Effect of Korean red ginseng on cold hypersensitivity in the hands and feet: study protocol for a randomized controlled trial.

BACKGROUND: Cold hypersensitivity in the hands and feet (CHHF) is one of the most common complaints among Asians, especially in women. Korean red ginseng (KRG), which is a steamed form of Panax ginseng, has vasodilating action in the peripheral vessels and increases blood flow under cold stress. However, few studies have evaluated the effect of KRG on cold hypersensitivity. METHODS/DESIGN: This trial is a randomized, double-blind, placebo-controlled trial in 80 CHHF patients. The trial will be implemented at Kyung Hee University Hospital at Gangdong in Seoul, Korea. The participants will take KRG or a placebo for eight weeks, after which they will be followed-up for four weeks. During the administration period, six capsules of 500 mg KRG or placebo will be provided twice a day. The primary outcome is change of skin temperature in the hands between baseline and after treatment. The secondary outcomes include the visual analogue scale scores of cold hypersensitivity in the hands, change of skin temperature and the VAS scores of cold hypersensitivity in the feet, the recovery rate of the skin temperature by the cold stress test of the hands, the distal-dorsal difference of the hands, power variables of heart rate variability, and the 36-item short form health survey. DISCUSSION: This study is the first trial to evaluate the efficacy of KRG on CHHF by using infrared thermography. Our study will provide basic evidence regarding CHHF. TRIAL REGISTRATION: CliniacalTrials.gov NCT01664156.

Safflower seed extract inhibits osteoclast differentiation by suppression of the p38 mitogen-activated protein kinase and IκB kinase activity.

Safflower seed has been reported to have a protective effect against bone loss diseases. However, the precise molecular mechanisms underlying the inhibitory effect of safflower seed in osteoclast differentiation remain unclear. In this study, we investigated the inhibitory action of safflower seed extract (SSE) on the receptor activator of nuclear factor κB ligand (RANKL)-induced osteoclastogenesis in cultured mouse-derived bone marrow macrophages (BMMs). We found that SSE significantly inhibited the formation of tartrate-resistant acid phosphatase (TRAP)-positive multinucleated cells in BMMs without cytotoxicity. The gene expressions of nuclear factor of activated T-cells (NFATc1) and TRAP, which are genetic markers of osteoclast differentiation, were substantially decreased by SSE in a dose-dependent manner. Also, SSE diminished RANKL-mediated intracellular reactive oxygen species (ROS) generation on osteoclastogenesis in a dose-dependent manner. The SSE thereafter suppressed RANKL-induced p38 mitogen-activated protein kinase and IκBα kinase signalling activities which were activated by ROS generation for osteoclastogenesis. Additionally, SSE was found to decrease RANKL-induced actin ring formation, which is required for bone resorption activity. Taken together, our results suggest that SSE acts as a RANKL-induced osteoclastogenesis inhibitor by suppression of ROS generation. This induces a remarkable suppression of the p38 and IκBα kinase pathways, thereby suppressing the gene expression of NFATc1 in osteoclast precursors.

Dangguijakyak-san, a medicinal herbal formula, protects dopaminergic neurons from 6-hydroxydopamine-induced neurotoxicity.

AIM OF THE STUDY: Dangguijakyak-san (DJS) is a multi-herbal formula that has long been widely used in traditional Oriental medicine to treat gynecologic disorders, including neurological symptoms. Recent clinical and experimental studies have reported aging and anti-neurodegenerative effects of DJS. In this study, we evaluated the neuroprotective effects of DJS on dopaminergic (DA) neurons damaged by 6-hydroxydopamine (6-OHDA). MATERIALS AND METHODS: To evaluate the protective effects of DJS, we analyzed viability in SH-SY5Y neuroblastoma cells and tyrosine hydroxylase (TH) staining in primary DA cells. To explore the possible mechanism(s) of neuroprotection, we assessed anti-oxidant activity by measuring reactive oxygen species (ROS) and glutathione (GSH) levels. To determine mitochondria-mediated apoptotic activity, we examined mitochondrial membrane potential, cytochrome c release, and caspase-3 activation. RESULTS: DJS at 0.05-5 µg/mL significantly protected SH-SY5Y cells from 6-OHDA toxicity, dose-dependently, and attenuated 6-OHDA damage in primary DA cells. DJS reduced 6-OHDA-induced intracellular ROS production and GSH depletion and inhibited mitochondrial membrane instability, cytosolic cytochrome c release, and caspase-3 activation. CONCLUSIONS: These results demonstrate that DJS has neuroprotective effects in DA neurons against 6-OHDA-induced toxicity through anti-oxidant and anti-mitochondrial-mediated apoptotic activities.

Protective effect of Cyperi rhizoma against 6-hydroxydopamine-induced neuronal damage.

Cyperi rhizoma, the rhizome of Cyperus rotundus L. (Family Cyperaceae), is a well-known functional food and traditional herbal medicine in Korea. It has been reported that Cyperi rhizoma has antioxidant and free radical scavenging activities that play a major role in protection of neurodegenerative disorders, such as Parkinson's disease (PD). In the present study, the neuroprotective effects of a water extract of Cyperi rhizoma (CRE) against 6-hydroxydopamine (6-OHDA)-induced neuronal damage were evaluated in an experimental model of PD. In PC12 cells, CRE showed a significant protective effect on cell viability at 50 and 100 microg/mL. CRE inhibited generation of reactive oxygen species and nitric oxide, reduction of mitochondrial membrane potential, and caspase-3 activity, which were induced by 6-OHDA. CRE also showed a significant protective effect against damage to dopaminergic neurons in primary mesencephalic culture. These results suggest that CRE has neuroprotective effects against 6-OHDA-induced toxicity through antioxidant and anti-apoptotic activities in an in vitro PD model.

Therapeutic effects of Chiljehyangbuhwan on primary dysmenorrhea: a randomized, double blind, placebo-controlled study.

OBJECTIVE: This clinical study was conducted to investigate the efficacy and safety of an oriental herbal medicine native to Korea, Chiljehyangbuhwan, in treating primary dysmenorrhea. DESIGN AND SETTING: A total of 100 primary dysmenorrhea patients who visited Kyung Hee University Korean Oriental Medicine Hospital between July 19 2004 and August 27 2004 were recruited. Secondary or drug-related dysmenorrhea was screened out through interviews and examination. The patients were grouped by fixed blocked randomization and administered either Chiljehyangbuhwan or placebo for one menstrual period in a double blind model. Visual Analogue Scale (VAS), Verbal Rating Scale (VRS), and Multidimensional Verbal Rating Scale (MVRS) were used to evaluate dysmenorrhea severity. A total of 71 patients who passed the screening test and remained to the last were divided into either placebo or Chiljehyangbuhwan group, and each were further split into smaller subsets (indication, non-indication, and unspecified group) according to Korean Oriental medical diagnosis. RESULTS: In the non-indication group, the placebo and Chiljehyangbuhwan group did not show significant difference in VAS, VRS, and MVRS scores before medication (1st VAS, 1st VRS, 1st MVRS), after medication (2nd VAS, 2nd VRS, 2nd MVRS), and in changes in scores before and after (DeltaVAS, DeltaVRS, DeltaMVRS). In the indication group, the placebo and Chiljehyangbuhwan group showed significant difference in change in VAS and MVRS scores (DeltaVAS and DeltaMVRS). No evidence of toxicity could be found, and no serious adverse reactions to Chiljehyangbuhwan were reported. CONCLUSION: The results suggest that Chiljehyangbuhwan is effective and safe in treating primary dysmenorrhea when prescribed appropriately under Korean Oriental medical diagnosis.

Clinical trial of herbal formula on weight loss in obese Korean children.

A traditional Korean herbal formula (KH), which is based on Taeumjowi-tang, is currently the most widely used herbal formula in Korea. In this study, KH was administered to obese children for 30 days, and was found to be clinically safe and effective. The subjects were children admitted to hospital to be treated for obesity with relative body weights (%RBW) of 20% or more. Originally, there were 31 subjects, but nine dropped out during the experiment. There were eight girls and 14 boys, whose average age was 11.00 +/- 2.62 years, average weight was 53.37 +/- 17.29 kg, and average period (30-day amount) of KH dosage was 51.18 +/- 22.58 days. The short-term effects of KH on obese children were the reduction of their BMI from 24.34 +/- 3.10 to 23.26 +/- 3.00 kg/m2, of %RBW from 34.41 +/- 10.90 to 25.94 +/- 11.18% (p < 0.01), of body fat mass from 17.99 +/- 5.37 to 16.50 +/- 4.82 kg, and of body fat from 34.16 +/- 3.75 to 32.08 +/- 3.15% (p < 0.01). Concerning anthropometrical measurements, abdominal skin-fold decreased from 26.16 +/- 9.08 to 22.90 +/- 8.35 mm, as did subscapular skin-fold from 20.86 +/- 5.20 to 18.46 +/- 5.31 mm (p < 0.01). In terms of serum lipid levels, which are indices of heart disease, their total cholesterol decreased from 195.38 +/- 31.39 to 183.25 +/- 33.27 mg/dl, the arteriosclerosis index from 4.100 +/- 0.81 to 3.84 +/- 0.64 mg/dl (p < 0.05), and serum leptin level from 14.91 +/- 6.59 to 12.24 +/- 4.98 ng/ml (p < 0.01). Concerning the safety of KH, there were no significant changes in the subjects' livers, hearts, or kidneys. Nor were there any short-term signs of clinically serious side effects or withdrawal symptoms observed. The short-term effects of KH on obese children are weight loss and a decrease in obesity.