45. Androgen Deficiency & Testosterone

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45. Androgen Deficiency & Testosterone

 

 

 

CATEGORY: Anabolic Steroids 100 Courses

COURSE NUMBER: 45

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TABLE OF CONTENTS

 ABSTRACT …………………………………………………………………………………………………………………………….. ii

EXECUTIVE SUMMARY ……………………………………………………………………………………………………………. iii

ACKNOWLEDGEMENTS ……………………………………………………………………………………………………………. v

TABLE OF CONTENTS ……………………………………………………………………………………………………………… vi

TABLE OF TABLES …………………………………………………………………………………………………………………… x

TABLE OF FIGURES ………………………………………………………………………………………………………………… xv

CHAPTER 1: INTRODUCTION ……………………………………………………………………………………………………. 1

1.1 RATIONALE ………………………………………………………………………………………………………………………. 1

1.2 WHY IS A REVIEW NEEDED NOW? ……………………………………………………………………………………….. 2

1.3 OBJECTIVES ……………………………………………………………………………………………………………………… 2

1.4 RESEARCH QUESTIONS ………………………………………………………………………………………………………. 2

1.5 OUTLINE ………………………………………………………………………………………………………………………….. 2

1.6 REFERENCES …………………………………………………………………………………………………………………….. 3

CHAPTER 2: BACKGROUND ……………………………………………………………………………………………………… 4

2.1 HYPOGONADISM ………………………………………………………………………………………………………………. 4

2.2 DIAGNOSIS OF HYPOGONADISM ………………………………………………………………………………………….. 5

2.3 EPIDEMIOLOGY ………………………………………………………………………………………………………………… 6

2.4 TESTOSTERONE REPLACEMENT THERAPY ………………………………………………………………………………. 8

2.5 CLINICAL PRACTICE GUIDELINES…………………………………………………………………………………………… 9

2.6 WHAT IS CURRENTLY KNOWN ……………………………………………………………………………………………. 10

2.6.1 BENEFITS ……………………………………………………………………………………………………………………………… 10

2.6.2 HARMS ………………………………………………………………………………………………………………………………… 11

2.7 WHY IS A REVIEW NEEDED NOW? ……………………………………………………………………………………… 14

2.8 REFERENCES …………………………………………………………………………………………………………………… 15

CHAPTER 3: BENEFITS OF TESOSTERONE REPLACEMENT THERAPY AMONG HYPOGONADAL MEN ….. 19

3.1 INTRODUCTION ………………………………………………………………………………………………………………. 19

3.2 METHODS ………………………………………………………………………………………………………………………. 20

3.2.1 SEARCH STRATEGY …………………………………………………………………………………………………………………….. 20

3.2.2 STUDY SELECTION …………………………………………………………………………………………………………………….. 21

3.2.3 OUTCOMES …………………………………………………………………………………………………………………………….. 22

3.2.4 DATA EXTRACTION ……………………………………………………………………………………………………………………. 22

3.2.5 RISK OF BIAS ……………………………………………………………………………………………………………………………. 22

3.2.6 PUBLICATION BIAS…………………………………………………………………………………………………………………….. 23

3.2.7 STATISTICAL ANALYSIS ……………………………………………………………………………………………………………….. 23

3.2.8 SENSITIVITY ANALYSIS ………………………………………………………………………………………………………………… 25

3.2.9 SUBGROUP ANALYSIS …………………………………………………………………………………………………………………. 25

3.3 RESULTS ………………………………………………………………………………………………………………………… 26

3.3.1 CHARACTERISTICS OF THE INCLUDED TRIALS……………………………………………………………………………………… 26

3.3.2 RISK OF BIAS ……………………………………………………………………………………………………………………………. 35

3.3.3 NETWORK META-ANALYSIS ………………………………………………………………………………………………………….. 37

DEPRESSION ………………………………………………………………………………………………………………………………… 38

QUALITY OF LIFE ……………………………………………………………………………………………………………………………. 47

ERECTILE FUNCTION ……………………………………………………………………………………………………………………….. 57

LIBIDO ……………………………………………………………………………………………………………………………………….. 66

TESTOSTERONE LEVELS ……………………………………………………………………………………………………………………. 75

3.3.4 SUBGROUP ANALYSIS …………………………………………………………………………………………………………………. 87

ROUTE OF ADMINISTRATION …………………………………………………………………………………………………………….. 87

TREATMENT DURATION …………………………………………………………………………………………………………………… 95

AGE …………………………………………………………………………………………………………………………………………. 106

COMORBIDITIES ………………………………………………………………………………………………………………………….. 118

3.4 DISCUSSION ………………………………………………………………………………………………………………….. 124

3.4.1 SUMMARY …………………………………………………………………………………………………………………………….. 124

3.4.2 CONTEXT ……………………………………………………………………………………………………………………………… 125

DEPRESSION ………………………………………………………………………………………………………………………………. 125

QUALITY OF LIFE ………………………………………………………………………………………………………………………….. 127

ERECTILE FUNCTION ……………………………………………………………………………………………………………………… 128

LIBIDO ……………………………………………………………………………………………………………………………………… 129

3.4.3 INFLUENCE OF INDUSTRY FUNDING ………………………………………………………………………………………………. 131

3.4.4 Publication bias ……………………………………………………………………………………………………………………. 132

3.4.5 INFLUENCE OF RISK OF BIAS ……………………………………………………………………………………………………….. 132

3.4.6 STRENGTHS AND LIMITATIONS ……………………………………………………………………………………………………. 133

3.4.7 CONCLUSION …………………………………………………………………………………………………………………………. 134

3.5 REFERENCES …………………………………………………………………………………………………………………. 135

CHAPTER 4: HARMS ASSOCIATED WITH THE USE OF TESTOSTERONE REPLACEMENT THERAPY IN

HYPOGONADAL MEN ………………………………………………………………………………………………………….. 141

4.1 INTRODUCTION …………………………………………………………………………………………………………….. 141

4.2 METHODS …………………………………………………………………………………………………………………….. 142

4.2.1 SEARCH STRATEGY …………………………………………………………………………………………………………………… 143

4.2.2 STUDY SELECTION …………………………………………………………………………………………………………………… 143

4.2.3 DATA EXTRACTION AND QUALITY ASSESSMENT ………………………………………………………………………………… 144

4.2.4 OUTCOMES …………………………………………………………………………………………………………………………… 144

4.2.5 PUBLICATION BIAS…………………………………………………………………………………………………………………… 145

4.2.6 STATISTICAL ANALYSIS ……………………………………………………………………………………………………………… 145

META-ANALYSIS ………………………………………………………………………………………………………………………….. 145

NETWORK META-ANALYSIS …………………………………………………………………………………………………………….. 145

4.2.7 SENSITIVITY ANALYSIS ………………………………………………………………………………………………………………. 146

4.2.8 SUBGROUP ANALYSIS ……………………………………………………………………………………………………………….. 147

4.3 RESULTS ………………………………………………………………………………………………………………………. 148

4.3.1 CHARACTERISTICS OF THE INCLUDED STUDIES …………………………………………………………………………………. 148

4.3.2 RISK OF BIAS ………………………………………………………………………………………………………………………….. 152

RANDOMIZED CONTROLLED TRIALS …………………………………………………………………………………………………… 152

NON-RANDOMIZED INTERVENTIONAL STUDIES …………………………………………………………………………………….. 152

4.3.4 EVIDENCE FROM RANDOMIZED CONTROLLED TRIALS …………………………………………………………… 154

CARDIOVASCULAR DEATH ………………………………………………………………………………………………………………. 155

MYOCARDIAL INFARCTION ……………………………………………………………………………………………………………… 160

STROKE …………………………………………………………………………………………………………………………………….. 165

PROSTATE CANCER ………………………………………………………………………………………………………………………. 167

SERIOUS ADVERSE EVENTS ……………………………………………………………………………………………………………… 172

WITHDRAWALS DUE TO ADVERSE EVENTS …………………………………………………………………………………………… 177

ERYTHROCYTOSIS ………………………………………………………………………………………………………………………… 188

DIABETES ………………………………………………………………………………………………………………………………….. 188

SUBGROUP ANALYSES …………………………………………………………………………………………………………………… 191

4.3.5 EVIDENCE FROM NON-RANDOMIZED INTERVENTIONAL STUDIES ………………………………………….. 231

CARDIOVASCULAR DEATH ………………………………………………………………………………………………………………. 233

MYOCARDIAL INFARCTION ……………………………………………………………………………………………………………… 234

STROKE …………………………………………………………………………………………………………………………………….. 235

PROSTATE CANCER ………………………………………………………………………………………………………………………. 235

SERIOUS ADVERSE EVENTS ……………………………………………………………………………………………………………… 236

WITHDRAWALS DUE TO ADVERSE EVENTS …………………………………………………………………………………………… 237

DIABETES ………………………………………………………………………………………………………………………………….. 237

HEART DISEASE …………………………………………………………………………………………………………………………… 237

ERYTHROCYTOSIS ………………………………………………………………………………………………………………………… 237

SKIN REACTIONS ………………………………………………………………………………………………………………………….. 237

4.4 DISCUSSION ………………………………………………………………………………………………………………….. 239

4.4.1 SUMMARY …………………………………………………………………………………………………………………………….. 239

4.4.2 CONTEXT ……………………………………………………………………………………………………………………………… 239

CARDIOVASCULAR DEATH ………………………………………………………………………………………………………………. 240

MYOCARDIAL INFARCTION ……………………………………………………………………………………………………………… 241

STROKE …………………………………………………………………………………………………………………………………….. 241

PROSTATE CANCER ………………………………………………………………………………………………………………………. 242

SERIOUS ADVERSE EVENTS ……………………………………………………………………………………………………………… 243

4.4.3 INFLUENCE OF INDUSTRY FUNDING ………………………………………………………………………………………………. 244

4.4.4 PUBLICATION BIAS…………………………………………………………………………………………………………………… 245

4.4.5 INFLUENCE OF RISK OF BIAS ……………………………………………………………………………………………………….. 246

4.4.6 STRENGTHS AND LIMITATIONS ……………………………………………………………………………………………………. 246

4.4.7 CONCLUSION …………………………………………………………………………………………………………………………. 247

4.5 REFERENCES …………………………………………………………………………………………………………………. 248

CHAPTER 5: SUMMARY AND FUTURE DIRECTIONS ………………………………………………………………….. 256

5.1 SUMMARY ……………………………………………………………………………………………………………………. 256

5.2 CLINICAL IMPORTANCE ………………………………………………………………………………………………….. 259

5.2.1 Depression ………………………………………………………………………………………………………………………….. 259

5.2.2 Quality of life ………………………………………………………………………………………………………………………. 261

5.2.3 Erectile function …………………………………………………………………………………………………………………… 262

5.2.4 Libido …………………………………………………………………………………………………………………………………. 262

5.3 FUTURE DIRECTIONS ……………………………………………………………………………………………………… 262

5.4 IMPLICATIONS FOR PRACTICE ………………………………………………………………………………………….. 263

5.4 REFERENCES …………………………………………………………………………………………………………………. 264

APPENDIX 1: DETAILED LITERATURE SEARCH STRATEGY ……………………………………………………………. 265

APPENDIX 2: LIST OF INCLUDED STUDIES (RANDOMIZED AND NON-RANDOMIZED) ……………………….. 269

APPENDIX 3: LIST OF RECORDS EXCLUDED AT FULL-TEXT REVIEW ………………………………………………. 275

APPENDIX 4: LIST OF CONFERENCE ABSTRACTS ……………………………………………………………………….. 304

APPENDIX 5: RISK OF BIAS ASSESSMENT OF RANDOMIZED CONTROLLED TRIALS …………………………… 324

APPENDIX 6: EVALUATION OF NETWORK CONSISTENCY ……………………………………………………………. 357

APPENDIX 7: INCLUDED NON-RANDOMIZED STUDIES OF INTERVENTIONS …………………………………… 363

APPENDIX 8: ODDS RATIO, RELATIVE RISK, AND RISK DIFFERENCE FOR HARMS OUTCOMES ……………. 365

APPENDIX 9: COMPARISON OF ODDS RATIOS FOR HARMS OUTCOMES UNDER THE RANDOMAND

FIXED-EFFECTS MODELS ……………………………………………………………………………………………….. 396

Androgen Deficiency & Testosterone


Androgens play a crucial role in bone, muscle and fat metabolism, erythropoiesis and cognitive health. In men aged 40-79 years the incidence of biochemical deficiency and symptomatic hypogonadism is 2.1-5.7%. Decreased libido or reduced frequency and quality of erections, fatigue, irritability, infertility or a diminished feeling of wellbeing may be presenting complaints. However, a significant proportion of men with androgen deficiency will be identified when they present for unrelated concerns. Important factors to elicit from the history in addition to the presenting complaint include: a medical history of obesity, type 2 diabetes, systemic diseases or metabolic syndrome which all impact on testosterone physiology. A comprehensive medical review will identify agents which can cause low testosterone levels such as statins, steroids, opioids, dopamine antagonists and 5-alpha reductase inhibitors. Alcohol, anabolic steroids and illicit substance use such as marihuana can impact on testosterone levels and non-prescribed drug use should be routinely discussed. The mainstay of treatment in persisting androgen deficiency is to restore normal physiological levels of testosterone by using exogenous testosterone. It may take at least three to six weeks to notice any clinical improvement in symptoms. Men receiving testosterone supplementation should be followed closely and have their testosterone, haematocrit and PSA levels checked at three, six and twelve months after initiation of testosterone replacement therapy. Men should then be reviewed at least annually thereafter.
Androgen deficiency in women is a controversial concept. Androgens are hormones that contribute to growth and reproduction in both men and women. Androgen production in women tapers off with increasing age. By the time a woman is 40 years old, her androgen levels are about half of what they were when she was 20.
Some researchers believe that androgen deficiency in women can cause symptoms that include tiredness and loss of sexual interest. Other researchers believe that there is not enough evidence to support the existence of the condition.


What are androgens?
Androgens are hormones. Hormones are chemical messengers that communicate with tissues in the body to bring about many different changes. Androgens are usually thought of as male hormones, but the female body naturally produces a small amount of androgens too – on average, about one tenth to one twentieth of the amount produced by the male body.


The ovaries, adrenal glands, fat cells and skin cells make the female body’s supply of androgens. The ovaries convert testosterone into the female hormone oestrogen.


Symptoms of androgen deficiency in women
Some of the suggested symptoms of androgen deficiency in women may include:
• lethargy (tiredness)
• loss of muscle mass and strength
• loss of libido
• lack of motivation
• low wellbeing
• lowered mood.


Causes of androgen deficiency in women
Some of the possible causes of androgen deficiency in women include:
• ageing – a drop in testosterone (one of the androgens produced by women) naturally occurs in all women over time from about the late teenage years
• oophorectomy – the surgical removal of the ovaries
• chemical oophorectomy – ovarian failure caused by certain medication, such as gonadotropin-releasing hormone antagonists, chemotherapy or radiotherapy
• oral (tablet form) oestrogen therapy – the combined oral contraceptive pill or oestrogen tablets for managing the symptoms of menopause. The combined oral contraceptive pill shuts down the ovarian production of androgens. In addition, oral oestrogen of any type increases the binding protein for testosterone, making less testosterone available for biological action
• hypothalamic amenorrhoea – the loss of menstrual periods in a woman of reproductive age, which could be caused by various factors such as stress, extreme weight loss or extreme exercise. This again lowers the ovarian production of hormones including androgens
• hyperprolactinaemia – overproduction of the pituitary hormone prolactin
• premature ovarian failure – early menopause (before the age of 40), with various causes
• adrenal insufficiency – primary or secondary
• hypopituitarism – a rare disorder of the pituitary gland.


Diagnosis of androgen deficiency in women
If you think you may have androgen deficiency, it is important to have a full medical check-up. The symptoms of androgen deficiency are similar to those of many other conditions, such as:
• hypothyroidism (underactive thyroid)
• iron deficiency anaemia
• autoimmune disease
• depression.
Your doctor may need to assess you for these conditions.


No specific test for androgen deficiency exists. Many blood and salivary tests for testosterone levels lack accuracy when measuring the low levels present in women, though some sensitive testosterone tests are now available.


Testosterone is difficult to measure for many reasons. For example, the amount circulating in the blood does not reflect the amount active inside body cells. To further complicate matters, a woman’s blood test results can vary depending on when the test is taken, because hormone levels fluctuate, not just throughout the menstrual cycle, but during every day.


Typically, if you are having your testosterone levels checked, blood needs to be taken in the morning, when your testosterone levels are at their peak. If you are a woman of reproductive age, the test should take place about eight to 20 days after the start of your menstrual period.


Treatment of androgen deficiency in women (testosterone therapy)
As the existence of the condition ‘androgen deficiency in women’ is still under debate, there is no standard treatment, and no licensed or registered treatment is available for women in Australia.


Most Australian specialists familiar with androgen deficiency in women recommend treatment with a low-dose testosterone cream (one per cent) for daily application. The aim of testosterone treatment is to restore testosterone levels to those within the higher range of normal for an adult woman of early reproductive age.
One concern with testosterone therapy is that the most readily available testosterone products, designed for use in men, contain too much testosterone for the female body.


Doctors generally recommend that postmenopausal women do not have testosterone therapy unless they are also having oestrogen therapy (women who still have their uterus also require progesterone treatment). One clinical trial, however, showed that testosterone given without oestrogen is effective, although it also showed a slightly higher rate of breast cancer in the women given testosterone-only treatment.


Most research in this area has been performed in women who have undergone menopause and have had both ovaries removed.


Few studies have been done examining testosterone use in premenopausal women, as there is a risk that testosterone could harm a developing baby and result in the need for termination of pregnancy. For this reason, failsafe contraception is necessary if premenopausal women are treated with testosterone. This remains a very controversial area.


There have been no long-term studies of testosterone therapy in women, so the long-term health risks and benefits are unknown. The longest study of testosterone use in women was over a period of up to four years. The women involved were postmenopausal and received oestrogen treatment in addition to testosterone.
The main side effects noted in this study (using a testosterone patch) included skin reactions to the patch and unwanted hair growth. Three cases of breast cancer were detected over the four-year period, which was the expected rate in the age group of women in the study.


Side effects of testosterone therapy in women
Women who choose to have testosterone therapy need to consult a doctor who is knowledgeable in this area, can give accurate and up-to-date advice, and who can monitor their treatment properly. Close and regular monitoring is necessary to minimise the risk of side effects.


The risk of side effects depends on many factors, such as the treatment method, the dosage and the length of the therapy. Some of the known side effects of too much testosterone therapy in women include:
• masculine physical characteristics – such as facial hair growth, acne, male-pattern balding, deepened voice, clitoral enlargement (these last two are irreversible). These characteristics are extremely unlikely to develop if dosage is monitored appropriately and if testosterone levels are maintained within the normal range for young adult women of reproductive age
• aggression or irritability
• hirsutism – excess hair growth (at the site of testosterone cream application or elsewhere on the face or body).


When testosterone therapy in women is not appropriate
Testosterone therapy is not appropriate for women who:
• are pregnant or planning to become pregnant
• are of reproductive age and sexually active, but not using adequate contraceptive measures (testosterone can cause serious abnormalities to develop in an unborn baby and termination of pregnancy is likely to be advised if a woman becomes pregnant while using testosterone)
• are breastfeeding
• have acne
• have hirsutism (excessive body or facial hair)
• have alopecia (hair loss)
• have steroid-dependent cancers.

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