Dengzhan shengmai capsule combined with donepezil hydrochloride in the treatment of Alzheimer's disease: preliminary findings, randomized and controlled clinical trial.

OBJECTIVE: To observe the effects of Dengzhan Shengmai capsule combined with donepezil hydrochloride on cognitive function, daily living ability, and safety in patients with Alzheimer's disease. METHODS: A total of 294 patients with Alzheimer's disease were randomly divided into a treatment group and a control group, 147 cases each group. The control group was given oral donepezil hydrochloride 5 mg once a day, and the treatment group was given oral Dengzhan Shengmai capsule 0.36 g three times a day, based on the control group. RESULTS: At 3 and 6 months of treatment, the ADAS-cog score of the treatment group was 48.69±6.23 and 44.24±5.53; for the control group, 45.48±5.94 and 41.57±5.10. The difference between the two groups is statistically significant (p<0.05). At 3 and 6 months of treatment, the NO level in the treatment group was (46.28±6.68) umol/l, (43.55±7.92) umol/l, and the control group was (42.95±7.92) umol/l, (38.89±5.93) umol/l. The differences between both groups were statistically significant (p<0.05). At 3 and 6 months of treatment, ET levels in the treatment group were (156.08±17.39) ng/l, (144.91±17.60) ng/l, and the control group was (150.48±22.94) ng/l, (135.04±10.08) ng/l. Correlation analysis showed that ADAS-cog score was negatively correlated with NO and ET (p<0.001). CONCLUSIONS: Dengzhan Shengmai capsule combined with donepezil hydrochloride can improve cognitive function and the living capacity of patients with Alzheimer's disease, reduce the production of neurotoxic substances NO and ET, and provide higher safety.

Dengzhan shengmai capsule combined with donepezil hydrochloride in the treatment of Alzheimer's disease: preliminary findings, randomized and controlled clinical trial

SUMMARY OBJECTIVE: To observe the effects of Dengzhan Shengmai capsule combined with donepezil hydrochloride on cognitive function, daily living ability, and safety in patients with Alzheimer's disease. METHODS: A total of 294 patients with Alzheimer's disease were randomly divided into a treatment group and a control group, 147 cases each group. The control group was given oral donepezil hydrochloride 5 mg once a day, and the treatment group was given oral Dengzhan Shengmai capsule 0.36 g three times a day, based on the control group. RESULTS: At 3 and 6 months of treatment, the ADAS-cog score of the treatment group was 48.69±6.23 and 44.24±5.53; for the control group, 45.48±5.94 and 41.57±5.10. The difference between the two groups is statistically significant (p<0.05). At 3 and 6 months of treatment, the NO level in the treatment group was (46.28±6.68) umol/l, (43.55±7.92) umol/l, and the control group was (42.95±7.92) umol/l, (38.89±5.93) umol/l. The differences between both groups were statistically significant (p<0.05). At 3 and 6 months of treatment, ET levels in the treatment group were (156.08±17.39) ng/l, (144.91±17.60) ng/l, and the control group was (150.48±22.94) ng/l, (135.04±10.08) ng/l. Correlation analysis showed that ADAS-cog score was negatively correlated with NO and ET (p<0.001). CONCLUSIONS: Dengzhan Shengmai capsule combined with donepezil hydrochloride can improve cognitive function and the living capacity of patients with Alzheimer's disease, reduce the production of neurotoxic substances NO and ET, and provide higher safety.

Tribulus Terrestris for Female Sexual Dysfunction: A Systematic Review.

OBJECTIVE: We performed a systematic review to assess the effectiveness and safety of Tribulus terrestris to treat female sexual dysfunction (FSD). DATA SOURCES: We performed unrestricted electronic searches in the MEDLINE, CENTRAL, EMBASE, LILACS, CINAHL, PsycINFO, WHO-ICTR, Clinicaltrials.gov and OpenGrey databases. SELECTION OF STUDIES: We included any randomized controlled trials (RCTs) that compared T. terrestris versus inactive/active interventions. After the selection process, conducted by two reviewers, 5 RCTs (n = 279 participants) were included. DATA COLLECTION: Data extraction was performed by two reviewers with a preestablished data collection formulary. DATA SYNTHESIS: Due to lack of data and clinical heterogeneity, we could not perform meta-analyses. The risk of bias was assessed by the Cochrane Risk of Bias (RoB) tool, and the certainty of evidence was assessed with Grading of Recommendations, Assessment, Development and Evaluations (GRADE). RESULTS: After 1 to 3 months of treatment, premenopausal and postmenopausal women randomized to T. terrestris had a significant increase in sexual function scores. Three months of treatment with T. terrestris showed a significant increase in the serum testosterone levels of premenopausal women. There was no report of serious adverse events, and none of the studies assessed health-related quality of life. The certainty of the evidence was very low, which means that we have very little confidence in the effect estimates, and future studies are likely to change these estimates. CONCLUSION: More RCTs are needed to support or refute the use of T. terrestris. The decision to use this intervention should be shared with the patients, and the uncertainties around its effects should be discussed in the clinical decision-making process.Number of Protocol registration in PROSPERO database: CRD42019121130.

OBJETIVO: Nós realizamos uma revisão sistemática para avaliar a efetividade e a segurança do Tribulus terrestris no tratamento da disfunção sexual feminina (DSF). FONTES DE DADOS: Nós realizados uma busca eletrônica irrestrita nas seguintes bases de dados: MEDLINE, CENTRAL, EMBASE, LILACS, CINAHL, PsycINFO, WHO-ICTR, Clinicaltrials.gov, e OpenGrey. SELEçãO DOS ESTUDOS: Nós incluímos todos os ensaios clínico randomizados (ECR) que comparou T. terrestris com controles ativos/inativos. Após o processo de seleção, conduzido por 2 revisores, 5 ECRs (n = 279 participantes) foram incluídos. EXTRAçãO DE DADOS: O processo de extração de dados foi realizado por dois revisores, utilizando-se um formulário de extração de dados pré-estabelecido. SíNTESE DE DADOS: Devido à falta de dados disponíveis e à heterogeneidade clínica entre os estudos incluídos, nós não realizamos meta-análises. O risco de viés foi avaliado pela tabela de risco de viés da Cochrane e, a certeza do corpo da evidência foi avaliada pelo Grading of Recommendations, Assessment, Development and Evaluations (GRADE). RESULTADOS: Após 1 a três 3 meses de tratamento, mulheres na pré e pós-menopausa randomizadas ao T. terrestris tiveram um aumento significante nos escores de função sexual. O grupo com 3 meses de tratamento com T. terrestris exibiu um aumento significante dos níveis séricos de testosterona em mulheres pré-menopausa. Não houve relato de eventos adversos graves, e nenhum estudo avaliou qualidade de vida das participantes. A certeza da evidência foi considerada muito baixa, o que significa que existe pouca certeza na estimativa dos efeitos e que é provável que futuros estudos mudem estas estimativas. CONCLUSãO: Mais ECRs são importantes para apoiar ou refutar o uso do T. terrestris. A decisão de usar essa intervenção deve ser compartilhada com pacientes, e as incertezas sobre seus efeitos devem ser discutidas durante o processo de decisão clínica.

Tribulus terrestris for female sexual dysfunction: a systematic review / Tribulus terrestris para disfunção sexual feminina: uma revisão sistemática

Abstract Objective We performed a systematic review to assess the effectiveness and safety of Tribulus terrestris to treat female sexual dysfunction (FSD). Data sources We performed unrestricted electronic searches in the MEDLINE, CENTRAL, EMBASE, LILACS, CINAHL, PsycINFO,WHO-ICTR, Clinicaltrials.gov and OpenGrey databases. Selection of studies We included any randomized controlled trials (RCTs) that compared T. terrestris versus inactive/active interventions. After the selection process, conducted by two reviewers, 5 RCTs (n = 279 participants) were included. Data collection Data extraction was performed by two reviewers with a preestablished data collection formulary. Data synthesis Due to lack of data and clinical heterogeneity, we could not perform meta-analyses. The risk of bias was assessed by the Cochrane Risk of Bias (RoB) tool, and the certainty of evidence was assessed with Grading of Recommendations, Assessment, Development and Evaluations (GRADE). Results After 1 to 3 months of treatment, premenopausal and postmenopausal women randomized to T. terrestris had a significant increase in sexual function scores. Three months of treatment with T. terrestris showed a significant increase in the serum testosterone levels of premenopausal women. There was no report of serious adverse events, and none of the studies assessed health-related quality of life. The certainty of the evidence was very low, whichmeans that we have very little confidence in the effect estimates, and future studies are likely to change these estimates. Conclusion MoreRCTs are needed to supportor refute the use of T. terrestris. The decision to use this intervention should be shared with the patients, and the uncertainties around its effects should be discussed in the clinical decision-making process. Number of Protocol registration in PROSPERO database: CRD42019121130

Resumo Objetivo Nós realizamos uma revisão sistemática para avaliar a efetividade e a segurança do Tribulus terrestris no tratamento da disfunção sexual feminina (DSF). Fontes de dados Nós realizados uma busca eletrônica irrestrita nas seguintes bases de dados: MEDLINE, CENTRAL, EMBASE, LILACS, CINAHL, PsycINFO, WHO-ICTR, Clinicaltrials.gov, e OpenGrey. Seleção dos estudos Nós incluímos todos os ensaios clínico randomizados (ECR) que comparou T. terrestris com controles ativos/inativos. Após o processo de seleção, conduzido por 2 revisores, 5 ECRs (n = 279 participantes) foram incluídos. Extração de dados O processo de extração de dados foi realizado por dois revisores, utilizando-se um formulário de extração de dados pré-estabelecido. Síntese de dados Devido à falta de dados disponíveis e à heterogeneidade clínica entre os estudos incluídos, nós não realizamos meta-análises. O risco de viés foi avaliado pela tabela de risco de viés da Cochrane e, a certeza do corpo da evidência foi avaliada pelo Grading of Recommendations, Assessment, Development and Evaluations (GRADE). Resultados Após 1 a três 3 meses de tratamento, mulheres na pré e pós-menopausa randomizadas ao T. terrestris tiveram um aumento significante nos escores de função sexual. O grupo com 3 meses de tratamento com T. terrestris exibiu um aumento significante dos níveis séricos de testosterona emmulheres pré-menopausa. Não houve relato de eventos adversos graves, e nenhum estudo avaliou qualidade de vida das participantes. A certeza da evidência foi considerada muito baixa, o que significa que existe pouca certeza na estimativa dos efeitos e que é provável que futuros estudos mudem estas estimativas. Conclusão Mais ECRs são importantes para apoiar ou refutar o uso do T. terrestris. A decisão de usar essa intervenção deve ser compartilhada com pacientes, e as incertezas sobre seus efeitos devem ser discutidas durante o processo de decisão clínica.

Xuezhikang reduced arterial stiffness in patients with essential hypertension: a preliminary study.

This study aimed to test the effects of xuezhikang, a cholestin extract that contains statin-like components, on arterial stiffness in patients with essential hypertension. One hundred hypertensive patients from the Chinese PLA General Hospital were randomly allocated to receive xuezhikang (1200 mg/day, orally) or placebo (same capsules containing only pharmaceutical excipients). Physical examination outcomes, lipid profile, high sensitivity C-reactive protein (hs-CRP) levels, matrix metalloproteinases-9 (MMP-9) levels, and arterial outcomes, including stiffness parameter (ß), pressure-strain elasticity modulus (Ep), arterial compliance (AC), augmentation index (AI), and one-point pulse wave velocity (PWVß) were obtained at baseline and after 6 months of the intervention. Xuezhikang significantly reduced ß (8.4±3.1 vs 6.8±2.1, P=0.007), Ep (122.8±43.9 vs 100.7±33.2, P=0.009), PWVß (6.7±1.2 vs 6.1±1.0, P=0.013), low-density lipoprotein cholesterol (3.4±0.6 vs 2.9±0.5, P=0.001), hs-CRP [2.1 (0.4-10.0) vs 1.4 (0.3-4.1), P=0.020], and MMP-9 (17.2±2.4 vs 12.7±3.8, P <0.001) compared to baseline. The placebo had no effect on these parameters. The changes of PWVß in the xuezhikang group was significantly associated with the changes of hs-CRP and MMP-9 (r=0.144, P=0.043; r=0.278, P=0.030, respectively) but not with lipid profile changes. Our research showed xuezhikang can improve the parameters of arterial stiffness in hypertensive patients, and its effect was independent of lipid lowering.

Xuezhikang reduced arterial stiffness in patients with essential hypertension: a preliminary study

This study aimed to test the effects of xuezhikang, a cholestin extract that contains statin-like components, on arterial stiffness in patients with essential hypertension. One hundred hypertensive patients from the Chinese PLA General Hospital were randomly allocated to receive xuezhikang (1200 mg/day, orally) or placebo (same capsules containing only pharmaceutical excipients). Physical examination outcomes, lipid profile, high sensitivity C-reactive protein (hs-CRP) levels, matrix metalloproteinases-9 (MMP-9) levels, and arterial outcomes, including stiffness parameter (β), pressure-strain elasticity modulus (Ep), arterial compliance (AC), augmentation index (AI), and one-point pulse wave velocity (PWVβ) were obtained at baseline and after 6 months of the intervention. Xuezhikang significantly reduced β (8.4±3.1 vs 6.8±2.1, P=0.007), Ep (122.8±43.9 vs 100.7±33.2, P=0.009), PWVβ (6.7±1.2 vs 6.1±1.0, P=0.013), low-density lipoprotein cholesterol (3.4±0.6 vs 2.9±0.5, P=0.001), hs-CRP [2.1 (0.4-10.0) vs 1.4 (0.3-4.1), P=0.020], and MMP-9 (17.2±2.4 vs 12.7±3.8, P <0.001) compared to baseline. The placebo had no effect on these parameters. The changes of PWVβ in the xuezhikang group was significantly associated with the changes of hs-CRP and MMP-9 (r=0.144, P=0.043; r=0.278, P=0.030, respectively) but not with lipid profile changes. Our research showed xuezhikang can improve the parameters of arterial stiffness in hypertensive patients, and its effect was independent of lipid lowering.

Traditional Chinese Medicine and herbal hepatotoxicity: a tabular compilation of reported cases.

Traditional Chinese Medicine (TCM) with its focus on herbal use became popular worldwide. Treatment was perceived as safe, with neglect of rare adverse reactions including liver injury. To compile worldwide cases of liver injury by herbal TCM, we undertook a selective literature search in the PubMed database and searched for the items Traditional Chinese Medicine, TCM, Traditional Asian Medicine, and Traditional Oriental Medicine, also combined with the terms herbal hepatotoxicity or herb induced liver injury. The search focused primarily on English-language case reports, case series, and clinical reviews. We identified reported hepatotoxicity cases in 77 relevant publications with 57 different herbs and herbal mixtures of TCM, which were further analyzed for causality by the Council for International Organizations of Medical Sciences (CIOMS) scale, positive reexposure test results, or both. Causality was established for 28/57 different herbs or herbal mixtures, Bai Xian Pi, Bo He, Ci Wu Jia, Chuan Lian Zi, Da Huang, Gan Cao, Ge Gen, Ho Shou Wu, Huang Qin, Hwang Geun Cho, Ji Gu Cao, Ji Xue Cao, Jin Bu Huan, Jue Ming Zi, Jiguja, Kudzu, Ling Yang Qing Fei Keli, Lu Cha, Rhen Shen, Ma Huang, Shou Wu Pian, Shan Chi, Shen Min, Syo Saiko To, Xiao Chai Hu Tang, Yin Chen Hao, Zexie, and Zhen Chu Cao. In conclusion, this compilation of liver injury cases establishes causality for 28/57 different TCM herbs and herbal mixtures, aiding diagnosis for physicians who care for patients with liver disease possibly related to herbal TCM.

CYP1A2 polymorphism in Chinese patients with acute liver injury induced by Polygonum multiflorum.

The objective of this study was to evaluate the genotype and allelic frequencies of CYP1A2 in Chinese patients with acute liver injury induced by Polygonum multiflorum. We examined the clinical mechanism of acute liver injury induced by P. multiflorum. According to the diagnostic criteria for drug-induced liver injury (DILI), 43 cases of P. multiflorum-induced liver injury admitted to the First Affiliated Hospital, Zhejiang University were identified between January 2008 and December 2012. An additional 43 control subjects were also chosen. Several alleles, including 1C, 1F, 2, 7, 9, and 11 of CYP1A2 were amplified from genomic DNA and sequenced. We used the chi-square test to determine whether CYP1A2 allele polymorphisms are associated with acute liver injury induced by P. multiflorum. The frequency of the CYP1A2 1C allele was 46.5% in P. multiflorum-induced DILI patients, which was significantly different from the frequency of 27.9% observed in healthy subjects. The frequency of the CYP1A2 1F allele was 63.9% in P. multiflorum-induced DILI patients, compared to 57.0% in healthy controls; the difference was not significant. The allelic frequencies of CYP1A2 2, CYP1A2 7, CYP1A2 9, and CYP1A2 11 were too low to be detected. The frequency of the CYP1A2 1C mutation in Chinese patients with P. multiflorum-induced acute liver injury differed from that in healthy Chinese people, indicating that CYP1A2 1C is probably related to metabolism of P. multiflorum, which is followed by acute liver injury.

Liver injury from herbals and dietary supplements in the U.S. Drug-Induced Liver Injury Network.

UNLABELLED: The Drug-Induced Liver Injury Network (DILIN) studies hepatotoxicity caused by conventional medications as well as herbals and dietary supplements (HDS). To characterize hepatotoxicity and its outcomes from HDS versus medications, patients with hepatotoxicity attributed to medications or HDS were enrolled prospectively between 2004 and 2013. The study took place among eight U.S. referral centers that are part of the DILIN. Consecutive patients with liver injury referred to a DILIN center were eligible. The final sample comprised 130 (15.5%) of all subjects enrolled (839) who were judged to have experienced liver injury caused by HDS. Hepatotoxicity caused by HDS was evaluated by expert opinion. Demographic and clinical characteristics and outcome assessments, including death and liver transplantation (LT), were ascertained. Cases were stratified and compared according to the type of agent implicated in liver injury; 45 had injury caused by bodybuilding HDS, 85 by nonbodybuilding HDS, and 709 by medications. Liver injury caused by HDS increased from 7% to 20% (P < 0.001) during the study period. Bodybuilding HDS caused prolonged jaundice (median, 91 days) in young men, but did not result in any fatalities or LT. The remaining HDS cases presented as hepatocellular injury, predominantly in middle-aged women, and, more frequently, led to death or transplantation, compared to injury from medications (13% vs. 3%; P < 0.05). CONCLUSIONS: The proportion of liver injury cases attributed to HDS in DILIN has increased significantly. Liver injury from nonbodybuilding HDS is more severe than from bodybuilding HDS or medications, as evidenced by differences in unfavorable outcomes (death and transplantation). (Hepatology 2014;60:1399-1408).

Farmacovigilancia y medicina interna / Pharmacovigilance and internal medicine

En Medicina Interna es indispensable conocer y reportar las Reacciones Adversas a los Medicamentos (RAM). Se presentan cuatro (4) situaciones de este tipo, provenientes del Servicio de Medicina Interna del Hospital General del Oeste, Caracas, Venezuela. Caso 1: paciente con SIDA y toxoplasmosis cerebral, en tratamiento con antiretrovirales, trimetoprim-sulfa y pirimetamina. Consulta a la emergencia por presentar lesiones cutáneas. Caso 2: paciente de 24 años, síndrome de Down, con comunicación interventricular corregida, hipotiroidismo controlado y Hepatitis C en tratamientocon ribavirina – tegainterferon, con abscesoinguinal. Se encuentra pancitopenia severa y progresiva. Caso 3: Mujer de 70 años en preoperatori de facotomía en quien se diagnóstica trombosis venosa profunda poplítea izquierda. Se prescribe enoxaparina – warfarina y se aprecia un hematoma del recto anterior del abdomen. Se identifica el uso previo y simultáneo de productos herbarios. Caso 4: paciente que ingiere un producto sin registro sanitario y prohibido por las autoridades regulatorias del país; contiene compuestos no declarados: diclofenac sódico y esteroides. La farmacovigilancia es indispensable en un servicio de medicina interna.

Pharmacovigilanceis essential in the practice of Internal Medicine. Four situations from an Internal Medicine Department of the Hospital General del Oeste, Caracas, Venezuela, are analyzed. Case 1: patient with AIDS and cerebral toxoplasmosis, trated with antiretroviral drugs, trimetoprim-sulfimetoxasol and pyrimethamine. This patient consultedbecause of with cutaneous. Case 2: 24 year-old patient with Down syndrome, corrected congenital cardiac disease, treated hypothyroidism and hepatitis C treated with ribavirin - tegainterferon had an inguinal abscess. A severe and progressive pancytopenia is found and It analyzed the high suspicion causality of RAM. Case 3: A 70 year-old woman, was examined for a preoperative evaluation and a left popliteal deep vein thrombosis is found. Enoxaparin - warfarin were prescribed and in the next 24 hours a hematoma of abdominal rectus was found. The oriented anamnesis identifies the use of herbal products. Drug interaction is discussed. Case 4: regulatory authorities prohibit an unregistered health product that has not reported compounds: diclofenac and steroids. Pharmacovigilance is essential in a department of internal medicine.

Chronic kidney disease associated with environmental toxins and exposures.

People are exposed to various potentially toxic agents and conditions in their natural and occupational environments. These agents may be physical or chemical, may enter the human body through oral, inhalational, or transdermal routes, and may exert effects on all organ systems. Several well-known as well as lesser known associations exist between chronic kidney disease (CKD) and both environmental agents and conditions, such as heavy metals, industrial chemicals, elevated ambient temperatures, and infections. The effects of these agents may be modulated by genetic susceptibility and other comorbid conditions and may lead to the development of acute and CKD. In this article, we present environmental factors that are associated with CKD.

Acute hepatitis due to shen-min: a herbal product derived from Polygonum multiflorum.

Shen-Min is a herbal product sold as a supplement for women to enhance hair growth. It is widely available across Asia, Europe, and the United States and sold without prescription as a hair nutritional supplement. We describe a case of acute liver injury in a 28-year-old white woman who developed symptomatic hepatitis 8 weeks after starting Shen-Min. All other potential causes of acute hepatitis including viral, hypoxic/ischemic, metabolic, and autoimmune etiologies were excluded. The liver injury slowly resolved over 3 weeks after discontinuing the herbal product. Although the mechanism of Shen-Min hepatotoxicity is unknown, we suspect an idiosyncratic reaction because the patient developed a fine maculopapular rash, mild eosinophilia, and did not overdose. Shen-Min is a Chinese herbal product with a mixture of several plants and vitamins including Polygonum multiflorum, a root that has been previously associated with hepatotoxicity. Nonetheless to our knowledge this is the first reported case of herbal-induced hepatotoxicity in a patient taking Shen-Min per se. Clinicians taking care of patients with acute hepatitis of unclear etiology should be aware that the consumption of Shen-Min, a hair supplement widely available in the United States and Western countries might cause acute hepatitis.