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

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

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

AIMTo evaluate the efficacy and safety of SK3530, a newly developed type 5 phosphodiesterase inhibitor (PDE5I), in Korean men with erectile dysfunction (ED).

METHODSA total of 119 patients were randomized at 10 centers in Korea to receive either SK3530 (50, 100, or 150 mg; n = 89) or placebo (n = 30) taken l h before anticipated sexual activity for an 8-week period. The patients were evaluated at baseline and 4 and 8 weeks after beginning therapy. Efficacy was assessed using the International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP), and the Global Assessment Question (GAQ). Safety was analyzed by adverse events, laboratory values and vital signs.

RESULTSAt the end of the study, all the primary and secondary efficacy end-points were statistically significantly improved by SK3530 compared with placebo (P<0.05). Of the 89 patients in the treatment arm, 36 (42.3%) achieved normal erectile function after treatment, including six patients with severe ED. Treatment-related adverse events occurred in 32 patients. The most common adverse events were flushing, headache, dizziness and eye redness (10.9%, 7.6%, 2.5% and 2.5%, respectively), and most were mild. Only two patients discontinued treatment during the study period because of adverse events.

CONCLUSIONThe results of our phase II study have confirmed the efficacy and safety of SK3530 in a broad population of men with ED of various etiologies and severity. The optimal doses in terms of efficacy and safety were determined to be 50 mg and 100 mg, respectively.

Double-Blind Method ; Erectile Dysfunction ; drug therapy ; Humans ; Korea ; Male ; Middle Aged ; Patient Satisfaction ; Phosphodiesterase Inhibitors ; administration & dosage ; adverse effects ; Placebos ; Pyrimidinones ; administration & dosage ; adverse effects ; Sulfones ; administration & dosage ; adverse effects ; Treatment Outcome

This study was designed to evaluate the reproductive performance of Japanese black cows following the 3rd injection of gonadotropin releasing hormone (GnRH) analogue administered concurrently with Ovsynch-based treatment on day 6 (day 1 = the day of ovulation). In Experiment 1, 12 cows were allocated into three groups: a control group that was subjected to Ovsynch treatment and then injected with a placebo on day 6; group 1 (Ovsynch + GnRH), which was subjected to Ovsynch treatment and was injected with GnRH analogue on day 6, and group 2 (Ovsynch + controlled internal drug-release (CIDR) + GnRH), which received Ovsynch-CIDR treatment and was injected with GnRH analogue on day 6. Blood collection and ultrasonographic observation of the ovaries were conducted daily. Both treatments induced the formation of an accessory corpus luteum and significantly increased the cross-sectional area of the luteal tissue when compared to the control. However, plasma progesterone (P(4)) was significantly higher in the treatment groups than in the control group on days 11, 12, 17 and 18 in the group 1 and from day 10 to 21 in the group 2. In Experiment 2, 41 cows were assigned to the same three groups described above and then artificially inseminated on day 1. The pregnancy rates on day 45 did not differ among groups. In conclusion, administration of GnRH analogue on day 6 following Ovsynch-based treatment did not improve the reproductive performance of Japanese black cows, even though the P(4) concentration was higher in groups that received the GnRH.
Animals ; Cattle ; Corpus Luteum/anatomy & histology/drug effects/physiology ; Delayed-Action Preparations ; Drug Administration Schedule ; Estrus/drug effects/physiology ; Female ; Gonadotropin-Releasing Hormone/administration & dosage/*pharmacology ; Japan ; Ovulation/drug effects/physiology ; Placebos ; Progesterone/blood ; Reproduction/drug effects/*physiology

PURPOSE: This study was done to provide data for a nursing intervention to alleviate newborn pain clinically by investigating the effect of oral glucose. METHODS: Subjects were newborns hospitalized in the nursery. Informed consent was obtained from parents of 60 newborns. A heel stick was carried out for a test on 3 groups; the experimental, placebo, and control group. The Neonatal infant pain scale(NIPS), respiration rate, heart rate, peripheral oxygen partial pressure(SpO2), and crying duration were measured to assess pain reaction. All neonatal behaviors were recorded on videotape. RESULTS: There were significant differences in pain behavior during stimulus(F=4.195, p=.020), pain behavior immediately after blood-sampling (F=4.114, p=.021), and pain behavior 3 minutes after that (F=3.630, p=.033). However, there were no significant differences in heart rate, respiration rate, peripheral oxygen partial pressure or crying duration after the heel stick among the groups. CONCLUSIONS: Oral administration of glucose before a heel stick caused the reduction of neonatal pain behavior, which means that it has an effect of pain relief.
Administration, Oral ; Blood Specimen Collection ; Female ; Glucose/administration & dosage/*therapeutic use ; Heart Rate ; Heel ; Humans ; Infant, Newborn ; Male ; Neonatal Nursing/*methods ; Oximetry ; Pain/nursing/*prevention & control ; Pain Measurement ; Placebos ; Punctures/adverse effects ; Respiration ; Time Factors

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 observe the therapeutic effect and possible side effects of glutamine granules per os in patients with trauma, burns and major operations.

METHODSPatients inflicted with severe burns, trauma and major operations were enrolled in the study. One hundred and twenty patients were randomly divided into two groups, 60 in control group (C) and 60 in glutamine group (Gln). Randomized double blind and placebo control methods were employed in the study. All the patients in both groups were given diet with equal calories and equal nitrogen content. The patients in Gln group received glutamine granules in dose of 0.5 g.kg(-1).d(-1) orally or by gavage, while those in C group received same dose of placebo (glycine) for 7 days. The changes in the intestinal mucosal barrier function, the protein metabolism, the immune function, hepatic and renal functions, and the incidence of side effects of the medication in both groups of patients were observed and compared before and after the supplementation of glutamine or glycine.

RESULTSThe plasma contents of glutamine, proteins and interleukin 2 in both groups were all lower than normal values. But the plasma diamine oxidase (DAO) activity, endotoxin content, intestinal mucosal permeability (urine lactose/mannitol, L/M) and urine excretion of nitrogen increased obviously in both groups. The plasma glutamine concentration in Gln group increased by 38.04% after the administration of Gln for 7 days (P < 0.01). The plasma contents of pro-albumin, transferrin, and IL-2 were obviously higher than those in the C group (the increase rates were 21.19%, 51.11%, 57.54%, respectively, P < 0.01). The plasma DAO activity, L/M ratio, endotoxin content and urine nitrogen excretion in Gln group were evidently lower than those in C group (the decrease rates were 47.26%, 52.18, 22.22% and 27.78%, respectively, P < 0.05 or 0.01). There was no obvious difference in the plasma levels of total protein and albumin, the indices in blood and urine test, or the hepatic and renal functions between the two groups before and after the amino acid supplementation. Mild side effects such as nausea, diarrhea, constipation occurred in both groups, but all of them disappeared spontaneously afterwards (P > 0.05).

CONCLUSIONOral administration of glutamine could be helpful to increase plasma concentration of glutamine and to ameliorate obviously the intestinal mucosal injury, to promote systemic protein synthesis and to inhibit protein catabolism and to upgrade systemic immune function with little side effect in patients with severe injury.

Administration, Oral ; Adolescent ; Adult ; Burns ; therapy ; Double-Blind Method ; Female ; Glutamine ; administration & dosage ; adverse effects ; blood ; Humans ; Intestinal Mucosa ; drug effects ; pathology ; physiopathology ; Male ; Middle Aged ; Placebos ; Treatment Outcome ; Young Adult

AIMThe effect of a renewed SS-cream (RSSC) on the treatment of premature ejaculation (PE) was evaluated and compared with the original SS-cream (OSSC).

METHODSSixty male white New Zealand rabbits, weighing 2.5 kg-3.0 kg, were divided at random into 3 groups: the RSSC, OSSC and placebo groups. The spinal somatosensory evoked potential (SSEP) elicited by electric stimulation of the glans penis with disk electrode was investigated with an electrophysiograph (Poseidomn, Shanghai, China) before and 10, 30 and 60 min after drug or placebo application on the glans. The Onset and the N1 latencies and the amplitude of SSEP were recorded and analyzed.

RESULTSThere was no significant difference (P>0.05) in the mean Onset and N1 latency of SSEP among the 3 groups before drug application. Compared with the pre-application value, the mean Onset and N1 latencies in the RSSC and OSSC groups were significantly prolonged at 10, 30 and 60 min after treatment (P<0.05), while they were not significantly changed (P>0.05) in the placebo group. The mean Onset latency of RSSC at 10 and 30 min and that of OSSC at 30 min were significantly delayed (P<0.05) compared with the placebo group. The mean N1 latency of RSSC at 30 and 60 min and that of OSSC group at 30 min were also significantly delayed (P<0.05).

CONCLUSIONRSSC delays the latencies of SSEP, suggesting a local desensitizing effect on the sensory receptor of the glans penis dorsal nerve, which provides the potential for PE treatment. The desensitizing effect of RSSC is higher than that of OSSC.

Amphibian Venoms ; administration & dosage ; Animals ; Drug Combinations ; Ejaculation ; drug effects ; Electric Stimulation ; Evoked Potentials, Somatosensory ; drug effects ; Male ; Penis ; innervation ; Placebos ; Plant Extracts ; administration & dosage ; Rabbits ; Sexual Dysfunction, Physiological ; drug therapy

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