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A randomized, double-blind, placebo-controlled, multi-center phase Ⅱ clinical trial design was used in this study to recruit subjects who were in line with the syndrome of excess heat and fire toxin, and were diagnosed as recurrent oral ulcers, gingivitis, and acute pharyngitis. A total of 240 cases were included and randomly divided into a placebo group and a Huanglian Jiedu Pills group. The clinical efficacy of Huanglian Jiedu Pills in treating the syndrome of excess heat and fire toxin was evaluated by using the traditional Chinese medicine(TCM) syndrome scale. Enzyme-linked immunosorbent assay(ELISA) was used to determine and evaluate the levels of adenosine triphosphate(ATP), 4-hydroxynonenal(4-HNE), and adrenocorticotropic hormone(ACTH) in plasma of the two groups before and after administration and to predict their application value as clinical biomarkers. The results showed that the disappearance rate of main symptoms in the Huanglian Jiedu Pills group was 69.17%, and that in the placebo group was 50.83%. The comparison between the Huanglian Jiedu Pills group and the placebo group showed that 4-HNE before and after administration was statistically significant(P<0.05). The content of 4-HNE in the Huanglian Jiedu Pills group decreased significantly after administration(P<0.05), but that in the placebo group had no statistical significance and showed an upward trend. After administration, the content of ATP in both Huanglian Jiedu Pills group and placebo group decreased significantly(P<0.05), indicating that the energy metabolism disorder was significantly improved after administration of Huanglian Jiedu Pills and the body's self-healing ability also alleviated the increase in ATP level caused by the syndrome of excess heat and fire toxin to a certain extent. ACTH in both Huanglian Jiedu Pills group and placebo group decreased significantly after administration(P<0.05). It is concluded that Huanglian Jiedu Pills has a significant clinical effect, and can significantly improve the abnormal levels of ATP and 4-HNE in plasma caused by the syndrome of excess heat and fire toxin, which are speculated to be the effective clinical biomarkers for Huanglian Jiedu Pills to treat the syndrome of excess heat and fire toxin.
Subject(s)
Humans , Adrenocorticotropic Hormone , Hot Temperature , Medicine, Chinese Traditional , Adenosine TriphosphateABSTRACT
Objective To observe the clinical efficacy of Dachaihu decoction in treatment of stroke-associated pneumonia (SAP) in the elderly patients with excess-heat syndrome and acute ischemic stroke (AIS). Methods One hundred elderly patients with excess-heat syndrome and SAP admitted to the Department of Neurology of Tianjin Nankai Hospital from August 2015 to September 2016 were enrolled, and they were divided into a control group and an observation group according to the random number table, 50 cases in each group. Both groups were given conventional neurological treatment, while the observation group additionally received Dachaihu decoction (the ingredients of the decoction: bupleurum 15 g, scutellariae 10 g, pinellia 10 g, fructus aurantii immaturus 15 g, radix paeoniae alba 10 g, rhubarb 5 g, ginger 10 g, jujube 2), and according to the individual's symptoms and signs, the above ingredients can be added and/or subtracted, 1 dose per day, divided into two parts, 1 part taken in the morning and 1 part in the evening orally, 14 days as a therapeutic course. The body temperature recovery time, the duration of antibiotic treatment, the changes of Clinical Pulmonary Infection Score (CPIS) and National Institutes of Health Stroke Scale (NIHSS) score before and after treatment of the two groups were observed and the therapeutic effects in the two groups were evaluated. Results The body temperature recovery time (days: 6.56±2.70 vs. 8.08±3.23) and the duration of antibiotic treatment (days: 8.78±2.80 vs. 10.02±2.90) in the observation group were significantly shorter than those in the control group (both P ＜ 0.05); with the prolongation of treatment, after treatment, the CPIS and NIHSS score were decreased significantly in both groups, reaching the lowest levels on the 14th day, and the degrees of score descent in observation group were more significant than those of the control group (CPIS score: 0.68±0.59 vs. 1.12±0.96, NIHSS score: 6.38±2.31 vs. 7.44±2.74, both P ＜ 0.05); the total effective rate in the observation group was significantly higher than that in the control group [92% (46/50) vs. 76% (38/50), P ＜ 0.05]. Conclusion The therapeutic effect of Dachaihu decoction used for treatment of SAP in elderly patients with excess-heat syndrome is favorably effective and safe.
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Objective: To evaluate the efficacy and safety of different dosages of Pudilan Xiaoyan Oral Liquid (PXOL) in treatment of infantile acute pharyngitis-tonsillitis with lung-stomach excess-heat syndrome. Methods: A randomized controlled, double-blind, positive drug parallel controlled, and multi-center clinical trial was conducted. Totally 324 children from seven research centers were included, 108 cases in experimental high dose group (A Group), 108 cases in experimental low dose group (B Group), 54 cases in positive medicine group (Xiaoer yanbian Granula, C Group), and 54 cases in placebo group (D Group), with the ratios of 2:2:1:1.5 in a course. Results: (1) Totally 317 cases were in full analysis set (FAS), 284 cases in per-protocol set (PPS) and 324 cases in Safety Set (SS). (2) Evaluation on effectiveness: There was significant difference (P<0.001) between each two groups in the total effective rate of pharyngalgia and pharyngeal swelling. A Group and B Group were both superior to D Group, and were non-inferior to C Group. B Group was non-inferior to A Group. There was significant difference (P<0.001) between each two groups in total effective rate of syndrome of traditional Chinese medicine. There was significant difference (P<0.05) between each two groups in the median time of improving pharyngalgia syndrome. There was significant difference (P<0.001) between each two groups in the median time of pharyngalgia syndrome disappearing. There were significant differences (P<0.05) between each two groups in total effective rate of halitosis, cough, thirst, deep-colored urine, and dry stool. The analysis on PPS agrees with that of FAS. (3) Evaluation on safety: No adverse reactions in clinical significant laboratory examination were found during the trial. Conclusion: High and low dosages of PXOL show advantages over placebo and are non-inferior to the positive medicine Xiaoer Yanbian Granula. High dose group does not show advantage comparing with low dose group. No adverse reactions are found during the trial. Low dose therapy is recommended.
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<p>A 54-year-old female had cesarean sections at ages 26 and 29, a left salpingophrectomy for left ovarian cyst at age 31, and a total abdominal hysterectomy for fibroids at age 41. After total abdominal hysterectomy, she had repeated bouts of ileus and started taking daikenchuto (DKT), which is commonly used to prevent ileus. At age 54, she visited our hospital when DKT failed to relieve her constipation and lower abdominal pain and had occasional heat flash above her neck. Tongue examination revealed pale red tongue and fissured tongue signs with yellow fur and dilation of the sublingual collateral vessels. Kampo diagnosis was blood stasis and excess heat, for which keishibukuryogan was prescribed to be taken daily and with which her symptoms dissipated after 7 days. Despite the popular use of DKT, its potential to cause excess heat after long-term use is not as well known. It is extremely important to warn clinicians who prescribe Kampo not to focus solely on a disease-to-prescription model but also to be learned of the discipline and to take measures to prevent adverse long-term effects and complications.</p>
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<p>We present a 35-year-old male with palpebral hemispasm, which often occurred while at work. Because there were no ophthalmological findings, he consulted our clinic to receive Kampo therapy. He easily became fatigued and he had subchondral resistance and discomfort (kyo-kyo-kuman), so we treated him with saikokeishito and shakuyakukanzoto. However, they were ineffective, and therefore we reconsidered his symptoms.<br>Although he complained of fatigue, he was well built and had been a heavy drinker until a few years before presenting. Furthermore, he easily blushed and sweated in the upper body during the daytime, and his palpebral hemispasm often occurred during this blushing and sweating, and was accompanied by headache. We considered that this represented an excess-heat pattern rather than a deficiency pattern, and prescribed orengedokuto. His symptoms improved, and disappeared after six months.<br>There has been no detailed report of orengedokuto for the treatment of palpebral hemispasm. Orengedokuto may be useful for palpebral hemispasm in the context of symptoms of excess-heat pattern, such as blushing, sweating in the upper body and headache.</p>
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Bofutsushosan has recently become a well-known Kampo formulation for treating metabolic syndrome. It is effective for obesity in people who have mental disorder, but few reports suggest that it is effective for mental disorder itself. We report a case of depressive complaints treated effectively with bofutsushosan. The case was 63 years-old male who had had depression for twenty years. His depressed condition had been stable owing to antidepressant therapies. However, he had could not read books, and so had not been able to enjoy the pleasure of reading since nine months previously. He did not believe that his depression had taken a turn for the worse, but rather that he had the partial androgen decline (or deficiency) of aging males. Therefore he did not consult his psychiatrist, and he wanted to be treated with Kampo formulations. He was diagnosed with a hyperfunctional constitution, heat pattern, and a <i>ki </i>obstruction pattern. Bofutsushosan was prescribed, and his complaints improved remarkably. This suggests that bofutsushosan is effective for treatment of not only obesity but also mental disorder itself.
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[Objective] To observe the relationship between humoral immunity and syndrome patterns of excess-heat and deficiency-heat. [Methods] Serum globulin contents of IgG, IgA, IgM and IgE, circulatory immune compound (CIC) and serum complements of C3 , C4 and CH50 were detected in 30 cases of healthy volunteers (group A), 27 of excess-heat syndrome (group B) and 35 of deficiency-heat syndrome (group C). [Results] Serum globulin contents of IgG, IgA, IgM, C3 and CH50 in group C were lower than those in group A ( P
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[Objective] To investigate the relationship of thyroid hormones with excess-heat syndrome and deficiency-heat syndrome. [Methods] Serum levels of thyroid hormones and thyroid-stimulating hormone (TSH) in 30 healthy volunteers (Group A) , 27 cases of excess-heat syndrome (Group B) and 35 cases of deficiency-heat syndrome (Group C) were detected by radioimmunoassay. [Results] Serum levels of triiodothyronine (T3) and thyroxine (T4) were higher and reverse T3 (rT3) lower in Group C than those in Group A (P 0.05). [Conclusion] Serum thyroid hormones level in deficiency-heat syndrome is different from that of excess-heat syndrome may be related to the hypothalamus-pituitary-thyroid function.
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Objective:To observe differences of peripheral T-lymphocyte subsets between the patients of excess-heat syndrome and deficiency-heat syndrome.Methods:T-lymphocyte subsets in a normal group(n=30),excess-heat syndrome group(n=27)and deficiency-heat syndrome group(n=35)were detected with indirect immunofluorescence staining method.Results:CD_3,CD_4 and CD_4/CD_8 ratio decreased significantly in the excess-heat syndrome group arid the deficiency-heat syndrome group as compared with normal group(P