ABSTRACT
To analyze and discuss placebo-related information in clinical research literatures in the past 30 years, including placebo's dosage form, ingredients, preparation process and quality control. Effort were made to research the CNKI. full-text database to preliminary find 700 placebo-related clinical research literature, screen out 301 eligible articles by hand, read the literatures to extract placebo-related information and make statistics and discussions. According to the results, Chinese randomized placebo-controlled clinical studies were characterized by diverse dosage forms of placebo with lack of reports for components, as evidenced by the only 17 literatures describing placebo's preparation or specific composition among the 301 literatures. Placebo-controlled clinical trials covered a wide range of disease spectra, but with a specific tropism of diseases in terms of system classification. Although placebo plays a key role in blinded clinical studies, researchers made less records of placebo, perhaps because they paid less attention to placebo or more attention to the research process or restricted by other objective conditions. Moreover, placebo production, quality control and quality evaluation also need to be further standardized.
Subject(s)
Humans , Biomedical Research , History , Reference Standards , China , History, 20th Century , History, 21st Century , Placebo Effect , Quality Control , Randomized Controlled Trials as Topic , History , Reference StandardsABSTRACT
Chinese Pharmacopoeia I (2010 edition) covers dosage and usage of traditional Chinese medicinal herbs and decoction pieces, and provides dosage ranges of most of decoction pieces. By using the descriptive statistical method, the article discusses the distribution of maximum dosage, minimum dosage and dosage range of decoction pieces set forth in Chinese Pharmacopoeia, and compares toxic drugs and non-toxic drugs. Altogether 617 drugs are included into the study. Except for 16 decoction pieces whose dosages are not clear, all of the remaining decoction pieces are covered by Chinese Pharmacopoeia, with the maximum common dosage, minimum common dosage and dosage range of 3, 10 and 6 g. Upon comparison, we discovered that Chinese Pharmacopoeia sets stricter standards for toxic drugs than non-toxic drugs. Compared with dosages in classical prescriptions and actual clinical usages, dosage ranges described in Chinese Pharmacopoeia are much narrower. There is no significant difference between drugs that can be used as foods or healthcare foods and other drugs according to Chinese Pharmacopoeia.
Subject(s)
Humans , Drug Dosage Calculations , Drug Therapy , Reference Standards , Drugs, Chinese Herbal , Chemistry , Pharmacology , Toxicity , Prescriptions , Reference StandardsABSTRACT
<p><b>BACKGROUND</b>Type 2 diabetes mellitus (T2DM) results from the complex association of insulin resistance and pancreatic β-cell failure. Recent studies have shown that patients diagnosed with T2DM present with a significant decrease in β-cell function, which can be further compromised during the progression of the disease. Several mechanisms have been shown to play a role in this process such as glucotoxicity and lipotoxicity, which contribute to accelerating insulin secretion. In this regard, Chinese medicine has a certain advantage. This experiment was performed to observe the effect of a Chinese medicine named Kaiyuqingre formula (KYQRF) on β-cell function and its mechanisms of action therein.</p><p><b>METHODS</b>High glucose was used to set up a model of β-cell function failure. At the same time, medicated serum of KYQRF with different doses were administered to the cells. Rosiglitazone was taken as a control to observe the changes in insulin secretion, ATP-sensitive K(+) channels (K(ATP) channel) and uncoupling protein-2 (UCP-2) in each group.</p><p><b>RESULTS</b>KYQRF had some effects on the insulin secretion. In a low glucose environment, no effective change in insulin secretion was observed (P > 0.05). However, insulin levels increased significantly when INS-1 cells were exposed to a high glucose environment (P < 0.05). KYQRF could also enhance cell viability (P < 0.05) in an effect similar to rosiglitazone. Although KYQRF had no effect on inwardly rectifying potassium channels (Kir6.2) (P > 0.05), it could decrease the overexpression of both UCP-2 and sulfonylurea receptor 1 (P < 0.05).</p><p><b>CONCLUSION</b>KYQRF can protect islet function by decreasing UCP-2 and sulfonylurea receptor 1.</p>