A Phase Ⅲ Clinical Observation of Yishen Yangxin Anshen Tablets in Treatment of Insomnia with Deficiency of Heart Blood and Insufficiency of Kidney Essence / 中国实验方剂学杂志

ObjectiveTo confirm the clinical efficacy and safety of Yishen Yangxin Anshen tablets in the treatment of insomnia （heart-blood deficiency and kidney-essence insufficiency syndrome）. MethodA randomized block， double-blind， placebo-controlled， multi-center clinical trial design method was adopted， and a total of 480 patients with insomnia due to deficiency of heart blood and insufficiency of kidney essence （treatment group-control group 3∶1） from seven hospitals （Guang'anmen Hospital， China Academy of Chinese Medical Sciences， The First Clinical Hospital， Jilin Province Academy of Traditional Chinese Medicine（TCM）， The Second Affiliated Hospital of Liaoning University of TCM， The First Affiliated Hospital of Henan University of Chinese Medicine， Henan Province Hospital of TCM， Hebei General Hospital， The First Hospital of Hunan University of Chinese Medicine） were enrolled. The treatment group was given Yishen Yangxin Anshen tablets and the control group received placebo tablets （4 tablets/time， 3 times/day， 4 weeks of administration， 4 weeks of follow-up after drug withdrawal）. The sleep dysfunction rating scale （SDRS） score， pittsburgh sleep quality index （PSQI） score， TCM， polysomnography （PSG） indicators from four hospital （Guang'anmen Hospital， China Academy of Chinese Medical Sciences， Henan Province Hospital of TCM， Hebei General Hospital， The First Hospital of Hunan University of Chinese Medicine）， and other efficacy indicators were compared between the two groups before and after treatment. Through general physical examination， laboratory examination， and observation of adverse events， the safety of the drugs was evaluated. ResultThe baseline indexes of the two groups showed no significant difference and thus the two groups were comparable. After treatment， the total score of SDRS in the treatment group was lower than that in the control group （P<0.01）. After drug withdrawal for 4 weeks， the total score of SDRS demonstrated no significant change in the treatment group as compared with that at the end of treatment， indicating that the rebound change of curative effect was not obvious. After treatment， the total score of PSQI in the treatment group decreased as compared with that in the control group （P<0.01）， and the change of total score of PSQI in the treatment group was statistically significant （P<0.05） after drug withdrawal for 4 weeks but small， indicating that the rebound change of curative effect was not obvious. After treatment， the total effective rate about the TCM symptoms in the treatment group was higher than that in the control group （χ2=137.521，P<0.01）. After treatment， the disappearance rates of single indexes in the treatment group， such as difficulty in falling asleep， easily waking up after sleeping， early awakening， short sleep time， dreamfulness， palpitation， forgetfulness， dizziness， mental fatigue， and weakness of waist and knee， increased compared with those in the control group （P<0.01）. After treatment， the treatment group demonstrated fewer awaking times （AT）， longer total sleep time （TST）， lower ATA/TST ratio， and higher sleep efficiency （%） than the control group （P<0.05）. No abnormal value or aggravation related to drugs was observed in either group. The incidence of adverse events in the treatment group and the control group was 5.57% and 8.40% respectively. No serious adverse events or adverse events leading to withdrawal happened in either group. ConclusionYishen Yangxin Anshen tablets is effective and safe for patients with insomnia of deficiency of heart-blood and insufficiency of kidney-essence.

Efficacy of Curcumin on Cognitive Function Scores in Women with Premenstrual Syndrome and Dysmenorrhea: A Triple-Blind, Placebo-Controlled Clinical Trial / 中国结合医学杂志

OBJECTIVE@#To assess the efficacy of a curcumin supplementation on cognitive abilities in women suffering from premenstrual syndrome (PMS) and dysmenorrhea.@*METHODS@#A randomized, triple-blind, placebo-controlled trial was conducted from December 2019 to March 2020. A total of 124 women who had both PMS and dysmenorrhea were enrolled, and were equally and randomly assigned to the curcumin group or placebo group, 62 cases in each. Each subject received either a capsule containing 500 mg of curcuminoid, or a placebo daily, for 10 days (7 days before and until 3 days after the onset of menstrual bleeding) over 3 menstrual cycles. The cognitive abilities questionnaire was used to measures cognitive functions in 7 specific areas. Adverse reactions were monitored during and after the trial in both groups.@*RESULTS@#Administration of curcumin was associated with a significant increase in memory score (P=0.002), inhibitory control and selective attention (P=0.020), and total cognitive ability task (P=0.024). In addition, significant increments were found in scores of memory (3.5±3.1 vs. 0.4±3.8 in the curcumin and placebo groups, respectively; P=0.035), inhibitory control and selective attention (3.0±3.7 vs. 0.4±3.7; P=0.027) and total cognitive abilities (8.3±12.3 vs. 2.2±12.4; P=0.025) in the curcumin group versus placebo groups. Curcumin was safe and well-tolerable in current clinical trial.@*CONCLUSION@#Curcumin has a beneficial efficacy on cognitive function scores in women with PMS and dysmenorrhea, with improvements in memory, inhibitory control and selective attention. (Registration No. IRCT20191112045424N1, available at: https://www.irct.ir ).

Effectiveness of Dry Needling in Bothersome Chronic Tinnitus in Patients with Myofascial Trigger Points

Abstract Introduction Therapeutic dry needling (DN) is effective in reducing the discomfort of chronic somatosensory tinnitus in patients with myofascial trigger points (MTP)s. Objective To evaluate the efficacy of DN in chronic somatosensory tinnitus discomfort in patients with MTP. Methods Placebo-controlled paired trial that included 16 patients with a diagnosis of somatosensory chronic tinnitus and with the presence of at least one active or latent MTP. Treatment was performed in two phases: (1) four sessions (one session per week for four consecutive weeks) of placebo DN and (2) four sessions of therapeutic DN with a gap (washout) of 15 days between these phases. Results The Tinnitus Handicap Inventory (THI) variable and its emotional domain had a statistically significant reduction in therapeutic DN when compared with placebo DN (p= 0.024 and p = 0.011, respectively). The tinnitus visual analogic scale (VAS) signaled a reduction in tinnitus discomfort when compared with moments before and after therapeutic DN (p< 0.05). Conclusion The therapeutic DN technique for MTP in patients with chronic tinnitus of somatosensory origin proved effective in reducing symptom discomfort, as measured by the THI (total score) and its emotional domain when compared with placebo DN.

On the safety and effectiveness of COVID-19 vaccines, certainties and uncertainties / Sobre a segurança e efetividade das vacinas para COVID-19, certezas e incertezas

Introduction: The COVID-19 vaccines in use (inactivaded virus, encapsulated m-RNA, non-replicating adenovirus-vectored DNA) were clinically tested in randomized placebo- controlled phase-3 studies. Objective: To address certainties and uncertainties about safety and effectiveness of COVID-19 vaccines that were approved for use in various countries.Method: The evidence provided by clinical studies on the efficacy and safety of COVID-19 vaccines was critically appraised. Results: COVID-19 vaccines proved to be efficacious and safe in clinical trials. Adverse events were mostly those of minor severity commonly noted with other vaccines such as injection site pain, mild flu-like symptoms, headache and asthenia. Although being very rare, anaphylaxis-like reactions were noted with mRNA vaccines. Uncertainties regarding vaccine effectiveness refer mainly to the (long-term) duration of immunity provided by vaccination, the degree of protection conferred to elderly people, and how effective vaccines are against emerging SARS-CoV-2 variants. There are few uncertainties about vaccine safety including the absence of clinical trial data in pregnant women (and the impact on the unborn child), children and adolescents. Conclusions: Notwithstanding the knowledge gaps about effectiveness and safety of COVID-19 vaccines (to be further addressed by observational studies), there is overwhelming evidence that public health benefits of vaccination by far outweigh any foreseeable risk.

Introdução: As vacinas contra COVID-19 (vírus inativado, m-RNA encapsulado, vetor adenovírus não replicante) foram testadas em ensaios clínicos randomizados (fase-3) controlados com placebo. Objetivo: Abordar as certezas e incertezas sobre segurança e efetividade das vacinas para COVID-19 já aprovadas para uso em vários países. Método: A evidência clínica de eficácia e segurança das vacinas contra COVID-19 foram examinadas criticamente. Resultados: As vacinas (COVID-19) mostraram ser eficazes e seguras nos ensaios clínicos. Os eventos adversos foram predominantemente os de menor gravidade comumente observados com outras vacinas, tais como dor no local da injeção, sintomas gripais leves, cefaleia e fraqueza. Embora sejam raras, reações do tipo anafilático foram registradas com vacinas mRNA. As incertezas sobre efetividade referem-se à duração da imunidade conferida pela vacina, o grau de proteção de idosos, e a efetividade das vacinas contra as novas variantes do SARS-CoV-2. As incertezas sobre segurança são poucas e incluem a ausência de estudos clínicos em grávidas (e sobre o bebê no útero), em crianças e adolescentes. Conclusões: Não obstante as poucas lacunas acerca da efetividade e segurança das vacinas contra COVID-19 (a serem abordadas por estudos observacionais), os previsíveis benefícios da vacinação para a saúde pública excedem de longe quaisquer riscos antecipáveis.

Effectiveness and Safety of Umbilicus Treatment with Modified Dinggui Powder () in Patients with Chronic Nonbacterial Prostatitis: A Randomized, Double-blind, Placebo-controlled Clinical Trial / 中国结合医学杂志

OBJECTIVE@#To evaluate the effectiveness and safety of Chinese herbal external umbilicus treatment with Modified Dinggui Powder (, MDGP) in patients with chronic nonbacterial prostatitis (CNP).@*METHODS@#A randomized, double-blind, placebo-controlled clinical trial was conducted among 72 patients with CNP. Participants were randomly allocated to a treatment group and a placebo group using computer software in a 1:1 ratio, and received either MDGP external umbilicus treatment (MDGP group, 36 cases) or placebo control groupl (36 cases) at acupoints Shenque (CV 8), twice a week for 4 weeks. In addtion, patients all received herbal medicine treatment twice a day for 4 weeks. The primary outcomes was the US National Institutes of Health Chronic Prostatitis Symptom Scores Index (NIH-CPSI) with a questionnaire at weeks 2 and 4. The secondary outcomes including prostatic fluid examination (white blood cells and lecithin bodies), the clinical efficacy evaluation, and the adverse events were also assessed during the entire trial.@*RESULTS@#The NIH-CPSI scores regarding pain or discomfort scores showed greater improvement in the MDGP group than placebo control group at weeks 2 (P0.001) and week 4 (P0.004), respectively. NIH-CPSI scores of symptom severity, total scores, the amount of leukocytes number in the prostatic fifluid in the MDGP group were significantly improved (P0.05). The clinical effective rate was 73.53% (25/34) in the MDGP group, which was significally higher than the placebo control group with 48.39% (25/31, P<0.05). Patients were blinded successfully, and no serious adverse effects were found during the trial.@*CONCLUSION@#A 4-week course of umbilicus treatment with modified Dinggui Powder seems to relieve pain and symptom severity effectively and increase the amount of leukocytes number in patients with CNP (Trial registration No. ChiCTR1800014687).

Evaluation of the potential inhibitory activity of a combination of L. acidophilus, L. rhamnosus and L. sporogenes on Helicobacter pylori: A randomized double-blind placebo-controlled clinical trial / 中国结合医学杂志

<p><b>OBJECTIVES</b>To investigate whether three strains of probiotics, L. acidophilus, L. rhamnosus, and L. sporogenes, had signifificant inhibitive effects on Helicobacter pylori (H. pylori).</p><p><b>METHODS</b>This is a 4-week, randomly assigned, parallel-group, doubled-blind, and placebo-controlled study. Fifty patients with a positive H. pylori infection urea breath test (△UBT) result > 10% and without ulcer symptoms were randomized into a treatment group and a placebo group by a computer generated allocation sheet with 1:1. These subjects took one capsule of probiotics or placebo twice daily. The primary measurement was the change in △UBT values.</p><p><b>RESULTS</b>The △UBT values during the 4-week treatment period and the 2-week follow-up period were not signifificantly different between the treatment group and the placebo group, indicating that the inhibitive effects on H. pylori were comparable between both groups. The monocyte count (%) was 5.77±1.11 in the treatment group versus 5.09±1.12 in the placebo group (P=0.044), and the basophile count was 0.55±0.32 in the treatment group versus 0.36±0.23 in the placebo group (P=0.024) at week 2 of the treatment period, both of which reached statistical signifificance. The monocyte count was 5.75±1.26 in the treatment group and 4.72±0.99 in the placebo group at the end of the follow-up period (P=0.003).</p><p><b>CONCLUSION</b>There was no signifificant inhibitive effects of the three probiotic strains (L. acidophilus, L. rhamnosus, and L. sporogenes) on H. pylori. Probiotics can not play the same role as antibiotics in the eradication of H. pylori, the role of probiotics is likely to be important as adjuvant to the triple or quadruple therapy for H. pylori, especially in resistance cases.</p>

Effects of Black Bean Vinegar on Functional Constipation: A Randomised, Double-blind, Placebo-controlled Study

Functional constipation is a widespread gastrointestinal ailment associated with infrequent defecation, unfavorably affecting quality of life. However, it has not been well studied worldwide. This study aimed to investigate the effects of black bean vinegar (black bean and black bean yeast) consumption in alleviating functional constipation. Methods: A randomised, double-blind, placebo-controlled, parallel group study involving 70 adults with functional constipation was conducted in Peninsular Malaysia from May till July 2016. Subjects aged 18-60 years diagnosed with a score of more than 15 based on the Constipation Scoring System were included. A third-party-controller assigned black bean vinegar and placebo drinks to two groups with 1:1 ratio using randomisation software. Participants received once-daily doses of black bean vinegar (20 ml daily) or fruit-flavored squash placebo (20 ml daily) which contained vitamins, minerals, trace elements and carbohydrates, without black bean and black bean yeast, for four weeks. Analysis was conducted on an on-treatment basis (i.e., all randomised participants conformed to the study protocol by consuming 20 ml of drinks daily, with less than 10% leftover drinks at post-intervention assessment). Data were analysed using SPSS version 22. Results: Administration of black bean vinegar did not demonstrate statistically significant differences in any of the outcomes when compared with a placebo drink at α=5% level. However, black bean vinegar consumption significantly improved overall score at postintervention assessment compared to placebo group (p<0.05). Conclusion: Since the present study was only able to demonstrate the beneficial effects of black bean vinegar consumption in improving overall score at post-intervention assessment compared to placebo group, further randomised, controlled intervention studies are warranted to confirm whether conventional dietary intervention may play a role in improving functional constipation among Malaysian adults.

Effects of cetirizine in dogs with chronic atopic dermatitis: a randomized, double blind, placebo-controlled trial

This study was conducted to evaluate the effects of cetirizine in dogs with atopic dermatitis (AD) while fulfilling Favrot's diagnostic clinical criteria. Dogs received either 3 mg/kg cetirizine (n = 27), or a placebo (n = 23) orally once daily for 14 days in a randomized, double blind, placebo-controlled study, without concomitant medication. The effects were evaluated using a pruritus visual analog scale at the start (day 0) and at day 14. After 14 days, cetirizine clearly had no effect on the pruritus in dogs with chronic AD, and there was no significant difference between groups. These findings indicated that cetirizine (and likely H1 histamine receptor antagonists in general) should not be recommended for the control of pruritus in dogs with long term allergies.

ALERGIA A LA PROTEíNA DE LA LECHE DE VACA. EVALUACIóN DE SU RESOLUCIóN ESPONTáNEA POR MEDIO DE DESAFíOS DOBLE CIEGO PLACEBO CONTROLADOS / cows milk allergy. an assesment of its spontaneous resolution through double blind placebo controlled challenges.

Introducción. la alergia a la leche de vaca (aplv) es un problema sanitario global. Su diagnóstico adecuado y su seguimiento son esenciales ya que la leche de vaca es un alimento importante en la dieta de muchos lactantes. los desafíos orales doble ciego controlados por placebo (ddcpc) son la herramienta ideal para el diagnóstico y seguimiento de las alergias alimentarias. este estudio describe las características evolutivas de pacientes con aplv y las posibles variables que la pudieran modificar. material y métodos. Se estudiaron pacientes con diagnóstico de aplv previo con desafíos abiertos. Se catalogaron las reacciones de acuerdo a la normativa dracma. positivas fueron las pruebas en las que se presentaron alteraciones clínicas o variaciones hemodinámicas. negativas fueron aquellas en las que el paciente toleró la leche. Se consideraron edades de inicio y de realización del ddcpc, sexo y patología de aplv. resultados. Se estudiaron 106 pacientes (50 masculinos, 56 femeninos), promedio edad de inicio de síntomas 5,31 m (rango: 1-48 meses) y al procedimiento 23,14 m (5 meses - 5 años), y 13 pruebas positivas. un conjunto se refirió al mecanismo fisiopatológico y se dividió en ige mediadas (n=55) con 8 pruebas positivas y mixtas/celulares (n=51) con 5 pruebas positivas. otro conjunto fueron no gastrointestinales (n=61) con 7 pruebas positivas y gastrointestinales (n=45) con 6 pruebas positivas. todos los grupos fueron similares en cuanto a las variables demográficas. el sexo masculino y el diagnóstico de anafilaxia fueron factores de riesgo para no resolver su aplv (p=0,0125 y p=0,002 respectivamente). conclusiones. el momento de resolución de la aplv es independiente del mecanismo fisiopatológico subyacente o la edad de inicio de los síntomas. en general resuelven el problema de manera espontánea hacia los dos años de vida en más de un 87% de los casos. el sexo masculino (en ige mediadas) y el antecedente de anafilaxia podrían ser factores de riesgo para tener menos probabilidades de resolver la APLV. (AU)

Introduction: cow´s milk allergy (cma) is a global health issue. a proper diagnosis and follow up become essential. double blind placebo controlled challenges (dbpcc) is the gold standard for this purpose. this paper describes clinical evolution and characteristics of cma, as well as variables that may modify the affection course. methods & material: a group of patients, with a previous diagnosis of cma by open challenges, has been studied and its results cataloged according to dracma guidelines. tests with hemodynamic changes or clinical symptoms were considered as positives, while those with no clinical reaction were considered as negatives. variables involved were: age of symptoms starting, age of dbpcc performing, gender and cma clinical manifestations. results: 106 patients has been studied (50 male, 56 female), with a median age of 5,31 mo (range 5 ­ 48 mo) at the starting symptoms, and a median age of 23,14 mo (range 5 mo ­ 5 y) at the performing of dbpcc. 13 tests were negative. as regards to the different immune mechanisms, 55 were ige dependent (8 negative), and 51 were mediated by mixed/cellular (5 negative). patients were divided into two groups: with gastrointestinal symptoms (n=45) and with no gastrointestinal symptoms (n=61). they showed 6 and 7 negative results, respectively. all groups were similar. male gender, and anaphylaxis diagnosis turned out to be risk factors not to resolve cma (p=0,0125 and p=0,002 respectively). conclusions: cma resolution is independent of the immune mechanisms involved or the age of its symptoms starting. cma is solved spontaneously towards the age of two in 87% of the cases. male gender, and anaphylaxis may become risk factors not to resolve cma.(AU)

Prevalence and Clinical Impact of IgE-Mediated Food Allergy in School Children With Asthma: A Double-Blind Placebo-Controlled Food Challenge Study

PURPOSE: Recent studies indirectly suggest a possible link between food allergy (FA) and asthma. Most of them have evaluated the occurrence of FA in asthmatic children, especially in the first year of life, using questionnaire-based studies or specific IgE (sIgE) assay. The aim of this study was to evaluate the prevalence and clinical impact of IgE-mediated FA in school children with asthma using a double-blind placebo-controlled food challenge (DBPCFC). METHODS: The study group consisted of school children with atopic asthma who were admitted to the Department of Pediatric Allergology, Gastroenterology and Nutrition, Medical University of Lodz, for the evaluation of food hypersensitivity. The diagnosis of FA was established using questionnaires, sIgE analysis, and the DBPCFC. Asthma severity and asthma control state were also assessed. RESULTS: A relationship between consumed food and complaints was reported in 180 children (49.7%). Seventy children (19.3%) were sensitized to food allergens. IgE-mediated FA was confirmed in 24 children (6.6%), while 11 children (3%) demonstrated respiratory symptoms. Food-induced asthma exacerbations were observed in 9 patients (2.5%). Statistically significant differences in the prevalence of atopic dermatitis (P<0.002), urticaria (P<0.03), digestive symptoms (P<0.03), rhinitis (P<0.02), sIgE level (P<0.001), positive family history of atopy (P<0.001) and FA in history (P<0.001) were found between asthmatic children with FA and those without. Children with food-induced asthma exacerbations demonstrated significantly greater severity, poorer controls, and worse morbidity compared to those without. CONCLUSIONS: Although food-induced respiratory reactions in children with asthma were rare, they were classified as severe and associated with worse morbidity, greater severity, and poorer control. As the most commonly observed symptoms were coughing and rhinitis, which can be easily misdiagnosed, a proper diagnosis is essential for improving the management of both clinical conditions.

Safety and effectiveness of autoinoculation therapy in cutaneous warts: A double - blind, randomized, placebo - controlled study.

Background: In spite of the availability of multiple treatment options, viral warts are known for their persistence and recurrence, causing frustration to patients and treating physicians. Aims: To study the effectiveness and safety of autoinoculation as a treatment modality in cutaneous warts. Methods: A double‑blind, placebo‑controlled study was carried out. In the treatment group, full‑thickness warty tissue was excised, minced and implanted in a small dermal pocket. In the control group, warty tissue was only excised and not implanted, though a dermal pocket was made. Patients were evaluated every four weeks with lesion counts. The procedure was repeated at 4 and 8 weeks. Response was assessed at each visit and at 12 weeks. Results: Forty‑eight patients with cutaneous warts (male: female = 32:16) were randomized into autoinoculation and control groups. The number of warts at baseline was comparable in both groups (P = 0.293). Reduction in the number of warts was significantly more in the autoinoculation group (8.50 ± 13.88) than in the control group (10.04 ± 5.80) from 8 weeks onwards (P = 0.010). Complete resolution occurred only in the autoinoculation group, in 62.5% of cases. Adverse effects were seen in 11 patients, including infection of the donor site (5 cases), keloid formation (3) and hypopigmentation (3). Conclusion: Autoinoculation may be an effective therapeutic modality for cutaneous warts and two sessions may be required for optimum results.

Efficacy and safety of benidipine in patients with mild- to- moderate hypertension, a multicenter double-blind randomized controlled clinical trial / 中国药学杂志

METHODS: With random and double-blinded method in multicenters, 201 eligible patients aged from 18 to 75 years with mild to moderate hypertension were devided into two groups after received placebo for 2 weeks, 99 patients in experimental group received benidipine 2 mg once a day, 102 patients in control group were given lacidipine 4 mg, once a day for 4 weeks. The dose is adjusted after 4 weeks in the patients not reaching the blood pressure target of DBP or SBP. The whole treatment was continued for 8 weeks, patients must finish one visit every 2 weeks for observing efficacy and adverse events.

Efficacy of Probiotic Therapy on Atopic Dermatitis in Children: A Randomized, Double-blind, Placebo-controlled Trial

PURPOSE: To evaluate a therapeutic efficacy of probiotics mixture (probiotics) in the treatment of children with mild-to-moderate atopic dermatitis (AD). METHODS: Randomized, double-blind, placebo-controlled, parallel trial with a washout period of 2 weeks and an intervention period for 6 weeks, conducted from November 2010 to October 2011. One hundred children with mild to moderate AD (2-9 years old) were randomly allocated to the probiotics (Lactobacilluss casei, Lactobacillus rhamnosus, Lactobacillus plantarum, and Bifidobacterium lactis) or placebo groups. The assessment of efficacy was based on the change in eczema area severity index (EASI), visual analogue scale for pruritus (VASP), fecal cell counts of each strains (log10[cell counts/g stool]), and serum cytokine levels (Interleukin-4 [IL-4]; IL-10; Tumor necrosis factor alpha, [TNF-alpha]) in weeks 0 and 6. RESULTS: Demographics and baseline characteristics at the week 0 were not significantly different between the 2 groups. The significant increments in fecal-cell counts were observed in the probiotcs group at week 6 (P=0.00), while the cytokine levels between the 2 groups were not significantly different in week 6 (IL-4, P=0.50; IL-10, P=0.58; TNF-alpha, P=0.82). The probiotics significantly improved clinical severity after 6 weeks' intervention of probiotics; however, the placebo group also showed significant improvement (EASI; P=0.00, VASP; P=0.00). CONCLUSIONS: Our findings showed that probiotics successfully colonized in the intestine after 6 weeks' intervention; nevertheless, we could not find an additional therapeutic or immunomodulatory effects on the treatment of AD. Further long-term studies will be necessary to clarify the therapeutic efficacy of probiotics.

A randomized, double-blind and placebo-controlled clinical trail of topical administration of 1％ azithromycin eye drops for acute bacterial conjunctivitis / 中华实验眼科杂志

Background Acute bacterial conjunctivitis is a common ocular infectious disease.It can be cured by topical administration of antibiotics,but these antibiotic eye drops often was used several times per day at present.Azithromycin is thought to offer less using times and shorten the duration of treatment.Objective The purpose of this clinical trail was to evaluate the clinical efficacy and safety of topical administration of 1％azithromycin eye drops for the treatment of acute bacterial conjunctivitis.Methods This study was approved by Ethic Committee of Beijing Tongren Hospital and followed the Declaration of Helsinki.Written informed consent was obtained prior to entering into this trial.A randomized,double-blind and placebo-controlled study was designed.One hundred and eighty patients with acute bacterial conjunctivitis were enrolled in Affiliated Hospital of Qingdao Medical College and Qingdao Municipal Hospital from may,2011 to September,2011.Azithromycin eye drops at the concentration of 1％ was topically administered on 89 eyes of 89 patients twice per day initial and once per day later for 9 days in the trial group,and placebo eye drops was used on 91 eyes of 91 patients in the same way in the control group.The inflammation response of all eyes was examined and scored under the slit lamp microscope,and germiculture was carried out.All adverse responses were assessed during the follow-up.Clinical efficacy was evaluated with the clinical cure rate as the primary indicator and bacterial clearance rate as the secondary indicator.The safety of drug was determined,including the ocular irritation sign,lens transparency and intraocular pressure.The differences of the examining results mentioned-above were compared with Chi Square test.Results One hundred and eighty patients completed the clinical trials according to the program without lost and exclusion cases.The clinical cure rate in 89 subjects in the trial group and 91 control individuals was 76.40％ (68/89) and 43.96％ (40/91),respectively,with significant difference between them (x2=19.73,P＜0.01).The bacterial eradication rate was 85.71％ (24/28) in the trial group and 60.53％ (23/38) in the control group,showing a significant difference (x2 =4.99,P＜0.05).Both 1％ azithromycin eye drops and placebo were well-tolerated with a low incidence of adverse events.Conclusions One percent azithromycin eye drops is effective and safe for the treatment of acute bacterial conjunctivitis with less adverse reaction.

A Clinical Trial and Extension Study of Infliximab in Korean Patients with Active Rheumatoid Arthritis despite Methotrexate Treatment

Currently, infliximab is given for disease control for active rheumatoid arthritis (RA) patients despite methotrexate treatment. However, the efficacy and safety of infliximab in Korean patients has not been assessed appropriately. Therefore, we performed placebo-controlled, double-blind, randomized study and extension study. One-hundred forty-three patients with active RA were randomized to receive placebo or infliximab 3 mg/kg intravenously at week 0, 2, 6, 14, and 22 with methotrexate maintenance. Primary endpoint was American College of Rheumatology 20% improvement criteria (ACR20) at 30 week. After the clinical trial, patients on placebo (Group 1) and patients on infliximab who showed ACR20 response (Group 2) were treated with infliximab through another 84 week for evaluation of safety. During clinical trial, patients in infliximab group showed higher ACR20 at week 30 than patients in placebo group (50.1% vs 30.6%, P=0.014). A total of 92 patients participated in the extension study. The maintenance rate of infliximab was 62.0% at 84 weeks of extension study. The overall rate of adverse events was not different between Group 1 and Group 2. In Korean patients with active RA despite methotrexate treatment, infliximab in combination with methotrexate is effective and the long-term treatment with infliximab is well tolerated. (ClinicalTrials.gov No. NCT00202852, NCT00732875)

Use of Specific IgE and Skin Prick Test to Determine Clinical Reaction Severity.

Aims: To determine whether specific IgE and skin prick test correlate better in predicting reaction severity during a double-blinded placebo controlled food challenge (DBPCFC) for egg, milk, and multiple tree nut allergens. Study design: Prospective study. Place and Duration of Study: Department of Pediatrics, Stanford University School of Medicine, August 2009 and ongoing. Methodology: We examined the reaction severity of twenty-four subjects to nine possible food allergens: milk, egg, almond, cashew, hazelnut, peanut, sesame, pecan and walnut. Specific IgE and SPT were performed before each DBPCFC. DBPCFC results were classified into mild (1), moderate (2), or severe (3) reactions using a modified Bock’s criteria. Results: Twenty four subjects underwent a total of 80 DBPCFC. Eighty percent of all DBPCFCs resulted in a positive reaction. A majority, 71%, were classified as mild. No reactions occurred with a SPT of zero mm while three reactions occurred with a negative specific IgE. All reactions were reversible with medication. Conclusion: These data suggest that SPT and specific IgE levels are not associated with reaction severity (p<0.64 and 0.27, respectively). We also found that combining specific IgE and SPT improved specificity but did not help to achieve clinically useful sensitivity. For instance, an SPT > 5mm had a sensitivity of 91% and specificity of 50%. Combining SPT > 5mm and IgE > 7 resulted in a reduced sensitivity of 64%. Unexpectedly, a history of anaphylaxis 70% (n=17) was not predictive of anaphylaxis on challenge 4% (n=2).

Designs for research of High Dilutons in animal models: an update / Designs for research of High Dilutons in animal models: an update

This article discusses the series of tests on animal experimental models carried out by our group to evaluate the effect of homeopathic preparations selected according to traditional criteria of pathogenetic similarity. Our overall experience indicates that it is not difficult to carry out experimental studies assaying homeopathic medicines in randomized placebo-controlled tests returning statistically analyzable results. The basic requirement for this purpose is to select validated experimental models. The simplest and most reliable ones are the ones arising from common daily clinical practice or those taken from classical pharmacological studies modified as to fit the goals of a homeopathic assay. By proceeding in this way it will be possible to build a sound body of evidence for the biological effects of high dilutions [1].

Identification of IgE-mediated food allergy and allergens in older children and adults with asthma and allergic rhinitis.

Background and objective. Prevalence of immunoglobulin (Ig) E-mediated food allergy is primarily reported for certain pediatric populations and adults. The present study was aimed to investigate the relative prevalence of food allergy and allergens in older children and adults with asthma and allergic rhinitis. Methods. Patients (12-62 years) were screened using standard questionnaire and skin prick-test (SPT) with common foods and aeroallergens. Specific IgE level was determined by enzyme linked immunosorbent assay (ELISA) and allergy was established by blinded food challenges. Results. Of 1860 patients screened, 1097 (58.9%) gave history of food allergy. Of the history positive patients skin tested (n=470), 138 (29.3%) showed a marked positive reaction to food extracts. Rice elicited positive SPT reaction in maximum number of cases 29 (6.2%) followed by blackgram 28 (5.9%), lentil 26 (5.5%), citrus fruits 25 (5.3%), pea 18 (3.8%), maize 18 (3.8%) and banana 17 (3.6%). The SPT positive patients showed elevated specific IgE levels (range: 0.8-79 IU/mL) against respective food allergens than normal controls (0.73 IU/mL, mean±2SD). Food allergy was confirmed in 21/45 (46.6%) of the patients by blinded controlled food challenges. The prevalence of food allergy was estimated to be 4.5% (2.6%-6.34%) at 95% confidence interval (95% CI) in test population (n=470). Sensitisation to food was significantly associated with asthma (p=0.0065) while aeroallergens were strongly related to rhinitis (p<0.01). Conclusions. Food allergy is estimated to be 4.5% in adolescents and adults with asthma, rhinitis or both. Rice, citrus fruits, blackgram and banana are identified as major allergens for inducing allergic symptoms.

Designs for research of high dilutons in animal models: an update

This article discusses the series of tests on animal experimental models carried out by our group to evaluate the effect of homeopathic preparations selected according to traditional criteria of pathogenetic similarity. Our overall experience indicates that it is not difficult to carry out experimental studies assaying homeopathic medicines in randomized placebo-controlled tests returning statistically analyzable results. The basic requirement for this purpose is to select validated experimental models. The simplest and most reliable ones are the ones arising from common daily clinical practice or those taken from classical pharmacological studies modified as to fit the goals of a homeopathic assay. By proceeding in this way it will be possible to build a sound body of evidence for the biological effects of high dilutions

Este artigo discute a série de experimentos em modelos animais realizada por nosso grupo para avaliar o efeito de preparações homeopáticas escolhidas de acordo com o critério tradicional de similitude patogenêtica. Nossa experiência global indica que não é difícil realizar estudos experimentais com medicamentos homeopáticos em ensaios randomizados controlados com placebo que forneçam resultados analisáveis estatisticamente. O requisito básico para este propósito é escolher modelos experimentais validados. Os mais simples e mais confiáveis são aqueles derivados da prática clínica cotidiana assim como aqueles tomados de estudos farmacológicos clássicos modificados de modo a se corresponderem com os objetivos de um experimento homeopático. Procedendo desse modo, será possível construir um corpo sólido de evidência a favor dos efeitos biológicos das altas diluições.

Este artículo discute la serie de experimentos en modelos animales realizada por nuestro grupo, con el propósito de evaluar el efecto de preparados homeopáticos elegidos según el criterio tradicional de similitud patogenética. Nuestra experiencia global indica que no es difícil llevar a cabo estudios experimentales con medicamentos homeopáticos en ensayos randomizados controlados con placebo que resulten en datos pasibles de análisis estadística. El requisito fundamental para este fin es elegir modelos experimentales validados. Los más simples y confiables son aquellos derivados de la praxis clínica cotidiana así como los tomados de estudios farmacológicos clásicos, modificados para cumplir los objetivos de un experimento homeopático. Actuando de esta manera, será posible construir un corpus sólido de evidencia favorable a los efectos biológicos de las altas diluciones.

The Effect of Red-Yeast-Rice Supplement on Serum Lipid Profile and Glucose Control in Subjects with Impaired Fasting Glucose or Impaired Glucose Tolerance

This study was aimed at evaluating the effect of red-yeast-rice supplementation on cholesterol-lowering and glucose control in subjects with impaired fasting glucose (IFT) or impaired glucose tolerance (IGT). We conducted a doubleblind, placebo-controlled study with 3 groups ; placebo, low dose group (red yeast rice 210.0 mg/capsule, 2.52 g/day)and high dose group (red yeast rice 420.0 mg/capsule, 5.04 g/day), which were randomly assigned to subjects with impaired fasting glucose or impaired glucose tolerance. We measured fasting serum concentrations of total-, LDL-, HDL-cholesterol, triglyceride, glucose, insulin, free fatty acid (FFA) and 2 h oral glucose tolerence test (OGTT) before and after the supplementation. Both low dose and high dose groups had significant decrease in LDL cholesterol and atherogenic index (AI) compared with placebo group (p < 0.05). Additionally, total and HDL cholesterol improved significantly in high dose group compared with placebo group (p < 0.05). Fasting serum glucose decreased in test groups and increased in placebo group after intervention. However, it was not significant differences. In subjects which fasting blood glucose is more than 110 mg/dL, fasting glucose had a tendency to decrease in high dose group (p < 0.1) and Hemoglobin A1c (HbA1c) had significant decrease in low dose group (p < 0.05), while insulin and HOMA-IR had a tendency to increase in placebo group after intervention. Mean changes of glucose related parameters (fasting glucose, insulin, HOMA-IR) compared with placebo group did not show significant differences. In conclusion, subjects with impaired fasting glucose or impaired glucose tolerance were significantly improved in serum lipid profile by red yeast rice supplementation without serious side effects. These are more effective in the case of a high dose. The effects of red yeast rice supplementation on glucose control were insignificant.