Efficacy of cranberry juice on Helicobacter pylori infection: a double-blind, randomized placebo-controlled trial

BACKGROUND: Helicobacter pylori infection is a major cause of peptic ulcer disease and gastric cancer. This study postulated that cranberry juice would be effective in the suppression of H. pylori in an endemically infected population at high risk for gastric cancer. MATERIALS AND METHODS: A prospective, randomized, double-blind, placebo-controlled trial was conducted in Linqu County of Shandong Province, China, where 189 adults aged 48.9 +/- 11.2 years (mean +/- SD) with H. pylori infection were randomly divided into two groups: cranberry juice (n = 97) and placebo (n = 92). Participants were assigned to orally receive two 250-ml juice boxes of cranberry juice or matching placebo beverage daily for 90 days. The degree of H. pylori infection was determined using the 13C-urea breath test before randomization at 35 and 90 days of intervention to assess the efficacy of cranberry juice in alleviating infection. RESULTS: A total of 189 subjects with positive 13C-urea breath test results prior to randomization completed the study. At day 35 of intervention, 14 of the 97 (14.43%) from the the cranberry juice treatment group and 5 of the 92 (5.44%) of the placebo recipients had negative 13C-urea breath test results. After 90 days, the study concluded that 14 of the 97 subjects in the cranberry juice treatment group versus 5 of the 92 in the placebo group yielded negative test results. Eleven individuals from the cranberry juice treatment group and only two from the placebo group were negative at 35 and 90 days of experiment. These results are significant (p < .05). CONCLUSIONS: Regular consumption of cranberry juice can suppress H. pylori infection in endemically afflicted populations.     

Effects of Nigella sativa L. seed oil on abnormal semen quality in infertile men: A randomized,double-blind,placebo-controlled clinical trial

In recent years, wide utilization of herbal drugs has encouraged scientists to determine their impressive effects on health. Since Nigella sativa L. seed (N. sativa) has many uses including infertility in traditional medicine, the effects of Nigella sativa L. seed oil on abnormal semen quality in infertile men with abnormal semen quality are of interest. This study was conducted on Iranian infertile men with inclusion criteria of abnormal sperm morphology less than 30% or sperm counts below 20 × 10⁶/ml or type A and B motility less than 25% and 50% respectively. The patients in N. sativa oil group (n = 34) received 2.5 ml N. sativa oil and placebo group (n = 34) received 2.5 ml liquid paraffin two times a day orally for 2 months. At baseline and after 2 months, the sperm count, motility and morphology and semen volume, pH and round cells as primary outcomes were determined in both groups. Results showed that sperm count, motility and morphology and semen volume, pH and round cells were improved significantly in N. sativa oil treated group compared with placebo group after 2 months. It is concluded that daily intake of 5 ml N. sativa oil for two months improves abnormal semen quality in infertile men without any adverse effects.     

肠道菌群在中药研究中的应用概况

自上个世纪以来,随着肠道菌群的相关性研究日益增多,人们发现肠道菌群与人类健康密切相关。近年来,肠道菌群在中药的研究方面也引发了科学家们激烈的讨论。本文主要对肠道菌群在中药研究中的相互作用、相互影响进行综述,阐述了较为前沿的肠道菌群的研究方法。同时对近十年来关于肠道菌群的相关文献的不同及进步进行思考和展望。该综述为预防、治疗肠道菌群失调开辟新的思路。     

A randomized, placebo-controlled, double-blind trial of supplemental docosahexaenoic acid on cognitive processing speed and executive function in females of reproductive age with phenylketonuria: A pilot study

Low blood docosahexaenoic acid (DHA) is reported in patients with phenylketonuria (PKU); however, the functional implications in adolescents and adults are unknown. This pilot study investigated the effect of supplemental DHA on cognitive performance in 33 females with PKU ages 12–47 years. Participants were randomly assigned to receive DHA (10 mg/kg/day) or placebo for 4.5 months. Performance on cognitive processing speed and executive functioning tasks was evaluated at baseline and follow up. Intention-to-treat and per protocol analyses were performed. At follow up, biomarkers of DHA status were significantly higher in the DHA-supplemented group. Performance on the cognitive tasks and reported treatment-related adverse events did not differ. While no evidence of cognitive effect was seen, a larger sample size is needed to be conclusive, which may not be feasible in this population. Supplementation was a safe and effective way to increase biomarkers of DHA status (www.clinicaltrials.gov; Identifier: NCT00892554).     

In silico toxicity studies of traditional Chinese herbal medicine: A mini review

With the availability of public databases that store compound-target/compound-toxicity information, and Traditional Chinese medicine (TCM) databases, in silico approaches are used in toxicity studies of TCM herbal medicine. Here, three in silico approaches for toxicity studies were reviewed, which include machine learning, network toxicology and molecular docking. For each method, its application and implementation e.g., single classifier vs. multiple classifier, single compound vs. multiple compounds, validation vs. screening, were explored. While these methods provide data-driven toxicity prediction that is validated in vitro and/or in vivo, it is still limited to single compound analysis. In addition, these methods are limited to several types of toxicity, with hepatotoxicity being the most dominant. Future studies involving the testing of combination of compounds on the front end i.e., to generate data for in silico modeling, and back end i.e., validate findings from prediction models will advance the in silico toxicity modeling of TCM compounds.     

A randomized double blind placebo-controlled clinical trial of Hochuekkito, a traditional herbal medicine, in the treatment of elderly patients with weakness N of one and responder restricted design

OBJECTIVE: To evaluate the effects of Hochuekkito, a traditional Japanese and Chinese medicine, in the treatment of elderly patients with general weakness. To devise a suitable study design for assessing the clinical effectiveness of traditional herbal medicines. METHODS: Fifteen elderly patients (mean +/- SD: age 78.4 +/- 7.8; m/f 3/12) participated in this study. A multicenter, prospective, randomized, double-blind, placebo-controlled study with N of one and responder restricted design was performed. After the run-in period, the patients were divided into responders and non-responders. Only responders were entered in the study, and were randomized into three groups: an active-placebo group, a placebo-active group and an active-active group. The study consisted of two 6-week terms with a 2-week washout period in between. We assessed the Short Form 36 Health Survey (SF-36) and Profile of Mood States (POMS) as an endpoint of quality of life (QOL). In addition, we assessed the biodefense status by measuring the natural killer cytolytic activity (NK activity), IL-2 producing activity of peripheral lymphocytes, lymphocyte proliferating activity and lymphocyte cell-surface antigens. RESULTS: The physical component summary of the SF-36 analysis significantly improved in the Hochuekkito-treated group. Four components (A-H: anger-hostility, F: fatigue, T-A: tension-anxiety, C: confusion) out of six improved in the Hochuekkito-treated group in the POMS analysis. Lymphocyte proliferating activity improved in the Hochuekkito-treated group but not significantly. Concerning the surface antigens of peripheral lymphocytes, the population of CD3 positive cells and CD3CD4 double positive cells increased in the Hochuekkito-treated group. CONCLUSION: We revealed that Hochuekkito improved the QOL and immunological status of elderly patients with weakness by randomized controlled trial. Our study design might be useful for assessing the efficacy of traditional herbal medicine in the future.     

抑郁症发病机制及中药治疗研究进展

抑郁症是一种常见的精神疾病,发病率高,严重威胁着人类的健康,但其病因、发病机制尚不清楚,由于合成抗抑郁药大多存在抗抑郁谱窄、不良反应大、药价高和易复发等缺陷,近年来随着人们对抑郁症发病机制的研究,人们逐渐把目光投向传统的中医药,以期从中寻找出多靶点、低毒的抗抑郁药。现对近年来抑郁症的病因、病机、及中药治疗的研究情况做一综述     

中药注射剂澄明度影响因素的研究进展

本文介绍了中药注射剂在生产过程中影响澄明度的因素。在分析过程中以生产流程为主线,介绍了各个生产环节对澄明度的影响,重点分析了原料药材、pH值、安瓿、灌装、封口的影响因素及提高澄明度的有效措施。     

微生物-肠-脑轴与抑郁症中医药研究进展

肠道微生物-肠-脑轴因其在调节精神疾病中的可能生物学基础作用而受到越来越多的关注。肠道微生物与抑郁症等精神疾病密切相关,肠道微生物可通过与"肠-脑轴"交互作用影响抑郁症的发生和发展,然而,肠道微生物与抑郁症之间的具体相互作用及机制还未十分明晰。深入研究微生物-肠-脑轴和抑郁症之间的相互关系,有助于我们从另一个角度更为深刻地认识和阐明抑郁症这种精神疾病。调节肠道微生物组成来治疗、预防抑郁症等精神疾病是今后的研究方向之一,可为探索中医药治疗、预防抑郁症机理提供新的思路。     

中医药治疗菌群失调腹泻的研究进展

肠道菌群与人体存在共生关系,并易受外部环境及肠道内环境的调节。当外部环境或肠道条件发生改变时,可能引起肠道菌群在种类、丰度、比例、定位和生物学特性上的变化,即发生肠道菌群失调。以抗生素相关性腹泻为代表的菌群失调腹泻的发病率逐年上升。中医药治疗菌群失调腹泻的优势不断显现,表现在症状缓解显著、治愈率高和复发率低,这与中医药纠正肠道内、外环境,调整肠道菌群,提高肠道免疫力有关。本文论述了菌群失调腹泻的肠道菌群改变特征、中医药治疗菌群失调腹泻的临床疗效及机制,为临床应用及实验研究提供理论依据。

     

Treatment of anxiety, tension and restlessness states with Kava special extract WS® 1490 in general practice: A randomized placebo-controlled double-blind multicenter trial

The efficacy and tolerability of 150 mg/d Kava special extract WS 1490 were investigated in a randomized, placebo-controlled, double-blind multicenter study in patients suffering from neurotic anxiety (DSM-III-R diagnoses 300.02, 300.22, 300.23, 300.29, or 309.24). 141 adult, male and female out-patients received 3 x 1 capsule of 50 mg/d WS 1490 or placebo for four weeks, followed by two weeks of observation without study-specific treatment. During randomized treatment the total score of the Anxiety Status Inventory (ASI) observer rating scale showed more pronounced decreases in the WS 1490 group than in the placebo group. Although a treatment group comparison of the post-treatment ASI scores was not significant (p > 0.05), an exploratory analysis of variance across the differences between treatment end and baseline, with center as a second factor, showed superiority of the herbal extract over placebo (p < 0.01, two-sided). 73% of the patients treated with WS 1490 exhibited ASI score decreases > 5 points versus baseline, compared to 56% for placebo. Significant advantages for WS 1490 were also evident in a structured well-being self-rating scale (Bf-S) and the Clinical Global Impressions (CGI), while the Erlangen Anxiety, Tension and Aggression Scale (EAAS) and the Brief Test of Personality Structure (KEPS) showed only minor treatment group differences. Although the results show consistent advantages for WS 1490 over placebo in several psychiatric scales and indicate significant improvements in the patients' general well-being, the differences versus placebo were not as large as in previous trials which employed 300 mg/d of the same extract. WS 1490 was well tolerated, with no influence on liver function tests and only one trivial adverse event (tiredness) attributable to the study drug.     

中药调节肠道菌群防治高血压的研究进展

肠道菌群是人体内环境的重要组成部分,可影响机体的代谢、免疫和炎症反应,与原发性高血压的发生发展密切相关,已成为防治高血压的研究热点。中药在临床用于原发性高血压的治疗且疗效显著。研究表明中药可被肠道菌群分解代谢为易于吸收的活性物质,而这些活性物质又可通过调节肠道菌群结构及其代谢产物防治高血压。本文以肠道菌群作为切入点,通过分析肠道菌群与原发性高血压发生发展的关系和中药在调节原发性高血压肠道菌群方面的研究,总结中药通过调节肠道菌群防治原发性高血压的作用和机制,以期为中药防治高血压及药物研发提供新的研究思路。     

Antipyretic effect of Mao-to, a Japanese herbal medicine, for treatment of type A influenza infection in children

Mao-to is a Japanese traditional herbal medicine which has been used since ancient times for the treatment of influenza-like illness. This study was conducted to evaluate the effect of oral Mao-to administration in children with type A influenza, in comparison to Oseltamivir. We performed a controlled trial of 60 children, from 5 months through 13 years of age, with fever and influenza-like symptom of up to 48 h duration. Diagnosis of influenza type A was performed by virus isolation or detection of a viral gene by RT-PCR. Patients assigned into the following 3 groups: oral Mao-to powder (TJ-27) 0.06 g/kg body wt./dose three times daily (n=17), Oseltamivir 2 mg/kg body wt./dose twice daily (n=18) or both oral Mao-to plus Oseltamivir (n=14). The median duration of fever after treatment was significantly shorter in the Mao-to and Mao-to plus Oseltamivir groups, compared with the Oseltamivir only group (15 h [95%CI 13.2-22.1] p<0.01; 18 h[15.2-27.7] p<0.05; 24 h[23.5-43.0], respectively). Oral Mao-to administration was effective in the control of fever due to type A influenza infection in children.     

The effect of the boron-based gel on the treatment of diabetic foot ulcers: A prospective,randomized controlled trial

BackgroundChronic ulcers represent impaired healing capacity with high mortality in the elderly or patients with systemic disorders such as diabetes. Boron is an effective agent in wound healing by promoting cell migration and proliferation and reducing inflammation in the wound area. This study aimed to evaluate the therapeutic effect of a sodium pentaborate-based topical formulation compared to control on the treatment of diabetic foot ulcers.MethodsA prospective, double-blind, randomized controlled trial was conducted to apply randomly the topical sodium pentaborate 3% gel or topical conventional remedy (control) by patients diagnosed with diabetic foot ulcers. The 171 eligible participants aged 18–75 years received the allocated medicines twice a day for a month with an allocation ratio of 3:1. Twenty-five days and two months after the end of the trial, participants were reinvestigated for their ulcer condition and any recurrence. Wagner’s classification of diabetic foot ulcers was applied to this purpose (0−5).Results161 participants (57 females, 104 males; mean age: 59.37) completed this study. After the intervention, most participants in the intervention group had a lower ulcer grade than the control group (adjusted mean difference (95% CI): − 0.91 (−1.1 to −0.73); p < 0.001). Moreover, most participants in the intervention group (n = 109 (90.8%)) were treated at a higher rate than the control group (n = 5 (12.2%)) after intervention (adjusted odds ratio (95% CI): 0.008 (0.002–0.029); p < 0.001). There was no case of recurrence in the intervention group while its rate was (n = 2 (40%)) in the control group (p < 0.001).ConclusionThe present study suggests that topical sodium pentaborate gel may help treat and decrease the grade of diabetic foot ulcers and prevent the recurrence of diabetic foot ulcers.     

Evaluation of the anti-fatigue effects of a traditional herbal drug,Gongjin-dan,under insufficient sleep conditions: study protocol for a randomised controlled trial

BackgroundMany herbal medicines are traditionally used as anti-fatigue agents in east Asian countries; however, there is a dearth of clinical evidence supporting the anti-fatigue effects of such medicines and their mechanisms. This study is a feasibility trial to assess the clinical efficacy of Gongjin-dan (GJD) and verify its mechanisms by exploring fatigue outcomes, including endocrine and immunological biomarkers in humans.Methods/DesignTo investigate the anti-fatigue effects of GJD and the mechanism underlying these effects, a randomised, double-blind, placebo-controlled crossover clinical trial was designed. Participants (24 healthy male volunteers) will be hospitalised for 4 days (3 nights), during which acute fatigue and stress conditions will be induced by sleep deprivation, and GJD or a placebo will be administered (twice daily). The primary outcome will be changes in serum cortisol levels, measured in the morning, as an objective biomarker of sleep deprivation-induced fatigue and stress. The secondary outcomes will include: the Fatigue Severity Scale; the Brief Fatigue Inventory, and the Leeds Sleep Evaluation Questionnaire scores; levels of salivary cortisol, epinephrine, norepinephrine, oxidative stress-related biomarkers, homocysteine, and immunological factors; and heart rate variability. After a washout period of more than 4 weeks, a second treatment phase will commence in which participants who were previously administered the placebo will receive the drug and vice versa, following the same treatment regime as in the first phase.DiscussionThis study protocol provides a unique opportunity to enhance our understanding of fatigue and the effects of GJD on fatigue in terms of endocrine and immunological mechanisms by validating the study design and determining feasibility. Findings from this trial will help researchers to design a pilot or definitive clinical trial of traditional herbal medicine for chronic fatigue.

Trial registration

Korean National Clinical Trial Registry CRIS; KCT0001681, registered on 29 October 2015.     

Effects of traditional Chinese medicine on immune responses in abalone, Haliotis discus hannai Ino

A traditional Chinese medicine (TCM) preparation was formulated from orange peel (Pericarpium Citri Reticulatae), hawthorn (Crataegus pinnatifida), astragalus (Astragalus membranaceus (Fisch.) Bunge), pilose asiabell root (Radix codonopsis), indigowoad root (Radix isatidis), taraxacum (Herba taraxaci) and malt (Fructus Hordei Germinatus) at a weight ratio of 1:1:1.5:1.5:1.5:1.5:2. A feeding experiment was conducted to determine the effects of TCM on innate immunity of abalone, Haliotis discus hannai Ino. Artificial diets containing 1%, 3%, 5% TCM preparation, 1% hawthorn or 1% astragalus, respectively, were fed to juvenile abalone (initial weight 10.38+/-2.51 g; initial shell length 44.15+/-4.15 mm) for 80 days. A TCM-free diet was used as a control. Each diet was fed to three replicate groups of abalone using a randomized design. The results indicated that phagocytic activity was significantly higher in abalone fed 3%, 5% TCM preparation, 1% astragalus or 1% hawthorn (P<0.05). Respiratory burst activity was significantly higher in abalone fed 1%, 3%, 5% TCM preparation, 1% astragalus or 1% hawthorn (P<0.05). Agglutination titre was significantly higher in abalone fed 5% TCM preparation (P<0.05). Weight gain ratio (WGR), daily increment in shell length (DISL), total haemocyte count (THC), plasma protein concentration, and the activity of acid phosphatase (ACP) were not significantly affected by the TCM preparation (P>0.05). These results indicate that TCM preparation can modulate the immunity of H. discus hannai, and it is very possible that TCM might be used as immunostimulants in abalone farming.     

Antipyretic effect of ibuprofen in Gabonese children with uncomplicated falciparum malaria: a randomized, double-blind, placebo-controlled trial

Background

The protection afforded by human erythrocyte polymorphisms against the malaria parasite, Plasmodium falciparum, has been proposed to be due to reduced ability of the parasite to invade or develop in erythrocytes. If this were the case, variable levels of parasitaemia and rates of seroconversion to infected-erythrocyte variant surface antigens (VSA) should be seen in different host genotypes.

Methods

To test this hypothesis, P. falciparum parasitaemia and anti-VSA antibody levels were measured in a cohort of 555 asymptomatic children from an area of intense malaria transmission in Papua New Guinea. Linear mixed models were used to investigate the effect of α⁺-thalassaemia, complement receptor-1 and south-east Asian ovalocytosis, as well as glucose-6-phosphate dehydrogenase deficiency and ABO blood group on parasitaemia and age-specific seroconversion to VSA.

Results

No host polymorphism showed a significant association with both parasite prevalence/density and age-specific seroconversion to VSA.

Conclusion

Host erythrocyte polymorphisms commonly found in Papua New Guinea do not effect exposure to blood stage P. falciparum infection. This contrasts with data for sickle cell trait and highlights that the above-mentioned polymorphisms may confer protection against malaria via distinct mechanisms.     

Combined therapy of percutaneous cryoablation and traditional Chinese medicine can be a promising strategy for elderly or advanced lung cancer patients based on a retrospective clinical study

Presently, elderly and advanced lung cancer patients have very limited treatment options. With no promising therapy, treatment of these patients is challenging. We have reviewed 119 primary lung cancer patients who received a combined percutaneous cryoablation and traditional Chinese medicine therapy (Cryo-TCM therapy) between 2005 and 2013. Out of 119 patients, 84.1% patients were elderly or advanced lung cancer when receiving cryoablation. Overall Survival time from the time of Diagnosis (DOS) and Cryoablation (COS) was 19 and 10 months respectively, which were longer than data previously published. Patients who accepted only Cryo-TCM therapy got similar DOS as those who were treated with Cryo-TCM and other classic anticancer therapies. Thus, Cryo-TCM therapy can prolong the survival time and can be used as the main therapy for the elderly or advanced lung cancer patients in China both in quality of life and cost effectiveness.     

Efficacy and safety of Indigo naturalis extract in oil (Lindioil) in treating nail psoriasis: A randomized,observer-blind,vehicle-controlled trial

Treating nail psoriasis is notoriously difficult and lacks standardized therapeutic regimens. Indigo naturalis has been demonstrated to be safe and effective in treating skin psoriasis. This trial was conducted to evaluate the efficacy and safety of refined indigo naturalis extract in oil (Lindioil) in treating nail psoriasis. Thirty-one outpatients with symmetrically comparable psoriatic nails were enrolled. Lindioil (experimental group) or olive oil (control group) was applied topically to the same subjects’ two bilaterally symmetrical psoriatic nails twice daily for the first 12 weeks and then subjects applied Lindioil to both hands for 12 additional weeks. Outcomes were measured using Nail Psoriasis Severity Index (NAPSI) for five nails on one hand and for the single most severely affected nail from either hand. The results show a reduction of NAPSI scores for the 12-week treatment for the Lindioil group (49.8% for one hand and 59.3% for single nail) was superior to the reduction in the scores for the control group (22.9%, 16.3%, respectively). There were no adverse events during the 24 weeks of treatment. This trial demonstrates that Lindioil is a novel, safe and effective therapy for treating nail psoriasis.