Clinical effects of a hop water extract on Japanese cedar pollinosis during the pollen season: a double-blind, placebo-controlled trial

The clinical effects of an oral administration of a hop water extract (HWE) on the improvement of Japanese cedar pollinosis (JCPsis) symptoms were investigated. In a double-blind, placebo-controlled trial, 39 subjects took a drink containing either 100 mg of HWE or a placebo for 12 weeks during the pollen season. Nasal symptoms (sneezing attacks, nasal discharge, and nasal obstruction) were assessed from the subjects' diaries. A clinical examination and blood sampling were carried out before and 4, 8 and 12 weeks after the initiation of treatment. As a result, a significant difference was observed in the symptom score and in the symptom-medication score 10 weeks after the intervention in comparison with the placebo group. Improvements were observed in nasal swelling, nasal color, amount of nasal discharge, and characteristics of nasal discharge in the intervention group 12 weeks after the treatment. No significant eosinophil infiltration into the nasal discharge was apparent in the intervention group throughout the study period, although it was observed in the placebo group. These findings indicate that an oral administration of HWE may be effective in alleviating the allergic symptoms related to JCPsis.     

Lactobacillus strains stabilize intestinal microbiota in Japanese cedar pollinosis patients

A randomized double-blind, placebo-controlled trial was conducted to ascertain the intestinal microbiota-altering properties of LGG and L. gasseri TMC0356 (TMC0356) in Japanese cedar Cryptomeria japonica pollinosis patients. Fecal bacteria communities were examined before and after fermented milk administration using culture, FISH and T-RFLP methods. Test group subjects showed the presence of LGG and TMC0356 along with a significant increase in fecal lactobacilli ( P < 0.001) after giving LGG and TMC0356 fermented milk. Culture and FISH analysis revealed no significant changes in other intestinal bacterial groups. Each subject exhibited a characteristic T-RFLP profile pattern that varied quantitatively and qualitatively with JCP shedding. Profile changes were observed in 53% of placebo group subjects and in 21% of test group subject's post-administration, indicating that LGG and TMC0356 suppressed intestinal microbiota changes in JCPsis patients. The results suggest that intestinal microbiota might be more sensitive to exposure to environmental allergens than expected from the results of general culture method studies. Stabilization of intestinal microbiota by selected probiotic strains such as LGG and TMC0356 could be beneficial to homeostasis of the intestinal microbiota and useful in the management of JCPsis.     

Oral administration of a hop water extract ameliorates the development of dermatitis induced by the periodical topical application of a mite antigen in atopic dermatitis model NC/Nga mice

We investigated the inhibitory effect of an oral administration of a hop water extract (HWE) on the development of dermatitis by using NC/Nga atopic dermatitis model mice. The induction of allergic dermatitis was conducted by tape-stripping and topical application of a mite antigen (Dermatophagoides farinae) on to the ear once a week for 10 weeks. HWE was orally administered at a dose of 100 or 500 mg/kg. The total immunoglobulin E (IgE) concentration in serum and the ear thickness were periodically examined. Finally, the antigen-specific IgE level in the serum and the production of interleukin (IL)-4, IL-12 and interferon (IFN)-gamma from splenocytes and cervical lymph node cells were measured. The oral administration of HWE significantly inhibited the increase of total IgE production and ear swelling throughout the experimental period. The production of IL-12 was significantly lower in the HWE administered group than in the control group. The results suggest that the intake of HWE may be effective in preventing and alleviating the development of atopic dermatitis-like skin disease.     

Impact of Acacia bark extract tablets on the skin of healthy humans: a randomized,double-blind,placebo-controlled study

This study investigated the effects of proanthocyanidins derived from Acacia (Acacia mearnsii) bark extract in healthy Japanese adult subjects experiencing uncomfortable skin symptoms. All subjects were randomly allocated into two groups (n = 33 each) using a computerized random-number generator. The subjects received either Acacia bark extract tablets or placebo for 8 weeks. Evaluations included water content in the stratum corneum, transepidermal water loss (TEWL), Skindex-16, dermatology life quality index (DLQI), visual analog scale for desire to scratch, and blood tests. At 4 weeks, the symptom/feeling score of DLQI, subjective symptoms related to uncomfortable skin, and the desire to scratch were significantly reduced in the intervention group than in the placebo group. At 8 weeks, the intervention group exhibited significantly lower TEWL on facial skin than that in the placebo group. In conclusion, the intake of Acacia bark extract tablets reduced TEWL and improved dry and uncomfortable skin.     

Augmentation of antimicrobial metronidazole therapy of bacterial vaginosis with oral probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14: randomized, double-blind, placebo controlled trial

This study enrolled 125 premenopausal women diagnosed with bacterial vaginosis (BV) by presence of vaginal irritation, discharge and 'fishy' odor, and Nugent criteria and detection of sialidase enzyme. The subjects were treated with oral metronidazole (500 mg) twice daily from days 1 to 7, and randomized to receive oral Lactobacillus rhamnosus GR-1 (1 x 10(9)) and Lactobacillus reuteri RC-14 (1 x 10(9)) or placebo twice daily from days 1 to 30. Primary outcome was cure of BV as determined by normal Nugent score, negative sialidase test and no symptoms or signs of BV at day 30. A total of 106 subjects returned for 30-day follow-up, of which 88% were cured in the antibiotic/probiotic group compared to 40% in the antibiotic/placebo group (p<0.001). Of the remaining subjects, 30% subjects in the placebo group and none in the probiotic group had BV, while 30% in the placebo and 12% in the probiotic group fell into the intermediate category based upon Nugent score, sialidase result and clinical findings. High counts of Lactobacillus sp. (>10(5) CFU/ml) were recovered from the vagina of 96% probiotic-treated subjects compared to 53% controls at day 30. In summary, this study showed efficacious use of lactobacilli and antibiotic in the eradication of BV in black African women.     

Efficacy of Oral Administration of a Heat-Killed Lactobacillus gasseri OLL2809 on Patients of Japanese Cedar Pollinosis with High Japanese-Cedar Pollen-Specific IgE

A randomized, double-blind, placebo-controlled clinical trial was conducted to determine whether oral administration of heat-killed Lactobacillus gasseri OLL2809 would affect the immune response and reduce the symptoms of Japanese cedar pollinosis (JCP) in subjects with JCP. Following a 1-week pre-observation period, the subjects were randomly divided into two groups and were orally administered a placebo or tablets containing 100 mg of L. gasseri OLL2809 per d for 8 weeks during the pollen season in 2007. The results showed no obvious differences between the groups. Supplementary subgroup analysis revealed that the OLL2809 subgroups with CAP-RAST scores of 4 or 5 exhibited improvement in nasal symptoms scores and serum allergy-related items, including Japanese cedar pollen-specific IgE levels. L. gasseri OLL2809 was found to be effective in reducing symptoms in subjects with a high predisposition to allergies by modulating systemic immune systems.     

Oral Administration of a Hop Water Extract Ameliorates the Development of Dermatitis Induced by the Periodical Topical Application of a Mite Antigen in Atopic Dermatitis Model NC/Nga Mice

We investigated the inhibitory effect of an oral administration of a hop water extract (HWE) on the development of dermatitis by using NC/Nga atopic dermatitis model mice. The induction of allergic dermatitis was conducted by tape-stripping and topical application of a mite antigen (Dermatophagoides farinae) on to the ear once a week for 10 weeks. HWE was orally administered at a dose of 100 or 500 mg/kg. The total immunoglobulin E (IgE) concentration in serum and the ear thickness were periodically examined. Finally, the antigen-specific IgE level in the serum and the production of interleukin (IL)-4, IL-12 and interferon (IFN)-γ from splenocytes and cervical lymph node cells were measured. The oral administration of HWE significantly inhibited the increase of total IgE production and ear swelling throughout the experimental period. The production of IL-12 was significantly lower in the HWE administered group than in the control group. The results suggest that the intake of HWE may be effective in preventing and alleviating the development of atopic dermatitis-like skin disease.     

综合护理干预对老年住院糖尿病患者影响的临床观察

目的：观察综合护理干预对老年住院糖尿病患者的临床影响,探讨改善老年住院糖尿病患者临床表现及预后的护理方式。方法：选择老年住院糖尿病患者160例,随机均分为对照组和观察组,对照组采取常规专科护理,观察组加行综合护理干预,治疗2周后比较两组患者焦虑自评量表（SAS）和抑郁自评量表（SDS）评分;出院3个月后比较两组患者自我管理和生活质量（GQOL-100）评分结果：治疗2周和出院3个月后,两组患者在上述方面比较,差异具有统计学意义（P〈0.01,P〈0.05）,观察组优于对照组。结论：对老年住院DM患者施行综合护理干预措施,具有积极的临床意义。     

芪菊袋泡茶在慢性鼻窦炎伴鼻息肉功能性鼻内镜术后的临床疗效

目的:评估芪菊袋泡茶对功能性鼻内镜术(FESS)术后的临床疗效。方法:采用随机数字表法将纳入观察的FESS术后患者分为两组,对照组为常规处理,治疗组在常规处理的基础上给予芪菊袋泡茶雾化吸入及饮用:术后6h开始予芪菊袋泡茶治疗,以芪菊袋泡茶一袋配30 mL饮用水,作雾化吸入,另予一袋配100 mL饮用水泡服,每天2次,雾化联合饮用共1周。雾化疗程结束后,则以每次2袋,每天2次泡服,再饮用2周,并随访12周。比较两组间鼻窦炎相关症状(包括鼻塞、头痛、面痛、嗅觉障碍、鼻涕)评分、鼻腔粘膜改变和术腔上皮化程度、术后咽喉部症状(包括咽痛、异物感、排痰、咳嗽)评分。结果:术后2、4、8、12周,治疗组鼻窦炎相关症状总评分与对照组比较差异有统计学意义(P0.05);治疗组在术后4、8、12周鼻腔粘膜评分、上皮化程度较对照组显著改善,差异有统计学意义(P0.05);治疗组在术后1d、3d咽喉部症状总评分、咽痛和异物感症状评分显著较对照组改善,差异有统计学意义(P0.05)。结论:芪菊袋泡茶在慢性鼻窦炎伴鼻息肉FESS术后能取得良好的临床疗效,明显改善术后症状,值得临床推广。     

鼻窦内镜术治疗鼻窦炎合并鼻息肉的疗效及对鼻腔通气和嗅觉功能的影响

目的:探讨鼻窦内镜术治疗鼻窦炎合并鼻息肉的临床疗效及对鼻腔通气和嗅觉功能的影响。方法:选取2014年1月至2016年6月我院收治的鼻窦炎合并鼻息肉患者80例。根据随机数字表法分为观察组和对照组,各40例。对照组给予传统摘除术治疗,观察组则行鼻窦内镜术治疗。比较两组临床疗效以及治疗前、治疗后3个月症状评分、鼻气道总阻力、嗅觉功能评分。结果:观察组治疗总有效率为95.00%,显著高于对照组的77.50%(P0.05)。治疗前两组患者鼻塞、脓涕、嗅觉障碍、疼痛及总症状评分比较无统计学差异(P0.05),治疗后3个月两组患者鼻塞、脓涕、嗅觉障碍、疼痛及总症状评分均低于治疗前,且观察组患者鼻塞、脓涕、嗅觉障碍、疼痛及总症状评分低于对照组(P0.05)。治疗前两组患者鼻气道总阻力、嗅觉功能评分比较无统计学差异(P0.05),治疗后3个月两组患者鼻气道总阻力、嗅觉功能评分均低于治疗前,且观察组低于对照组(均P0.05)。结论:鼻窦内镜术治疗鼻窦炎合并鼻息肉有利于改善患者临床症状,促进患者嗅觉功能以及鼻腔通气的恢复,是治疗鼻窦炎合并鼻息肉的有效方法。     

Extracorporeal shock wave therapy for plantar fasciitis: randomised controlled multicentre trial

Objective To determine the effectiveness of extracorporeal shock wave therapy compared with placebo in the treatment of chronic plantar fasciitis.Design Randomised, blinded, multicentre trial with parallel group design.Setting Nine hospitals and one outpatient clinic in Germany.Participants 272 patients with chronic plantar fasciitis recalcitrant to conservative therapy for at least six months: 135 patients were allocated extracorporeal shock wave therapy and 137 were allocated placebo.Main outcome measures Primary end point was the success rate 12 weeks after intervention based on the Roles and Maudsley score. Secondary end points encompassed subjective pain ratings and walking ability up to a year after the last intervention.Results The primary end point could be assessed in 94% (n=256) of patients. The success rate 12 weeks after intervention was 34% (n=43) in the extracorporeal shock wave therapy group and 30% (n=39) in the placebo group (95% confidence interval - 8.0% to 15.1%). No difference was found in the secondary end points. Few side effects were reported.Conclusions Extracorporeal shock wave therapy is ineffective in the treatment of chronic plantar fasciitis.     

Effects of "natural oestrogen" replacement therapy on menopausal symptoms and blood clotting.

In a double-blind study on the value of equine ("natural") oestrogens 30 patients presenting with menopausal symptoms in a group practice were monitored for possible adverse effects on blood clotting, weight, and blood pressure. The women were randomly allocated to two groups and given either three months'' hormone treatment followed by three months'' placebo or vice versa. An appreciable amelioration of all symptoms on placebo made it difficult to asses the genuine value of oestrogen treatment during the period of study. Both groups made a dramatic clinical improvement during the first three months. Nevertheless, the symptoms of the 15 women who received oestrogen first returned after the cross-over to placebo without any suggestion of a placebo response. In contrast, the other group who took placebo first did not deteriorate after changing to oestrogen. The menopausal index and the karyopyknotic index were not reliable guides to the need for oestrogen treatment. Hot flushes, however, were proportionately reduced on oestrogen and they seemed to be more readily eliminated in individual cases by oestrogen. The results of blood clotting studies indicated that natural oestrogen administration raised the levels of the extrinsic clotting factors VII and X and accelerated the prothrombin time. The findings were similar to those observed after three months synthetic oestrogen administration with oral contraception. Long-term studies and epidemiological surveys of the clinical incidence of thrombotic and other sequelae are needed before large-scale oestrogen replacement treatment can be recommended.     

盐酸氨基葡萄糖联合塞来昔布治疗不同程度膝关节骨性关节炎的临床研究

目的:研究盐酸氨基葡萄糖联合塞来昔布治疗不同程度膝关节骨性关节炎的临床价值。方法:选取2011年1月至2014年2月已被收治的符合标准的病例共150例,按照病情轻重分为轻度(64例)、中度(52例)及重度(34例)3组,各组又随机等分为治疗组和对照组两组,治疗组给盐酸氨基葡萄糖联合塞来昔布治疗,对照组仅给予盐酸氨基葡萄糖治疗,分别于给药第2、4、6周以及停药8、12周观察两组患者经两种不同的治疗方案治疗后患者的Lequesne评分有无统计学差异。结果:轻度:两组停药12周后Lequesne评分仍低于治疗前,差异有统计学意义(P0.05),停药12周时治疗组低于对照组,差异有统计学意义(P0.05)。中度:用药2周、4周、6周及停药8周时两组相比差异均有统计学意义(P0.05)。重度:对照组与治疗组在给药4周及给药6周时其Lequesne评分差异有统计学意义(P0.05),停药后均无统计学意义(P0.05)。结论:单用盐酸氨基葡萄糖可改善轻度膝关节骨性关节炎的临床症状,对于中度患者联合非类固醇类抗炎药类有较好疗效,对于重度患者两种方式都无明显效果。     

Double-blind, placebo-controlled pilot and phase III study of activity of standardized Andrographis paniculata Herba Nees extract fixed combination (Kan jang) in the treatment of uncomplicated upper-respiratory tract infection.

Two randomized double-blind, placebo-controlled parallel group clinical trials were performed to investigate the effect of a standardized extract (SHA-10) of Andrographis paniculata fixed combination (Kan jang) in the treatment of uncomplicated upper-respiratory tract infections. 46 patients in the pilot study and 179 patients in the phase III study completed the study according to the protocol. Medication was taken three times daily for a minimum of 3 days and a maximum of 8 days for the pilot study, and for exactly three days in the phase III study. The primary outcome measures in the patients self-evaluation were: related to pain in the muscle, cough, throat symptoms, headache, nasal symptoms and eye symptoms and temperature. The physician's fixed score diagnosis was based mainly on sign/symptoms: ears, nose, oral cavity, lymph glands-tonsils and eyes. The total symptom score showed a tendency toward improvement in the pilot study (p = 0,08), while both the total symptom score and total diagnosis score showed highly significant improvement (p < or = 0.0006 resp. 0.003) in the verum group as compared with the placebo. In both studies throat symptoms/signs, were found to show the most significant improvement.     

Improved hypnotic treatment using chlormethiazole and temazepam.

The effects of a single 384 mg oral dose of chlormethiazole were compared with those of 20 mg of temazepam and placebo in healthy old and young women (mean ages 72.9 and 24.7 years respectively). Both drugs were effective hypnotics and had no detectable pharmacological action the next morning. Even four hours after administration performance of a simple psychomotor test was not impaired and sway (measured by an ataxiameter) was not increased in either age group. Pharmacokinetic studies showed that chlormethiazole was rapidly absorbed, distributed, and eliminated by both groups, so that minimal plasma concentrations existed 11 hours after administration. Temazepam, however, was less quickly absorbed and distributed, especially in the young group, and substantial amounts remained in the plasma 11 hours after administration. No unwanted effects occurred after temazepam, but 17 of the 20 subjects suffered from nasal irritation after taking chlormethiazole. Thus hangover effects may be avoided in elderly subjects after they have taken hypnotic drugs, and temazepam and chlormethiazole allow sleep to be interrupted safely.     

运动后补充肉碱可提升骨骼肌糖原合成代谢

本研究旨在探讨单次口服肉碱是否有利于促进人体运动后骨骼肌糖原恢复。本研究为交叉实验设计,选取20名受试者,随机分为肉碱试验(实验组)和安慰剂试验(安慰剂组),两次实验间隔至少7 d。所有受试者接受单次60 min 70%VO_2max功率车测试,运动后立即给予高碳水化合物饮食补充和肉碱胶囊或安慰剂淀粉胶囊口服补充,同时观察运动后3 h恢复期内的生理反应。功率车运动后第0、第3小时从股外侧肌采集肌肉样本,同期间隔每30 min收集血液样本,每60 min收集10 min气体样本。研究发现,实验组肌糖原含量增加率显著增加,在血液生化值方面,两组的血糖浓度在各时间点均无显著差异,但实验组的胰岛素反应显著低于安慰剂组。同时在运动恢复期间,实验组呼吸交换率明显低于安慰剂组,这代表运动恢复期口服肉碱后,身体以脂肪为主要能量来源。研究表明,运动后立即补充肉碱能显著提升人体运动后肌糖原恢复,具备临床进一步推广应用的价值。     

慢性精神分裂症患者前瞻性记忆障碍的康复训练

目的探讨慢性精神分裂症患者前瞻性记忆障碍实施康复训练的效果。方法选取我院2014年1月~2016年3月收治的60例慢性精神分裂症前瞻性记忆障碍患者,采用随机数字表法将患者分为对照组和观察组,对照组患者实施常规康复训练,观察组患者实施综合康复训练,观察两组患者实施康复训练6周和12周后记忆障碍的恢复情况。结果经过康复训练,观察组患者在康复训练6周和12周后记忆功能均较康复训练前的瞬时、短时、长时记忆有明显好转(P0.05),对照组患者在康复训练6周和12周后记忆功能与康复训练前比较无明显差异性(P0.05),两组患者康复训练后同时期记忆功能比较差异有统计学意义(P0.05)。两组患者入院时和出院时的焦虑情况比较,观察组患者明显优于对照组,差异有统计学意义(P0.05);出院时SCL-90症状自评量表评分,观察组各项指标均低于住院时(P0.05),而对照组各项指标与住院时比较无明显改变(P0.05),两组指标比较,观察组明显低于对照组,差异具有统计学意义(P0.05)。结论在慢性精神分裂症患者前瞻性记忆障碍的治疗中采取康复训练,能使患者的记忆功能显著提高,缓解了患者的临床症状,促进了患者康复。     

In vitro and in vivo anti-allergic effects of ‘benifuuki’ green tea containing O-methylated catechin and ginger extract enhancement

‘Benifuuki’, a tea (Camellia Sinensis L.) cultivar in Japan, is rich in anti-allergic epigallocatechin-3-O-(3-O-methyl) gallate (EGCG3″Me). ‘Benifuuki’ green tea and simultaneous addition of ginger extract remarkably suppressed cytokine (TNF-α and MIP-1α) secretion from mouse bone marrow-derived mast cells after antigen stimulation and, as expected, suppressed delay-type allergy. After drinking ‘benifuuki’ green tea containing 43.5 mg of EGCG and 8.5 mg of EGCG3″Me, the AUC (area under the drug concentration time curve; min μg/ml) of EGCG was 6.72 ± 2.87 and EGCG3″Me was 8.48 ± 2.54 in healthy human volunteers. Though the dose of EGCG was 5.1 times the dose of EGCG3″Me, the AUC of EGCG3″Me was higher than that of EGCG. A double blind clinical study on subjects with Japanese cedar pollinosis was carried out. At the 11th week after starting the study, in the most severe cedar pollen scattering period, symptoms, i.e., blowing the nose and itching eyes, were significantly relieved in the ‘benifuuki’ intake group compared with the placebo group, and blowing the nose, itching eyes and nasal symptom score, and at the 11th and 13th weeks, stuffy nose, throat pain and the nasal symptom medication score were significantly relieved in the ‘benifuuki’ containing ginger extract group compared with the placebo group. These results suggested that over one consecutive month, drinking ‘benifuuki’ green tea was useful to reduce some of the symptoms from Japanese cedar pollinosis, and did not affect any normal immune response in subjects with seasonal rhinitis, and the ginger extract enhanced the effect of ‘benifuuki’ green tea.     

Diversity of Intestinal Bifidobacteria in Patients with Japanese Cedar Pollinosis and Possible Influence of Probiotic Intervention

This study was conducted to evaluate the potential association between intestinal bifidobacteria and Japanese cedar pollinosis (JCPsis) and possible influences of probiotic intervention. In this study, fecal samples were the collected from 29 JCPsis patients. The qualitative and quantitative analyses of fecal bifidobacteria were conducted by quantitative real-time PCR with 16S rRNA-gene-targeted species-specific primers before cedar pollen spread and after a 10-week intervention with fermented milk prepared with Lactobacillus GG and L. gasseri TMC0356 during pollen spread. Each JCPsis patient had a unique diversity of bifidobacteria, which varied qualitatively and quantitatively in an individual-dependent manner during pollen spread. The serum IgE concentration of JCPsis patients with more than 3 detectable Bifidobacterium species was significantly lower than that of patients with less than 2 detected species. The prevalence of B. adolescentis, B. longum, and B. catenulatum increased after probiotic intervention, although the changes were not statistically significant. These results suggest that lower diversity of intestinal Bifidobacterium species might be a pathological aspect of JCPsis. The diversity of intestinal bifidobacteria could be a prospective target for using probiotics in the management of IgE-mediated allergic disorders including JCPsis.     

A double blind, placebo-controlled study of Andrographis paniculata fixed combination Kan Jang in the treatment of acute upper respiratory tract infections including sinusitis.

A double blind, placebo-controlled, parallel-group clinical study was carried out to evaluate the effect of an Andrographis paniculata (N.) extract SHA-10 fixed combination, Kan Jang, in the treatment of acute upper respiratory tract infections, including sinusitis. Ninety-five individuals in the treatment group and 90 individuals in the placebo group completed the study according to the protocol. The medication was taken for 5 days. Temperature, headache, muscle aches, throat symptoms, cough, nasal symptoms, general malaise and eye symptoms were taken as outcome measures with given scores. The total score analysis showed a highly significant improvement in the verum group versus the placebo. This result applied to the group as a whole and to the sinusitis subgroups. The individual symptoms of headache and nasal and throat symptoms together with general malaise showed the most significant improvement while cough and eye symptoms did not differ significantly between the groups. Temperature was moderately reduced in the verum group. It can be concluded that Kan Jang has a positive effect in the treatment of acute upper respiratory tract infections and also relieves the inflammatory symptoms of sinusitis. The study drug was well tolerated.