scholarly journals Effect of Eurycoma longifolia standardised aqueous root extract– Physta® on testosterone levels and quality of life in ageing male subjects: a randomised, double-blind, placebo-controlled multicentre study

2021 ◽  
Author(s):  
Sasikala M. Chinnappan ◽  
Annie George ◽  
Pragya Pandey ◽  
Govinda Narke ◽  
Yogendra Kumar Choudhary
Keyword(s):  
Quality Of Life ◽  
Free Testosterone ◽  
Total Testosterone ◽  
Double Blind ◽  
Testosterone Levels ◽  
Eurycoma Longifolia ◽  
Ageing Male ◽  
Secondary Endpoints ◽  
Male Subjects

Background: Low testosterone levels cause physiological changes that compromise the quality of life in ageing men. A standardised water extract from the root of Eurycoma longifolia (EL), known as Physta®, is known to increase testosterone levels. Objective: To evaluate the safety and efficacy of Physta® in improving the testosterone levels and quality of life in ageing male subjects. Design: This randomised, double-blind, placebo-controlled study enrolled 105 male subjects aged 50–70 years with a testosterone level <300 ng/dL, BMI ≥ 18 and ≤30.0 kg/m2. The subjects were given either Physta® 100 mg, 200 mg or placebo daily for 12 weeks. The primary endpoints were changes in serum total and free testosterone levels. The secondary endpoints included changes in the level of sex hormone-binding globulin (SHBG), dihydroepiandrosterone (DHEA), glycated haemoglobin (HbA1c), insulin-like growth factor-1 (IGF-1), thyroid function tests (T3, T4, TSH and Free T3) and cortisol. Changes in Ageing Male Symptoms (AMS) score, Fatigue Severity Scale (FSS) score and muscle strength are other secondary endpoints. The safety of the intervention products was measured by complete blood count, lipid profile, liver and renal function tests. Results: There was a significant increase in the total testosterone levels at week 12 (P < 0.05) in the Physta® 100 mg group and at weeks 4 (P < 0.05), 8 (P < 0.01) and 12 (P < 0.001) in the Physta® 200 mg group compared to placebo. No significant between-group differences in free testosterone levels were observed but a significant within-group increase occurred at weeks 4 (P < 0.01), 8 (P < 0.001) and 12 (P < 0.001) in the Physta®100 mg group and at weeks 2 (P < 0.01), 4 (P < 0.01), 8 (P < 0.001) and 12 (P < 0.001) in the Physta® 200 mg group. The AMS and FSS showed significant reduction (P < 0.001) in total scores at all time-points within- and between-group in both Physta® groups. DHEA levels significantly increased (P < 0.05) within-group in both Physta® groups from week 2 onwards. Cortisol levels significantly (P < 0.01) decreased in the Physta® 200 mg group, while muscle strength significantly (P < 0.001) increased in both Physta® groups at week 12 in the within-group comparison. There were no significant changes in SHBG. No safety related clinically relevant changes were observed. Conclusion: Supplementation of Physta® at 200 mg was able to increase the serum total testosterone, reduce fatigue and improve the quality of life in ageing men within 2 weeks’ time. Trial registration: This clinical study has been registered in ctri.nic.in (CTRI/2019/03/017959).

scholarly journals Testosterone replacement therapy of opioid-induced male hypogonadism improved body composition but not pain perception: a double-blind, randomized, and placebo-controlled trial

2020 ◽  
Vol 182 (6) ◽  
pp. 539-548 ◽  
Author(s):  
Dorte Glintborg ◽  
Henrik Bjarke Vaegter ◽  
Louise Lehmann Christensen ◽  
Emma Bendix ◽  
Thomas Graven-Nielsen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Body Composition ◽  
Lean Body Mass ◽  
Body Mass ◽  
Fat Mass ◽  
Pain Perception ◽  
Adrenal Function ◽  
Total Testosterone ◽  
Double Blind

Background Hypogonadism is prevalent during opioid treatment, but the effect of testosterone replacement treatment (TRT) on body composition, pain perception, and adrenal function is unclear. Purpose To measure changes in body composition, pain perception, quality of life, and adrenal function after TRT or placebo in opioid-treated men with chronic non-malignant pain. Methods Double-blind, placebo-controlled study in 41 men (>18 years) with total testosterone <12 nmol/L were randomized to 24 weeks TRT (Testosterone undecanoate injection three times/6 months, n = 20) or placebo (placebo-injections, n = 21). Outcomes Body composition (lean body mass and fat mass assessed by DXA), clinical pain intensity (numerical rating scale), and experimental pain perception (quantitative sensory assessment), quality of life (SF36), and adrenocorticotrophic hormone (ACTH) test. Data were presented as median (quartiles). Mann–Whitney tests were performed on delta values (24–0 weeks) between TRT and placebo. Results The median age was 55 years (46; 59) and total testosterone before intervention was 6.8 (5.0; 9.3) nmol/L. TRT was associated with change of testosterone levels: 12.3 (7.0; 19.9) nmol/L (P < 0.001 vs placebo), increased lean body mass: 3.6 (2.3; 5.0) kg vs 0.1 kg (−2.1; 1.5) during TRT vs placebo and decreased total fat mass: −1.2 (−3.1; 0.7) kg vs 1.2 kg (−0.9; 2.5) kg, both P < 0.003. Changed pain perception, SF36, and ACTH-stimulated cortisol levels were non-significantly changed during TRT compared with placebo. Conclusions Six months of TRT improved body composition in men with opioid-induced hypogonadism without significant changes in outcomes of pain perception, quality of life, or adrenal function.

scholarly journals Transdermal Testosterone Administration in Women with Acquired Immunodeficiency Syndrome Wasting: A Pilot Study1

1998 ◽  
Vol 83 (8) ◽  
pp. 2717-2725 ◽  
Author(s):  
Karen Miller ◽  
Colleen Corcoran ◽  
Catharina Armstrong ◽  
Kim Caramelli ◽  
Ellen Anderson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ideal Body Weight ◽  
Free Testosterone ◽  
Testosterone Levels ◽  
Wasting Syndrome ◽  
Acquired Immunodeficiency ◽  
Testosterone Administration ◽  
Ideal Body ◽  
Immunodeficiency Syndrome

abstract Although human immunodeficiency virus (HIV) disease is increasing rapidly among women, no prior studies have investigated gender-based therapeutic strategies for the treatment of acquired immunodeficiency syndrome (AIDS) and its complications in this population. Markedly decreased serum androgen levels have been demonstrated in women with AIDS and may be a contributing factor to the wasting syndrome in this population. To assess the effects of androgen replacement therapy in women with AIDS wasting, we conducted a randomized, placebo-controlled, pilot study of transdermal testosterone administration. The primary aim of the study was to determine efficacy in terms of the change in serum testosterone levels, safety parameters and tolerability. A secondary aim of the study was to investigate testosterone effects on weight, body composition, quality of life, and functional indexes. Fifty-three ambulatory women with the AIDS wasting syndrome defined as weight less than 90% of ideal body weight or weight loss of more than 10% of the preillness maximum, free of new opportunistic infection within 6 weeks of study initiation, and with screening serum levels of free testosterone less than the mean of the normal reference range (&lt;3 pg/mL) were enrolled in the study. Subjects were age 37 ± 1 yr old (mean ± sem), weighed 92 ± 2% of ideal body weight, and had lost 17 ± 1% of their maximum weight. CD4 count was 324 ± 36 cells/mm3, and viral burden was 102,382 ± 28,580 copies. Subjects were randomized into three treatment groups, in which two placebo patches (PP), one active/one placebo patch (AP group), or two active patches (AA group) were applied twice weekly to the abdomen for 12 weeks. The expected nominal delivery rates of testosterone were 150 and 300 μg/day, respectively, for the AP and AA groups. Forty-five subjects completed the study (PP group, n = 13; AP group, n = 14; AA group, n = 18). Two additional subjects from the PP group and two from the AP group were included in the intent to treat analysis. Serum free testosterone levels increased significantly from 1.2 ± 0.2 to 5.9 ± 0.8 pg/mL (AP) and from 1.9 ± 0.4 to 12.4 ± 1.6 pg/mL (AA) in response to testosterone administration (P &lt; 0.0001 for comparison of AA vs. PP and AP vs. PP; normal range, 1.3–6.8 pg/mL). Testosterone administration was generally well tolerated locally and systemically, with no adverse trends in hirsutism scores, lipid profiles, or liver function tests. Weight increased significantly in the AP group (1.9 ± 0.7 kg) vs. the PP group (0.6 ± 0.8 kg; P = 0.043), but did not increase significantly in the AA group (0.9 ± 0.4 kg; P = 0.263 vs. PP, by mixed effects model assessing the interaction of time and treatment on all available data, one-tailed test). Improved social functioning (P = 0.024, by one-tailed test) and a trend toward improved pain score (P = 0.059) were observed in the AP vs. the PP-treated patients (RAND 36-Item Health Survey questionnaire). Five of six previously amenorrheic patients in the AP group had spontaneous resumption of menses compared to only one of four amenorrheic patients in the AA group (P = 0.045 for comparison of actual number of periods during the study). This study is the first investigation of testosterone administration in women with AIDS wasting. We demonstrate a novel method to augment testosterone levels in such patients that is safe and well tolerated during short term administration. At the lower of the two doses administered in this study, testosterone therapy was associated with positive trends in weight gain and quality of life. Higher, more supraphysiological, dosing was not associated with positive trends in weight or overall well-being. These data suggest that testosterone administration may improve the status of women with AIDS wasting. Further studies are needed to assess the effects of testosterone on weight in HIV-infected women and to define the optimal therapeutic window for testosterone administration in this population.

scholarly journals Effect of Roux-en-Y Gastric Bypass Surgery on the Sex Steroids and Quality of Life in Obese Men

2009 ◽  
Vol 94 (4) ◽  
pp. 1329-1332 ◽  
Author(s):  
Ahmad Hammoud ◽  
Mark Gibson ◽  
Steven C. Hunt ◽  
Ted D. Adams ◽  
Douglass T. Carrell ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Gastric Bypass ◽  
Bypass Surgery ◽  
Gastric Bypass Surgery ◽  
Free Testosterone ◽  
Reproductive Hormones ◽  
Total Testosterone ◽  
Sexual Quality Of Life ◽  
The Impact

Abstract Context: The effect of bariatric surgery on the reproductive function of obese men is not entirely elucidated. Objective: The aim of the study was to define the effect of Roux-En-Y gastric bypass surgery on the reproductive hormones and sexual function in obese men. Design and Setting: The cohort was followed for 2 yr at a clinical research center. Patients: Sixty-four severely obese men (22 who had gastric bypass surgery and 42 controls) participated in the study. Intervention(s): Anthropometrics [weight, body mass index (BMI), and percentage body fat] and reproductive hormones were measured. The sexual quality of life was assessed using the Impact of Weight on the Quality Of Life-Lite questionnaire. Main Outcome Measure(s): Reproductive hormones and sexual quality of life were measured. Results: The mean age was 48.9 ± 1.2 yr. At baseline, mean weight was 333.0 ± 7.1 lb, BMI was 46.2 ± 0.9 kg/m2, and total testosterone was 339.9 ± 21.32 ng/dl. BMI correlated positively with estradiol and negatively with total and free testosterone. Indices of dissatisfaction with sexual quality of life correlated positively with measures of obesity. Difficult sexual performance and low sexual desire correlated negatively with free and total testosterone (r = −0.273, P = 0.038; and r = −0.267, P = 0.042, respectively). After 2 yr, the gastric bypass surgery group had a significant decrease in BMI (−16.6 ± 1.2 vs. −0.46 ± 0.51 kg/m2) and estradiol (−8.1 ± 2.4 vs. 1.6 ± 1.4 pg/ml) and had an increase in total testosterone (310.8 ± 47.6 vs. 14.2 ± 15.3 ng/dl) and free testosterone (45.2 ± 5.1 vs. −0.4 ± 3.0 pg/ml). Sexual quality of life was improved after gastric bypass surgery. Conclusion: Hormonal alterations and diminished sexual quality of life among obese men are related to degree of obesity, and both are improved after gastric bypass surgery.

Free Testosterone Level And Quality of Cauda Epididymis Sperm of Local Rabbit That Given Commercial Feed Supplemented By Cod Fish Liver Oil

2016 ◽  
Vol 2 (3) ◽  
pp. 1
Author(s):  
Ni Gusti Ayu Manik Ermayanti ◽  
I Gusti Lanang Oka ◽  
I Gede Mahardika ◽  
I Putu Suyadnya
Keyword(s):  
Testosterone Level ◽  
Sperm Quality ◽  
Free Testosterone ◽  
Fish Liver ◽  
Testosterone Levels ◽  
Commercial Feed ◽  
One Way Anova ◽  
Free Testosterone Level ◽  
Range Test

This study was intended to determine the free testosterone levels and sperm quality of local rabbit that was given commercial feed supplemented cod fish liver oil.  The experiment design that was used in this research was Complete Random Design (CRD) with four experiments of feed, i.e. commercial feed without cod fish liver oil (R-0) as control, commercial feed + 1,5% cod fish liver oil (R-1), commercial feed + cod fish liver oil 3% (R-2), commercial feed + cod fish liver oil 4,5% (R-3). The each experiment included eight rabbits and feed experiment was given starting by 13 weeks to 26 weeks years old. The variable that observed was free testosterone level and sperm quality of local rabbit. The data that was obtained to be analyzed with One Way Anova and if its contrast was done more test with Duncan’s Multiple Range Test (DMRT). The result of this research was to show that supplementation of cod fish liver oil in commercial feed was to show the result that a real distinction of (P<0, 05) towards free testosterone level and sperm quality of local rabbit.

scholarly journals Evaluation of the Use of Sterilized and Non-Sterilized Peruibe Black Mud in Patients with Knee Osteoarthritis

2021 ◽  
Vol 18 (4) ◽  
pp. 1666 ◽  
Author(s):  
Paulo Fávio Macedo Gouvêa ◽  
Zélia Maria Nogueira Britschka ◽  
Cristina de Oliveira Massoco Salles Gomes ◽  
Nicolle Gilda Teixeira de Queiroz ◽  
Pablo Antonio Vásquez Salvador ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Knee Osteoarthritis ◽  
Short Form ◽  
Serum Levels ◽  
Double Blind ◽  
Sf 36 ◽  
Radiographic Grade ◽  
Physical Functions ◽  
Kellgren And Lawrence

This study aimed to evaluate the effects of treatment with Peruíbe Black Mud (PBM) on the clinical parameters and quality of life of patients with knee osteoarthritis and to compare the effects of PBM samples simply matured in seawater and PBM sterilized by gamma radiation. A controlled, double-blind trial was conducted with 41 patients divided into two treatment groups composed of 20 and 21 patients: one group was treated with matured PBM and the other with sterilized PBM. Evaluations were done using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Medical Outcomes Study Short Form 36 (SF-36) questionnaires, the Kellgren and Lawrence (KL) radiographic scale, and the quantification of the serum levels of inflammatory biomarkers. An improvement in pain, physical functions, and quality of life was observed in all of the patients who underwent treatment with both simply matured and sterilized PBM. Nine patients showed remission in the KL radiographic scale, but no statistically significant differences were observed in the serum levels of inflammatory mediators before or after treatment. Peruíbe Black Mud proves to be a useful tool as an adjuvant treatment for knee osteoarthritis (OA), as shown by the results of the WOMAC and SF-36 questionnaires and by the remission of the radiographic grade of some patients on the Kellgren and Lawrence scale.

scholarly journals Adjunctive Garcinia mangostana Linn. (Mangosteen) Pericarp for Schizophrenia: A 24-Week Double-blind, Randomized, Placebo Controlled Efficacy Trial: Péricarpe d’appoint Garcinia mangostana Linn (mangoustan) pour la schizophrénie : un essai d’efficacité de 24 semaines, à double insu, randomisé et contrôlé par placebo

2020 ◽  
pp. 070674372098243
Author(s):  
Alyna Turner ◽  
Andrea Baker ◽  
Olivia M. Dean ◽  
Adam J. Walker ◽  
Seetal Dodd ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Schizoaffective Disorder ◽  
Negative Symptoms ◽  
Controlled Trial ◽  
Safety Data ◽  
Rate Of Change ◽  
Adjunctive Treatment ◽  
Garcinia Mangostana ◽  
Double Blind

Objectives: Garcinia mangostana Linn. (“mangosteen”) pericarp contains bioactive compounds that may target biological pathways implicated in schizophrenia. We conducted a double-blind randomized placebo-controlled trial evaluating the efficacy of adjunctive mangosteen pericarp, compared to placebo, in the treatment of schizophrenia. Methods: People diagnosed with schizophrenia or schizoaffective disorder ( Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition), recruited across 2 sites (Brisbane and Victoria, Australia), were randomized to receive 24 weeks of adjunctive mangosteen pericarp (1,000 mg/day) or matched placebo. The primary outcome measure was the Positive and Negative Symptom Scale total score. Secondary outcomes included positive and negative symptoms, general psychopathology, clinical global severity and improvement, participant reported overall improvement, depressive symptoms, functioning, quality of life, and safety data at 24 and 28 weeks (4 weeks postdiscontinuation). Data were collected from July 2016 to February 2019. Results: Baseline assessments were conducted on 148 people (mangosteen = 74, placebo = 74); data analyses were conducted on 136 (92%) participants with postbaseline data. The treatment group had significantly higher symptom severity compared to placebo, and both groups significantly improved on all symptom, functioning, and quality of life measures over time. No between-group differences were found for the rate of change between baseline and 24 or 28 weeks. Conclusion: Despite promising preclinical and clinical work, our results do not support mangosteen pericarp extract as an adjunctive treatment for schizophrenia or schizoaffective disorder.

scholarly journals Amelioration of mild and moderate depression through Pranic Healing as adjuvant therapy: randomised double-blind controlled trial

2017 ◽  
Vol 26 (1) ◽  
pp. 82-87 ◽  
Author(s):  
R Rajagopal ◽  
Srikanth N Jois ◽  
Sumanth Mallikarjuna Majgi ◽  
MN Anil Kumar ◽  
HB Shashidhar
Keyword(s):  
Quality Of Life ◽  
Adjuvant Therapy ◽  
Mental Disorder ◽  
Controlled Trial ◽  
Antidepressant Drug ◽  
Double Blind ◽  
Average Decrease ◽  
Moderate Depression ◽  
Post Assessment

Objectives: Depression is a mental disorder, affecting the quality of life. Our study explores the efficacy of Pranic Healing (PH), as an adjuvant therapy in treating depression Methods: In this randomised double-blind controlled trial, 52 participants with a mean age of 34.4 years, with mild to moderate depression were assessed using the Hamilton Depression Rating (HAM-D) scale during the 5-week study. Both Medication + PH (MedPH) and Medication + Mock PH (MedMockPH) groups comprising 26 members received Pranic and mock healing lasting 20 minutes per session respectively once a week for 4 weeks, along with the antidepressant drug. Results: The average decrease in HAM-D score in MedPH was median 11 (Interquartile Range (IQR) 7–12) and was significantly higher compared with the MedMockPH group median 6.5 (IQR 3–9). At pre-assessment, both groups had 8 cases of mild and 18 cases of moderate depression. At post-assessment, HAM-D showed that the improvement in depression category was seen in 69.2% of participants in the MedMockPH group and 100% in MedPH group. Conclusions: These results give first the evidence that PH can aid as an adjuvant therapy for depressed people.

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