J Clin Med Res

Journal of Clinical Medicine Research, ISSN 1918-3003 print, 1918-3011 online, Open Access

Article copyright, the authors; Journal compilation copyright, J Clin Med Res and Elmer Press Inc

Journal website http://www.jocmr.org

Original Article

Volume 2, Number 4, August 2010, pages 159-166

Long-term Safety of Testosterone and Growth Hormone Supplementation: A Retrospective Study of Metabolic, Cardiovascular, and Oncologic Outcomes

**Table 1.** Hormonal Regimens
Therapy (route)	Goal	Measurement
*Also includes use of human chorionic gonadotropin to increase endogenous testosterone production
Testosterone, men (intramuscular)*	Concentration representing 66th percentile (±12.5%) for 40-year-old men	Total 700 - 900 ng/dL, free 130 - 200 pg/mL
Testosterone, women (transdermal or sublingual)	Upper 33% of normal range for premenopausal women	Total 52-70 ng/dL
Human growth hormone (subcutaneous)	Upper 40% of normal range for age 39-54 years	Rise of ≥ 100% in insulin-like growth factor-1, to a maximum of 360 ng/mL

Table 1. Hormonal Regimens

Therapy (route)

Goal

Measurement

*Also includes use of human chorionic gonadotropin to increase endogenous testosterone production

Testosterone, men (intramuscular)*

Concentration representing 66th percentile (±12.5%) for 40-year-old men

Total 700 - 900 ng/dL,
free 130 - 200 pg/mL

Testosterone, women (transdermal or sublingual)

Upper 33% of normal range for premenopausal women

Total 52-70 ng/dL

Human growth hormone (subcutaneous)

Upper 40% of normal range for age 39-54 years

Rise of ≥ 100% in insulin-like growth factor-1, to a maximum of 360 ng/mL

**Table 2.** Markers of Glucose Metabolism in Patients Not Receiving Concomitant Oral Hypoglycemic Agents
Marker	Treatment	N	Initial Value	Final Value	P value*
Tes: supplementation with testosterone (including use of human chorionic gonadotropin [hCG]); GH: supplementation with human growth hormone; Tes+GH: supplementation with testosterone and/or hCG, in combination with human growth hormone; HbA_1c: glycated hemoglobin.*Change from initial to final value within treatment group.
Fasting blood glucose (mg/dL)	Tes	39	90	93	0.549
GH	53	92	89	0.395
Tes+GH	82	90	92	0.177
Insulin (μIU/mL)	Tes	39	6.5	5.4	0.372
GH	51	5.7	7.3	0.137
Tes+GH	75	5.7	5.8	0.893
HbA_1c (%)	Tes	47	5.4	5.5	0.964
GH	57	5.1	5.4	< 0.001
Tes+GH	90	5.1	5.4	< 0.001

Table 2. Markers of Glucose Metabolism in Patients Not Receiving Concomitant Oral Hypoglycemic Agents

Marker

Treatment

Initial Value

Final Value

P value*

Tes: supplementation with testosterone (including use of human chorionic gonadotropin [hCG]); GH: supplementation with human growth hormone; Tes+GH: supplementation with testosterone and/or hCG, in combination with human growth hormone; HbA_1c: glycated hemoglobin.*Change from initial to final value within treatment group.

Fasting blood glucose (mg/dL)

Tes

0.549

0.395

Tes+GH

0.177

Insulin (μIU/mL)

Tes

6.5

5.4

0.372

5.7

7.3

0.137

Tes+GH

5.7

5.8

0.893

HbA_1c (%)

Tes

5.4

5.5

0.964

5.1

5.4

< 0.001

Tes+GH

5.1

5.4

< 0.001

**Table 3.** Marker of Glucose Metabolism In Patients Treated With Tes+GH With Versus Without Concomitant Oral Hypoglycemic Agents
Marker	Treatment: Tes+GH	N	Initial Value	Final Value	P value*
Tes+GH: supplementation with testosterone and/or human chorionic gonadotropin, in combination with human growth hormone.Change from initial to final value within treatment group.*Difference between treatment groups at initial assessment and at final assessment.
Insulin (μIU/mL)	With hypoglycemics	10	9.2	12.3	0.326
Without hypoglycemics	75	5.7	5.8	0.893
P value**	< 0.005	< 0.001

Table 3. Marker of Glucose Metabolism In Patients Treated With Tes+GH With Versus Without Concomitant Oral Hypoglycemic Agents

Marker

Treatment: Tes+GH

Initial Value

Final Value

P value*

Tes+GH: supplementation with testosterone and/or human chorionic gonadotropin, in combination with human growth hormone.*Change from initial to final value within treatment group.**Difference between treatment groups at initial assessment and at final assessment.

Insulin (μIU/mL)

With hypoglycemics

9.2

12.3

0.326

Without hypoglycemics

5.7

5.8

0.893

P value**

< 0.005

< 0.001

**Table 4.** Markers of Lipid Metabolism in Patients Not Receiving Concomitant Statins
Marker	Treatment	N	Initial Value	Final Value	P value*
Tes: supplementation with testosterone (including use of human chorionic gonadotropin [hCG]); GH: supplementation with human growth hormone; Tes+GH: supplementation with testosterone and/or hCG, in combination with human growth hormone; HDL: high-density lipoprotein cholesterol; LDL: low-density lipoprotein cholesterol.*Change from initial to final value within treatment group.
Cholesterol (mg/dL)	Tes	35	224	177	0.155
GH	7	204	198	0.759
Tes+GH	106	208	183	< 0.001
HDL (mg/dL)	Tes	39	48	48	0.947
GH	7	47	56	0.286
Tes+GH	113	55	54	0.729
LDL (mg/dL)	Tes	39	115	105	0.116
GH	7	125	115	0.597
Tes+GH	114	129	108	< 0.001
Triglycerides (mg/dL)	Tes	39	134	121	0.483
GH	7	136	110	0.636
Tes+GH	114	114	97	0.058

Table 4. Markers of Lipid Metabolism in Patients Not Receiving Concomitant Statins

Marker

Treatment

Initial Value

Final Value

P value*

Tes: supplementation with testosterone (including use of human chorionic gonadotropin [hCG]); GH: supplementation with human growth hormone; Tes+GH: supplementation with testosterone and/or hCG, in combination with human growth hormone; HDL: high-density lipoprotein cholesterol; LDL: low-density lipoprotein cholesterol.*Change from initial to final value within treatment group.

Cholesterol (mg/dL)

Tes

224

177

0.155

204

198

0.759

Tes+GH

106

208

183

< 0.001

HDL (mg/dL)

Tes

0.947

0.286

Tes+GH

113

0.729

LDL (mg/dL)

Tes

115

105

0.116

125

115

0.597

Tes+GH

114

129

108

< 0.001

Triglycerides (mg/dL)

Tes

134

121

0.483

136

110

0.636

Tes+GH

114

0.058

**Table 5.** Markers of Lipid Metabolism in Patients Treated With Tes+GH With Versus Without Concomitant Statins
Marker	Treatment: Tes+GH	N	Initial Value	Final Value	P value*
Tes+GH: supplementation with testosterone and/or human chorionic gonadotropin, in combination with human growth hormone; HDL: high-density lipoprotein cholesterol; LDL: low-density lipoprotein cholesterol.Change from initial to final value within treatment group.*Difference between treatment groups at initial assessment and at final assessment.
HDL (mg/dL)	With statins	35	52	53	0.844
Without statins	113	55	54	0.729
P value**	0.373	0.719
LDL (mg/dL)	With statins	35	137	97	< 0.001
Without statins	114	129	108	< 0.001
P value**	0.267	0.122
Triglycerides (mg/dL)	With statins	35	154	110	< 0.05
Without statins	114	114	97	0.058
P value**	< 0.05	0.255

Table 5. Markers of Lipid Metabolism in Patients Treated With Tes+GH With Versus Without Concomitant Statins

Marker

Treatment: Tes+GH

Initial Value

Final Value

P value*

Tes+GH: supplementation with testosterone and/or human chorionic gonadotropin, in combination with human growth hormone; HDL: high-density lipoprotein cholesterol; LDL: low-density lipoprotein cholesterol.*Change from initial to final value within treatment group.**Difference between treatment groups at initial assessment and at final assessment.

HDL (mg/dL)

With statins

0.844

Without statins

113

0.729

P value**

0.373

0.719

LDL (mg/dL)

With statins

137

< 0.001

Without statins

114

129

108

< 0.001

P value**

0.267

0.122

Triglycerides (mg/dL)

With statins

154

110

< 0.05

Without statins

114

0.058

P value**

< 0.05

0.255