (18-67), with an estimated average number of recurrences the previous year of 12.8 (3-30). The number of recurrences was significantly reduced on treatment with LV during the latter four of the six months (p less than 0.01) where 31% were totally free of recurrences. Subjective all-over evaluation of treatment period was significantly in favour of LV. LV induced no adverse reactions and is the first harmless systemic treatment which has proved better than placebo in the prevention of RAU.

[Immunomodulating effect of LongoVital in patients with recurrent aphthous stomatitis. 2]. / Immunmodulerende effekt af LongoVital hos patienter med recidiverende aftøs stomatit. 2.

LongoVital (LV) (DK. reg. no. 5178/75) is a herbal-based tablet enriched with recommended doses of vitamins. Peripheral lymphocyte subsets: T-helper/CD4 (OKT4+) and T-suppressor/cytotoxic/CD8 (OKT8+) were studied quantitatively in 31 otherwise healthy patients with minor recurrent aphthous ulceration (RAU) during six months' daily LV intake in a double-blind, randomised, crossover 1-year study. Fourteen had had LV during the first six months (GrA) and 17 LV during the latter six months (GrB). OKT4+ percentages increased significantly during the LV period in both groups (p less than 0.05). OKT8+ percentages increased in both groups, however, only significantly in GrA (P less than 0.05). It is concluded that LV acts as an immunostimulator in patients with RAU and that the increase in T-lymphocyte subsets may account for the previously reported benefit of LV in RAU prevention.

LongoVital in the prevention of recurrent aphthous ulceration.

LongoVital (LV) (DK. Reg. No. 5178/75) is a herbal based tablet enriched with recommended doses of vitamins. The present study was undertaken to investigate prevention of recurrent aphthous ulceration (RAU) during 6 months' daily intake of LV as compared with placebo in a double-blind, randomized clinical, cross-over 1-yr study. The population comprised 29 otherwise healthy minor RAU patients (18 F, 11 M), mean age 36 (18-67), with an estimated average number of recurrences the previous year of 12.8 (3-30). The number of recurrences was significantly reduced on LV the latter 4 of the 6 months (P less than 0.01) where 31% were totally free of recurrences. Subjective all-over evaluation of treatment period was significantly in favor of LV. LV induced no adverse reactions and is the first harmless systemic treatment which has proved better than placebo in the prevention of RAU.

Immunomodulation by LongoVital in patients with recurrent aphthous ulceration.

LongoVital (LV) (DK. Reg. No. 5178/75) is a herbal based tablet enriched with recommended doses of vitamins. Peripheral lymphocyte subsets: T-helper/CD4 (OKT4+) and T-suppressor/cytotoxic/CD8 (OKT8+) were studied quantitatively in 31 otherwise healthy patients with minor recurrent aphthous ulceration (RAU) during 6 months' daily LV intake in a double-blind, randomized, crossover 1-year study. Fourteen had had LV during the first 6 months (GrA) and 17 LV during the latter 6 months (GrB). OKT4+ percentages increased significantly during the LV period in both groups (P less than 0.05). OKT8+ percentages increased in both groups, however, only significantly in GrA (P less than 0.05). It is concluded that LV acts as an immunostimulator in patients with RAU and that the increase in T-lymphocyte subsets may account for the previously reported benefit of LV in RAU prevention.