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Efficacy of Hwangryunhaedok-tang (Huang-lian-jie-du-tang, Oren-gedoku-to) for patients with hyperlipidemia: a study protocol for a randomized, double-blind, placebo-controlled, parallel, investigator-initiated clinical trial.
Lee, B, Han, K, Park, HJ, Kim, AR, Kwon, OJ, Yang, C, Cho, CS
Trials. 2020;(1):750
Abstract
BACKGROUND The prevalence of hyperlipidemia continues to increase due to aging and lifestyle changes. Statins are currently used as the first choice for treating hyperlipidemia, but are limited by adverse reactions. Hwangryunhaedok-tang (HHT) has received attention as a promising intervention for hyperlipidemia through a few experimental and clinical trials. This study aims to explore the feasibility, effectiveness, and safety of HHT for hyperlipidemia treatment. METHODS This is a study protocol for a randomized, double-blind, placebo-controlled, parallel, investigator-initiated, pilot clinical trial held in Daejeon, Republic of Korea. Thirty patients with hyperlipidemia will be randomly allocated to HHT or placebo granule groups in equal proportions. Participants will be administered HHT or placebo granules three times per day for 8 weeks and followed up for another 4 weeks. The primary outcome is low-density lipoprotein cholesterol at 8 weeks from the commencement of treatment. Other blood lipid parameters, biomarkers of atherosclerosis, the degree of arteriosclerosis, blood glucose parameters, blood pressure, anthropometric parameters, health-related quality of life, and the changes in the general symptoms of cold and hot patterns will be measured as secondary outcomes. Adverse events and laboratory test results will be investigated to assess the safety. Changes in the gut microbiome before and after intervention will also be assessed as an exploratory outcome through next-generation sequencing. Data will be recorded in electronic case report forms and analyzed using SAS® Version 9.4. DISCUSSION This is a rigorously designed pilot clinical trial to explore the effect and safety of Hwangryunhaedok-tang compared to placebo control for patients with hyperlipidemia, thereby potentially facilitating better management of hyperlipidemia. The results of this pilot study could form the foundation for a future large-scale, confirmatory clinical trial. TRIAL REGISTRATION Clinical Research Information Service KCT0004564 . Registered on December 18, 2019.
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Dihuang Yinzi, a Classical Chinese Herbal Prescription, for Amyotrophic Lateral Sclerosis: A 12-Year Follow-up Case Report.
Qiu, H, Li, JH, Yin, SB, Ke, JQ, Qiu, CL, Zheng, GQ
Medicine. 2016;(14):e3324
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Abstract
Amyotrophic lateral sclerosis (ALS) is a devastating progressive neurodegenerative disease with no effective treatment and death within 2 to 5 years after symptom onset. Here, we reported a case of ALS patient using modified Dihuang Yinzi (DHYZ), a classical traditional Chinese medicine (TCM) prescription, who has survived 12 years with significant improvement in bulbar paralysis.A 41-year-old Chinese Han nationality woman was admitted to the hospital with complaints of weakened bilateral grip, slurred speech, stumbling, and muscle twitching for 3 years. The electromyography showed neurogenic injury in bilateral upper limbs and tongue. She was diagnosed with ALS according to the revised El escorial criteria. The patient was orally administrated with Riluzole 100 mg daily for 10 months and then stopped. Subsequently, she resorted to TCM. Based on the TCM theory, the patient was diagnosed with Yinfei syndrome because of kidney deficiency. DHYZ was chosen because it has the function of replenishing kidney essence to treat Yinfei syndrome. Up to now, she has been using modified DHYZ continuously for 12 years. The patient survived with ALS and did not require permanent continuous ventilator. In addition, the symptoms of choking on liquids are improved, and the utility of 30 mL water swallow test was improved with grade 2. The symptoms of muscle fibrillations of limbs are also reduced. However, muscle strength worsened slowly. The repeated electromyography showed motor conduction amplitude reducing gradually and velocity not changing more when compared with the initial electromyography.Our findings suggested that DHYZ can be potentially used in ALS patients because of its multi-targeted neuroprotection and general safety, although ALS does not have a cure. In addition, we identified the area that is worthy of further study and DHYZ as a promising candidate for further clinical application and ALS trials. Rigorous randomized controlled trials are needed in the future.
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Chylous ascites treated by traditional Chinese herbal medicine: a case report and discussion.
Xiu, L, Yan, B, Qin, Z, Liu, X, Wu, F, Wang, X, Wei, P
Complementary therapies in medicine. 2015;(1):63-7
Abstract
Chylous ascites, which can lead to peritonitis, intestinal obstruction, metabolic disorder, and even death from pyemia, is a rare complication of abdominal surgery. Currently, first-line treatment involves conservative management, which includes oral diet and total parenteral nutrition (TPN). However, the efficacy of these treatments cannot be guaranteed. For example, single diet control can result in consecutive drainage for up to 1 month, and salvage surgery is required for some invalid cases. Here, we report 6 cases of chylous ascites after abdominal surgery. In addition to diet control, we delivered traditional Chinese herbal medicine (TCHM) twice daily orally. The drainage volume of the chylous fistula showed an obvious decrease 1 day after the TCHM administration and all 6 patients completely recovered within 4 to 8 days (median: 5.5 days). Although relevant data are limited, our cases would suggest that TCHM could play an important role in the management of chylous ascites. However, randomized controlled trials are still needed to confirm its efficacy in a larger population.
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Combination therapy of traditional Chinese medicine and Western medicine to treat refractory polymyositis: a case report.
Cheng, YC, Tsai, MY, Chen, CJ, Hung, YC
Journal of alternative and complementary medicine (New York, N.Y.). 2015;(5):304-6
Abstract
OBJECTIVE To illustrate the potential for clinical improvement and regimen decrement in treating a patient with a refractory case of polymyositis (PM) with a combination of Western medicine and traditional Chinese medicine (TCM). INTERVENTIONS AND OUTCOME MEASURES A 40-year-old man diagnosed with steroid-resistant PM in January 2011 demonstrated a poor response to immunosuppressants. Complementary TCM treatments were applied to treat his weakness at a clinic integrating TCM and rheumatology in February 2012. He was treated with herbal formula powders named "Bu-Zhong-Yi-Qi-Tang" and "Si-Jun-Zi-Tan." Within 1 month of treatment, the patient seemed to show significant improvement in the grade of disability. Daily doses of methotrexate and methylprednisolone were tapered to 25% and 95.8% after TCM treatments, respectively. Creatine phosphokinase also decreased from 6655 to 718 U/L until December 2013. CONCLUSIONS In our experience, weakness related to PM can be improved by invigorating the spleen-Qi with TCM treatments. This might indicate that TCM treatments can not only play a role in symptom control but also accelerate steroid tapping for refractory cases. Long-term follow-up and future experimental studies are warranted to examine the efficacy and explore the mechanism of TCM treatments for PM.
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Traditional Chinese medicine speeds-up humerus fracture healing: two case reports.
Hsueh, TP, Chiu, HE
Complementary therapies in medicine. 2012;(6):431-3
Abstract
OBJECTIVE Two cases illustrate the potential benefit of traditional Chinese medicine (TCM) treatments on speeding-up proximal humeral fracture healing. CLINICAL FEATURES The cases include two patients with traumatic right proximal humerus closed fracture, one who fell down while standing on a chair and the other hit by a moped. Alternative treatments had been applied to restore humerus fracture. They were treated with the same modality by acupuncture on LI4, LI10, LI1, LI15, LI16 and SI9, with occasional electroacupuncture at LI4 and LI16, as well as concomitant herbal formula powder prescription named "Zhèng Gŭ Zĭ Jīn Dān". Within 2 months treatment, both patients seemed to have speed-up bone healing. The Constant Score increased from 9 to 42 and 36, before and after acupuncture therapy. CONCLUSIONS To our experience, the old patients' fracture had speed-up healing while under TCM treatments. This might hint that TCM treatments not only play a role in pain control, but also accelerate bone healing for certain fracture cases. Long-term follow-up and future experimental studies are warranted to examine the efficacy of TCM treatments for healing bone fracture in the elderly.
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[Drug-induced liver injury caused by an herbal medicine, bofu-tsu-sho-san].
Motoyama, H, Enomoto, M, Yasuda, T, Fujii, H, Kobayashi, S, Iwai, S, Morikawa, H, Takeda, T, Tamori, A, Sakaguchi, H, et al
Nihon Shokakibyo Gakkai zasshi = The Japanese journal of gastro-enterology. 2008;(8):1234-9
Abstract
A 37-year-old woman was admitted to a hospital with jaundice. Within a couple of weeks, her liver function improved with only symptomatic therapy. About 30 to 60 days before admission, she had taken a herbal medicine, bofu-tsu-sho-san. A diagnosis of drug-induced liver injury was made according to the diagnostic scale proposed at the Digestive Disease Week-Japan 2004. A drug-lymphocyte stimulation test for each ingredient of bofu-tsu-sho-san; the results were positive for Cnidii Rhizoma, Angelicae Radix and Menthae Herba. The liver biopsy specimen revealed features of acute hepatitis. Physicians should be aware that bofu-tsu-sho-san can cause liver injury, as this drug is commonly used as an over-the-counter medicine.
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[Kampo medicine for the pain and the psychosomatic disorder--diagnosis and treatment].
Kita, T
Masui. The Japanese journal of anesthesiology. 2007;:S179-84
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Multifocal and recurrent subarachnoid hemorrhage due to an herbal supplement containing natural coumarins.
Friedman, JA, Taylor, SA, McDermott, W, Alikhani, P
Neurocritical care. 2007;(1):76-80
Abstract
INTRODUCTION Over-the-counter herbal and alternative medicines are classified as dietary supplements and, unlike drugs, are not rigorously regulated by the United States Food and Drug Administration. Their potential adverse effects are often poorly characterized. METHOD Red clover, dong quai, and Siberian ginseng are herbal compounds used for treatment of perimenopausal symptoms such as hot flashes. These compounds are known to contain coumarins, and thus carry the potential for hemorrhagic complications; however, no cases of intracranial hemorrhage have been reported. DISCUSSION We report a 53-year-old woman with spontaneous subarachnoid hemorrhage due to the use of an herbal supplement containing red clover, dong quai, and Siberian ginseng.
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[Successful treatment of an elderly patient with idiopathic thrombocytopenic purpura accompanied with chronic subdural hematoma, using a Chinese herbal medicine, EK-49, and ascorbic acid].
Hirano, A, Ueoka, H
Nihon Ronen Igakkai zasshi. Japanese journal of geriatrics. 2001;(2):224-8
Abstract
An 88 year-old woman was admitted complaining of headache. CT scan of the head revealed a right subdural hematoma. She had been followed by a local physician because of chronic thrombocytopenia. Her peripheral platelet count on admission was 0.5 x 10(4)/microliter, with a high serum level of PAIgG. Bone marrow examination revealed marked increase of megakaryocyte. Idiopathic thrombocytopenic purpura(ITP) accompanied with chronic subdural hematoma was diagnosed. Transient increase of platelet count and improvement of subdural hematoma was obtained by administration of prednisolone. However, platelet count decreased with tapering of prednisolone. Then combined administration of a Chinese herbal medicine, EK-49, and ascorbic acid was started. Platelet count gradually increased and no adverse effects were experienced. These results indicated that elderly patients with chronic subdural hematoma can be treated non-invasively, and that a combination of EK-49 and ascorbic acid may be effective in the treatment of refractory ITP.