Single-blind Placebo-controlled Clinical Trial Research Articles

Evaluation of Omega-3 Effect as Adjuvant Therapy to Methotrexate on Alkaline Phosphatase Level in Iraqi Patients with Active Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a common inflammatory disease associated with many extraarticularfeatures. The aim: of the current study is to assess the influence of omega-3 fatty acids(EPA, DHA) on serum alkaline phosphatase in patients with active RA. A single blinded placebocontrolled clinical trial with 12 weeks follow up period at which 50 patients with active RAusing methotrexate were randomized into 2 groups to receive either omega-3 (1000 mg) capsulethree times daily or capsules prefilled with glucose as placebo and were evaluated at zero time(baseline) and after 12 weeks for alkaline phosphatase level in serum. In addition to twenty fivehealthy subjects as control group. The age of RA patients in omega-3 group ranged from 25-80years (50.36±2.46), whereas the age of RA patients in placebo group ranged from 35-68 years(50.08±1.84 ), while the age of apparently healthy subjects in control group where ranged from40-60 years (94.20±1.12). The RA disease activity was measured using disease activity score of28 joints(DAS28-ESR) and clinical disease activity index (CDAI). After 12 weeks of startingadjuvant treatment with either omega-3 or placebo, the results showed that there were nosignificant difference between the effect of omega- 3 and placebo on alkaline phosphatase level.In Conclusion, omega-3 significantly decreased alkaline phosphatase level in patient with activerheumatoid arthritis

Usefulness of Curcuma longa in the Cases of Functional Dyspepsia—A Parallel Arm-Controlled Study

Abstract Background Functional dyspepsia is one of the common gastrointestinal (GI) disorders. This prospective experimental, randomised, single-blind placebo-controlled clinical trial was conducted at SKHMC, Jaipur, for a period of 1 year (March 2018–March 2019) with a 3 -month intervention and follow-up period, aiming to ascertain the usefulness of Curcuma longa in the cases of functional dyspepsia. Materials and Methods In this study, after screening of 220 patients using ROME III diagnostic criteria, 88 cases of functional dyspepsia fulfilling the eligibility criteria were included and enrolled in the study in a ratio of 1:1. Assuming 10% drop-outs to obtain 80 evaluable cases, that is, 40 cases were randomly allocated to experimental group (Curcuma longa), while another 40 cases were allocated to controlled group (Placebo). Both the arms followed dietary and lifestyle modifications. Usefulness of homoeopathic medicine and placebo in cases with functional dyspepsia on day 35 was compared with baseline. Potency used was 30 CH. Assessment and reassessment were done using gastrointestinal symptom (GIS) score. Results Eighty cases completed the study, in (50%) subjects marked improvement was seen in 12 (30%) cases in Curcuma longa group and 00(0%) cases in placebo group, moderate improvement was seen in 8 (20%) cases in Curcuma longa and 01 (2.5%) in placebo group, mild improvement was seen in 6 (15%) cases in Curcuma longa and 2 (5%) cases in placebo group, no relief was seen in 14 (35%) cases in Curcuma longa and 37 (92.5%) cases in placebo group. Functional dyspepsia is found in middle-aged persons of 36 to 45 years, with predominance in females. To analyse the change in the GIS scores of symptoms of functional dysplasia, paired t-test was applied for both treatment group and control group. It was observed from the paired t-test result that there is a one-point increase in the pre- and post-average GIS score (from 28.65 to 29.65) in the control group and it is not statistically significant (t = −0.760 and p = .452). Whereas there is 13.3-point decrease (from 29.55 to 16.25) in the treatment group and it is statistically significant (t = 9.347 and p = 0.000). Conclusion It indicates medicine is effective in lowering down the GIS score, which was statistically significant to conclude that homoeopathic medicine Curcuma longa was effective in the cases of functional dyspepsia.

Comparison of the clinical efficacy of daily use of L-arginine, tadalafil and combined L-arginine with tadalafil in the treatment of elderly patients with erectile dysfunction.

This study aimed to evaluate the efficacy of the daily oral administrations of L-arginine, tadalafil and combined L-arginine with tadalafil in treatments of elderly patients with erectile dysfunction (ED). It was designed as a single-blind placebo-controlled clinical trial. It was conducted on 120 male patients aged ≥60years old with ED. Patients were randomised classified into four groups (n=30 each). Oral daily use of L-arginine (5g), tadalafil (5mg), combined L-arginine (5g) with tadalafil (5mg) and placebo were taken for 6weeks in each group of patients respectively. Patients were assessed before and after treatments using the Sexual Health Inventory for Men (SHIM) questionnaire and total serum testosterone. The means of Q1-5, total scores of SHIM and total testosterone, in L-arginine, tadalafil and combined L-arginine with tadalafil groups were significantly higher after treatments (p=.001). Combined L-arginine with tadalafil group had the highest SHIM scores and levels of total testosterone. This clinical trial deduced that the combined daily use of L-arginine with tadalafil therapy for elderly male patients with ED could significantly increase the SHIM scores and levels of total testosterone in comparison to L-arginine, or tadalafil alone.

Correction to: Effectiveness and tolerability of lidocaine 5% spray in the treatment of lifelong premature ejaculation patients: a randomized single-blind placebo-controlled clinical trial.

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

Effectiveness and tolerability of lidocaine 5% spray in the treatment of lifelong premature ejaculation patients: a randomized single-blind placebo-controlled clinical trial.

This study aimed to appraise the effectiveness and tolerability of lidocaine 5% spray in the treatment of patients with premature ejaculation (PE). The current study has been designed as a randomized single-blind placebo-controlled clinical trial. It was done on 150 lifelong PE patients with normal erection. They were randomized evenly categorized into two treatment groups. Group 1 (n = 75); was given on demand lidocaine 5% spray for 8 weeks. Group 2 (n = 75); was given placebo in the form on demand alcohol spray for 8 weeks. All medications were applied on the glans penis for 10-20 min, and then cleaned before planned sexual intercourse. Patients were evaluated with the Arabic Index of Premature Ejaculation (AIPE) scores, intravaginal ejaculatory latency times (IELTs), and frequency of sexual intercourse before and after treatments. The mean values of the AIPE scores, IELTs, and sexual intercourse frequency in the lidocaine 5% spray group were statistically significant increased than the group of placebo after treatment (P value 0.0001). The present study deduced that local use of lidocaine 5% spray on glans penis 10-20 min prior to sexual intercourse could significantly improve PE patients, with tolerated local adverse effects.

Effect of Eicosapentaenoic Acid on Body Composition and Inflammation Markers in Patients with Head and Neck Squamous Cell Cancer from a Public Hospital in Mexico

ABSTRACTIntroduction: Head and neck cancer patients are at high risk of anorexia-cachexia syndrome and literature shows that Eicosapentaenoic acid (EPA) could regulate it. We aim to determine the EPA effect on body composition and pro-inflammatory markers in patients with head neck cancer. Materials and methods: A randomized single-blind placebo-controlled clinical trial was conducted in patients with head and neck squamous cell cancer who received a polymeric diet with 2 g of EPA or a standard polymeric diet for six weeks before antineoplastic treatment. We assessed body composition by bioelectrical impedance analysis and determined IL-1β, IL-6, TNF-α and IFN-γ, CRP, serum proteins, and blood count at baseline and at the end of the study. Results: 32 patients received EPA (2 g/day) and 32 became controls. A decrease in serum levels of IL-1β, IL-6, TNF-α, and IFN-γ was observed in the experimental group, as well as regulation of body weight (−0.3 ± 5.9 vs. −2.1 ± 3.7), lean body mass (−0.2 ± 3.8 vs. −1.3 ± 3.6), body fat mass (0.2 ± 3.5 vs. −1.2 ± 3.8), and quality of life (10 ± 33 vs. 5 ± 34). Conclusion: Supplementing with 2 g/day of EPA to head and neck cancer patient during antineoplastic treatment regulates serum pro-inflammatory cytokines, body weight, lean body mass, and improve quality of life.

Effects of Clopidogrel on Longevity of Permanent Double-Lumen Catheter Patency in Dialysis Patients: A Single-Blind Placebo-Controlled Clinical Trial

Background: Vascular access (VA) complications are recognized as important causes of hospitalization, morbidity, and mortality in dialysis patients. Thrombosis-induced central catheter failure is the most frequent VA complication. Clopidogrel, as an antiplatelet drug, may increase the patency of central catheters. Nevertheless, there is limited evidence regarding the effects of antiplatelet drugs on central catheter patency. Methods: A total of 100 patients, admitted to our dialysis clinic, were enrolled in this prospective study from January 2014 to June 2016. In this randomized, controlled, comparative study, two groups were recruited and observed to determine the effects of Clopidogrel on the central catheter patency. The function of permanent catheters (permcaths) was evaluated during 6 months. The patients’ demographics, including comorbidities and medical history, were also determined to evaluate the probable effects on permcath patency. In this study, t test was used to analyze quantitative variables, while Chi square and Fisher’s exact tests were used to analyze qualitative variables. Results: The mean age of patients in the Clopidogrel and placebo groups was 55.5 ± 11.8 and 55.7 ± 12.1 years, respectively. The catheter survival was significantly longer in the Clopidogrel group in comparison with the placebo group (P = 0.02). On the other hand, the frequency of complications showed no significant difference between the groups (P > 0.05). Conclusions: The results suggest that application of Clopidogrel following permcath insertion may be beneficial for catheter survival.

Validation of Placebo in a Manual Therapy Randomized Controlled Trial.

At present, no consensus exists among clinical and academic experts regarding an appropriate placebo for randomized controlled trials (RCTs) of spinal manipulative therapy (SMT). Therefore, we investigated whether it was possible to conduct a chiropractic manual-therapy RCT with placebo. Seventy migraineurs were randomized to a single-blinded placebo-controlled clinical trial that consisted of 12 treatment sessions over 3 months. The participants were randomized to chiropractic SMT or placebo (sham manipulation). After each session, the participants were surveyed on whether they thought they had undergone active treatment (“yes” or “no”) and how strongly they believed that active treatment was received (numeric rating scale 0–10). The outcome measures included the rate of successful blinding and the certitude of the participants’ beliefs in both treatment groups. At each treatment session, more than 80% of the participants believed that they had undergone active treatment, regardless of group allocation. The odds ratio for believing that active treatment was received was >10 for all treatment sessions in both groups (all p < 0.001). The blinding was maintained throughout the RCT. Our results strongly demonstrate that it is possible to conduct a single-blinded manual-therapy RCT with placebo and to maintain the blinding throughout 12 treatment sessions given over 3 months.

Increase of success rate for women undergoing embryo transfer by transcutaneous electrical acupoint stimulation: a prospective randomized placebo-controlled study

To evaluate the effect of transcutaneous electrical acupoint stimulation (TEAS) on pregnancy rates (PR) in women undergoing ET. Prospective, randomized, single-blinded placebo-controlled clinical trial. Research and laboratory facilities. A total of 309 patients, less than 45 years old, undergoing cryopreservation embryos transplant or fresh cycle IVF with or without intracytoplasmic sperm injection (ICSI). The subjects were randomly allocated to three groups: mock TEAS treatment: 30 minutes after ET (group I, n = 99); single TEAS treatment: 30 minutes after ET (group II, n = 110); and double TEAS treatments: 24 hours before ET and 30 minutes after ET (group III, n = 100). Clinical PR, embryos implantation rate, live birth rate. The clinical PR, embryos implantation rate, and live birth rate of group I (29.3%, 15.0%, and 21.2%, respectively) were significantly lower than those in group II (42.7%, 25.7%, and 37.3%, respectively) and group III (50.0%, 25.9%, and 42.0%, respectively). Transcutaneous electrical acupoint stimulation, especially double TEAS, significantly improved the clinical outcome of ET.

Effect of taurine supplementation on exercise capacity of patients with heart failure

Taurine (2-aminoethanesulfonic acid) is a semi-essential amino acid found in mammalian tissues that is not involved in protein synthesis. The function of taurine is not completely understood. Some studies have demonstrated that taurine supplementation reduces death rate in rabbits with heart failure (HF) and diminishes HF severity in human models of congestive HF. In this study we have evaluated the effect of taurine supplementation on exercise capacity of patients with HF. A randomized single-blind placebo-controlled clinical trial was conducted on 29 patients with HF with left ventricular ejection fraction (LVEF) less than 50% who were in functional class II or III according to New York Heart Association classification. A total of 15 patients received taurine supplementation 500 mg three times a day while the remaining 14 patients received placebo for 2 weeks. All patients performed exercise tolerance test before and after taurine and placebo supplementation. The mean age of patients was 60.57 ± 6.54 years, they were mostly male (26 of 29), and had mean LVEF of 29.27 ± 6.97%. There were no significant differences in terms of LVEF, body mass index, and also exercise time, metabolic equivalents (METS) and exercise distance before supplementation. Exercise time, METS, and exercise distance increased significantly in patients who received taurine supplement for 2 weeks (p-value<0.0001 for all), but did not increase significantly in patients who received placebo (p-values 0.379, 0.244, and 0.577 respectively). Taurine supplementation in patients with HF who are taking standard medical treatment can increase their exercise capacity.

A Trial to Assess the Efficacy of Glutamic Acid in Prevention of Vincristine-induced Neurotoxicity in Pediatric Malignancies: A Pilot Study

Vincristine is considered as a backbone of therapy in the induction and consolidation phases of pediatric malignancies. Neurotoxicity is a principal side effect of its use. This study is a randomized single-blinded placebo-controlled clinical trial to evaluate the role of glutamic acid in ameliorating neurotoxicity in pediatric patients with hematologic and solid tumors receiving vincristine during induction course. Fifty-four patients in the glutamic acid group received glutamic acid 1.5 grams daily orally in 3 divided doses during the 4-week induction with vincristine in a dose of 1.5 mg/m² IV weekly. Placebo group (40 patients) received oral placebo 3 times daily in the same way as the glutamic acid group. The onset of neurotoxicity was significantly earlier in placebo group than in glutamic acid group regarding tendon Achilles reflex, Patellar reflex, parasthesia, and increased frequency of constipation. This was statistically significant mostly in third and fourth visits, no severe cases of strength and mental alteration side effects in both groups. Glutamic acid was well tolerated with no gastrointestinal side effects in patients. This study suggests that the coadministration of oral glutamic acid with repetitive intravenous bolus injections of vincristine resulted in a reduction of its neurotoxicity.