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Objective: To observe the improvement of androgen deficiency syndrome after endocrine therapy by "Jianpi Lishi Huayu Method" for advanced prostate cancer and its clinical effect. Methods: A total of 60 patients with advanced prostate cancer were randomly divided into observation group (30 cases) and control group (30 cases). The control group was treated with intermittent endocrine therapy (androgen blocking). The treatment group was treated with "Jianpi Lishi Huayu Decoction" on the basis of the control group. The end point of the study was the time to develop castration-resistant prostate cancer. ISS scale scores, disease progression-free survival, PSA, serum testosterone, I-PSS and TCM clinical symptom scores were compared between the two groups. Results: The median progression-free survival time of the patients in the observation group was 23 months, and there was no significant difference between the two groups. After treatment, the total ISS score, physical symptoms score, vasomotor symptoms score and psychosocial symptoms score in the observation group were significantly lower than those before treatment, and lower than those in the control group (P < 0.05). After treatment, the effective rate of ISS score in the observation group (73.33%) was significantly higher than that in the control group (16.67%); The PSA level in both groups decreased significantly after treatment, and the PSA level in the observation group (2.13 ± 0.58) ng/mL was better than that in the control group (5.30 ± 1.40) ng/mL (P < 0.05); There was no significant difference in serum testosterone between the two groups after treatment. After treatment, the I-PSS score and TCM clinical symptom score of the observation group and the control group were improved, and the observation group was better than the control group (P < 0.05). After treatment, the effective rate of the I-PSS score of the observation group (96.67%) and the improvement rate of TCM clinical symptom score (76.67%) were better than those of the control group (73.33%, 26.67%). Conclusion: On one hand, "invigorating spleen, draining dampness and removing blood stasis" method combined with endocrine therapy can prolong the time for hormone-dependent prostate cancer to develop into castrated resistant prostate cancer, improve clinical efficacy, reduce the level of tumor markers, stabilize the level of testosterone, and improve some androgen deficiency syndrome after endocrine therapy, especially in ovariectomized resistant prostate cancer. It has obvious advantages in improving physical symptoms, vasomotor symptoms and psycho-psychological symptoms. It can obviously alleviate adverse reactions after endocrine therapy. On the other hand, it can better improve clinical symptoms, reduce I-PSS scores and TCM clinical symptoms scores, improve the quality of life of patients, and give full play to the role of reducing TCM toxicity and increasing synergism efficiency.
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OBJECTIVE: To investigate the efficacy of a transdermal nanoemulsion testosterone associated with transdermal estrogen therapy as a novel protocol treatment for emergent loss of libido. METHODS: Twenty-four women, aged 31-75 years (mean age, 51.7), with emergent loss of libido were allocated to treatment with a novel transdermal formulation of 500 µg/day of testosterone (Biolipid/B2®-testosterone) for 12 weeks, as part of an open label prospective study on peri- and post-menopausal women. Subjects applied the formulation on the right forearm. Clinical and laboratorial parameters including the sexual complaints; serum concentrations of testosterone, insulin, C-reactive protein, weight, blood pressure; body mass index and waist circumference were compared between baseline and 12 weeks after treatment. RESULTS: The mean total serum testosterone increased significantly (p = 0.009) after 12 weeks of treatment. No adverse or androgenic events were observed. There were positive and significant differences (p < 0.05) on sexual complaints, blood pressure, body mass index and waist circumference after transdermal nanoemulsion testosterone treatment. CONCLUSION: This protocol is effective in increasing testosterone levels in peri- and postmenopausal women with low libido.
OBJETIVO: Investigar a eficácia de uma nanoemulsão transdérmica de testosterona associada à terapia com estrogênio transdérmico como tratamento para a perda emergente da libido. MÉTODOS: Vinte e quatro mulheres, com idade entre 31-75 anos (idade média de 51,7), com perda emergente de libido foram incluídas num protocolo para tratamento de libido reduzida com uma formulação transdérmica de 500 µg/dia de testosterona (biolípido/B2®-testosterona) com 12 semanas de duração, como parte de um estudo prospectivo aberto em mulheres peri- e pós-menopausa. As participantes aplicaram a formulação no antebraço direito. Os parâmetros clínicos e laboratoriais, incluindo as queixas sexuais foram comparados entre os valores iniciais e 12 semanas após o tratamento. Mediram-se as concentrações séricas de testosterona, insulina, proteína C-reactiva, o peso, a pressão arterial; o índice de massa corporal e a circunferência da cintura. RESULTADOS: A média de testosterona total no soro aumentou significativamente (p = 0,009) após 12 semanas de tratamento. Não foram observados efeitos adversos ou androgênicos. Registraram-se reduções significativas (p < 0,05) sobre as queixas sexuais, da pressão arterial, do índice de massa corporal e da circunferência da cintura após o tratamento transdérmico com nanoemulsão de testosterona. CONCLUSÃO: O protocolo mostrou eficacia em aumentar os níveis de testosterona em e melhorar a libido em mulheres peri e pós-menopausa com baixa libido.
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Humans , Female , Testosterone/therapeutic use , Premenopause , Postmenopause , Nanotechnology/methods , Nanoparticles , Libido/drug effects , Administration, Cutaneous , Guidelines as TopicABSTRACT
Objective To observe the effect of electro-acupuncture on reproductive endocrine and renal contents of superoxide dismutase (SOD) and malondialdehyde (MDA) in aging male (PADAM) rats with partial androgen deficiency. Methods Forty male rats were randomly divided into normal control group (n = 10) and model group (n = 30). Rats in the model group were injected with cyclophosphamide 20 mg/(kg · d) into the abdominal cavities to establish PADAM model. The 24 successful model rats were further randomized into electro-acupuncture, androlin treatment and blank groups; rats received corresponding treatment for 8 weeks. The general conditions of the animals were observed before and 1 day after modeling and at the end of treatment. Tail suspension experiments and exhaustion swimming tests were performed; and the serum total testosterone (TT) and free testosterone (FT) levels were determined. The contents of SOD and MDA in renal tissues were examined at the end of the experiments by hydroxylamine method. Results After treatment with cyclophosphamide, the serum levels of TT and FT in rats were significantly decreased (P0.05). Conclusion Electro-acupuncture can increase serum TT and FT levels in PADAM rats, improve the depression state, myodynamia and energy in the aging rats, with its effect being equivalent to that of testosterone propionate. Electro-acupuncture can increase SOD level and decease MDA level in PADAM rats, indicating that electro-acupuncture may function by improving the free radicals system of PADAM rats.
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Objective To explore the characteristics of bone mineral density (BMD) and the incidence of osteoporosis in partial androgen deficiency in aging male (PADAM) patients.Methods Fifty-six PADAM patients (PADAM group) and 51 healthy persons (control group) were selected according to their age and body mass index (BMI),and measured their BMD in the second to fourth lumber and the neck of femur with the dual-energy C X-ray BMD measuring instrument.MES-01S20 muscle function analyzer was used to determinate the distribution and mechanical properties of muscle.The biochemical and bone metabolic markers and sexual hormones were collected and observed by multivariate stepwise regression analysis.Results Compared with control group,BMD significantly decreased in the Ward triangle,femoral neck and big rotor (P ＜ 0.01 ) and no significant change in lumbar in PADAM group (P ＞ 0.05 ),and the fracture strength of femoral neck (FS) and the lower-limb muscular strength (MS) also significantly decreased (P ＜ 0.01 ).The incidence of osteopenia were 48.2% (27/56) and 35.3% ( 18/51 ),osteoporosis were 30.4% (17/56) and 21.6% ( 11/51 ) respectively in PADAM group and control group.There was significant difference between two groups (P＜0.05).The BMD was positively correlated to BMI at the first to fourth lumber and negatively correlated to age,positively correlated to BMI and serum level of andrusol at the proximal left femur in the patients with PADAM.Conclusion BMD and the resistance to fracture aresignificantly lower in PADAM patients,and aging lower BMI and androgen deficiency are the risk factors of low BMD in PADAM patients.There is the potential of osteoporotic fracture risk,and it is important to strengthening the prevention and treatment of fractures in elderly PADAM patients.
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In contrast to previous dogma, the decline in testosterone levels in postmenopausal women is thought to be age-related and not a specific function of the menopause. In addition to normal aging, many conditions affecting ovarian and adrenal function, factors leading to increased SHBG levels can decrease androgen levels below the physiologic range in women. Clinical symptoms of female androgen deficiency include a loss of libido, lack of well-being, and persistent fatigue. However, the diagnosis of female androgen deficiency, as recently provided by the Princeton consensus statement, is under debate due to several limitations. Testosterone therapy in postmenopausal women with symptoms suggestive of androgen deficiency remains controversial. The adverse effects of testosterone therapy appear to be low in incidence, but more studies are necessary to assess long-term safety. Therefore, the decision to treat or not to treat androgen deficiency in postmenopausal women must be carefully considered on an individual basis by comprehensive evaluation of potential benefits and risks.
Subject(s)
Female , Humans , Aging , Consensus , Fatigue , Incidence , Libido , Menopause , Risk Assessment , TestosteroneABSTRACT
The old term of PADAM is "male climacteric" or "andropause" with the synoym of "ADAM" or " late hypogonadism".The serum level of testosterone in male progressives declined after the age of 40 while SHBG increased.At age of 70,around 30% of the total testosterone and 40% of the free testosterone lost.The diagnosis of PADAM is based on the low serum level of androgen and the presence of related symptoms.The basic treatment for PADAM is androgen supplementation(TST).Testosterone undecanoate is a common agent for this purpose.The skin patch or gel of testosterone are also recommended.The benefits of TST are improvement of sexual function,increase of lean body mass,decrease of body fat,enhancement of bone formation and cognition function,and decreased the risks of suffering from type 2 diabetes and cardiovascular disease.On the way of TST,it is necessary to monitor erythrocytes,liver function,prostate digital examination and serum PSA regularly.
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PADAM is defined by International Society for the Study of the Aging Male(ISSAM) as a biochemical syndrome associated with advancing age and characterized by a deficiency in serum androgen with or without decreased tissue sensitivity to androgen. The precise role of androgens in the aging process of men remains unclear, and there have been few controlled clinical studies in aging men to investigate the effects of androgen replacement therapy on various organs and human functions known to deteriorate with age(except for studies on muscle and bone). These organs and functions include the mind, the cardiovascular system, the immune system, and the composition of body fat. In addition, the effect of androgen replacement therapy on the prostate is very important in terms of its safety in aging men. Good randomized, double-blind, placebo-controlled clinical studies in the aging male are clearly lacking. We need studies that can help us better understand the effect of long-term androgen replacement therapy(both with testosterone and DHEA) on important aspects of men's health: cardiovascular disease, body composition, cognition and dementia, osteoporosis, and the prostate. Until such data will become available(probably not for the next decade), we recommend a careful and individualized evaluation of present health problems combined with assessment of prostatic health(rectal examination, transrectal ultrasound, and PSA measurement), cardiovascular health, and cerebral status(including overall quality of life) be undertaken before androgen replacement is initiated. Treatment should be monitored by the same criteria. The future will probably bring the development of 'designer androgens' with(ideally) beneficial effects on the cardiovascular system, bone, muscle, fat tissues, and brain, and simultaneous neutral or even inhibitory effects on the prostate. The onset of PADAM is unpredictable and its manifestations are subtle and variable, which has led to a paucity of interest in its diagnosis and treatment. Urological practice commonly includes a large proportion of men older than 50 years. Therefore, it is important for urologists to recognize the manifestations of PADAM and be familiar with evaluations necessary to document, monitor, and treat it.
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Humans , Male , Adipose Tissue , Aging , Androgens , Body Composition , Brain , Cardiovascular Diseases , Cardiovascular System , Cognition , Dementia , Diagnosis , Hormone Replacement Therapy , Immune System , Men's Health , Osteoporosis , Prostate , Testosterone , UltrasonographyABSTRACT
The authors introduce current problems with regard to the male climacteric, or Partial Androgen Deficiency in Aging Males (PADAM) in Japan. They also emphasize the need for an official guideline for diagnosis and treatment, and new testosterone drugs for PADAM.<br>Dysfunction in the aging male is always a quality of life concern. The authors take this opportunity to focus on the possibilities and expectations with Kampo medicine in Japan, while discussing their view of ideal Kampo treatment for PADAM.
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[Objective] To investigate the effect of sporoderm-broken spores of Ganoderma Lucidum in the treatment of partial androgen deficiency of the aging male (PADAM) . [Methods] Random number table was used for the division of 138 PADAM cases. Sporoderm-broken Ganoderma Lucidum spores capsules were given orally to group A (n=80) and placebo to group B (n=58). The treatment course lasted 3 weeks. Self-scoring of physical ability, vasomotoricity, mental psychological state and sexual function was used to evaluate the therapeutic effect. Meanwhile, blood contents of testosterone (T), erythrocyte superoxide dismutase (SOD) and malondialdehyde (MDA) were determined and adverse reaction was observed. [Results] After a 3-week treatment, the scores of physical ability, vasomotoricity, mental psychological state and sexual function were decreased in group A (P 0.05) and the difference was significant between the two groups (P
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PURPOSE: This study investigated the changes of quality of life after the supplement of testosterone in the aging male partial androgen deficiency(PADAM). MATERIALS AND METHODS: The changes of subjective symptoms were estimated in 56 cases(experimental group: 48 cases, placebo group: 8 cases) with PADAM over 55 year-old, who were treated with transdermal testosterone(Androderm(R)) or a placebo patch by single blind method from September, 1997 to July, 1998. The 12.2mg testosterone patch was attached daily on the lower abdomen, thigh, upper arm and back on a period of three months. Laboratory tests were done on pretreatment and monthly after treatment, which include serum testosterone, PSA, cholesterol, AST and ALT. Changes in the quality of life were evaluated by the PNUH QOL system, which consisted of 21 questions inquiring the following 7 functions: metabolic, cardiopulmonary, musculoskeletal, gastrointestinal, neurologic, psychiatric and sexual function. RESULTS: The 56 cases showed an age distribution of 55-80 year-old(mean 64.3 year-old). During the follow-up period, the drop-out rate after treatment in the experimental group was 18 cases(37.5%) and 7 cases(14.6%) in the posttreatment 1st and 2nd months, respectively. Serum testosterone was significantly increased in the posttreatment 1st, 2nd, 3rd months when compared to pretreatment levels only in the experimental group(r=0.897, p=0.009). Prior to treatment, sexual dysfunction was inquired the most common problem, and followed by psychiatric, musculoskeletal, metabolic, cardiopulmonary, neurologic and gastrointestinal dysfunction in order. After treatment, sexual dysfunction showed the most improvement, and followed by metabolic, musculoskeletal, cardiopulmonary, psychiatric, gastrointestinal and neurologic dysfunction in order. Except for neurologic and gastrointestinal dysfunctions, other subjective symptoms improved in proportion to duration of treatment. The most common complication was a skin rash, which occured in 36 cases(64.2%) and caused the drop out of 14 cases(25%). CONCLUSIONS: According to the above results, it revealed that testosterone supplement therapy induced the improvement of the quality of life in PADAM. Therefore, treatment proctocols including indication, dosage and duration as well as the exact mechanism of the biological role of testosterone should be prepared to popularize hormonal therapy in PADAM.
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Humans , Male , Middle Aged , Abdomen , Age Distribution , Aging , Arm , Cholesterol , Exanthema , Follow-Up Studies , Neurologic Manifestations , Quality of Life , Single-Blind Method , Testosterone , ThighABSTRACT
PURPOSES: To evaluate the effect of Androderm(TM) on sexual function and its safety in partially androgen-deficient aging men with erectile dysfunction. MATERIALS AND METHODS: Two Androderm patches, designed to deliver 5mg of testosterone per day, were applied daily for 4 months to the back, abdomen, upper arm, or thigh of 21 patients (mean age 52.4+/-6.76 years; range 41-63 years) with partial androgen deficiency and erectile dysfunction, The degree of symptom using the Watts (sexual arousal, desire, orgasm, and satisfaction) and Davidson (number and quality of penile erections) questionnaires, Blood levels of total and bioavailable testosterone, estradiol, luteinizing hormone, follicle-stimulating hormone, and sex hormone-binding globulin were measured monthly. The safety variables examined were lipid profiles, liver and kidney function tests, prostate specific antigen, hematologic values, body mass index, and local skin reaction. RESULTS: Blood concentrations of total and bioavailable testosterone and estradiol were significantly (p<0.05) increased, but all were within the normal range during androgen replacement with Androderm. One third of the patients reported improvement in the quality of their erections. there were no significant differences in Watts sexual function scores, number of spontaneous and morning erections, or the quality of erections compared with baseline data. No changes in blood lipid profiles, measures of liver and kidney function, PSA, hematologic values, or body mass index were noted. However, 22% of the patients dropped out of the trial because of severe skin irritation symptoms. CONCLUSION: Androderm was partially effective in improving the quality of erection in partially androgen-deficient aging men and is physiologic and safe.
Subject(s)
Humans , Male , Abdomen , Aging , Arm , Arousal , Body Mass Index , Erectile Dysfunction , Estradiol , Follicle Stimulating Hormone , Kidney , Kidney Function Tests , Liver , Luteinizing Hormone , Orgasm , Prostate-Specific Antigen , Reference Values , Sex Hormone-Binding Globulin , Skin , Testosterone , Thigh , Surveys and QuestionnairesABSTRACT
PURPOSES: To evaluate the effect of Androderm(TM) on sexual function and its safety in partially androgen-deficient aging men with erectile dysfunction. MATERIALS AND METHODS: Two Androderm patches, designed to deliver 5mg of testosterone per day, were applied daily for 4 months to the back, abdomen, upper arm, or thigh of 21 patients (mean age 52.4+/-6.76 years; range 41-63 years) with partial androgen deficiency and erectile dysfunction, The degree of symptom using the Watts (sexual arousal, desire, orgasm, and satisfaction) and Davidson (number and quality of penile erections) questionnaires, Blood levels of total and bioavailable testosterone, estradiol, luteinizing hormone, follicle-stimulating hormone, and sex hormone-binding globulin were measured monthly. The safety variables examined were lipid profiles, liver and kidney function tests, prostate specific antigen, hematologic values, body mass index, and local skin reaction. RESULTS: Blood concentrations of total and bioavailable testosterone and estradiol were significantly (p<0.05) increased, but all were within the normal range during androgen replacement with Androderm. One third of the patients reported improvement in the quality of their erections. there were no significant differences in Watts sexual function scores, number of spontaneous and morning erections, or the quality of erections compared with baseline data. No changes in blood lipid profiles, measures of liver and kidney function, PSA, hematologic values, or body mass index were noted. However, 22% of the patients dropped out of the trial because of severe skin irritation symptoms. CONCLUSION: Androderm was partially effective in improving the quality of erection in partially androgen-deficient aging men and is physiologic and safe.