The Clinical Efficacy and Safety of Gumiganghwal-Tang in Knee Osteoarthritis: A Phase II Randomized Double Blind Placebo Controlled Study.

BACKGROUND: Gumiganghwal-tang (GMGHT) is a traditional herbal medicine consisting of nine different herbs. GMGHT inhibits the mRNA expression and production of inflammatory cytokines tumor necrosis factor-α (TNF- α), interleukin-6 (IL-6), and TNF- ß on lipopolysaccharide- (LPS-) stimulated peritoneal macrophages in a dose-dependent manner. It is empirically used for the treatment of inflammatory disease, but there are few reports of clinical trials that investigate its efficacy and safety. The current study aimed to investigate the clinical efficacy and safety of GMGHT in patients with knee osteoarthritis (OA). METHODS: This was a multicenter, two-armed, double-blinded, randomized, placebo controlled study of GMGHT over 6 weeks. Eligible patients who fulfilled the American College of Rheumatology criteria for OA were randomized to receive either GMGHT or the placebo. Clinical assessments included measurement of knee pain and function using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), patient global assessment (PGA), and knee pain scores every 2 weeks. RESULTS: A total of 128 patients were enrolled (91.4% female; mean age, 58.7 ± 8.1 years). At baseline, pain visual analogue score (VAS) was 67.2 ± 1.4, resp. 71.3 ± 1.6 (treatment, resp. placebo group, p=0.84), and total WOMAC score was 55.2 ± 1.6, resp. 55.6 ± 1.5 (p = 0.84). After 6 weeks, the pain VAS was 43.0 ± 2.5, resp. 61.6 ± 2.5 (p < 0.01) and the total WOMAC score was 34.1 ± 2.4, resp. 46.9 ± 1.8 (p < 0.01). No patients withdrew because of treatment emergent adverse events. Expected adverse events including dyspepsia, liver function abnormality, and lower extremity edema were comparable between both groups. CONCLUSIONS: Treatment with GMGHT resulted in significant improvement in pain, function, and global assessment, and it was generally safe and well tolerated in patients with OA.

Factors Associated with the Use of Complementary and Alternative Medicine for Korean Patients with Rheumatoid Arthritis.

OBJECTIVE: Rheumatoid arthritis (RA) is a chronic autoimmune disease that is often painful and debilitating. Patients with RA are increasingly receiving complementary and alternative medicine (CAM). We aimed to identify the patient characteristics and disease-specific factors associated with Korean patients with RA who decide to start treatment with CAM. METHODS: Among the total 5371 patients with RA in the KORean Observational study Network for Arthritis (KORONA), 2175 patients who had no experience with CAM were included in our study. In our study, we assessed the frequency of new incident CAM use, its patterns, and the predictive factors of new CAM use. RESULTS: Of the 2175 patients, 229 patients (10.5%) newly started receiving CAM within a year of enrolling in the cohort. Of those who started treatment with CAM, 17.0% received only herbal medicine, 54.6% only acupuncture treatments (7.0% used a combination of both), and 21.4% "Other" (e.g., physical therapy and placental extract injections). Women (OR 1.89, 95% CI 1.13-3.14) and patients with depression (OR 3.52, 95% CI 1.65-7.50) were significantly more likely to be treated with CAM. Regarding household types, patients who lived in an extended family (OR 1.78, 95% CI 1.08-2.95) or as part of a couple (OR 1.55, 95% CI 1.07-2.24) were more likely to be treated with CAM than patients living in a nuclear family. CONCLUSION: Our study found, within a year, an incidence rate of 10.5% for new CAM use among patients with no previous experience with CAM. Sex, depression, and household type were significantly associated with new CAM use.

Influence of Panax ginseng on the offspring of adult rats exposed to prenatal stress.

The exposure of pregnant females to stress during a critical period of fetal brain development is an environmental risk factor for the development of schizophrenia in adult offspring. Schizophrenia is a group of common mental disorders of unclear origin, affecting approximately 1% of the global population, showing a generally young age at onset. In the present study, a repeated variable stress paradigm was applied to pregnant rats during the final week of gestation. The effects of an extract of Panax ginseng C.A. Meyer (PG) on rats exposed to prenatal stress (PNS) were investigated in terms of behavioral activity and protein expression analyses. In the behavioral tests, grooming behavior in a social interaction test, line-crossing behavior in an open-field test and swimming activity in a forced-swim test were decreased in the rats exposed to PNS compared with the non-stressed offspring; the changes in behavioral activity were reversed upon oral treatment with PG (300 mg/kg). Subsequently, western blot analysis and immunohistochemical analyses of the prefrontal cortex and hippocampus revealed that the downregulation of several neurodevelopmental genes which occurred following exposure to PNS was reversed upon treatment with PG. The current findings demonstrate that the downregulation of several genes following exposure to PNS may affect subsequent behavioral changes, and that these phenomena are reversed following treatment with PG during pregnancy. Our results suggest that oral treatment with PG reduces the incidence of psychiatric disorders, such as schizophrenia.

Transient complete atrioventricular block associated with curcumin intake.

Curcumin is a polyphenol responsible for the yellow color of turmeric, a curry spice. A large body of evidence showed that curcumin possessed a variety of beneficial activities. We report a case of transient complete atrioventricular block in a 38-year-old man, after intake of curcumin containing pills for on 1 month. Since all other possible causes of conduction disturbance were excluded and causal relation was achieved by re-intake of the same amount of turmeric containing pills, side-effect of the curcumin containing pills was identified as the most likely diagnosis. After cessation of the pills, no further conduction disturbances and associated symptoms were noticed for the ensuing 6 months since discharge.

Assessment of prescribed herbal medicine on liver function in Korea: a prospective observational study.

OBJECTIVE: The aim of this study was to investigate the influence of herbal medicine (HM) prescribed by doctors of Korean medicine (KMD) on liver function in Korea. DESIGN AND INTERVENTIONS: For this multicenter, prospective, observational study, we enrolled patients who wished to take HM prescribed by KMD for various medical purposes in Korea. One hundred and twenty-two (122) patients took HM for an average of 20.6 +/- 8.4 (mean +/- standard deviation) days, and completed questionnaires. OUTCOME MEASURES: Liver function tests (LFTs) were performed before (first test) and after each HM treatment (second test). For LFT, aspartate aminotransferase, alanine aminotransferase, total bilirubin (t-Bil), direct bilirubin, alkaline phosphatase, and gamma-glutamyl transferase were measured. RESULTS: There were no significant changes in LFT data between the first and second tests, except in the t-Bil level. However, all data of total bilirubin level in second test were within normal range, except only one patient. Multivariate analysis did not identify any herb that significantly increased t-Bil; hence no hepatotoxic herb was found. Twenty-one (21) of the 122 patients were abnormal on first testing, and 10 at the second testing. Of the patients taking herbs, 4 changed from normal to abnormal and 15 from abnormal to normal (p = 0.019). CONCLUSION: The current study showed that ingestion of HM prescribed by KMD did not increase the frequency of abnormal LFTs, at least in the short term.