The Effect of Fenugreek in Type 2 Diabetes and Prediabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Fenugreek is a widely used herbal medicine as a complementary therapy for diabetes mellitus. Lots of clinical trials have proved its beneficial effect on glycemic control parameters and lipid profiles. Thus, we conducted a systematic review and meta-analysis to evaluate the effectiveness and safety of fenugreek as a treatment for type 2 diabetes mellitus. We searched PubMed, Embase, Cochrane, China Knowledge Resource Integrated Database (CNKI), Korean studies Information Service System (KISS), Research Information Sharing Service (RISS), and ScienceON to select RCTs which used fenugreek targeting hyperglycemia with a control group. We used either a random effect model or a fixed model in a meta-analysis of Fasting blood glucose (FBG), 2 h plasma glucose during a 75 g oral glucose tolerance test (OGTT) (2-hPG), homeostatic model assessment for insulin resistance (HOMA-IR), glycosylated hemoglobin (HbA1c)/total cholesterol (TC), triglyceride (TG), high density lipoprotein (HDL-C), low density lipoprotein (LDL-C), body mass index (BMI). After screening, a total of 10 studies (706 participants) remained. Fenugreek significantly reduced FBG, 2-hPG, and HbA1c, but it did not significantly decrease HOMA-IR. Moreover, it significantly improved TC, TG, and HDL-C, while there were no significant differences in LDL-C and BMI. Hepatic or renal toxicity was not observed, and there were no severe adverse events associated with fenugreek despite mild gastrointestinal side effects in some studies. In conclusion, fenugreek improves overall glycemic control parameters and lipid profile safely.

Repeated Intramuscular-dose Toxicity Test of Watersoluble Carthami Flos (WCF) Pharmacopuncture in Sprague-Dawley Rats.

OBJECTIVES: Water-soluble carthami flos (WCF) is a new mixture of Carthami flos (CF) pharmacopuncture. We conducted a 4-week toxicity test of repeated intramuscular injections of WCF in Sprague-Dawley rats. METHODS: Forty male and 40 female rats were divided into 4 groups of 10 male and 10 female SD rats: The control group received 0.5 mL/animal/day of normal saline whereas the three experimental groups received WCF at doses of 0.125, 0.25, and 0.5 mL/animal/day, respectively. For 4 weeks, the solutions were injected into the femoral muscle of the rats alternating from side to side. Clinical signs, body weights, and food consumption were observed; opthalmological examinations and urinalyses were performed. On day 29, blood samples were taken for hematological and clinical chemistry analyses. Then, necropsy was conducted in all animals to observe weights and external and histopathological changes in the bodily organs. All data were tested using a statistical analysis system (SAS). RESULTS: No deaths were observed. Temporary irregular respiration was observed in male rats of the experimental group for the first 10 days. Body weights, food consumptions, opthalmological examinations, urinalyses, clinical chemistry analyses, organ weights and necropsy produced no findings with toxicological meaning. In the hematological analysis, delay of prothrombin time (PT) was observed in male rats of the 0.25- and the 0.5- mL/animal/day groups. In the histopathological test, a dose-dependent inflammatory cell infiltration into the fascia and panniculitis in perimuscular tissues was observed in all animals of the experimental groups. However, those symptoms were limited to local injection points. No toxicological meanings, except localized changes, were noted. CONCLUSION: WCF solution has no significant toxicological meaning, but does produce localized symptoms. No observed adverse effect level (NOAEL) of WCF in male and female rats is expected for doses over 0.5 mL/animal/day.

Single Intramuscular-dose Toxicity of Water soluble Carthmi-Flos herbal acupuncture (WCF) in Sprague-Dawley Rats.

OBJECTIVES: This experiment was conducted to examine the toxicity of Water soluble Carthmi-Flos herbal acupuncture (WCF) by administering a single intramuscular dose of WCF in 6-week-old, male and female Sprague-Dawley rats and to find the lethality dose for WCF. METHODS: The experiment was conducted at Biotoxtech according to Good Laboratory Practices under a request by the Korean Pharmacopuncture Institute. This experiment was performed based on the testing standards of "Toxicity Test Standards for Drugs" by the Ministry of Food and Drug Safety. Subjects were divided into 4 groups: 1 control group in which normal saline was administered and 3 test groups in which 0.1, 0.5 or 1.0 mL of WCF was administered; a single intramuscular dose was injected into 5 males and 5 females in each group. General symptoms and body weights were observed/measured for 14 days after injection. At the end of the observation period, hematological and clinical chemistry tests were performed, followed by necropsy and histopathological examinations of the injected sections. RESULTS: No mortalities were observed in any group. Also, symptoms, body weight, hematology, clinical chemistry and necropsy were not affected. However, histopathological examination of the injected part in one female in the 1.0-mL group showed infiltration of mononuclear cells and a multi-nucleated giant cell around eosinophilic material. CONCLUSION: Administration of single intramuscular doses of WCF in 3 groups of rats showed that the approximate lethal dose of WCF for all rats was in excess of 1.0 mL, as no mortalities were observed for injections up to and including 1.0 mL.

Single Intravenous-dose Toxicity of Water-soluble Carthami-flos Pharmacopuncture (WCF) in Rats.

OBJECTIVES: This study was performed to analyze the toxicity and to find the lethal dose of the test substance Water-soluble Carthami-flos pharmacopuncture (WCF) when used as a single intravenous-dose in 6-week-old, male and female Sprague-Dawley rats. METHODS: The experiment was conducted at Biotoxtech according to Good Laboratory Practices. 20 female and 20 male Spague-Dawley rats were divided into 4 groups of 5 female and 5 male animals per group. The rats in the three experimental groups received single intravenous injections with 0.125-mL, 0.25-mL and 0.5-mL/animal doses of WCF, Groups 2, 3, and 4, respectively, and the control group, Group 1, received a single intravenous injection with a 0.5-mL dose of normal saline. Clinical signs were observed and body weight measurements were carried out for 14 days following the injections. At the end of the observation period, hematology, clinical chemistry, histopathological tests and necropsy were performed on the injected parts. RESULTS: No deaths occurred in any of the groups. Also, no significant changes in body weight, hematological parameters or clinical chemistry test results between the control group and the experimental groups were observed. Visual inspection after necropsy showed no abnormalities. Histopathological tests on the injected parts showed no significant differences, except for Group 1 females; however, the result was spontaneous generation and had no toxicological meaning because it was not dose-dependent. Therefore, this study showed that WCF had no effect on the injected parts in terms of clinical signs, body weight, hematology, clinical chemistry, and necropsy. CONCLUSION: As a result of single intravenous-dose tests of the test substance WCF in 4 groups of rats, the lethal dose for both males and females exceeded 0.5 mL/animal. Therefore, WCF is a relatively safe pharmacopuncture that can be used for treatment, but further studies should be performed.

Trend of pharmacopuncture therapy for treating cervical disease in Korea.

OBJECTIVES: The purpose of this study is to analyze trends in domestic studies on pharmacopuncture therapy for treating cervical disease. METHODS: This study was carried out on original copies and abstracts of theses listed in databases or published until July 2014. The search was made on the Oriental medicine Advanced Searching Integrated System (OASIS) the National Digital Science Library (NDSL), and the Korean traditional knowledge portal. Search words were 'pain on cervical spine', 'cervical pain', 'ruptured cervical disk', 'cervical disc disorder', 'stiffness of the neck', 'cervical disk', 'whiplash injury', 'cervicalgia', 'posterior cervical pain', 'neck disability', 'Herniated Nucleus Pulposus (HNP)', and 'Herniated Intervertebral Disc (HIVD)'. RESULTS: Twenty-five clinical theses related to pharmacopuncture were selected and were analyzed by year according to the type of pharmacopuncture used, the academic journal in which the publication appeared, and the effect of pharmacopuncture therapy. CONCLUSION: The significant conclusions are as follows: (1) Pharmacopunctures used for cervical pain were Bee venom pharmacopuncture, Carthami-flos pharmacopuncture, Scolopendra pharmacopuncture, Ouhyul pharmacopuncturen, Hwangryun pharmacopuncture, Corpus pharmacopuncture, Soyeom pharmacopuncture, Hwangryunhaedoktang pharmacopuncture, Shinbaro phamacopuncture. (2) Randomized controlled trials showed that pharmacopuncture therapy combined with other methods was more effective. (3) In the past, studies oriented toward Bee venom pharmacopuncture were actively pursued, but the number of studies on various other types of pharmacopuncture gradually began to increase. (4) For treating a patient with cervical pain, the type of pharmacopuncture to be used should be selected based on the cause of the disease and the patient's condition.

Single Intramuscular-dose Toxicity of Anti-inflammatory Pharmacopuncture in Rats.

OBJECTIVES: This study was performed to analyze the toxicity of the test substance, anti-inflammatory pharmacopuncture (AIP), when used as a single intramuscular-dose in 6-week-old, male and female Sprague-Dawley rats and to find the lethal dose. METHODS: The experiment was conducted at Biotoxtech according to Good Laboratory Practices. Twenty (20) female and 20 male Spague-Dawley rats were divided into 4 groups of five 5 female and 5 male animals per group. The rats in the three experimental groups received single intramuscular injections with 0.1-㎖, 0.5-㎖ and 1.0-㎖/animal doses of AIP, Groups 2, 3, and 4, respectively, and the control group, Group 1, received a single intramuscular injection with a 1.0-㎖ dose of normal saline. Clinical signs were observed and body weight measurements were carried out for 14 days following the injections. At the end of the observation period, hematology, clinical chemistry, histopathological tests and necropsy were performed on the injected parts. RESULTS: No deaths occurred in any of the groups. Also, histopathological tests showed that AIP had no effect on the injected parts in terms of clinical signs, body weight, hematology, clinical chemistry, and necropsy. CONCLUSIONS: As a result of single intramuscular-dose tests of the test substance AIP in 4 groups of rats, the lethal dose for both males and females exceeded 1.0㎖/animal. Therefore, AIP is a relatively safe pharmacopuncture that can be used for treatment, but further studies should be performed.