RESUMO
BACKGROUND: Tianshu capsule (TSC), a formula of traditional Chinese medicine, has been widely used in clinical practice for prophylactic treatment of headaches in China. However, former clinical trials of TSC were small, and lack of a standard set of diagnostic criteria to enroll patients. The study was conducted to re-evaluate the efficacy and safety of TSC post-marketing in an extending number of migraineurs who have diagnosed migraine with the International Classification of Headache Disorders, 3rd edition (beta version, ICHD-3ß). METHODS: The study was a double-blind, randomized, placebo-controlled clinical trial that conducted at 20 clinical centers in China. At enrollment, patients between 18 and 65 years of age diagnosed with migraine were assigned to receive either TSC (4.08 g, three times daily) or a matched placebo according to a randomization protocol. The primary endpoint was a relative reduction of 50% or more in the frequency of headache attacks. The secondary outcomes included a reduction in the incidence of headache, the visual analogue scale of headache attacks, days of acute analgesic usage, and percentage of patients with a decrease of 50% or more in headache severity. Accompanying symptoms were also assessed. RESULTS: One thousand migraine patients were initially enrolled in the study, and 919 of them completed the trial. Following the 12-week treatment, significant improvement was observed in the TSC group concerning both primary and secondary outcomes. After therapy discontinuation, the gap between the TSC group and the placebo group in efficacy outcomes continued to increase. There were no severe adverse effects. CONCLUSIONS: TSC is an effective, well-tolerated medicine for prophylactic treatment of migraine, and still have prophylactic effect after medicine discontinuation. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02035111; Data of registration: 2014-01-10.
Assuntos
Analgésicos/uso terapêutico , Medicamentos de Ervas Chinesas/uso terapêutico , Transtornos de Enxaqueca/tratamento farmacológico , Adulto , Analgésicos/efeitos adversos , Método Duplo-Cego , Medicamentos de Ervas Chinesas/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do TratamentoRESUMO
OBJECTIVE: To study the effect of Morinda officinalis (MO) extract on cytoxan (CTX) -impaired spermatogenesis of adult male SD rats. METHODS: We randomly divided 56 adult male SD rats into seven groups of equal number: blank control, CTX model, CTX + NS, CTX + 10 g/kg MO, CTX + 20 g/kg MO, CTX + 30 g/kg MO, and CTX + 40 g/kg MO. We made the models of impaired spermatogenesis in the SD rats by intraperitoneal injection of CTX and treated the animal models by intragastric administration of MO at the concentrations of 10, 20, 30, and 40 g per kg per d, respectively. After two weeks of medication, we observed the changes in the body weight, testicular and epididymal indexes, and microstructure of the testis tissue, measured the mean seminiferous tubule diameter (MSTD) , and obtained testicular biopsy scores (TBS) in different groups, followed by comparative analyses. RESULTS: After treatment, the CTX + NS group showed no remarkable differences in the body weight ([234.83 ± 28.77] g) and epididymal index (2.71 ± 0.34) from those of the four CTX + MO groups, but exhibited a significantly lower testicular index ([12.15 ± 1.04] g) than those in the CTX + 20 g/kg MO ([13.71 ± 0.97] g), CTX + 30 g/kg MO, ([13.30 ± 0.29] g), and CTX + 40 g/kg MO group ([13.48 ± 0.51] g) (P < 0.05). Light microscopy revealed obvious pathological changes of the testis tissue in the CTX + NS group and significantly ameliorated structures of the seminiferous tubules in the CTX + MO 10, 20, 30, and 40 g/kg groups, with the MSTD of (204.78 ± 11.03), (216.55 ± 10.93), (218.03 ± 11.23), and (218.59 ± 14.06) µm, respectively, and the TBS of 9.03 ± 0.39, 9.69 ± 0.26, 9.83 ± 0.18, and 9.89 ± 0.11, respectively, all significantly higher than (189.74 ± 8.55) µm and 5.95 ± 1.21 in the CTX + NS group (P < 0.05). The efficacy of MO extract was increased in a concentration-dependent manner. CONCLUSION: Morinda officinalis extract can repair cytoxan-induced damage to rat spermatogenesis, with may achieve the best effect at the concentrations of 30 and 40 g per kg per d.
Assuntos
Morinda/química , Extratos Vegetais/farmacologia , Espermatogênese/efeitos dos fármacos , Animais , Peso Corporal/efeitos dos fármacos , Ciclofosfamida/toxicidade , Epididimo/efeitos dos fármacos , Masculino , Mutagênicos/toxicidade , Extratos Vegetais/administração & dosagem , Distribuição Aleatória , Ratos , Ratos Sprague-Dawley , Túbulos Seminíferos/efeitos dos fármacos , Túbulos Seminíferos/patologia , Testículo/efeitos dos fármacos , Testículo/ultraestruturaRESUMO
This study investigates heavy metal contamination of commonly consumed medicinal herbs and human health risks to the Chinese population arising from the consumption of herbs that contain potentially harmful elements. Food safety standards for Chinese residents are becoming stricter, and much work in this field needs to be performed. This study examines Co, Ba, Fe, Cr, Mn, Ni, Zn, As, Cd, Pb, Cu, Be, Sb, and Bi concentrations in four regularly consumed Chinese herb species: Radix Paeoniae Alba (RPA), Radix Angelicae Dahuricae (RAD), Rhizoma Atractylodis Macrocephalae (RAM), and Radix Puerariae (RP). A pollution status examination and evaluation of heavy metals in RPA, RAD, RAM, and RP were performed. The human health risk assessment associated with the intake of potentially harmful elements in herbs was calculated in terms of the estimated daily intake (EDI), the target hazard quotient (THQ), the estimated hazard index (HI), and the lifetime cancer risk (CR). The mean single-factor pollution index (PI) showed that in the RPA, RAD, RAM, and RP samples, approximately 10.0%, 10.0%, 30.0%, and 10.0%, respectively, were polluted by Cd. The present study indicated that the pattern of consumption of the studied herbs in China does not seem to suggest an excessive health hazard associated with any of the toxic elements studied.
Assuntos
Metais Pesados , Plantas Medicinais , Poluentes do Solo , Humanos , Cádmio , Metais Pesados/análise , Medição de Risco , China , Monitoramento Ambiental , Poluentes do Solo/análiseRESUMO
BACKGROUND: Inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease, is a chronic inflammatory disease in the lower gastrointestinal tract. Mounting evidence suggests that the predominance of the classically activated (M1) macrophages versus the alternatively activated (M2) macrophages plays a role in the progression of IBD. Thus, agents able to shift pro-inflammatory M1 macrophages to anti-inflammatory M2 macrophages may be beneficial to IBD. The pentacyclic triterpene Lup-20(29)-en-3ß-ol (Lupeol), a potent anti-inflammatory natural product, has been shown to inhibit pro-inflammatory cytokine production, suggesting it is potentially able to modulate macrophage polarization, thereby beneficial to IBD. METHODS: CD4(+) monocytes were differentiated to M1 or M2 macrophages, which were cocultured with epithelial cell lines, T84 and Caco-2, in the absence or presence of Lupeol (10µM). Experimental colitis was induced with dextran sodium sulfate (DSS), with or without oral administration of Lupeol (50mg/kg, q.d.). Cytokines were measured with Luminex kits. M1/M2 genes were measured with real-time polymerase chain reaction. Macrophage phenotypes were defined by measuring M1 and M2 markers with confocal microscopy. Proteins were measured with Western blotting, while cell surface markers were measured with confocal microscopy or flow cytometry. Histology was evaluated with H&E staining. RESULTS: Treatment of M1 macrophages with Lupeol resulted in a marked decrease in the production of pro-inflammatory cytokines, including IL-12, IL6, IL-1ß and TNFα, and a marked increase in the production of IL-10, an anti-inflammatory cytokine. This was associated with a down-regulation of CD86, a typical marker of M1 macrophages, and an up-regulation of CD206, a typical M2 macrophage marker. IRF5, a transcription factor that is critically involved in M1 polarization, was down-regulated in M1 macrophages after being incubated with Lupeol, associated with a marked decrease in the phosphorylation of p38 mitogen activated protein kinase. Coculture of epithelial cells with M1 macrophages resulted in down-regulation of the tight junction protein ZO-1 and disruption of epithelial integrity, which were blocked by Lupeol treatment of the M1 macrophages. Moreover, oral administration of Lupeol to dextran sulfate sodium (DSS)-induced colitis mice resulted in mitigated intestinal inflammation and increased survival from lethal colitis, associated with decreased expression of M1-related genes and increased expression of M2-related genes. CONCLUSION: Lupeol ameliorates experimental inflammatory bowel disease through, at least in part, inhibiting M1 and promoting M2 macrophages.