부자 (규제)

A systematic review of pharmacokinetic studies on herbal drug Fuzi: Implications for Fuzi as personalized medicine.

1. Phytomedicine. 2018 May 15;44:187-203. doi: 10.1016/j.phymed.2018.03.001. Epub 2018 Mar 1. A systematic review of pharmacokinetic studies on herbal drug Fuzi: Implications for Fuzi as personalized medicine. Wu JJ(1), Guo ZZ(1), Zhu YF(1), Huang ZJ(1), Gong X(1), Li YH(1), Son WJ(1), Li XY(1)

Altered TNF-α response by Aconibal® and methotrexate in a lipopolysaccharide-induced setting of inflammatory conditions: Potential on a synergistic combination.

2. J Ethnopharmacol. 2018 Mar 1;213:191-197. doi: 10.1016/j.jep.2017.11.020. Epub 2017 Nov 21. Altered TNF-α response by Aconibal® and methotrexate in a lipopolysaccharide-induced setting of inflammatory conditions: Potential on a synergistic combination. Park G(1), Lee SH(2), Han JY(3), Oh DS(

Efficacy and Safety of Shenfu Injection for Severe Pneumonia in the Elderly: A Systematic Review and Meta-Analysis Based on Western and Eastern Medicine.

1. Front Pharmacol. 2022 Aug 25;13:779942. doi: 10.3389/fphar.2022.779942. eCollection 2022. Efficacy and Safety of Shenfu Injection for Severe Pneumonia in the Elderly: A Systematic Review and Meta-Analysis Based on Western and Eastern Medicine. Shi S(1)(2)(3), Wang F(1), Chen B(4), Pan J(5), Luo D(1), Pei C(1), Huang D(1), Wang X(1), Wang Y(1), Shen Z(1), Li W(6), Wu Y(7)(8), He Y(1), Wang Z(1). Author information: (1)Department of Geriatric, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China. (2)Department of Epidemiology and Public Health, Swiss Tropical and Public Health Institute, Basel, Switzerland. (3)Faculty of Science, University of Basel, Basel, Switzerland. (4)State Key Laboratory of Translational Oncology, Department of Anatomical and Cellular Pathology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China. (5)Department of Pathology, Stanford University School of Medicine, Palo Alto, CA, United States. (6)Cardiology Division, West China Hospital, Sichuan University, Chengdu, China. (7)Chongqing Key Laboratory of Traditional Chinese Medicine for Prevention and Cure of Metabolic Diseases, Chongqing, China. (8)College of Traditional Chinese Medicine, Chongqing Medical University, Chongqing, China. Background: Although increasing clinical trials studying Shenfu injection (SFI) comprising panaxoside 0.8 mg/ml extracted from Panax ginseng C.A. Mey. and aconitine 0.1 mg/ml extracted from Aconitum carmichaeli Debeaux for elderly patients with severe pneumonia on biomarkers associated with COVID-19 progression are emerging, there is no evidence-based evaluation for the effect of SFI on elderly severe pneumonia. Objectives: To evaluate the effect of SFI on elderly patients with severe pneumonia providing hints for treating critical COVID-19, we conducted a systematic review and meta-analysis. Methods: Nine databases, namely, PubMed, EMBASE, Web of Science, Science Direct, Google Scholar, Wanfang, Chongqing VIP Database, CNKI, and SinoMed were used to search clinical trials reporting the effect of SFI as an adjuvant for elderly severe pneumonia on outcomes of interest. Primary outcomes were total effective rate, Acute Physiology and Chronic Health Evaluation (APACHE) II score, mortality, and safety. Secondary outcomes were predictors associated with COVID-19 progression. Duplicated or irrelevant articles with unavailable data were excluded. Cochrane Collaboration's tool was used to evaluate the risk of bias by two reviewers independently. All data were analyzed by Rev Man 5.4. Continuous variables were shown as weighted mean difference (WMD) or standard mean difference (SMD) with 95% confidence intervals (95% CI), whereas dichotomous data were calculated as the risk ratio (RR) with 95% CI. Results: We included 20 studies with 1, 909 participants, and the pooled data showed that compared with standard control, SFI could improve the total effective rate (RR = 1.25, 95% CI = 1.14-1.37, and n = 689), APACHE II score (WMD = -2.95, 95% CI = -3.35, -2.56, and n = 809), and predictors associated with COVID-19 progression (brain natriuretic peptide, creatine kinase, stroke volume, cardiac output, left ventricular ejection fraction, cardiac index, sE-selectin, von Willebrand factor, activated partial thromboplastin time, platelet counts, D-Dimer, procalcitonin, and WBC count). SFI may reduce mortality (RR = 0.52, 95% CI = 0.37-0.73, and n = 429) and safety concerns (RR = 0.29, 95% CI = 0.17-0.51, and n = 150) for elderly severe pneumonia. Conclusion: SFI as an adjuvant may improve the total effective rate, APACHE II score, gas exchange, and predictors associated with COVID-19 progression, reducing mortality and safety concerns for elderly patients with severe pneumonia. Copyright © 2022 Shi, Wang, Chen, Pan, Luo, Pei, Huang, Wang, Wang, Shen, Li, Wu, He and Wang. DOI: 10.3389/fphar.2022.779942 PMCID: PMC9454296 PMID: 36091817 Conflict of interest statement: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Shenhuang Granules for patients with sepsis: study protocol of a multicenter, randomized, double-blind, placebo-controlled clinical trial.

2. Front Med (Lausanne). 2025 Nov 21;12:1700749. doi: 10.3389/fmed.2025.1700749. eCollection 2025. Shenhuang Granules for patients with sepsis: study protocol of a multicenter, randomized, double-blind, placebo-controlled clinical trial. Shen MY(#)(1), Li ZJ(#)(1), Feng DD(#)(2), Yang DD(3), Liu S(4), Fu YH(1), Fang BJ(5), Wu JN(2). Author information: (1)The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, Zhejiang, China. (2)Department of Intensive Care Unit, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, Zhejiang, China. (3)Department of Emergency, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, Zhejiang, China. (4)Center of Clinical Evaluation, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, Zhejiang, China. (5)Department of Emergency, LongHua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China. (#)Contributed equally BACKGROUND: Sepsis is a life-threatening condition characterized by organ dysfunction due to a dysregulated host response to infection, with a persistently high mortality rate. In recent years, the role of Traditional Chinese Medicine in treating sepsis has gained recognition both domestically and internationally. Shenhuang Granules (SHG), composed of six ingredients: Panax ginseng C.A.Mey. (Ginseng Radix et Rhizoma), Rheum palmatum L. (Rhei Radix et Rhizoma), Sargentodoxa cuneata (Oliv.) Rehder & E.H.Wilson (Sargentodoxae Caulis), Taraxacum mongolicum Hand.-Mazz. (Taraxaci Herba), Aconitum carmichaelii Debeaux (Aconiti Lateralis Radix Praeparata), and Whitmania pigra (Whitman, 1884) (Hirudo), has been reported to strengthen and consolidate vital energy, clear heat and detoxify, promote qi circulation and gastrointestinal function, and enhance blood circulation. This study aims to evaluate the clinical efficacy and safety of SHG in patients with sepsis. METHODS AND ANALYSIS: A multicenter, randomized, double-blind, placebo-controlled clinical trial will be conducted and will enroll 410 patients aged ≥ 18 years who meet the diagnostic criteria of Sepsis 3.0. Participants will be randomly assigned in a 1:1 ratio to either the SHG group or the placebo group via a central randomization system. The SHG group will receive 7 days of standard sepsis bundle management combined with SHG, while the placebo group will receive the same management with a placebo for 7 days. Each dose will be dissolved in 100 mL of warm water (approximately 40 °C) and administered twice daily either orally or via a feeding tube (gastric or intestinal). The primary endpoint was 28-day all-cause mortality. Secondary endpoints include 28-day cumulative mechanical ventilation-free days, APACHE II score, SOFA score, overall mortality rate, total hospital stay, hospitalization cost, and inflammatory factors. Adverse events will be recorded throughout the study period. DISCUSSION: This trial represents the first multi-center randomized controlled study in China evaluating the effect of SHG on patients with sepsis. The findings are expected to provide robust evidence regarding the efficacy and safety of SHG in sepsis management, offering evidence-based recommendations for clinical practice. CLINICAL TRIAL REGISTRATION: The study was registered on September 21, 2024, with the identifier number NCT06514339. Copyright © 2025 Shen, Li, Feng, Yang, Liu, Fu, Fang and Wu. DOI: 10.3389/fmed.2025.1700749 PMCID: PMC12678277 PMID: 41357500 Conflict of interest statement: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Observation on the efficacy of moxibustion with fuzi cake combined with auricular point pressing in treating anxiety and depression in newly diagnosed people living with HIV: A randomized controlled trial.

3. Medicine (Baltimore). 2025 Sep 5;104(36):e44437. doi: 10.1097/MD.0000000000044437. Observation on the efficacy of moxibustion with fuzi cake combined with auricular point pressing in treating anxiety and depression in newly diagnosed people living with HIV: A randomized controlled trial. Meng Y(1), Zhang J(1), Yang Y(1), Zhang Y(2), Liu X(1), Guo L(2), Zhang Y(1), Hong N(2), Chen B(1). Author information: (1)Guangxi University of Chinese Medicine, Nanning, Guangxi Zhuang Autonomous Region, China. (2)Faculty of Chinese Medicine Science, Guangxi University of Chinese Medicine, Nanning, Guangxi Zhuang Autonomous Region, China. BACKGROUND: This study investigated the efficacy of moxibustion with aconite cake combined with earlobe acupressure in alleviating anxiety and depression in newly diagnosed human immunodeficiency virus patients. METHODS: Ninety eligible patients from the Affiliated Ruikang Hospital of Guangxi University of Chinese Medicine were randomly divided into an intervention group and a control group of 45 each. The control group received conventional care, while the intervention group received the combined therapy. The treatment lasted for 3 months. Efficacy was evaluated using the self-rating anxiety scale (SAS), self-rating depression scale (SDS), and quality-of life scale before and after treatment. RESULTS: After 3 months, the intervention group's SAS and SDS scores were significantly lower than the control group's (P <.05). Their quality-of-life scores and CD4 + T - lymphocyte counts improved more than the control group's (P <.05). No significant adverse reactions occurred in the intervention group. CONCLUSION: Moxibustion with aconite cake combined with earlobe acupressure can effectively alleviate anxiety and depression in newly diagnosed human immunodeficiency virus patients, enhance their quality-of-life, and may improve immune function. The treatment is safe and well - tolerated, with good clinical potential for application and promotion. Copyright © 2025 the Author(s). Published by Wolters Kluwer Health, Inc. DOI: 10.1097/MD.0000000000044437 PMCID: PMC12419420 PMID: 40922288 [Indexed for MEDLINE] Conflict of interest statement: The authors have no conflicts of interest to disclose.

[Aconite-isolated moxibustion at Yongquan (KI 1) combined with rivaroxaban for lower extremity venous thrombosis after total knee arthroplasty: a randomized controlled trial].

4. Zhongguo Zhen Jiu. 2023 Feb 12;43(2):144-8. doi: 10.13703/j.0255-2930.20220327-0004. [Aconite-isolated moxibustion at Yongquan (KI 1) combined with rivaroxaban for lower extremity venous thrombosis after total knee arthroplasty: a randomized controlled trial]. [Article in Chinese; Abstract available in Chinese from the publisher] Zhang C(1), Shen YF(1), Xie SJ(1), Quan RF(1). Author information: (1)Department of Joint Surgery, Hangzhou Xiaoshan District Hospital of TCM, Hangzhou 311201, Zhejiang Province, China. OBJECTIVE: To investigate the clinical effect of aconite-isolated moxibustion at Yongquan (KI 1) combined with rivaroxaban for lower extremity venous thrombosis after total knee arthroplasty and the influence on hypercoagulation. METHODS: Seventy-three patients of knee osteoarthritis with lower extremity venous thrombosis after total knee arthroplasty (KOA) were randomly divided into an observation group (37 cases, 2 cases dropped off) and a control group (36 cases, 1 case dropped off). The patients in the control group took orally rivaroxaban tablets, 10 mg a time, once a day. On the basis of the treatment as the control group, the aconite-isolated moxibustion was applied to Yongquan (KI 1) for the patients of the observation group, once daily and 3 moxa cones were used in each treatment. The duration of treatment was 14 days in both groups. Before treatment and 14 days into treatment, the ultrasonic B test was adopted to determine the conditions of lower extremity venous thrombosis in the two groups. Before treatment, 7 and 14 days into treatment, the coagulation indexes (platelet [PLT], prothrombin time [PT], activated partial prothrombin time [APTT], fibrinogen [Fib] and D-dimer[D-D]), the blood flow velocity of the deep femoral vein and the circumference of the affected side were compared between the two groups separately, and the clinical effect was evaluated. RESULTS: Fourteen days into treatment, the venous thrombosis of the lower extremity was relieved in both groups (P<0.05), and that of the observation group was better than the control group (P<0.05). Seven days into treatment, the blood flow velocity of the deep femoral vein was increased compared with that before treatment in the observation group (P<0.05), and the blood flow rate in the observation group was higher than that in the control group (P<0.05). Fourteen days into treatment, PT, APTT and the blood flow velocity of the deep femoral vein were increased in the two groups compared with those before treatment (P<0.05); and PLT, Fib, D-D and the circumference of the limb (knee joint, 10 cm above the patella and 10 cm below the patella) were all reduced in the two groups (P<0.05). Compared with the control group 14 days into treatment, the blood flow velocity of the deep femoral vein was higher (P<0.05), PLT, Fib, D-D and the circumference of the limb (knee joint, 10 cm above the patella and 10 cm below the patella) were all lower in the observation group (P<0.05). The total effective rate was 97.1% (34/35) in the observation group, higher than 85.7% (30/35) in the control group (P<0.05). CONCLUSION: Aconite-isolated moxibustion at Yongquan (KI 1) combined with rivaroxaban can effectively treat lower extremity venous thrombosis after total knee arthroplasty, relieve hypercoagulation, accelerate the blood flow velocity and alleviate swelling of the lower extremity in the patients with knee osteoarthritis. Publisher: 目的：观察隔附子饼灸涌泉穴联合利伐沙班治疗全膝关节置换术后下肢静脉血栓的临床疗效及对血液高凝状态的影响。方法：将73例膝关节骨关节炎全膝关节置换术后下肢静脉血栓患者随机分为观察组（37例，脱落2例）和对照组（36例，脱落1例）。对照组患者口服利伐沙班片，每次10 mg，每日1次；在对照组的基础上，观察组患者采用隔附子饼灸患侧涌泉穴治疗，每次3壮，每日1次，两组均治疗14 d。治疗前及治疗14 d后，采用B超检测两组患者下肢静脉血栓情况；治疗前及治疗7、14 d后，比较两组患者凝血指标[血小板（PLT）、凝血酶原时间（PT）、活化部分凝血酶原时间（APTT）、纤维蛋白原（Fib）、D-二聚体]及患侧股深静脉血流速度、肢体周径；并评定两组临床疗效。结果：治疗14 d后，两组患者下肢静脉血栓情况均较治疗前好转（P<0.05），且观察组好于对照组（P<0.05）。治疗7 d后，观察组患者股深静脉血流速度较治疗前升高（P<0.05），且观察组高于对照组（P<0.05）。治疗14 d后，两组患者PT、APTT、股深静脉血流速度较治疗前升高（P<0.05），PLT、Fib、D-二聚体、肢体周径（膝关节、髌骨上10 cm、髌骨下10 cm）较治疗前降低（P<0.05）；且观察组患者股深静脉血流速度高于对照组（P<0.05），PLT、Fib、D-二聚体、肢体周径（膝关节、髌骨上10 cm、髌骨下10 cm）低于对照组（P<0.05）。观察组总有效率为97.1%（34/35），高于对照组的85.7%（30/35，P<0.05）。结论：隔附子饼灸涌泉穴联合利伐沙班可有效治疗膝关节骨关节炎患者全膝关节置换术后下肢静脉血栓，改善血液高凝状态、加快下肢血流速度及减轻下肢肿胀。. DOI: 10.13703/j.0255-2930.20220327-0004 PMID: 36808507 [Indexed for MEDLINE]

[Huayu Tongluo moxibustion combined with intradermal needling in patients with mild to moderate depression after cerebral infarction].

5. Zhongguo Zhen Jiu. 2022 Nov 12;42(11):1211-5. doi: 10.13703/j.0255-2930.20220424-k0004. [Huayu Tongluo moxibustion combined with intradermal needling in patients with mild to moderate depression after cerebral infarction]. [Article in Chinese; Abstract available in Chinese from the publisher] Shao J(1), Li B(2), Yuan AH(1), Hu XQ(2), Guo J(2), Ren MX(2), Yang J(3). Author information: (1)Second Department of Acupuncture-Moxibustion and Rehabilitation, First Affiliated Hospital of Anhui University of CM, Hefei 230031, China; Second Department of Acupuncture-Moxibustion and Rehabilitation, Anhui Hospital of Integrated Traditional Chinese and Western Medication, Hefei 230031. (2)Second Department of Acupuncture-Moxibustion and Rehabilitation, Anhui Hospital of Integrated Traditional Chinese and Western Medication, Hefei 230031. (3)Second Department of Acupuncture-Moxibustion and Rehabilitation, First Affiliated Hospital of Anhui University of CM, Hefei 230031, China. OBJECTIVE: To observe the effect of Huayu Tongluo (resolving stasis and promoting collateral circulation) moxibustion combined with intradermal needling on depressive symptoms, quality of life and cognitive impairment in patients with mild to moderate depression after cerebral infarction on the basis of western medicine treatment. METHODS: Fifty patients with mild to moderate depression after cerebral infarction were randomly divided into an acupuncture combined with western medication group (group A, 25 cases) and a western medication group (group B, 25 cases). In the group B, paroxetine hydrochloride tablets were taken orally, 20 mg after breakfast, once a day, and the dose could be adjusted to the maximum 40 mg/d according to the patients' condition, for 4 weeks totally. On the basis of the treatment in the group B, the group A was treated with Huayu Tongluo moxibustion, namely aconite cake-separated moxibustion at Baihui (GV 20) and suspended moxibustion at Dazhui (GV 14) and Shenting (GV 24), combined with intradermal needling at Shenmen (HT 7), Jianshi (PC 5), Zusanli (ST 36), etc. Huayu Tongluo moxibustion was performed 6 times a week, and intradermal needling was performed 3 times a week，for 4 weeks totally. In the two groups, the scores of Hamilton depression scale (HAMD), stroke specific quality of life scale (SS-QOL) and mini mental state examination (MMSE) were observed before and after treatment, and the clinical efficacy and safety were compared. RESULTS: After treatment, the HAMD score in the each group was decreased compared with that before treatment (P<0.05), and that in the group A was lower than the group B (P<0.05); after treatment, the SS-QOL score in the group A and MMSE score in the two groups were increased compared with those before treatment (P<0.05), and the SS-QOL score in the group A was higher than the group B (P<0.05). The total effective rate was 88.0% (22/25) in the group A, which was higher than 60.0% (15/25) in the group B (P<0.05). There was no significant difference in the incidence of adverse reactions between the two groups (4.0% [1/25] vs 16.0%[4/25], P>0.05). CONCLUSION: On the basis of the treatment of western medication paroxetine hydrochloride tablets, Huayu Tongluo moxibustion combined with intradermal needling therapy can effectively improve the depressive symptoms, quality of life and cognitive impairment of patients with mild to moderate depression after cerebral infarction. Publisher: 目的：观察在西药治疗基础上，化瘀通络灸联合揿针治疗对脑梗死后轻中度抑郁患者抑郁症状、生活质量及认知功能障碍的影响。方法：将50例脑梗死后轻中度抑郁患者随机分为针药组和西药组，每组25例。西药组予盐酸帕罗西汀片，每天早餐后顿服20 mg，剂量可根据病情调整至最高40 mg/d，连续治疗4周；在西药组治疗基础上，针药组加用化瘀通络灸（隔附子饼灸百会，悬灸大椎、神庭）联合揿针（穴取神门、间使、足三里等）治疗，化瘀通络灸每周6次，揿针每周3次，均治疗4周。观察两组治疗前后汉密尔顿抑郁量表（HAMD）、脑卒中专用生活质量量表（SS-QOL）、简易精神状态检查表（MMSE）评分，并比较两组临床疗效及不良反应发生情况。结果：治疗后，两组HAMD评分较治疗前降低（P<0.05），且针药组低于西药组（P<0.05）；治疗后，针药组SS-QOL、两组MMSE评分较治疗前升高（P<0.05），针药组SS-QOL评分高于西药组（P<0.05）。针药组总有效率为88.0%（22/25），高于西药组的60.0%（15/25，P<0.05）。针药组不良反应发生率与西药组比较差异无统计学意义[4.0%（1/25）vs 16.0%（4/25），P>0.05]。结论：在西药盐酸帕罗西汀片治疗基础上，化瘀通络灸联合揿针治疗能有效改善脑梗死后轻中度抑郁患者抑郁症状，提高生活质量及认知功能。. DOI: 10.13703/j.0255-2930.20220424-k0004 PMID: 36397216 [Indexed for MEDLINE]

Efficacy and safety of Fengshi Gutong Capsule in patients with active ankylosing spondylitis: A 4-week randomized controlled, double-blinded, double-dummy trial.

6. J Ethnopharmacol. 2022 Mar 1;285:114731. doi: 10.1016/j.jep.2021.114731. Epub 2021 Oct 8. Efficacy and safety of Fengshi Gutong Capsule in patients with active ankylosing spondylitis: A 4-week randomized controlled, double-blinded, double-dummy trial. Xie Y(1), Tu L(2), Zhang Y(3), Yu Q(4), Wu H(5), Ye S(6), Li H(7), Chen Z(8), Wu J(9), Cao S(10), Wei Q(11), Gu J(12). Author information: (1)Department of Rheumatology and Immunology, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China. Electronic address: xieyasysu@qq.com. (2)Department of Rheumatology and Immunology, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China. Electronic address: tld_717@163.com. (3)Department of Rheumatology and Immunology, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China. Electronic address: zhangyanli04386@163.com. (4)Department of Rheumatology and Immunology, ZhuJiang Hospital of Southern Medical University, Guangzhou, China. Electronic address: yuqinghonghome@163.com. (5)Department of Rheumatology and Immunology, Dongguan TungWah Hospital, Dongguan, China. Electronic address: 13609667865@139.com. (6)Department of Rheumatology and Immunology, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. Electronic address: yeshanhui@126.com. (7)Department of Rheumatology and Immunology, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China. Electronic address: lihaiboqq@163.com. (8)Department of Rheumatology and Immunology, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China. Electronic address: chenzena09@163.com. (9)Department of Rheumatology and Immunology, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China. Electronic address: 244844471@qq.com. (10)Department of Rheumatology and Immunology, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China. Electronic address: yanzefei@126.com. (11)Department of Rheumatology and Immunology, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China. Electronic address: wqiujin8211@163.com. (12)Department of Rheumatology and Immunology, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China. Electronic address: gujieruo@163.com. ETHNOPHARMACOLOGICAL RELEVANCE: Fengshi Gutong Capsule (FSGTC) is a traditional Chinese herbal medicine that is composed of seven herbs. It has been widely used for the treatment of joint pain in China. However, the clinical evidence supporting its use in patients with ankylosing spondylitis (AS) is lacking. AIM OF THE STUDY: This study aims to explore the efficacy and safety of FSGTC in the treatment of AS. MATERIALS AND METHODS: This randomized, controlled, double-blinded, double-dummy trial enrolled patients with active AS defined as Bath Ankylosing Spondylitis Disease ActivityIndex (BASDAI) ≥ 4 or Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDAS-CRP) ≥ 2.1. Eligible patients were randomized (1:1:1) into combination group (FSGTC plus imrecoxib), FSGTC group (FSGTC plus imrecoxib placebo) or imrecoxib group (imrecoxib plus FSGTC placebo) over a 4-week treatment. The primary endpoint was the composite outcome measure of the Assessment in Ankylosing Spondylitis 20% (ASAS20) response at week 4. The secondary endpoints included ASDAS-CRP, BASDAI, Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), patient's global assessment of disease activity (PGTA) and safety. RESULTS: Of the 180 randomized patients, 159 patients (88.3%) completed the 4-week treatment. ASAS20 response rate at week 4 was achieved by 27.5% in imrecoxib group, compared with 37.0% in combination group (P > 0.05) and 37.0% in FSGTC group (P > 0.05). In comparison to imrecoxib group, there were significantly greater improvements of ASDAS-CRP and PTGA in combination group and greater improvement of ASDAS-CRP in FSGTC group while the rest of the secondary endpoints shown similar improvement. The incidence of gastrointestinal adverse events in imrecoxib group (15.7%) was significantly higher than that of FSGTC group (1.9%) and without a significant difference to combination group (7.4%). CONCLUSION: FSGTC alone or combined with NSAIDs has therapeutic efficacy in decreasing disease activity of active AS patients and with good gastrointestinal tolerability after 4-week of treatment. Copyright © 2021 Elsevier B.V. All rights reserved. DOI: 10.1016/j.jep.2021.114731 PMID: 34634368 [Indexed for MEDLINE]

[Aconitum in treatment of rheumatoid arthritis: benefit-risk assessment].

7. Zhongguo Zhong Yao Za Zhi. 2018 Jan;43(2):234-241. doi: 10.19540/j.cnki.cjcmm.20171106.007. [Aconitum in treatment of rheumatoid arthritis: benefit-risk assessment]. [Article in Chinese] Zhang XM(1), Jin YN(1), Zhang B(1), Li N(1). Author information: (1)Beijing University of Chinese Medicine, Beijing 100029, China. Rheumatoid arthritis (RA) has the characteristics of long course of disease and difficulty in treatment. The conventional therapy may easily induce adverse drug reactions or events (ADR/ADE) due to the long-time medication. Thus, it should be given special attentions to treatment benefit and medication risk of RA patients. Aconitum, a kind of toxic traditional Chinese herbs, is an important complement therapy for RA, with some controversy in clinical application. Coming straight to the practical problem of combined use of traditional Chinese medicines (TCM) and Western medicines (WM), this study conducted quantitative assessment on the benefits and risks of Aconitum using combined with WM or not, which was carried out by the method of multi-criteria decision analysis model. RevMan 5.2 software was used to separately analyze the results of every index of 21 random clinical trials (RCTs) of Aconitum exclusive use in the treatment of RA, and 49 RCTs of Aconitum combined use with WM. The merged results indicated that as compared with the conventional therapy of WM, no matter the exclusive use or the combined use of Aconitum could improve the efficacy and decrease the incidence of ADR/ADEs. Based on the benefit-risk assessment decision tree of RA treatment, Hiview 3 software and Crystal Ball Monte Carlo simulation were used to calculate the benefit value, risk value and benefit-risk value of Aconitum exclusive use and the combined use of Aconitum with WM. The results showed that the combination therapy had significantly better benefits than Aconitum exclusive using, difference value was 15, (95%CI[9.72, 20.25]), but the risk of combined use was higher difference value=23, （95%CI[15.57, 30.55]）. In comprehensive consideration of the benefit and risk, the total benefit-risk value of using Aconitum alone was 58, while that of the combination therapy was 55, and the probability of the former superior to the latter was 81.07%. The study showed that Aconitum was the important therapy to supply RA treatment. In clinical application, the patient's acceptability of benefit and risk need to be considered; if patients cannot bear the risk, the combination use of Aconitum and WM is not recommended. Copyright© by the Chinese Pharmaceutical Association. DOI: 10.19540/j.cnki.cjcmm.20171106.007 PMID: 29552838 [Indexed for MEDLINE] Conflict of interest statement: The authors of this article and the planning committee members and staff have no relevant financial relationships with commercial interests to disclose.

[Meta-analysis on efficacy and safety of combination therapy of Aconitum and Western medicine in treatment of rheumatoid arthritis].

8. Zhongguo Zhong Yao Za Zhi. 2018 Jan;43(2):227-233. doi: 10.19540/j.cnki.cjcmm.20171106.005. [Meta-analysis on efficacy and safety of combination therapy of Aconitum and Western medicine in treatment of rheumatoid arthritis]. [Article in Chinese] Zhang XM(1), Zhang B(1), Li F(1), Tian ZP(1). Author information: (1)Beijing University of Chinese Medicine, Beijing 100029, China. To analyze the efficacy and safety of the combination therapy of Aconitum and Western medicine in the treatment of rheumatoid arthritis (RA) by Meta-analysis, and provide evidence for its clinic application for RA. The random clinical trials (RCTs) regarding the combination therapy for treating RA were retrieved in the database of China National Knowledge Infrastructure database, China Science and Technology Journal database, WanFang, Chinese Biomedical Medical Database, PubMed, and Cochrane Library up to July 2017. According to the given inclusion criteria, 8 RCTs involving 659 participants were included, and the included RCTs could be further divided into three subgroups according to the herb type, which were Aconiti Radix (Chuanwu) subgroup (6RCTs), Aconiti Kusnezoffii Radix (Caowu) subgroup (1RCT), and Chuanwu-Caowu subgroup (1RCT). The Meta-analysis results indicated that as compared with Western medicine, the combined use of Aconitum and Western medicine, no matter Chuanwu, Caowu or Chuanwu-Caowu subgroups, could improve the total effective rate of RA (6RCTs, RR=1.19, 95%CI [1.10, 1.28], P<0.000 01), (1 RCT, RR=1.43, 95%CI [1.18, 1.73], P=0.000 2), (1 RCT, RR=1.27, 95%CI [1.02, 1.58], P=0.03) respectively. The combined use of Aconitum and Western medicine was also effective on the number of joint swelling, duration of morning stiffness, patients' handgrip, and the erythrocyte sedimentation rate, C-reactive protein and rheumatoid factor. However, its action was not significant on joint tenderness. And also, in the included RCTs, there were 34 cases of adverse drug reactions/events (ADR/ADE) in the Chuanwu subgroup, while 86 cases in the Western medicine control group. The ADR/ADE incidence was even more lower in Chuanwu-Caowu subgroup, but no difference between Caowu subgroup and Western medicine group. Based on the included RCTs, the combined use of Aconitum and Western medicine could achieve more satisfying efficacy and lower ADRs incidence for RA as compared with Western medicine alone. However, due to the limitation in the not-high quality of included RCTs and the lack of large-scale multi-center research, the results still need to be further validated in the clinic application. Copyright© by the Chinese Pharmaceutical Association. DOI: 10.19540/j.cnki.cjcmm.20171106.005 PMID: 29552837 [Indexed for MEDLINE] Conflict of interest statement: The authors of this article and the planning committee members and staff have no relevant financial relationships with commercial interests to disclose.

[Aconite cake-separated moxibustion for knee osteoarthritis with kidney-marrow deficiency].

9. Zhongguo Zhen Jiu. 2018 Jan 12;38(1):45-9. doi: 10.13703/j.0255-2930.2018.01.011. [Aconite cake-separated moxibustion for knee osteoarthritis with kidney-marrow deficiency]. [Article in Chinese] Chen M(1), Hu R(1), Lin J(2), Huang Y(1), Mao W(1), Wen Y(2), Dai G(2). Author information: (1)Hunan TCM College, Zhuzhou 412012, China. (2)Department of Acupuncture and Moxibustion, the Second Hospital of Zhuzhou City. OBJECTIVE: To observe the effects among aconite cake-separated moxibustion, moxibustion and acupuncture for knee osteoarthritis (KOA) with kidney-marrow deficiency and to explore the feasibility of cake-separated moxibustion as a home remedy solution. METHODS: Ninety patients were randomized into an aconite cake-separated moxibustion group, a moxibustion group and an acupuncture group, 30 cases in each one. The acupoints in the three groups were Neixiyan (EX-LE 4), Dubi (ST 35) in the affected side, and bilateral Xuehai (SP 10), Liangqiu (ST 34), Heding (EX-LE 2), Shenshu (BL 23) and Zusanli (ST 36). All the treatment was given for 3 sessions, 10 days as a session with 2 to 3 days between 2 sessions, and once a day. The first 2 courses of aconite cake-separated moxibustion was applied in the hospital and the other 1 session was used at home guided by officer physician. Symptoms and physical signs classification score and life quality scores were recorded before and after treatment and 6 months after treatment, including walking pain, knee pain in stoop and squat, knee discomfort in stair activity and daily discomfort. The effects were evaluated. RESULTS: The symptoms and physical signs classification scores in the three groups after treatment and at follow-up were lower than those before treatment (P<0.01, P<0.05), and the scores in the aconite cake-separated moxibustion group were better than those in the moxibustion group and acupuncture group (all P<0.01). The scores of walking pain, knee pain in stoop and squat, knee discomfort in stair activity and daily discomfort were lower in the three groups after treatment and 6 months after treatment (P<0.01, P<0.05), and the scores of walking pain and daily discomfort in the aconite cake-separated moxibustion group were lower than those in the moxibustion group and acupuncture group (P<0.01, P<0.05). After treatments, the cured and markedly effective rate in the aconite cake-separated moxibustion group was 63.3% (19/30); that in the moxibustion group was 50.0% (15/30) and one in the acupuncture group was 43.3% (13/30). The cured and markedly effective rate of aconite cake-separated moxibustion group was more promising than those in the other two groups (both P<0.05). At follow-up, the cured and markedly effective rate in the aconite cake-separated moxibustion group was 56.7% (17/30), which was better than 36.7% (11/30) in the moxibustion group and 40.0% (12/30) in the acupuncture group (both P<0.05). CONCLUSION: Aconite cake-separated moxibustion can be used for KOA patients with kidney-marrow deficiency, which can improve patients' life quality and is better than moxibustion and acupuncture. The method is feasible as a home remedy solution. DOI: 10.13703/j.0255-2930.2018.01.011 PMID: 29354936 [Indexed for MEDLINE]

Shenfu decoction as adjuvant therapy for improving quality of life and hepatic dysfunction in patients with symptomatic chronic heart failure.

10. J Ethnopharmacol. 2015 Jul 1;169:347-55. doi: 10.1016/j.jep.2015.04.016. Epub 2015 May 1. Shenfu decoction as adjuvant therapy for improving quality of life and hepatic dysfunction in patients with symptomatic chronic heart failure. Wei H(1), Wu H(2), Yu W(3), Yan X(4), Zhang X(3). Author information: (1)Beijing Haidian Hospital, Haidian Section of Peking University Third Hospital, Beijing 100080, China; Guang׳anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China. (2)Beijing Haidian Hospital, Haidian Section of Peking University Third Hospital, Beijing 100080, China. Electronic address: whjyuanzhang@aliyun.com. (3)Beijing Hospital of Integrated Traditional and Western Medicine, Beijing 100039, China. (4)Beijing Hospital of Integrated Traditional and Western Medicine, Beijing 100039, China; Postdoctoral Workstation of the Zhongguancun Haidian Science Park, No.6 Sijiqing Road, Haidian District, Beijing 100195, China. ETHNOPHARMACOLOGICAL RELEVANCE: Shenfu decoction (SFD) is a water extract of the dried root or root stalk of Panax ginseng C. A. Mey (Asian ginseng) and the lateral root of Aconitum carmichaeli Debx (prepared by Fuzi, Heishunpian in Chinese). It has been used to treat heart failure for over a thousand years. The main active components of SFD, ginsenosides and higenamine, enhance heart contractility, increase the coronary blood supply, improve ischemic myocardial metabolism, scavenge free radicals and protect myocardial ultrastructure. AIM OF THE STUDY: To investigate the effect of SFD on quality of life (QOL) and hepatic function in symptomatic chronic heart failure (CHF) patients. MATERIALS AND METHODS: Forty patients enrolled in the study were randomized into two groups: an SFD group (18 cases) and a control group (22 cases). All the patients received standard heart failure therapy, and the SFD group patients were also treated with Shenfu granules for 14 days as an adjunctive therapy. The effects of SFD on QOL, plasma alanine aminotransferase (ALT) level, cardiac function, left ventricular ejection fraction (LVEF) and tumor necrosis factor-α (TNF-α) level were studied. ALT threshold in hepatic injury are 21U/L for men and 17U/L for women. RESULTS: Minnesota Living with Heart Failure Questionnaire (MLHFQ) scores were improved by 35.27±10.72 vs. 23.87±11.96 in the SFD and control groups respectively (p<0.01). Subgroup analysis of the MLHFQ results demonstrated that both physical and emotional scores were significantly higher in the SFD group (21.00±5.66 vs. 16.75±6.25, p<0.05; 4.64±4.84 vs. 1.13±2.85, p<0.05). Circulating ALT was significantly decreased by SFD (13.3IU/L vs. 0.6IU/L, p<0.01). The grading of cardiac function and LVEF were increased by 1.6±0.5 vs. 1.1±0.3 and 18%±13% vs. 8%±8% in the SFD and control groups respectively (p<0.05 and p<0.05). The level of TNF-α declined more in SFD than control group (64.8±5.0 to 57.6±4.1, p<0.05; vs. 61.6±5.9 vs. 57.7±3.2. p>0.05). CONCLUSION: Compared with standard heart failure treatment, oral SFD as an adjuvant therapy significantly improved QOL and hepatic injury in CHF patients. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved. DOI: 10.1016/j.jep.2015.04.016 PMID: 25937255 [Indexed for MEDLINE]

Clinical curative effect of fuzi-cake-separated moxibustion for preventing dysuria after operation for lower limb fracture.

11. J Tradit Chin Med. 2014 Oct;34(5):544-9. doi: 10.1016/s0254-6272(15)30060-1. Clinical curative effect of fuzi-cake-separated moxibustion for preventing dysuria after operation for lower limb fracture. Yue Y, Tao L, Fang J, Xie Q, He S, Huang C, Yang X. OBJECTIVE: To assess the clinical curative effect of fuzi-cake-separated moxibustion at Zhongji (CV 3) and Guanyuan (CV 4) for preventing dysuria after internal fixation of lower limb fractures. METHODS: Sixty patients conforming to the inclusion standards were randomly divided into a treatment group (n = 30) and a control group (n = 30). Fuzi-cake-separated moxibustion was performed at Guanyuan (CV 4) and Zhongji (CV 3), 20 min at a time, twice a day, for 3 days before operation in the treatment group. No fuzi-cake-separated moxibustion was performed in the control group. After treatment, the score for symptoms of first urination, urinary time, urinary volume, 24 h remaining urinary volume, incidence of uroschesis, and rate of controlling dysuria were compared to evaluate the curative effect of preventing post-operative dysuria. RESULTS: The score for symptoms of first urination, 24 h remaining urinary volume (maximum 120 mL vs 250 ml, and less than 10 ml in 24 cases vs 15 cases), and the rate of controlling dysuria (83.34% vs 30%) were significantly better (P < 0.05, P < 0.05, and P < 0.001, respectively) in the treatment compared with the control group. There was no statistical difference (P > 0.05) between the two groups in first post-operative urinary time, urinary volume, or incidence of 24 h uroschesis. CONCLUSION: Fuzi-cake-separated moxibustion at Zhongji (CV 3) and Guanyuan (CV 4) can better prevent post-operative dysuria, effectively promote the functional restoration of the urinary bladder, and control the incidence of post-operative dysuria. DOI: 10.1016/s0254-6272(15)30060-1 PMID: 25417403 [Indexed for MEDLINE]

Factorial study of moxibustion in treatment of diarrhea-predominant irritable bowel syndrome.

12. World J Gastroenterol. 2014 Oct 7;20(37):13563-72. doi: 10.3748/wjg.v20.i37.13563. Factorial study of moxibustion in treatment of diarrhea-predominant irritable bowel syndrome. Zhao JM(1), Wu LY(1), Liu HR(1), Hu HY(1), Wang JY(1), Huang RJ(1), Shi Y(1), Tao SP(1), Gao Q(1), Zhou CL(1), Qi L(1), Ma XP(1), Wu HG(1). Author information: (1)Ji-Meng Zhao, Lu-Yi Wu, Hong-Yi Hu, Ren-Jia Huang, Jia-Ying Wang, Li Qi, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China. AIM: To identify an appropriate therapeutic regimen for using aconite cake-separated moxibustion to treat diarrhea-predominant irritable bowel syndrome (D-IBS). METHODS: A factorial design was employed to examine the two factors of moxibustion frequency and number of cones. The two tested frequencies were three or six moxibustion sessions per week, and the two tested doses were one or two cones per treatment. A total of 166 D-IBS patients were randomly divided into four treatment groups, which included each combination of the examined frequencies and doses. The bilateral Tianshu acupoints (ST25) and the Qihai acupoint (RN6) were selected for aconite cake-separated moxibustion. Each patient received two courses of treatment, and each course had a duration of 2 wk. For each group, the scores on the Birmingham irritable bowel syndrome (IBS) symptom questionnaire, the IBS Quality of Life scale, the Self-Rating Depression Scale (SDS), the Self-Rating Anxiety Scale (SAS), the Hamilton Depression (HAMD) scale, and the Hamilton Anxiety (HAMA) scale were determined before treatment, after the first course of treatment, and after the second course of treatment. RESULTS: The symptom, quality of life, SDS, SAS, HAMD, and HAMA scores of the patients in all 4 aconite cake-separated moxibustion groups were significantly lower after the first and second courses of treatment than before treatment (P < 0.001 for all). The symptom, quality of life, SDS, SAS, HAMD, and HAMA scores of the patients in all four aconite cake-separated moxibustion groups were significantly lower after the second course of treatment than after the first course of treatment (P < 0.001 for all). Between-group comparisons after the second course of treatment revealed that the symptom scores for group 1 (1 cone, 3 treatments/wk) and group 3 (2 cones, 3 treatments/wk) were significantly lower than that for group 2 (1 cone, 6 treatments/wk) (5.55 ± 5.05 vs 10.45 ± 6.61, P < 0.001; 5.65 ± 4.00 vs 10.45 ± 6.61, P < 0.001). Regarding the two levels of the two examined factors for aconite cake-separated moxibustion, after the first course of treatment, the changes in HAMA scores were significantly different for the two tested moxibustion frequencies (P = 0.011), with greater changes for the "6 treatments/wk" groups than for the "3 treatments/wk" groups; in addition, there were interaction effects between the number of cones and moxibustion frequency (P = 0.028). After the second course of treatment, changes in symptom scores for the 2 tested moxibustion frequencies were significantly different (P = 0.002), with greater changes for the "3 treatments/wk" groups than for the "6 treatments/wk" groups. CONCLUSION: An aconite cake-separated moxibustion treatment regimen of 3 treatments/wk and 1 cone/treatment appears to produce better therapeutic effects for D-IBS compared with the other tested regimens. DOI: 10.3748/wjg.v20.i37.13563 PMCID: PMC4188908 PMID: 25309087 [Indexed for MEDLINE]

[Effect of aconite cake-separated moxibustion at Guanyuan (CV 4) and Mingmen (GV 4) on thyroid function in patients of Hashimoto's thyroiditis].

13. Zhongguo Zhen Jiu. 2012 Feb;32(2):123-6. [Effect of aconite cake-separated moxibustion at Guanyuan (CV 4) and Mingmen (GV 4) on thyroid function in patients of Hashimoto's thyroiditis]. [Article in Chinese] Xia Y(1), Xia MZ, Li Y, Liu SM, Ju ZY, He JS. Author information: (1)College of Acupuncture-Moxibustion and Massage, Shanghai University of TCM, Shanghai 201203, China. OBJECTIVE: To explore the effects on thyroid function in patients of Hashimoto's thyroiditis treated with aconite cake-separated moxibustion and option the better therapeutic program. METHODS: Eighty-five cases were randomly divided into a moxibustion group (42 cases) and a western medication group (43 cases). The moxibustion group was treated by aconite cake-separated moxibustion therapy with acupoints of two groups [(1) Danzhong (CV 17), Zhongwan (CV 12), Guanyuan (CV 4); (2) Dazhui (GV 14), Shenshu (BL 23), Mingmen (GV 4)] alternatively and oral administration of 25 microg Euthyrox everyday. The western medication group was oral administration of 25 microg Euthyrox everyday. Indices of thyroid function before and after treatment and clinical effect were compared between two groups. RESULTS: The clinical total effective rate and effective rate of thyroid function were 25.0% (10/40), 87.5% (35/40) in moxibustion group respectively, 7.53% (3/40) and 57.5% (23/40) in western medication group, with significant differences between two groups (both P < 0.05). Content of serum free thyroxine index (FT4) increased significantly in the moxibustion group after treatment (P < 0.01); content of serum supersensitive thyrotropin (S-TSH) in the moxibustion group was lower than that of western medication group, and contents of serum FT4 and free triiodothyronine (FT3) were higher than those of western medication group, but with no significant differences (all P > 0.05). CONCLUSION: Aconite cake-separated moxibustion at Guanyuan (CV 4) and Mingmen (GV 4) combined with oral administration of Euthyrox can improve clinical symptoms and thyroid function in patients of Hashimoto's thyroiditis, which is better than simple oral administration of Euthyrox. PMID: 22493914 [Indexed for MEDLINE]

Simultaneous use of traditional Chinese medicine (si-ni-tang) to treat septic shock patients: study protocol for a randomized controlled trial.

14. Trials. 2011 Aug 24;12:199. doi: 10.1186/1745-6215-12-199. Simultaneous use of traditional Chinese medicine (si-ni-tang) to treat septic shock patients: study protocol for a randomized controlled trial. Chen HC(1), Chen WC, Lin KH, Chen YH, Lo LC, Lee TC, Hsia TC, Wang CH, Wu SH, Hsu HW, Chang YJ, Huang YC, Ku TH, Horng MH. Author information: (1)Graduate Institute of Integrated Medicine, College of Chinese Medicine, China Medical University, Taichung, Taiwan. BACKGROUND: Even though there are continually upgraded recommendations for managing sepsis, such as "Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock", mortality is still high. Si-ni-tang, a remedy documented in Shanghan Lun, a medical collection from ancient China, is used for treating patients with sepsis and septic shock. Using a well-designed clinical trial, we are eager to survey the effectiveness of the concurrent use of this remedy in restoring these patients' hemodynamic status, or "Yang Qi". METHODS/DESIGN: Patients admitted to our medical intensive care units with the diagnosis of septic shock, defined as persistent hypotension induced by sepsis despite adequate fluid resuscitation, are eligible for participation. The inclusion criteria include: age from 20 to 85 years, conditions meeting the definition of septic shock, use of vasopressors within 24 hours of entering the study, and use of a nasogastric tube for feeding. The enrolled patients are randomly allocated either to the si-ni-tang group or the placebo group. The prescription of the trial drugs (si-ni-tang/placebo) is 2.25 grams 4 times a day for 7 days or till shock reversal (if shock reversal occurs in less than 7 days). Data, including duration of vasopressor infusion, gender, age, co-morbidities, APACHE II score, predicted mortality, ICU mortality, ICU length of stay, hospital mortality, hospital length of stay, source of sepsis, and culture results, are collected for the following analysis. DISCUSSION: Si-ni-tang is composed of processed Zingiber officinale, Glycyrrhiza uralensis, and Aconitum carmichaeli. Zingiber officinale and Glycyrrhiza uralensis are found to have the ability to reduce pro-inflammatory cytokine production, to inhibit lipopolisaccharide-induced macrophage activation and function, and to lessen the bacterial load and suppress acute and chronic inflammation. Aconitum carmichaeli is known to have vasopressor activity, and positive chronotropic and inotropic effects. As this remedy has a potential benefit in treating septic shock patients, we designed a double-blind, prospective, randomized controlled trial and would like to publish the results and conclusions later. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01223430. DOI: 10.1186/1745-6215-12-199 PMCID: PMC3178491 PMID: 21864392 [Indexed for MEDLINE]

On: Piltan D, Rist L, Simões-Wüst A, Saller R: Test of a homeopathic dilution of Aconitum napellus. A clinical, randomized, double-blind, controlled crossover study in healthy volunteers. Forsch Komplementmed 2009;16:168-173.

15. Forsch Komplementmed. 2009 Oct;16(5):349. doi: 10.1159/000243809. Epub 2009 Oct 8. On: Piltan D, Rist L, Simões-Wüst A, Saller R: Test of a homeopathic dilution of Aconitum napellus. A clinical, randomized, double-blind, controlled crossover study in healthy volunteers. Forsch Komplementmed 2009;16:168-173. Thurneysen A. Comment on Forsch Komplementmed. 2009 Jun;16(3):168-73. doi: 10.1159/000219316. DOI: 10.1159/000243809 PMID: 19887816 [Indexed for MEDLINE]

Test of a homeopathic dilution of Aconitum napellus. A clinical, randomized, double-blind, controlled crossover study in healthy volunteers.

16. Forsch Komplementmed. 2009 Jun;16(3):168-73. doi: 10.1159/000219316. Epub 2009 Jun 5. Test of a homeopathic dilution of Aconitum napellus. A clinical, randomized, double-blind, controlled crossover study in healthy volunteers. Piltan D(1), Rist L, Simões-Wüst P, Saller R. Author information: (1)Research Department, Paracelsus Hospital, Richterswil, Switzerland. Comment in Forsch Komplementmed. 2009 Oct;16(5):349. doi: 10.1159/000243809. BACKGROUND: Although healthy persons often report on reactions to homeopathically diluted substances, the mechanism behind such reactions remains unclear. This study examines whether a distinction can be made between the short-term reactions of healthy volunteers to a homeopathically diluted substance - Aconitum napellus C30 - and to a placebo. PARTICIPANTS AND METHODS: From the 33 subjects randomized for this double-blind, placebo-controlled crossover study, 27 could be included in the analysis. The study comprised two 7-day-long treatment periods, each including the intake of a study preparation for 3 days and a wash-out period of 4 days. One group was first treated with Aconitum napellus C30 and then with placebo; the other group received the two study preparations in the reverse order. The signs and symptoms before the first treatment and after each treatment were collected, evaluated, weighted and repertorized. Based on this classification the blinded physician assessed these signs and symptoms as study outcome parameter to represent the responses to each of the study preparations. Statistical analysis of the data was performed using the Wilcoxon-Mann-Whitney rank test. RESULTS: Crossover differences yielded statistical significance between the classified reactions towards Aconitum napellus C30 and to placebo (p = 0.004). CONCLUSIONS: A clear difference between the reported short-term reactions of healthy subjects towards Aconitum napellus C30 and towards placebo was shown. The crossover design with intra-individual comparisons proved to be adequate to recognize the study preparations and for the statistical analysis of a small population sample. Copyright 2009 S. Karger AG, Basel. DOI: 10.1159/000219316 PMID: 19657201 [Indexed for MEDLINE]