Aging Males' Symptoms Scores Research Articles

Type 1 diabetes mellitus and sperm quality: A case-control study.

The potential impact of diabetes mellitus type 1 (DM1) on male fertility is currently poorly defined. Hyperglycaemia and insulin deficiency may affect spermatogenesis. Some evidence suggests that men with DM1 have a significant reduction in progressive sperm motility, sperm morphology and semen volume, without significant changes in sperm concentration and count, but definite data are lacking. To evaluate the impact of DM1 on clinical parameters related to male fertility and semen analysis. We compared a court of 42 male DM1 patients with 43 nondiabetic subjects overlapping in age and remaining clinical data in an observational case-control study. All subjects underwent a comprehensive andrological reproductive evaluation, including medical history, physical examination, and semen analysis. We collected biochemical data in all patients with DM1, while diabetic patients with any alteration in semen parameters underwent sperm culture and scrotal ultrasound. In addition, all men completed the IIEF-5 questionnaire (International Index of Erectile Function-5) and the AMS (Aging Male Symptom score) questionnaire. Patients with DM1 had a higher prevalence of infertility, erectile dysfunction and worse semen parameters compared with controls. In particular, semen volume, total sperm count, and total and progressive sperm motility were significantly lower (p<0.001, p=0.003, p=0.048, and p=0.022 respectively). In addition, the rate of semen anti-sperm antibody positivity, the AMS score and FSH levels were higher. Several mechanisms may contribute to these semen alterations in DM1 patients, such as oxidative damage to spermatogenesis, seminal infections and pelvic neurological changes. These data suggest that patients with DM1 should be counselled from an andrological-reproductive point of view.

Association of salivary testosterone levels during the post-awakening period with age and symptoms suggestive of late-onset hypogonadism in men

Background The lack of association between serum testosterone levels and symptoms suggestive of hypogonadism is a significant barrier in the determination of late-onset hypogonadism (LOH) in men. This study explored whether testosterone levels increase after morning awakening, likewise the cortisol awakening response (CAR) in the hypothalamic–pituitary–adrenal (HPA) axis, and whether testosterone levels during the post-awakening period are associated with age and symptoms suggestive of late-onset hypogonadism (LOH) in men. Methods Testosterone and cortisol levels were determined in saliva samples collected immediately upon awakening and 30 and 60 min after awakening, and scores of the Aging Males’ Symptoms (AMS) questionnaire were obtained from 225 healthy adult men. Results A typical CAR (an increase in cortisol level ≥ 2.5 nmol/L above individual baseline) was observed in 155 participants (the subgroup exhibiting typical CAR). In the subgroup exhibiting CAR, testosterone levels sharply increased during the post-awakening period, showing a significant negative correlation with age, total AMS score, and the scores of 11 items on the somatic, psychological, and sexual AMS subscales. Of these items, three sexual items (AMS items #15–17) were correlated with age. Meanwhile, there was no notable increase in testosterone levels and no significant correlation of testosterone levels with age and AMS score in the subgroup exhibiting no typical CAR (n = 70). Conclusions The results indicate that the hypothalamus-pituitary-gonad (HPG) axis responds to morning awakening, and determining testosterone levels during the post-awakening period in men with typical CAR may be useful for assessing HPG axis function and LOH.

TRACK_9: Testosterone replacement assessment: Classical vs. functional hypogonadism-knowledge from a 9-year study.

The longitudinal efficacy and clinical utility of Testosterone Therapy (TTh) in ameliorating functional hypogonadism (FH) remain contentious, with long-term data being scarce. To address this lacuna, a comprehensive long-term registry study, stratifying patients across a spectrum of hypogonadal etiologies, offers a robust investigative paradigm. This 9-year registry, encompassing 650 patients (equivalent to 4,362 cumulative years of treatment), included 188 patients diagnosed with FH (mean age 42.3±11.3 years) and 462 individuals with classical hypogonadism (CH). The cohort segregated into 266 men with primary hypogonadism (PH, mean age 34.0±11.7 years) and 196 with secondary hypogonadism (SH, mean age 31.9±12.0 years). Uniform treatment across the cohort involved intramuscular administration of testosterone undecanoate (1,000mg). A comparative analysis was conducted focusing on anthropometric, metabolic, and safety parameters. Serum testosterone levels increased from 6.6±2.4 to 19.3±2.9nmol/L (p<0.001). TTh was linked with weight reduction and decreased waist circumference (WC) in both CH and FH cohorts (both p<0.001). Cox regression and Kaplan-Meier analyses delineated disparities: men with FH demonstrated a higher propensity for losing>10% body weight and>5% WC compared to CH (hazard ratio [HR] 1.3 [1.1-1.4], p=0.008 and HR 1.4 [1.3-1.5], p=0.001). Increases in hematocrit>50% were uniform across groups, albeit amelioration of anemia was more pronounced in FH versus CH (p=0.002). Increments of prostate-specific antigen (PSA) levels were more likely to occur in FH (HR 1.3 [1.1-1.6], p=0.003). FH patients exhibited pronounced improvements in metabolic parameters and in aging male symptom score (AMS) and IIEF-EF questionnaire scores. These effects were markedly modulated by age and initial weight. Subgroup analysis of age-matched obese patients revealed an accentuated impact of TTh in CH compared to FH. The therapeutic outcomes of TTh across distinct hypogonadal populations demonstrate heterogeneous responses, significantly influenced by diagnostic categorization, age, and baseline risk factor profiles.

Association between andropause symptoms and work functioning impairment: a cross-sectional study in two Japanese companies.

The study aimed to assess the relationship between andropause, or male menopause, and work functioning in aging Japanese male workers. A cross-sectional study was conducted on 561 male employees from two Japanese companies. We measured andropause symptoms using the Aging Male's Symptoms (AMS) scale, and work functioning impairment using the Work Functioning Impairment Scale (WFun). The data were analyzed using Poisson regression with robust variance to estimate the relationship between andropause severity and work functioning impairment. The findings indicated a significant association between severe symptoms of andropause and increased work functioning impairment among male workers. Higher AMS scores, reflecting more severe symptoms, correlated with greater work functioning impairment, particularly with regard to physical and psychological health issues, such as muscle weakness and depressive symptoms. This study highlights the need for workplace health programs that include middle-aged and older male workers to address and manage symptoms of andropause. Further, it emphasizes the importance of recognizing andropause as a significant health issue that can adversely affect work performance and productivity. Future studies should incorporate the measurement of testosterone to ensure the more accurate assessment of andropause and its impact on work functioning.

(523) Changes in Testosterone Levels in Patients with Erectile Function

Abstract Introduction Erectile dysfunction (ED) is a disease that affects approximately 20% of adult men. Androgen deficiency is one of the organic etiologies described for this sexual dysfunction. Objective To estimate the frequency of alterations in the sex hormone binding globuline (SHBG), total testosterone (TT), calculated free (FT) and bioavailable testosterone (BT) in Spanish men with a clinical diagnosis of erectile dysfunction in Madrid, Spain. Patients and methods Cross-sectional study. Men over 18 years of age with a clinical diagnosis of erectile dysfunction and a score in the international index of erectile function (IIEF-EF) &amp;lt; 26 were included. Serum levels of SHBG, TT, TL and TB were evaluated and the proportion of men was estimated. with hormonal alterations defined as: a) serum levels &amp;lt;2.49 ng/mL of TT in men under 50 years and &amp;lt;1.93 ng/mL in men of 50 years or older; b) TL for calculated value &amp;lt;2% of total testosterone; c) TB for calculated value &amp;lt;40% of total testosterone; d) serum SHBG levels &amp;gt;54.1 nmol/L in men younger than 50 years and &amp;gt;76.7 nmol/L in men 50 years and older. Results 30 subjects participated in the study. The mean age was 50.6 years (+/− 13.2), the median scores for IIEF-EF, Erection Hardness Score (EHS) and Aging Male Symptoms Score (AMS) were 15 (range 1-24), 2 (range 1-3) and 29.5 (range 11-62) respectively. 6 patients (20%) had severe erectile dysfunction, 13 (43.3%) moderate, 8 (26.7%) mild to moderate, and 3 (10%) mild erectile dysfunction. The mean TT was 4.94 ng/mL (+/− 1.91), FT 1.94% (+/− 0.605), BT 45.6% (+/− 14.2), and SHBG 33.3 nmol/L ( +/− 14.5). Only 6.7% of the patients (n=2) presented alterations of the TT, while in 60% (n=18) an alteration of the FT was found, in 36.7% (n=11) an alteration of the BT and in 3.3% (n=1) SHBG alterations, alterations being more frequent in men with moderate ED. Conclusions Our study found alterations in total testosterone in a small percentage of patients with ED, however the alterations in Free Testosterone calculated turned out to be much higher. This study suggests that future research should be carried out to identify a relationship between changes in calculated free testosterone levels and the presence of erectile dysfunction. Disclosure No

Efficacy of testosterone replacement treatment for patients with symptoms of late-onset hypogonadism based on real-world patient satisfaction.

Late-onset hypogonadism is generally treated with testosterone replacement treatment. However, the efficacy rate of treatment for patients with low testosterone is not clear because patients without low testosterone are also treated in real-world clinical settings. This study comprised 110 men with low testosterone concentration of <3.0 ng/mL who underwent testosterone replacement treatment. Physical factors, laboratory and endocrinologic profiles, and scores of several questionnaires were assessed. Testosterone replacement treatment was performed with intramuscular injection of 250 mg of testosterone esters every 2-4 weeks, and efficacy was judged by patient satisfaction. After confirming efficacy, changes in several factors by the treatment were evaluated. Finally, the comparison between evaluation by patient satisfaction and by that with the questionnaires was assessed. Among the 110 patients, 77 (70.0%) were satisfied with the treatment, which was effective in 65.7%, 71.4%, and 73.1% of patients with mental, physical, and sexual dysfunction, respectively. The questionnaire scores including the Aging Males Symptoms rating scale were significantly improved in both the satisfaction and non-satisfaction group. However, no significant differences in the amount of change in questionnaire scores were found for all questionnaire scores improved by testosterone replacement treatment between the groups. Patient satisfaction was not associated with improvement of the Aging Males Symptoms score. Although testosterone replacement treatment was effective for 70.0% of the hypogonadal patients, patient satisfaction did not correlate with improvement of questionnaire scores. We concluded that not only questionnaire results but also patient satisfaction is important when evaluating efficacy in patients undergoing testosterone replacement treatment.

Outcomes of treatment for LOH syndrome assessed by free testosterone

ABSTRACT Objective Late-onset hypogonadism (LOH) is defined by reduced serum testosterone levels, and androgen replacement therapy (ART) is widely used. While serum total testosterone (TT) is used as an indicator for diagnosis and treatment for LOH in the United States and Europe, serum free testosterone (FT) is used in Japan. Patients with low FT levels (less than 8.5 pg/mL) are to be indicated for ART as LOH, and patients with moderate FT levels (between 8.5 pg/mL and 11.8 pg/mL) are also to be considered for ART as LOH borderline. In this study, we examined the outcomes of LOH and LOH borderline patients who were treated by ART. Methods We examined Aging Male Symptom (AMS) scale scores of LOH (n=76) and LOH borderline patients (n=16) who were treated with ART for at least 6 months at our hospital. Results In LOH patients, AMS score decreased from 52.1±12.3 to 41.5±12.2 (p&amp;lt;0.05). On the other hand, in borderline cases AMS score also decreased from 55.8±10.2 to 36.5±8.45 (p&amp;lt;0.05). There was no significant difference between two groups. Conclusion ART improves AMS score both in LOH and LOH borderline patients, but there were no significant differences between two groups in this study. Disclosure Work supported by industry: no.

Efficacy evaluation of Chinese herbal medicine, VGH-BPH1, for patients with benign prostatic hyperplasia: A randomized, double-blind, placebo-controlled, and crossover study.

Benign prostatic hyperplasia (BPH) can affect quality of life and cause various complications. Previous studies have suggested that Chinese herbal medicine can alleviate symptoms in patients with BPH. This study aimed to investigate whether the Chinese herbal medicine prescription VGH-BPH1 can alleviate BPH symptoms when used as an add-on treatment. In this crossover, randomized, double-blind, placebo-controlled trial, patients with BPH were randomly segregated into two groups: group A received VGH-BPH1, and group B received a placebo for 8 weeks. Subsequently, after a 2-week wash-out period, the two groups were switched to the opposite treatment for another 8 weeks. The International Prostate Symptoms Score and Aging Male Symptoms Score were adopted as the primary outcomes to assess improvement in BPH and patient quality of life. The secondary outcomes were the International Index of Erectile Function, Constitution Chinese Medicine Questionnaire, uroflowmetry results, and postvoid residual urine volume. VGH-BPH1 treatment significantly decreased the International Prostate Symptoms Score total score (p = 0.027); however, no significant difference was observed between the treatment and placebo groups. The Aging Male Symptoms Score "joint pain and muscular ache" score in the VGH-BPH1 group was significantly lower than that of the placebo group (p = 0.022). The "physical exhaustion" score also exhibited a decreasing trend when both groups were compared (p = 0.057). Although VGH-BPH1 treatment did not outperform the placebo in terms of improving BPH symptoms, it resulted in improvement in several quality of life indicators when relative to the placebo. Future research using a larger sample size with appropriate amendments to the protocol should be conducted to further investigate the effects of VGH-BPH1.

Novel testosterone gel improves aging males' symptoms in patients with late-onset hypogonadism: Active control equivalence, randomized, double-blind, crossover pilot study

ABSTRACT Introduction The standard treatment for late-onset hypogonadism (LOH) is testosterone replacement therapy (TRT). In Japan, testosterone enanthate intramuscular injection is recommended for LOH. But it needs regular clinic visits every 2-3 week, and it elicit pain. The 2% testosterone gel (AndroForte2®) is available for treatment LOH. Because of imported drug, AndroForte2® (AF2) is expensive. We have created a 2 % novel testosterone gel (NTG). Objective We hypothesized that our NTG improves Aging males' symptoms (AMS) scores, and serum testosterone in patients with LOH. Methods In this active control equivalence, randomized, double-blind, crossover study, it enrolled that were men with low serum free-testosterone (defined as below 11.8pg/mL), and symptoms of androgen deficiency (defined as AMS scores more than 27). The patients were randomly divided into two groups (A group, men receiving the NTG first; and B group, men receiving the AF2 first). Men with LOH received 2% AF2 for 28 days or 2% NTG for another 28 days separated by a 14-day washout period. The AMS score and serum hormonal data, and adverse events were assessed. Results Twenty-three patients aged 42–71 years old were enrolled in and concluded the study with no adverse events experienced. Serum testosterone and free-testosterone concentrations were significantly higher with NTG and AF2. And more, both concentrations were significantly higher in NTG than AF2. The AMS total score, physical subscore, mental subscore, and sexual subscore were significantly improved with NTG, but not significant with AF2. Conclusions This is the first study to show that our NTG may not be effective for improvement serum testosterone level but also for physical, mental, and sexual symptoms in patient with LOH. Disclosure Work supported by industry: no.

Age, testosterone levels, and hypogonadism-related symptoms among men with azoospermia

ABSTRACT Introduction Considering that most men who complain of infertility are of an age traditionally defined by social and physical activity, disability in performing these activities may worsen their quality of life. Among those who complain of infertility, it is suspected that some of them have hypogonadism or symptoms intrinsic to aging; however, these associations have not been completely elucidated in current literature. Objective This study aimed to assess the prevalence of aging- or hypogonadism-related symptoms among men with azoospermia. We also assessed relationships between serum testosterone levels and severity of symptoms under the domains of the Aging Males' Symptoms (AMS) -scoring system. Methods Clinical records of 494 patients with azoospermia (106 from obstructive and 388 from nonobstructive etiologies) who underwent surgical sperm extraction at Nagoya City University were retrospectively reviewed. Correlations between age and serum total testosterone (TT) and AMS scores (total and by each of three domains) were evaluated using the Spearman's rank correlation coefficient. Results Moderate or severe (total AMS score of≥ 37) symptoms were present in 9.5% and 12.7% of patients with obstructive and nonobstructive azoospermia, respectively. Symptoms were present regardless of etiology of azoospermia. Among our study population, no significant correlation between age and TT was observed (R=-0.057, p=0.21). However, there was positive correlation between age and total (R=0.090, p&amp;lt;0.05) or sexual (R=0.218, p&amp;lt;0.01) scores among the AMS scale's domains. Moreover, there were negative correlations between serum TT level and total (R=-0.177, p&amp;lt;0.01), psychological (R=-0.149, p&amp;lt;0.01), somatic (R=-0.183, p&amp;lt;0.01), and sexual (R=-0.097, p&amp;lt;0.05) domain scores. Multiple comparisons using Bonferroni-Holm's correction showed statistically significant correlations between aging and sexual symptoms and between hypogonadism (decreased serum TT) and psychological or somatic domains in the AMS-scoring scale. Conclusions This study revealed that men with azoospermia have not only underlying deterioration in sexual symptoms with aging, but that psychological and somatic symptoms also deteriorate as a function of hypogonadism. Our results indicate that assessment, treatment, and supportive management of underlying hypogonadism-related symptoms should be considered for patients with azoospermia who are currently undergoing infertility treatment. Disclosure Work supported by industry: no.

Late-Onset Hypogonadism in a Male Patient with Long COVID Diagnosed by Exclusion of ME/CFS

After the acute phase of COVID-19, some patients have been reported to have persistent symptoms including general fatigue. We have established a COVID-19 aftercare clinic (CAC) to provide care for an increasing number of these patients. Here, we report the case of a 36-year-old man who developed post-COVID fatigue after acute infection with SARS-CoV-2. In the acute phase of COVID-19, the patient’s fever resolved within four days; however, general fatigue persisted for three months, and he visited our CAC 99 days after the initial infection. Examination revealed a high Aging Male’s Symptoms (AMS) score of 44 and low free testosterone (FT) level of 5.5 pg/mL, which meet the Japanese criteria of late-onset hypogonadism (LOH) syndrome. Imaging studies revealed an atrophic pituitary in addition to fatty liver and low bone mineral density. Anterior pituitary function tests showed a low follicle-stimulating hormonelevel and delayed reaction of luteinizing hormone (LH) after gonadotropin-releasing hormone (GnRH) stimulation, indicating the possibility of hypothalamic hypogonadism in addition to primary hypogonadism seen in patients with post-COVID-19 conditions. After the initiation of Japanese traditional medicine (Kampo medicine: hochuekkito followed by juzentaihoto), the patient’s symptoms as well as his AMS score and serum FT level were noticeably improved. Furthermore, follow-up tests of GnRH stimulation revealed improvements in LH responsiveness. Although many patients have been reported to meet the criteria of ME/CFS such as our case, we emphasize the possibility of other underlying pathologies including LOH syndrome. In conclusion, LOH syndrome should be considered a cause of general fatigue in patients with post-COVID-19 conditions and herbal treatment might be effective for long COVID symptoms due to LOH (264 words).

A proprietary blend of standardized Punica granatum fruit rind and Theobroma cocoa seed extracts mitigates aging males' symptoms: A randomized, double-blind, placebo-controlled study.

Objective: We evaluated the safety and efficacy of a novel combination of Punica granatum fruit rind and Theobroma cocoa seed extracts (LN18178 or Tesnor®) in enhancing serum testosterone level and reducing aging males' symptoms (AMS) in a randomized, double-blind, placebo-controlled investigation (CTRI Reg. No. CTRI/2019/02/017506).Methods: One hundred twenty healthy male participants (age 36-55 years) were randomized (n=40) to placebo, 200 or 400 mg of LN18178 for a period of fifty-six consecutive days of supplementation. The primary efficacy parameter was the AMS score. The secondary parameters were serum testosterone (free and total) levels, hand-grip strength, and perceived stress scale (PSS-10) score. Measurement of other hormones included in the study was serum dihydrotestosterone (DHT), cortisol, and 17β-estradiol (E2). Total blood chemistry parameters, vital signs, and urinalysis were parts of the safety assessment.Results: Both doses of LN18178 significantly reduced the mean AMS scores after 56 days of supplementation. Furthermore, it significantly improved general, psychological, and sexual well-being. Serum levels of free testosterone and total testosterone levels were significantly increased in LN18178 supplemented (200 and 400 mg) participants compared to the baseline and placebo. Significant improvements in hand-grip strength and reduced PSS-10 scores were also observed.Conclusion: LN18178 supplementation reduced AMS scores and improved sexual performance. Also, LN18178 groups exhibited superior muscular strength and reduction in perceived stress. Total blood chemistry and urine analysis demonstrated the broad-spectrum safety.

A simple questionnaire for the detection of testosterone deficiency in men with late-onset hypogonadism.

The Aging Males' Symptoms (AMS) score, developed to screen for late-onset hypogonadism (LOH), contains 17 questions regarding mental, physical, and sexual parameters. In the Japanese guidelines, a free testosterone (FT) <8.5 pg/mL is recommended for testosterone treatment. However, previous studies have shown no correlation between total AMS scores and testosterone concentration. We aimed to develop a better questionnaire for the detection of testosterone deficiency in men, for the diagnosis of LOH. In 234 Japanese men, aged 40-64 years, we analyzed the relationships of AMS with serum total testosterone (TT), FT, calculated FT (cFT), and calculated bioavailable testosterone (cBT), and identified useful questions for the detection of testosterone deficiency. Four scores, a decrease in muscular strength, a decrease in ability to perform sexually or the frequency, a decrease in the number of morning erections, and a decrease in sexual desire/libido, were negatively associated with two or more of the above four testosterone parameters, and the sum of these four scores (named the selective score) correlated with TT and cFT, independent of age. Statistical analysis revealed an association between insulin resistance and testosterone deficiency, and a higher selective score in smokers than non-smokers. Cubic function model analysis and logistic regression analysis revealed that selective scores ≥10 corresponded with the testosterone concentrations recommended for the diagnosis of LOH, including FT <8.5 pg/mL, independent of age, insulin resistance, and smoking. Thus, the selective score represents a simple and useful means for screening of testosterone deficiency in Japanese men, as an indicator of LOH.

Change of preoperative symptoms of the late-onset hypogonadism syndrome after robot-assisted radical prostatectomy.

Background:As prostate cancer (PCa) is a common cancer among older men, patients with PCa often show aging male symptoms (AMSs). This study aimed to investigate the preoperative AMSs of the late-onset hypogonadism (LOH) syndrome and the effects on them after robot-assisted radical prostatectomy (RARP).Materials and methods:One hundred eighty-eight patients who underwent RARP without androgen deprivation therapy were measured for serum free and serum total testosterone, and were preoperatively assessed for symptoms of the LOH syndrome using a questionnaire containing an AMS score. Patients with a preoperative AMS score higher than 37 and a serum free testosterone level lower than 8.5 pg/mL were classified as Group A, with the remaining classified as Group B. AMS scores were measured at 1, 3, 6, 9, and 12 months after surgery.Results:Of the 188 patients, 49 and 139 patients were classified as Groups A and B, respectively. Preoperative AMS scores were 44.5 ± 8.2 in Group A and 28.6 ± 5.3 in Group B (p < 0.0001). AMS scores in Group A significantly improved 1 month after RARP (30.6 ± 8.4, p < 0.0001) compared with their preoperative scores and remained at the same level from 3 to 12 months postoperatively, whereas those in Group B became significantly worse (32.0 ± 7.8, p < 0.0001) than their preoperative ones. There were no differences between AMS scores in Groups A and B at every postoperative period (p = 0.3259, 0.2730, 0.2429, 0.4629, 0.1771 at 1, 3, 6, 9, and 12 months after surgery, respectively).Conclusions:Our results indicate that AMSs in PCa patients with the LOH syndrome can expect the same level of improvement as patients without it.

Clinical Characteristics of Low Androgen Status in Males with Type 2 Diabetes Mellitus.

To determine the clinical characteristics of low androgen status in adult males with diabetes, we retrospectively analyzed the medical records of patients with type 2 diabetes mellitus in whom serum free testosterone (FT) levels were examined for 1 year. Among the 46 patients (56 ± 1.5 years old), decreases in serum FT levels to < 8.5 pg/ml (indicating the occurrence of late-onset hypogonadism [LOH]) were detected in 18 (39%). The per-centages of patients with low FT levels were high in the ≥ 50 years age group (83%), the HbA1c < 7% group (67%), and the 25 ≤ BMI < 30 kg/m2 group (56%). The serum FT levels tended to decrease age-dependently. The level of HbA1c was significantly correlated with the Heinemann Aging Male Symptoms (AMS) score (R = 0.47). The low-FT group had decreased levels of hemoglobin. Of note, the serum FSH level (R = -0.32) was negatively correlated with the serum FT level, whereas the serum TSH level (R = 0.36) was positively correlated with the serum FT level. Collectively, these results revealed that many diabetic males may have low FT levels and that the AMS score is related to the HbA1c level. A slightly anemic condition, thyroid dysfunction, and obesity (class 1) might be involved in LOH in middle-aged diabetic males.

Serum sex hormone-binding globulin is associated with symptomatic late-onset hypogonadism in aging rural males: a community-based study.

A population-based cross-sectional study was conducted in Zhejiang rural communities. A total of 965 men (aged 40-80 years) were admitted to the aging males' symptoms (AMS) scale and related physical examinations including body mass index (BMI) and waist circumference were conducted. Serum total testosterone (TT), free testosterone (FT), sex hormone-binding globulin (SHBG) and serum lipid levels were measured separately. Serum level of bioavailable testosterone (Bio-T) was calculated. A total of 965 participants were divided into two groups, symptomatic late-onset hypogonadism (SLOH) group (n = 202) (AMS score ≥27) and control group (n = 763), according to total AMS score. Men in the SLOH group were older (61.57±9.06 vs 54.95±8.27 years) and had a smaller waist circumference (81.06±6.89 vs 82.54±6.60 cm) than those in the control group. Moreover, a relatively higher level of SHBG and lower levels of FT, Bio-T, triglyceride (TG) and total cholesterol (T-CHOL) were found in the SLOH group compared with that in the control group (P < 0.05). Receiver operating characteristic curves (ROC) analysis showed that age (AUC = 0.702, P < 0.001) and SHBG (AUC = 0.617, P < 0.001) were potential predictive indicators for SLOH diagnosis, with the best cut-off values of 59 years for age and 44.40 nmol/L for SHBG. SHBG might be a potential predictor in men with hypogonadism, whereas BMI had no proportionality to the measurement of AMS. Age and SHBG should be used for SLOH diagnosis.

A double blind, placebo-controlled randomized comparative study on the efficacy of phytosterol-enriched and conventional saw palmetto oil in mitigating benign prostate hyperplasia and androgen deficiency

BackgroundThe present clinical trial was conducted to evaluate the efficacy and tolerability of a standardized saw palmetto oil containing 3% β-sitosterol in the treatment of benign prostate hyperplasia (BPH) and androgen deficiency.MethodsSubjects aged 40–65 years with symptomatic BPH were randomized to 12-week double-blind treatment with 500 mg doses of β-sitosterol enriched saw palmetto oil, conventional saw palmetto oil and placebo orally in the form of capsules (n = 33 in each group). BPH severity was determined using the International Prostate Symptom Score (IPSS), uroflowmetry, serum measurement of prostate specific antigen (PSA), testosterone and 5α-reductase. During the trial, the androgen deficiency was evaluated using Aging Male Symptoms (AMS) scale, the Androgen Deficiency in the Aging Male (ADAM) questionnaire, serum levels of free testosterone.ResultsSubjects treated with β-sitosterol enriched saw palmetto oil showed significant decrease in IPSS, AMS and ADAM scores along with reduced postvoiding residual volume (p < 0.001), PSA (p < 0.01) and 5α-reductase from baseline to end of 12-week treatment as compared to placebo. There was also a significant increment in the maximum and average urine flow rate (p < 0.001), and serum free testosterone level of subjects treated with enriched saw palmetto oil as compared to placebo.ConclusionThis study demonstrates the efficacy of β-sitosterol enriched saw palmetto oil superior to conventional oil thus extending the scope of effective BPH and androgen deficiency treatment with improved quality of life through the intake of functional ingredients.Trial registrationCTRI/2018/12/016724 dated 19/12/2018 prospectively registered. URL: http://ctri.nic.in/Clinicaltrials/advsearch.php

The effects of a Chinese herbal medicine (VGHBPH0) on patients with benign prostatic hyperplasia: A pilot study.

Background:The current Western medicine treatment options for benign prostatic hyperplasia (BPH) have various degrees of documented effectiveness. However, the uses of these interventions are limited to specific patient populations or have certain side effects that interfere with patient quality of life. This study evaluated the clinical effects of a Chinese herbal medicine (CHM) on patients with BPH.Methods:This was a single-arm pilot study. Twenty BPH patients were enrolled, and they were required to take the investigated CHM three times a day for 8 weeks, along with their Western medicine. Patients returned to clinics as scheduled and completing international prostate symptoms scores (IPSS), aging male symptoms score, international index of erectile function, and body constitution questionnaire of traditional Chinese medicine. Uroflowmetry and sonography were also applied to evaluate the changes in urinary velocity and post-voiding residual urine volume from the baseline to the end of the study.Results:The mean IPSS total score was significantly decreased by 2.5 points after 8 weeks of treatment with the CHM (from 17.5 to 15.0, p = 0.03). The mean IPSS voiding subscore was decreased by 1.7 points (from 10.1 to 8.4, p = 0.02), and the mean incomplete emptying subscore was decreased by 0.8 points (from 2.9 to 2.1, p = 0.02), with both decreases being statistically significant. A descending trend in the post-voiding residual urine volume was also observed (from 52.9 to 30.8 mL, p = 0.07).Conclusion:This trial indicated that the add-on CHM treatment (VGHBPH0) might be a potential treatment for improving the lower urinary tract symptoms of BPH patients.

SAT-051 Effects of Testosterone Replacement on Glycemic Control and Other Cardiovascular Risk Factors in Hypogonadal Men with Uncontrolled Type 2 Diabetes (Stride Study): Design, Implementation and Baseline Data

Up to 40% of men with type II diabetes are testosterone deficient. There is growing evidence that testosterone therapy has a beneficial effect on glycemic control, insulin resistance and may have a cardioprotective effect, contrary to the traditional view that testosterone is detrimental to the heart. Our study aims to evaluate the effect of testosterone therapy on glycaemic control other cardiovascular risk factors, symptomatic benefit and quality of life in a randomised double-blind placebo controlled add-on of testosterone therapy to their normal hypoglycemic medication in hypogonadal men with uncontrolled type 2 diabetes. The study population includes 65 eligible men (140 screened) with poorly controlled diabetes (HbA1c between 53 and 80 mmol/mol) and confirmed hypogonadism by early morning [0800−1200h] total testosterone [TT] ≤12 nmol/L or calculated free testosterone ≤255 pmol/L on two occasions ≥1 week apart, with at least two symptoms of hypogonadism. The trial is divided into 2 phases. Phase 1: patients are randomly assigned to either treatment (depot testosterone undecanoate) arm or the placebo arm for 6 months. Phase 2: open label phase for 6 months with subjects on placebo on placebo initiated on to testosterone therapy while subjects in the treatment group continue to receive treatment for the 12 month duration. No change to anti- glycaemic therapy was made during the first phase of the study. The primary endpoint is HbA1c. Secondary endpoints include body composition (bioelectrical impedence DEXA scan), HOMA-IR, lipid profile, blood pressure (24 hr BP monitor), carotid media intima thickness, monocyte mRNA cytokine expression, Questionnaires include AMS (Aging Male Symptom Score), IIEF-5(International Index of Erectile Dysfunction), SF36-Quality of life, Mini mental score, New questionnaire for hypogonadism in diabetes (to be validated), NERI (New England Research Institute) hypogonadal screener. Baseline data indicate the mean age 59 (42-77) years. Mean Duration of diabetes was 8.6(0-21) years. 18 men were on Insulin. The remaining 47 men were either diet controlled or on oral hypoglycaemic medications. 9 men had pre-existing history of MI and 4 had history of angina. Mean HbA1c at baseline was 65(53-80) mmol/mol. Mean total testosterone level was 8.9(2.1-16.9) nmol/l. Mean weight and BMI at baseline were 107(71-187) kg and 34.5(24-52) respectively. Mean waist circumference was 115.7(46-160) cm The primary aim of this is to determine if testosterone therapy improves glycemic control in men with uncontrolled diabetes. Secondly to assess beneficial effects on specific cardiovascular parameters as well as QOL. This could have a major clinical implication on how we treat patients with hypogonadism and type 2 diabetes.

MP45-06 SHOULD WE TREAT TESTOSTERONE DEFICIENCY IN PATIENTS WHO DO NOT HAVE SYMPTOMS?

INTRODUCTION AND OBJECTIVE: Testosterone replacement therapy (TRT) is effective for treating the symptoms and ameliorating the metabolic consequences of hypogonadism. TRT improves muscle mass, bone mineral density, mood, and sexual performance. However, a significant number of patients have low serum levels of testosterone without any subjective symptoms or complaints. We evaluated the suitability of TRT for patients with non-symptomatic late-onset hypogonadism. METHODS: Seventy patients whose initial serum levels of testosterone were < 300 ng/dL without any symptoms or complaints were consecutively enrolled and followed for 30 weeks. All patients received 1,000 mg parenteral testosterone undecanoate on day 1, followed by additional injections on weeks 6, 18, and 30. Serological tests (for total testosterone, lipid profile, glucose, and prostate-specific antigen [PSA]) were performed and Body Mass Index (BMI), International Index of Erectile Function (IIEF) score, International Prostate Symptom Score (IPSS), the Aging Males’ Symptoms (AMS) questionnaire, and the Global Assessment Questionnaire (GAQ) were performed at baseline and at the end of the study. RESULTS: Mean patient age was 56.2 ± 10.5 years. The total IIEF score increased from 44.9 ± 12.9 at baseline to 54.8 ± 13.0 on week 30 (p < 0.001). The AMS score improved from 37.9 ± 11.5 at baseline to 24.6 ± 13.2 on week 30 (p < 0.001). Baseline and 30-week total testosterone levels were 272.2 ± 48.2 and 598.2 ± 52.5 ng/dL, respectively (p < 0.0001). No significant changes were detected in the IPSS, lipid profiles, glucose, BMI, or PSA level. The percentage of patients reporting improvement in the GAQ was 58.6%. Improvements in the sexual desire domain of the IIEF, sexual subscale of the AMS, and change in total testosterone (>300 ng/dL) were significantly correlated with a positive GAQ response. The majority of adverse events were mild, reversible, and of short duration. CONCLUSIONS: Although a patient may not complain of any subjective symptoms at the initial visit, TRT can be considered in patients with low testosterone levels and decreased sexual desire and function. It is postulated that patients with low testosterone levels may not recognize their symptoms. Thus, more specific screening is needed for such patients. Source of Funding: None