We investigated the effects of indacaterol on cough and phlegm in patients with stable chronic obstructive pulmonary disease (COPD). We performed a meta-analysis with five randomized controlled trials (RCTs) of indacaterol in stable COPD patients. The symptom severity was defined using the St. George's Respiratory Questionnaire (SGRQ). We analyzed patients treated with 150 microg (n = 945) and 300 microg (n = 832) out of 3,325 patients who completed the SGRQ from five RCTs. After a 12-week treatment of 150 microg indacaterol, cough improvement was reported in 36.5% (316/866) of patients treated with indacaterol vs. 32.2% (259/804) patients treated with placebo (Relative Ratio [RR], 1.13; 95% confidence interval [CI], 0.99-1.29). Phlegm improvement was reported in 31.0% (247/798) of patients treated with indacaterol vs. 30.6% (225/736) of patients treated with placebo (RR, 1.01; 95% CI, 0.87-1.18). Dyspnea improvement was reported in 39.5% (324/820) of patients treated with indacaterol vs. 31.5% (237/753) patients treated with placebo (RR, 1.33; 95% CI, 1.03-1.71; P = 0.001, I2 = 55.1%). Only dyspnea improvement was significant compared to placebo even at the 300 microg indacaterol dose. Compared to placebo, a 12-week treatment of the long-acting beta-agonist, indacaterol might not have a significant effect on cough or phlegm in stable COPD.
Administration, Inhalation ; Anti-Bacterial Agents/therapeutic use ; Bronchodilator Agents/*therapeutic use ; Cough/*drug therapy ; Dyspnea/*drug therapy ; Forced Expiratory Volume/drug effects ; Humans ; Indans/*therapeutic use ; Placebos/administration & dosage ; Pulmonary Disease, Chronic Obstructive/*drug therapy ; Quinolones/*therapeutic use ; Sputum/*drug effects ; Surveys and Questionnaires ; Treatment Outcome

To evaluate the efficacy of ronidazole for treatment of Tritrichomonas foetus infection, 6 Tritrichomonas-free kittens were experimentally infected with a Korean isolate of T. foetus. The experimental infection was confirmed by direct microscopy, culture, and single-tube nested PCR, and all cats demonstrated trophozoites of T. foetus by day 20 post-infection in the feces. From day 30 after the experimentally induced infection, 3 cats were treated with ronidazole (50 mg/kg twice a day for 14 days) and 3 other cats received placebo. Feces from each cat were tested for the presence of T. foetus by direct smear and culture of rectal swab samples using modified Diamond's medium once a week for 4 weeks. To confirm the culture results, the presence of T. foetus rRNA gene was determined by single-tube nested PCR assay. All 3 cats in the treatment group receiving ronidazole showed negative results for T. foetus infection during 2 weeks of treatment and 4 weeks follow-up by all detection methods used in this study. In contrast, rectal swab samples from cats in the control group were positive for T. foetus continuously throughout the study. The present study indicates that ronidazole is also effective to treat cats infected experimentally with a Korean isolate of T. foetus at a dose of 50 mg/kg twice a day for 14 days.
Animals ; Antiprotozoal Agents/*administration & dosage ; Cat Diseases/*drug therapy/parasitology ; Cats ; Disease Models, Animal ; Feces/parasitology ; Male ; Parasitology/methods ; Placebos/administration & dosage ; Polymerase Chain Reaction/methods ; Protozoan Infections/*drug therapy/parasitology ; Ronidazole/*administration & dosage ; Treatment Outcome ; Tritrichomonas foetus/genetics/isolation & purification/*pathogenicity

OBJECTIVE/strong: Topical cepae extract-heparin sodium-allantoin gel is one of the many non-invasive scar treatments available to improve the appearance and physical attributes of scars. This paper aims to compare the effectiveness of topical cepae extract-heparin sodium-allantoin gel versus placebo based on appearance and physical attributes of hypertrophic thyroidectomy scars.br /br /strongMETHODS/strong:br /strongDesign/strong: Randomized, double-blinded, split-scar controlled trialbr /strongSetting/strong: Out-Patient Department of a tertiary government hospitalbr /strongPatient/strong: 20 patients with hypertrophic thyroidectomy scars had each side of the scar randomly assigned treatment with topical extract cepae-heparin sodium-allantoin gel or placebo (glycerine gel). Each product was applied two times daily for six weeks, and scars were evaluated prior to initiation of treatment and after six weeks by patients and one observer. Pre- and post- treatment photo documentation and scar evaluation using a local language translation of the Patient and Observer Scar Assessment Scale (POSAS) were completed for each side of the scar.br /br /strongRESULTS/strong: There was no significant difference in effectiveness of topical cepae extract-heparin sodium-allantoin gel versus placebo for both the patient scale (p = 0.91) and observer scale (p = 0.87) in appearance and physical attributes of a thyroidectomy scar.br /br /strongCONCLUSION/strong: Topical cepae extract-heparin sodium-allantoin gel was not proven to be superior to the placebo as scar therapy in all parameters assessed by the Filipino translation of POSAS. The small sample size, duration of hypertrophic scar, duration of treatment, and validity and reliability of the Filipino translation of POSAS may have affected our results; and periodic subjective and objective assessments with multi-observer evaluation of scars and pre- and post- treatment photographs may be considered for further studies./p
Human ; Male ; Female ; Middle Aged ; Adult ; Young Adult ; Adolescent ; Cicatrix ; Administration, Topical ; placebos ; Placebo Effect ; Thyroidectomy ; Glycerol

OBJECTIVECompared with Shengmai Capsule (生脉胶囊, SM), the study was conducted to evaluate the efficacy and safety of Xuefu Zhuyu Capsule (血府逐瘀胶囊, XFZY) on the symptoms and signs and health-related quality of life (HR-QOL) in the unstable angina (UA) patients with blood-stasis syndrome (BSS) after percutaneous coronary intervention (PCI).

METHODSA randomized, double-blinded, double-dummy, and placebo-controlled trial was applied. Ninety patients, diagnosed as UA and BSS after successful PCI, were enrolled and equally randomized into three groups, XFZY group, SM group, and placebo group, and administered with the corresponding medications respectively for four weeks. The clinical symptoms and signs (CSS), electrocardiography (ECG), and BSS scores were recorded and compared among groups during and after the treatment. Short-form 36 (SF-36) and Seattle Angina Questionnaire (SAQ) were applied to assess the HR-QOL in each group before and after the treatment. Safety indexes (blood routine and liver and kidney function tests) were also examined at the beginning and after the treatment.

RESULTSEighty-six patients completed the whole study. After the treatment, the total effective rates of the XFZY group in ameliorating CSS and ECG were 76.7% and 60.0%, respectively, which were obviously higher than those in SM (CSS: 53.3%; ECG: 36.7%) and the placebo (CSS: 43.3%; ECG: 30.0%) groups. After one week's treatment, BSS scores slightly decreased in each group, but no significant differences were found among three groups (P>0.05). After four weeks' treatment, BSS scores in the XFZY group decreased to a lower level compared with SM (P <0.05) and the placebo (P <0.01) groups. After the treatment, the efficacy of XFZY group in improving body pain (BP), general health (GH), vitality (VT), society functioning (SF), role emotional (RE), angina stability (AS), angina frequency (AF), and treatment satisfaction (TS) were better than those in the placebo group (P <0.05,P <0.01). Meanwhile, the dimensions of BP, GH, SF, AS, AF, and TS were better improved than those in the SM group P <0.05). No obvious adverse reaction was found during and after the treatment except one case in the XFZY group reporting of stomach discomfort.

CONCLUSIONSCompared with SM Capsule treatment, a short-term treatment with XFZY Capsule exhibits better efficacy on CSS and BSS scores, and HR-QOL in UA patients with BSS after PCI. However, its long-term efficacy and safety still needs further investigation.

Aged ; Angina Pectoris ; drug therapy ; physiopathology ; surgery ; Angioplasty, Balloon, Coronary ; Double-Blind Method ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; therapeutic use ; Electrocardiography ; Female ; Humans ; Male ; Middle Aged ; Placebos ; Quality of Life

OBJECTIVETo investigate the effects and mechanisms of panaxoside Rg1 on the new vessel formation in acute myocardial infarction (AMI) rats.

METHODSThe AMI model of male Sprague-Dawley (SD) rats was established, and rats were randomly divided into the AMI model group, the treatment group of panaxoside Rg1, the placebo group and the treatment group of panaxoside Rg1 plus rapamycin. Cardiac creatases were determined with 1 mL blood drawn from vena caudalis of the rats 48 h after the model was successfully made. After 4 weeks, Evans blue was injected into the aorta roots of the rats, and then, red tetrazoline was dyed again and the myocardial infarction area was evaluated. The microvessel density (MVD) of infarction area was determined by the immunohistochemistry of CD31; enzyme-linked immunosorbent assay (ELISA) was used to detect the protein content of CD31 and hypoxia inducible factor-1alpha (HIF-1alpha) of the infarction area.

RESULTSThe MVD in the infarction area and the contents of CD31 and HIF-1alpha in the Rg1 treatment group were higher than those in the AMI model group significantly (P<0.05). The cardiac creatase and infarction area were lower in the Rg1 treatment group than those in the AMI model group significantly (P<0.05). The above effects, however, disappeared when rapamycin, the antagonist of mammalian target of rapamycin (mTOR), was administered simultaneously.

CONCLUSIONSPanaxoside Rg1 could increase the expression of HIF-1alpha and CD31 of myocardium and stimulate the angiogenesis. The above mentioned role of panaxoside Rg1 might be related to the excitation of mTOR receptor.

Animals ; Cell Count ; Collateral Circulation ; drug effects ; Drug Evaluation, Preclinical ; Ginsenosides ; administration & dosage ; pharmacology ; Hypoxia-Inducible Factor 1, alpha Subunit ; metabolism ; Intracellular Signaling Peptides and Proteins ; metabolism ; physiology ; Male ; Microvessels ; pathology ; Myocardial Infarction ; drug therapy ; metabolism ; pathology ; Neovascularization, Physiologic ; drug effects ; Placebos ; Platelet Endothelial Cell Adhesion Molecule-1 ; metabolism ; Protein-Serine-Threonine Kinases ; metabolism ; physiology ; Random Allocation ; Rats ; Rats, Sprague-Dawley ; Signal Transduction ; drug effects ; Sirolimus ; administration & dosage ; pharmacology ; TOR Serine-Threonine Kinases

The aim of this study was to conduct a randomized, double-blind and placebo-controlled study to investigate the effects of D-004, a lipid extract of the Roystonea regia fruit that prevents testosterone- and phenylepinephrine-induced prostate hyperplasia in rodents, on plasma oxidative markers in healthy men. We enrolled male volunteers (20-55 years) in good health and without lower urinary tract symptoms. Thirty-four eligible participants were randomized to placebo or D-004 (320 mg) capsules administered daily for 6 weeks. An interim check-up and a final visit were conducted after 3 and 6 weeks of therapy, respectively. Physical examinations were performed at each visit, and laboratory tests were performed at baseline and at treatment completion. Oxidative variables included plasma malondialdehyde (MDA), total hydroxyperoxides (TOH), sulphydryl (SH) groups and total antioxidant status (TAS). We assessed treatment compliance and addressed adverse experiences (AEs) at weeks 3 and 6. At week 6, with D-004, the mean reductions of plasma MDA (26.7%), TOH (18.8%) and SH groups (31.6%), and the mean increase of TAS (35.3%) were significantly different from those of placebo (P<0.001 for plasma TAS, P<0.0001 for all other comparisons). D-004 did not differ from the placebo in safety indicators. There were two withdrawals (both in the D-004 group), with one due to dyspepsia (the only AE during the trial). In conclusion, D-004 displayed antioxidant effects on plasma oxidative markers in healthy men, which was consistent with findings from laboratory experimental studies.
Adult ; Antioxidants ; administration & dosage ; adverse effects ; Arecaceae ; Biomarkers ; blood ; Humans ; Lipid Peroxidation ; drug effects ; Lipids ; Male ; Middle Aged ; Oxidative Stress ; drug effects ; Placebos ; Plant Extracts ; administration & dosage ; adverse effects ; Prostatic Hyperplasia ; drug therapy ; metabolism ; Young Adult

OBJECTIVETo determine whether the ingestion of a herbal supplement called Rhodiola-Gingko Capsule (RGC) would enhance the endurance performance of healthy volunteers and change relevant hormones in a favorable manner.

METHODSSeventy healthy male volunteers (age ranges from 18 to 22 years old) were randomly assigned to RGC group (35 cases, each capsule containing 270 mg herbal extracts, 4 capsules per day) or placebo group (35 cases, equivalent placebo preparation) for 7 weeks using computer produced digital random method. The endurance performance, serum testosterone and cortisol levels were measured at the baseline and the endpoint.

RESULTSSixty-seven subjects (34 in the RGC group and 33 in the placebo group) completed a 7-week treatment. The RGC group displayed a significantly greater baseline-to endpoint increase in maximal oxygen uptake (VO(2max)) than placebo group in both absolute (P=0.020) and relative values (P=0.023). At the endpoint, the serum cortisol level was unchanged in the RGC group compared with the baseline, but it was significantly elevated in the placebo group (P<0.05). The endpoint ratio of testosterone to cortisol, a surrogate for overtraining and fatigue in endurance exercises, was also indifferent compared with the baseline in the RGC group, but significantly decreased in the placebo group (P<0.05).

CONCLUSIONThe combined herbal supplement of Rhodiola and Gingko could improve the endurance performance by increasing oxygen consumption and protecting against fatigue.

Adolescent ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Fatigue ; drug therapy ; Ginkgo biloba ; Humans ; Hydrocortisone ; blood ; Integrative Medicine ; Male ; Oxygen Consumption ; drug effects ; Physical Endurance ; drug effects ; Placebos ; Rhodiola ; Testosterone ; blood ; Young Adult

Antineoplastic Agents ; administration & dosage ; therapeutic use ; Case-Control Studies ; Controlled Clinical Trials as Topic ; methods ; Ethics, Medical ; Helsinki Declaration ; Humans ; Neoplasms ; drug therapy ; Placebos ; Randomized Controlled Trials as Topic ; methods ; Therapeutic Equivalency

Placebo-controlled clinical trials have been more and more emphasized in traditional Chinese medicine (TCM) researches, while the preparation of TCM placebos is still to be improved. For this work, some elements should be taken into consideration comprehensively, including the design of clinical trial, the characteristics of researched disease, the nature of testing drugs, and the way of medication, etc. And the technological process for placebo manufacturing should be selected properly depending upon the basis of the above elements. Un-biased foodstuff is good as excipient for TCM placebos preparation. The placebo should be made in dosage-form similar to that of the testing drug as possible, if there are difficulties for simulating them in appearance and smell completely. However, its potential pharmacological activity meeting to the acceptance of researchers should be ensured.
Clinical Trials as Topic ; Drugs, Chinese Herbal ; administration & dosage ; therapeutic use ; Humans ; Medicine, Chinese Traditional ; methods ; Placebos ; standards

AIMTo evaluate the safety and efficacy of an extract of Ganoderma lucidum that shows the strongest 5alpha-reductase inhibitory activity among the extracts of 19 edible and medicinal mushrooms by a double-blind, placebo-controlled, randomized and dose-ranging study in men with lower urinary tract symptoms (LUTS).

METHODSIn this trial, we randomly assigned 88 men over the age of 49 years who had slight-to-moderate LUTS to 12 weeks of treatment with G. lucidum extract (6 mg once a day) or placebo. The primary outcome measures were changes in the International Prostate Symptom Score (IPSS) and variables of uroflowmetry. Secondary outcome measures included changes in prostate size, residual urinary volume after voiding, laboratory values and the reported adverse effects.

RESULTSG. lucidum was effective and significantly superior to placebo for improving total IPSS with 2.1 points decreasing at the end of treatment (mean difference, -1.18 points; 95% confidence interval, -1.74 to -0.62; P < 0.0001). No changes were observed with respect to quality of life scores, peak urinary flow, mean urinary flow, residual urine, prostate volume, serum prostate-specific antigen or testosterone levels. Overall treatment was well tolerated with no severe adverse effects.

CONCLUSIONThe extract of G. lucidum was well tolerated and improved IPSS scores. These results encouraged a further, large-scale evaluation of phytotherapy for a long duration using the extract of G. lucidum on men with LUTS.

Aged ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Ethanol ; Humans ; Male ; Middle Aged ; Phytotherapy ; Placebos ; Reishi ; Solvents ; Treatment Outcome ; Urination Disorders ; drug therapy ; Urodynamics ; drug effects