Efficacy of Testosterone Treatment in Hemodialysis Patients as Assessed by Aging Males’ Symptoms Scores: A Pilot Study

Numerous reports point to the beneficial effects of testosterone replacement therapy for patients with late-onset hypogonadism (LOH) syndrome. The aim of this study was to evaluate the effect of intramuscular injection of testosterone enantholactam acid ester on Aging Males’ Symptoms (AMS) scores in hemodialysis patients with LOH. A total of 24 male patients with LOH (total AMS scores ≥27) were randomized into groups receiving intramuscular injections of either placebo or testosterone enantholactam acid ester at the dose of 250 mg for 6 months. In all, 13 and 11 participants from the active treatment and placebo groups, respectively, completed this study. An intramuscular injection of either placebo or testosterone enantholactam acid ester was given every 2 weeks. Self-administered AMS questionnaires were completed at the start, at Week 12 and at Week 24. The total AMS score was significantly more improved in the treatment group than in the placebo group ( p = .049) during the 24-week period. The change in the mean of total AMS score was +1% in the placebo group and −13.2% in the treatment group. The mean somato-vegetative domain scores decreased significantly only in the treatment group, and not in the placebo group (−1.21 vs. −2.43, p = .028). Although a large-scale study is needed, testosterone treatment may be effective in male patients with hemodialysis who have poor health-related quality of life resulting from LOH.

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Naloxone administration does not affect gonadotropin secretion in patients with Klinefelter's syndrome

Acta Endocrinologica ◽

10.1530/acta.0.1150320 ◽

1987 ◽

Vol 115 (3) ◽

pp. 320-324 ◽

Cited By ~ 4

Author(s):

G. Forti ◽

M. L. De Feo ◽

M. Maggi ◽

A. D. Genazzani ◽

V. Fazzi ◽

...

Keyword(s):

Testosterone Replacement Therapy ◽

Klinefelter’S Syndrome ◽

Testosterone Enanthate ◽

Klinefelter's Syndrome ◽

Gonadotropin Secretion ◽

Testosterone Treatment ◽

Naloxone Administration ◽

Before And After ◽

The Mean ◽

Baseline Conditions

Abstract. Plasma LH and FSH were measured every 20 min in a group of patients with Klinefelter's syndrome before and after placebo or naloxone administration (8 mg iv as a bolus followed by an infusion of 4 mg/h for 4 h) both in baseline conditions (N = 6) and during treatment with testosterone enanthate (200 mg im every two weeks; N = 4). The mean LH areas measured during saline infusion in baseline conditions (7888 ± 758 IU/l per min mean ± sem) and during testosterone treatment (5042 ± 2039 IU/l per min) were not significantly different from those measured during naloxone infusion (baseline 8317 ± 818 IU/l per min; during testosterone treatment 5395 ± 2007 IU/l per min). Similar results were obtained for FSH. These data suggest that in patients with Klinefelter's syndrome, the opioidergic inhibition of gonadotropin release is lacking and is not restored by testosterone replacement therapy.

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Therapeutic Effects of Add-On Tenapanor for Hemodialysis Patients with Refractory Hyperphosphatemia

American Journal of Nephrology ◽

10.1159/000516156 ◽

2021 ◽

pp. 1-11

Author(s):

Takashi Shigematsu ◽

Yotaro Une ◽

Kazuaki Ikejiri ◽

Hironori Kanda ◽

Masafumi Fukagawa ◽

...

Keyword(s):

Placebo Group ◽

Hemodialysis Patients ◽

Serum Phosphorus ◽

Phosphate Binders ◽

Therapeutic Effects ◽

Efficacy And Safety ◽

Phosphorus Level ◽

Serum Phosphorus Level ◽

The Mean ◽

Phosphorus Levels

Introduction: Phosphate binders are used to treat hyperphosphatemia. Some patients have inappropriately controlled serum phosphorus levels, which may occur for many reasons, including a high pill burden and adverse events (AEs). Tenapanor selectively inhibits the passive paracellular transfer of phosphate in the gastrointestinal tract, thereby reducing serum phosphorus levels. This novel mechanism of action may contribute to improved phosphate management. The efficacy and safety of tenapanor have not been evaluated in Japanese patients with high serum phosphorus levels despite treatment with phosphate binders. This study aimed to assess the efficacy and safety of add-on tenapanor therapy for reducing serum phosphorus levels in this population. Methods: This multicenter, double-blind, randomized, placebo-controlled trial enrolled patients with refractory hyperphosphatemia undergoing hemodialysis. Patients were randomly assigned in a 1:1 ratio to receive tenapanor or placebo as an add-on to their phosphate binder regimen for 6 weeks. Change in serum phosphorus levels at week 6 (day 43) compared with the baseline value (day 1, week 0) (primary endpoint), achievement of target serum phosphorus levels (serum phosphorus level ≤6.0 or ≤5.5 mg/dL), and safety, based on all AEs and drug-related AEs, were among the outcomes evaluated. Results: In total, 24 patients were randomly assigned to the placebo group and 23 to the tenapanor group. The mean serum phosphorus level decreased from 7.01 mg/dL on day 1 to 6.69 mg/dL on day 43 in the placebo group and from 6.77 mg/dL on day 1 to 4.67 mg/dL on day 43 in the tenapanor group. In the placebo and tenapanor groups (modified intent-to-treat population), the mean (standard deviation) change in the serum phosphorus level at day 43 (last observation carried forward [LOCF]) was 0.08 (1.52) mg/dL and −1.99 (1.24) mg/dL, respectively, with a between-group difference of −2.07 (95% confidence interval: −2.89, −1.26; p < 0.001). The target achievement rate (serum phosphorus level ≤6.0 mg/dL at week 6 [LOCF]) was 37.5 and 87.0% in the placebo and tenapanor groups, respectively. Diarrhea was the most common drug-related AE, and it occurred in 8.3 and 65.2% of patients in the placebo and tenapanor groups, respectively. No specific AEs were observed with add-on tenapanor or with phosphate binders. Discussion/Conclusion: Therapy with existing phosphate binders and add-on tenapanor resulted in a significant decrease in serum phosphorus level compared with the placebo group in patients with refractory hyperphosphatemia despite treatment with phosphate binders. No new safety signals were raised, and add-on tenapanor was generally well tolerated.

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Clinical evaluation of polyherbal formulation (Uricare Tablet) in benign prostatic hyperplasia: randomized, placebo controlled, single blinded clinical study

International Journal of Clinical Trials ◽

10.18203/2349-3259.ijct20162796 ◽

2016 ◽

Vol 3 (3) ◽

pp. 147 ◽

Cited By ~ 1

Author(s):

Hardik R. Patel ◽

Manish Patel ◽

Mansi M. Patel ◽

Janmjay H. Patel ◽

Payal G. Patel ◽

...

Keyword(s):

Placebo Group ◽

Benign Prostatic Hyperplasia ◽

Treatment Group ◽

Prostate Volume ◽

Prostatic Hyperplasia ◽

Drug Of Choice ◽

Percentage Improvement ◽

Before And After ◽

Male Patients

Background: This was a randomized, placebo controlled, single blinded clinical trial undertaken in 60 male patients in the age group of 18-70 years diagnosed with benign prostatic hyperplasia (BPH) in the department of at P.D. Patel Kayachikitsha, Ayurveda Hospital, India.Methods: A medical history, especially on urinary symptoms was obtained from all patients on first visit along with Blood tests. 60 Patients were randomized into two groups. Uricare tablet was administered at the dose of 2 tablets twice a day for the period of 6 weeks to treatment group and Placebo tablet was administered with same doses to the remaining patients group. They were evaluated on BPH assessment parameters, IPSS (International prostate symptom score), quality of life (QOL), level of serum PSA and the prostate volume.Results: Percentage reduction in IPSS score was observed 25.62% and 1.80% in treatment and placebo group respectively. Percentage improvement in QOL was also observed 31.67% and 2.82% in treatment and placebo groups respectively. BPH assessment parameters also show moderate changes in before and after treatment in both groups. However, the reduction in prostate volume was identified up to -4.612cc and -1.427cc in treatment and placebo group respectively at the end of the trial. Prostate significant antigen (PSA) was significantly reduced in the treatment group than Placebo group. Conclusions:There were no serious adverse effects observed during the study. Hence, the therapy was assumed to be well tolerated by patients and can be considered as a drug of choice in the management of BPH.

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Therapeutic Effects of Hab Shabyar on Open-Angle Glaucoma: A Double-Blinded, Randomized, Placebo-Controlled Trial

10.31661/gmj.v0i0.1218 ◽

2019 ◽

Vol 8 ◽

pp. 1218

Author(s):

Ebrahim Khalil BaniHabib ◽

Ali Mostafai ◽

Seyyed Mohammad Bagher Fazljou ◽

Ghadir Mohammdi

Keyword(s):

Placebo Group ◽

Intraocular Pressure ◽

Open Angle Glaucoma ◽

Controlled Trial ◽

Intervention Group ◽

Therapeutic Effects ◽

Open Angle ◽

The Mean ◽

The Right ◽

Double Blinded

Background: Open-angle glaucoma (OAG) is one of the leading causes of blindness worldwide. This study evaluates the therapeutic effects of hab shabyar in patients with open-angle glaucoma. Materials and Methods: In this clinical randomized controlled trial, 50 patients with OAG were randomized into two groups. The intervention group was received a drop of timolol plus 500 mg of hab shabyar every 12 hours. The placebo group was received a drop of timolol every 12 hours plus 500 mg of wheat germ as a placebo. The intraocular pressure in patients with OAG was measured in each group and compared at before the intervention (t1), one month (t2), and two months (t3) after the intervention. Results: The mean decrease in intraocular pressure for the right eye at three times in the intervention group was statistically significant, but the mean decrease in the placebo group was not significant. Similar results were obtained for the left eye at t1 when compared to t3. The patients in the intervention group expressed more satisfaction than the patients in the placebo group (P≤0.001). Conclusion: Our study demonstrated that consumption of timolol plus hab shabyar instead of consuming of timolol alone was probably more effective for reducing intraocular pressure in patients with OAG.[GMJ.2019;In press:e1218]

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Effect of High Plane of Nutrition on Blood Biochemical Profile and Onset of Puberty in Prepubertal HF X Kankrej Crossbred Heifers

THE INDIAN JOURNAL OF VETERINARY SCIENCES AND BIOTECHNOLOGY ◽

10.21887/ijvsbt.15.2.4 ◽

2019 ◽

Vol 15 (02) ◽

pp. 14-17

Author(s):

K K Hadiya ◽

A J Dhami ◽

D V Chaudhari ◽

P M Lunagariya

Keyword(s):

Body Weight ◽

Treatment Group ◽

Plasma Levels ◽

Age Of Onset ◽

The Body ◽

Monthly Interval ◽

Control Group ◽

Blood Biochemical ◽

Lower Protein ◽

The Mean

This study was initiated on 24 prepubertal Holstein x Kankrej crossbred heifers of nearly identical age (7-9 months) and body weight (130-140 kg) at University farm to evaluate the effect of high plane of nutrition on blood biochemical and minerals profile and the age at puberty. Twelve heifers were managed under routine farm feeding (control) and the rest 12 under ideal optimum feeding regime (treatment) that included extra 1 kg concentrate, 30 g min mix and ad-lib dry fodder. The body weight and ovarian ultrasonography together with blood sampling was carried out at monthly interval from 10 to 18 months of age to study the ovarian dynamics and blood biochemical changes. High plane of nutrition to growing heifers was beneficial in reducing the age of onset of puberty (by 2-3 months) compared to routine farm fed group. The mean plasma total protein and cholesterol concentrations showed a rising trend with significant variations from 10 to 16 months of age, where it got mostly stabilized indicating adult profile. The activity of enzymes GOT and GPT also rose gradually and significantly from 10 months till 14-15 months of age, and thereafter it remained more or less static till 18 months of age. The levels of both these enzymes were higher, with lower protein and cholesterol, in control than the treatment group from 15-16 months of age onwards. The mean plasma levels of both calcium and phosphorus increased gradually and significantly with advancing age till 16-17 months of age, with little higher values in supplemented than a control group. The plasma levels of zinc, iron, copper, and cobalt also showed rising trend with significant differences between 10th and 12th-14th months of age, and from 15th to 18th months of age the levels were statistically the same in all the groups with slightly higher values in the treatment group.

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Intravenous lidocaine reduces perioperative opioids without negatively affecting the electrical stapedial reflex threshold in pediatric cochlear implants

Ain-Shams Journal of Anesthesiology ◽

10.1186/s42077-021-00153-7 ◽

2021 ◽

Vol 13 (1) ◽

Author(s):

W. Z. Bakhet ◽

L. M. El Fiky ◽

H. A. Debis

Keyword(s):

Placebo Group ◽

Cochlear Implants ◽

Opioid Consumption ◽

Intravenous Lidocaine ◽

Lidocaine Group ◽

Registration Number ◽

Stapedial Reflex ◽

The Mean ◽

Reflex Threshold ◽

High Doses

Abstract Background Total intravenous anesthesia (TIVA) with propofol and remifentanil is frequently used for pediatric cochlear implants (CIs) surgery as it does not suppress the electrical stapedial reflex threshold (ESRT). However, high doses of remifentanil exacerbate postoperative pain and increase opioid consumption. Intravenous lidocaine reduces pain and opioid requirement. This study investigated the effect of intravenous lidocaine on perioperative opioid consumption and ESRT in pediatric CIs. Results The mean (95% CI) remifentanil consumption was significantly lower in lidocaine group than in placebo group [0.57 (0.497–0.643) vs 0.69 (0.63–0.75)] μg/kg/min, P = 0.016. The mean (95% CI) propofol consumption was significantly lower in lidocaine group than in placebo group [155.5 (146–165) vs 171 (161–181) μg/kg/min, P = 0.02. MBP and HR were significantly lower after surgical incision, laryngeal mask airway (LMA) removal, and at PACU admission in the lidocaine group compared with the placebo group. The PACU pain score was significantly lower in the lidocaine group compared to the placebo group. The mean (95% CI) pethidine consumption in PACU was significantly lower in the lidocaine group than in the placebo group 7.0 (6.17–7.83) vs. 8.9 (7.84–9.96) mg, P = 0.012. There were no differences between groups regarding ESRT response. Conclusions Intravenous lidocaine infusion reduced perioperative opioid requirements without altering the ESRT in pediatric CIs. Trial registration Clinical registration number: NCT04194294.

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The Clinical Effect of Oral Vitamin D2 Supplementation on Psoriasis: A Double-Blind, Randomized, Placebo-Controlled Study

Dermatology Research and Practice ◽

10.1155/2019/5237642 ◽

2019 ◽

Vol 2019 ◽

pp. 1-9 ◽

Cited By ~ 9

Author(s):

Wareeporn Disphanurat ◽

Wongsiya Viarasilpa ◽

Panlop Chakkavittumrong ◽

Padcha Pongcharoen

Keyword(s):

Vitamin D ◽

Placebo Group ◽

Adverse Events ◽

Clinical Effect ◽

Vitamin D Supplementation ◽

P Value ◽

Vitamin D2 ◽

Oral Vitamin ◽

Pasi Score ◽

The Mean

Background. There are limited randomized controlled trials of oral vitamin D supplementation in psoriasis, especially in Asia, and the results are inconclusive. Objective. To investigate the clinical effect of oral vitamin D supplementation on psoriasis. Methods. Patients with psoriasis were randomized to receive vitamin D2 60,000 IU or similar-looking placebo pills once every 2 weeks for 6 months. The primary outcome was improvement of the Psoriasis Area and Severity Index (PASI) score at 3 and 6 months after treatment. Serum levels of 25(OH)D, calcium, phosphate, parathyroid hormone, and C-reactive protein and adverse events were monitored. The chi-square test, Fisher’s exact test, Student’s t-test, and Spearman’s correlation analysis were used in statistical analysis. Results. Of 50 subjects screened, 45 were eligible and randomized to the oral vitamin D2 group (n=23) or placebo group (n=22). At enrollment, the mean PASI score was 4.45, and 26.7% of patients had vitamin D deficiency. At 3 months, the oral vitamin D2 group had significantly higher PASI improvement than the placebo group (mean PASI improvement: 1.43 versus [vs.] -0.33, p-value=0.034; mean %PASI improvement: 34.21% vs. -1.85%, p-value=0.039). The mean serum 25(OH)D level was significantly higher in the oral vitamin D group than in the placebo group (27.4 vs. 22.4 ng/mL, p-value=0.029). Serum 25(OH)D concentrations were significantly inversely correlated with PASI scores at the 6-month follow-up. No major adverse event was observed overall. Conclusion. Oral vitamin D2 supplementation in patients with psoriasis increased the serum vitamin D level and significantly improved the treatment outcome without increasing adverse events. Trial Registration. This trial is registered with Thai Clinical Trials Registry TCTR20180613001.

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A randomized, double-blind, placebo-controlled trial on the efficacy and tolerability of sertraline in Iranian veterans with post-traumatic stress disorder

Psychological Medicine ◽

10.1017/s0033291711000201 ◽

2011 ◽

Vol 41 (10) ◽

pp. 2159-2166 ◽

Cited By ~ 20

Author(s):

Y. Panahi ◽

B. Rezazadeh Moghaddam ◽

A. Sahebkar ◽

M. Abbasi Nazari ◽

F. Beiraghdar ◽

...

Keyword(s):

Placebo Group ◽

Post Traumatic Stress Disorder ◽

Traumatic Stress ◽

Stress Disorder ◽

Controlled Trial ◽

Post Traumatic Stress ◽

Double Blind ◽

Double Blind Placebo ◽

Post Traumatic ◽

The Mean

BackgroundUnlike civilian post-traumatic stress disorder (PTSD), the efficacy of sertraline for the treatment of combat-related PTSD has not yet been proven. The present study aimed to evaluate the clinical efficacy of sertraline against combat-related PTSD in a randomized, double-blind, placebo-controlled trial.MethodSeventy Iranian veterans of the Iran–Iraq war who met the DSM-IV criteria for diagnosis of PTSD were randomized to receive either flexibly dosed sertraline (50–200 mg/day) (n=35, completers=32) or placebo (n=35, completers=30) for 10 weeks. Efficacy was evaluated by the Impact of Event Scale – Revised (IES-R) and the Clinical Global Impression scale – Severity (CGI-S) and Improvement (CGI-I) ratings. Responder criteria were defined as a ⩾30% reduction in the IES-R total score plus a CGI-I rating of ‘much’ or ‘very much’ improved.ResultsOn both intention-to-treat (ITT) and per protocol (completer) methods of analysis, the mean reductions in the IES-R total and subscale (re-experiencing/intrusion, avoidance/numbing and hyperarousal) scores (p<0.001) and also in the CGI-S score (p<0.01) were significantly greater in the sertraline group than in the placebo group. For the CGI-I, the mean endpoint score was significantly lower in the sertraline group than in the placebo group (p⩽0.001). The number of responders in the sertraline group was significantly higher than in the placebo group (44% v. 3%, p⩽0.001). Sertraline was well tolerated, with a 6% discontinuation rate as a result of adverse reactions.ConclusionsThe results of this study suggest that sertraline can be an effective, safe and tolerable treatment for combat-related PTSD in Iranian veterans.

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Primary or Redo Posterior Sagittal Anorectoplasty without a Stoma: To Feed or Not to Feed?

European Journal of Pediatric Surgery ◽

10.1055/s-0037-1608805 ◽

2017 ◽

Vol 29 (02) ◽

pp. 150-152 ◽

Cited By ~ 1

Author(s):

Clare Skerrit ◽

Alexander Dingemans ◽

Victoria Lane ◽

Alejandra Sanchez ◽

Laura Weaver ◽

...

Keyword(s):

Breast Milk ◽

Wound Dehiscence ◽

Anorectal Malformations ◽

Wound Complication ◽

Wound Complications ◽

Age At Surgery ◽

Significant Difference ◽

Male Patients ◽

The Mean ◽

Picc Line

Introduction Repair of anorectal malformations (ARMs), primarily or with a reoperation, may be performed in certain circumstances without a diverting stoma. Postoperatively, the passage of bulky stool can cause wound dehiscence and anastomotic disruption. To avoid this, some surgeons keep patients NPO (nothing by mouth) for a prolonged period. Here, we report the results of a change to our routine from NPO for 7 days to clear fluids or breast milk. Materials and Methods After primary or redo ARM surgery, patients given clear liquids were compared to those who were kept strictly NPO. Age, indication for surgery, incision type, use of a peripherally inserted central catheter (PICC) line, and wound complications were recorded. Results There were 52 patients, including 15 primary and 37 redo cases. Group 1 comprised 11 female and 15 male patients. The mean age at surgery was 4.9 years (standard deviation [SD]: 2.3). There were 8 primary cases and 18 redo cases. Twelve (46.6%) received a PICC line. The average start of clear liquids was on day 5.3 (SD: 2.2) after examination of the wound, and the diet advanced as tolerated. The first stool passage was recorded on average on day 2.3 (SD: 1.3). Four minor wound complications and no major wound complications occurred.Group 2 comprised 14 females and 12 male patients. The mean age at surgery was 3.5 (SD: 2.4) years. There were 7 primary and 19 redo cases. One (3.8%) patient required a PICC line. A clear liquid diet was started within 24 hours after surgery. A regular diet was started on average on day 5.8 (SD: 1.3). The first stool passage was recorded on an average of day 1.6 (SD: 0.9). Three minor wound complications occurred; however, there was no significant difference between the two groups (SD: 0.71). One major wound complication occurred. However, there was no significant difference in major wound complications between the groups (SD: 0.33). Conclusion No increase in wound problems was noted in children receiving clear liquids or breast milk compared with the strict NPO group, and PICC line use was reduced. We believe this change in practice simplifies postoperative care without increasing the risk of wound complications.

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Value of Whole-Body Washing With Chlorhexidine for the Eradication of Methicillin-ResistantStaphylococcus aureus:A Randomized, Placebo-Controlled, Double-Blind Clinical Trial

Infection Control and Hospital Epidemiology ◽

10.1086/519929 ◽

2007 ◽

Vol 28 (9) ◽

pp. 1036-1043 ◽

Cited By ~ 88

Author(s):

C. Wendt ◽

S. Schinke ◽

M. Württemberger ◽

K. Oberdorfer ◽

O. Bock-Hensley ◽

...

Keyword(s):

Clinical Trial ◽

Placebo Group ◽

Treatment Group ◽

Solution Treatment ◽

University Hospital ◽

Whole Body ◽

Double Blind ◽

Antiseptic Solution ◽

Double Blind Clinical Trial ◽

Double Blinded

Background.Whole-body washing with antiseptic solution has been widely used as part of eradication treatment for colonization with methicillin-resistantStaphylococcus aureus(MRSA), but evidence for the effectiveness of this measure is limited.Objective.To study the efficacy of whole-body washing with chlorhexidine for the control of MRSA.Design.Randomized, placebo-controlled, double-blinded clinical trial.Setting.University Hospital of Heidelberg and surrounding nursing homes.Patients.MRSA carriers who were not treated concurrently with antibiotics effective against MRSA were eligible for the study.Intervention.Five days of whole-body washing with either 4% chlorhexidine solution (treatment group) or with a placebo solution. All patients received mupirocin nasal ointment and chlorhexidine mouth rinse. The outcome was evaluated 3, 4, 5, 9, and 30 days after treatment with swab samples taken from several body sites.Results.Of 114 patients enrolled in the study (56 in the treatment group and 58 in the placebo group), 11 did not finish treatment (8 from the treatment group and 3 from the placebo group [P= .02]). At baseline, the groups did not differ with regard to age, sex, underlying condition, site of MRSA colonization, or history of MRSA eradication treatment. Eleven patients were MRSA-free 30 days after treatment (4 from the treatment group and 7 from the placebo group [P= .47]). Only groin-area colonization was significantly better eradicated by the use of chlorhexidine. The best predictor for total eradication was a low number of body sites positive for MRSA. Adverse effects were significantly more frequent in the treatment group than in the placebo group (any symptom, 71% vs 33%) but were reversible in most cases.Conclusion.Whole-body washing can reduce skin colonization, but it appears necessary to extend eradication measures to the gastrointestinal tract, wounds, and/or other colonized body sites if complete eradication is the goal.Trial Registration.ClinicalTrials.gov identifier: NCT00266448.

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