Impact of recombinant human growth hormone treatment on psychological profiles in hypopituitary patients with adult‐onset growth hormone deficiency

Giusti, Massimo; Meineri, I.; Malagamba, D; Cm, Cuttica; Fattacciu, G; Menichini, U; Rasore, E.; Giordano, G

doi:10.1046/j.1365-2362.1998.00239.x

Cited by 32 publications

(25 citation statements)

References 33 publications

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“…Specifically, because it relates to the findings of GHD and hypogonadism in this study, GH replacement is known to improve QoL in patients with adult-onset GHD and helps reduce fat mass and improve exercise capacity. 51,52,54,55,[74][75][76][77][78][79][80] The benefits of testosterone therapy for men are clear and considered standard practice. 50,57,81 In addition, the high prevalence of MetS in retired football players is important because lifestyle changes may reverse some of these findings and improve the cardiovascular and metabolic disease risks that are associated with MetS.…”

Section: Discussionmentioning

confidence: 99%

“…Both GHD and hypogonadism have been associated with poor QoL. [49][50][51][52][53][54][55][56][57][58][59][60] In addition to poor QoL, both GHD and hypogonadism can contribute to decreased lean body mass, increased fat mass (in particular, visceral fat), and poor exercise capacity that further contribute to poor QoL, obesity, and MetS, increasing cardiovascular disease (CVD) risk. 51,54,57,[61][62][63][64][65][66][67][68][69][70] Studies have shown that MetS is associated with, and predicts the development of, low serum testosterone levels in men.…”

Section: Previous Studies On Postconcussive Hypopituitarismmentioning

confidence: 99%

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Prevalence of Pituitary Hormone Dysfunction, Metabolic Syndrome, and Impaired Quality of Life in Retired Professional Football Players: A Prospective Study

Kelly

Chaloner

Evans

et al. 2014

Journal of Neurotrauma

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Hypopituitarism is common after moderate and severe traumatic brain injury (TBI). Herein, we address the association between mild TBI (mTBI) and pituitary and metabolic function in retired football players. Retirees 30-65 years of age, with one or more years of National Football League (NFL) play and poor quality of life (QoL) based on Short Form 36 (SF-36) Mental Component Score (MCS) were prospectively enrolled. Pituitary hormonal and metabolic syndrome (MetS) testing was performed. Using a glucagon stimulation test, growth hormone deficiency (GHD) was defined with a standard cut point of 3 ng/mL and with a more stringent body mass index (BMI)-adjusted cut point. Subjects with and without hormonal deficiency (HD) were compared in terms of QoL, International Index of Erectile Function (IIEF) scores, metabolic parameters, and football career data. Of 74 subjects, 6 were excluded because of significant non-football-related TBIs. Of the remaining 68 subjects (mean age, 47.3 -10.2 years; median NFL years, 5; median NFL concussions, 3; mean BMI, 33.8 -6.0), 28 (41.2%) were GHD using a peak GH cutoff of < 3 ng/mL. However, with a BMI-adjusted definition of GHD, 13 of 68 (19.1%) were GHD. Using this BMI-adjusted definition, overall HD was found in 16 (23.5%) subjects: 10 (14.7%) with isolated GHD; 3 (4.4%) with isolated hypogonadism; and 3 (4.4%) with both GHD and hypogonadism. Subjects with HD had lower mean scores on the IIEF survey ( p = 0.016) and trended toward lower scores on the SF-36 MCS ( p = 0.113). MetS was present in 50% of subjects, including 5 of 6 (83%) with hypogonadism, and 29 of 62 (46.8%) without hypogonadism ( p = 0.087). Age, BMI, median years in NFL, games played, number of concussions, and acknowledged use of performance-enhancing steroids were similar between HD and non-HD groups. In summary, in this cohort of retired NFL players with poor QoL, 23.5% had HD, including 19% with GHD (using a BMI-adjusted definition), 9% with hypogonadism, and 50% had MetS. Although the cause of HD is unclear, these results suggest that GHD and hypogonadism may contribute to poor QoL, erectile dysfunction, and MetS in this population. Further study of pituitary function is warranted in athletes sustaining repetitive mTBI.

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Section: Discussionmentioning

confidence: 99%

Section: Previous Studies On Postconcussive Hypopituitarismmentioning

confidence: 99%

Prevalence of Pituitary Hormone Dysfunction, Metabolic Syndrome, and Impaired Quality of Life in Retired Professional Football Players: A Prospective Study

Kelly

Chaloner

Evans

et al. 2014

Journal of Neurotrauma

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“…Three trials included participants with adult onset GH deficiency only (Bengtsson et al 1993, Baum et al 1998, Giusti et al 1998, one had participants with child onset GH deficiency only (Deijen et al 1996) while the remainder included both child and adult onset participants. In all trials that reported data, participants with multiple and isolated deficiencies were included.…”

Section: Characteristics Of Included Trialsmentioning

confidence: 99%

“…Only five trials (29·5%) reported both withdrawals from the study because of adverse events and specific adverse events with numbers per study arm and per type (Whitehead et al 1992, Beshyah et al 1995, Verhelst et al 1997, Baum et al 1998, Cuneo et al 1998. Six further trials (35%) reported either withdrawal details (Bengtsson et al 1993, Florkowski et al 1998, Giusti et al 1998, de Novaes Soares et al 1999 or specific adverse event details (Attanasio et al 1997) or partial data on specific adverse events (Wallymahmed et al 1997). Six trials (35%), however, did not report information on either withdrawals or specific adverse events (McGauley 1989, Degerblad et al 1990, Burman et al 1995, McKenna et al 1997a,b, Deijen et al 1996.…”

Section: Adverse Event Reportingmentioning

confidence: 99%

“…Ten of the 17 studies (59%) reported the number of patients who withdrew from the study due to adverse events per study arm and per type of adverse event (Whitehead et al 1992, Bengtsson et al 1993, Beshyah et al 1995, Verhelst et al 1997, Wallymahmed et al 1997, Baum et al 1998, Cuneo et al 1998, Florkowski et al 1998, Giusti et al 1998, de Novaes Soares et al 1999. In all cases where the number of withdrawals was given per study arm, withdrawals per type of adverse event was also given.…”

Section: Withdrawalsmentioning

confidence: 99%

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Endocrinology trial design: adverse event reporting in randomised controlled trials of recombinant human GH in GH-deficient adults

Bryant¹,

Loveman²,

Cave³

et al. 2002

Journal of Endocrinology

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We have evaluated the reporting of withdrawals due to adverse effects and specific adverse effects in randomised controlled trials of recombinant human GH in adults. A systematic review was carried out of randomised controlled trials of the clinical effectiveness of recombinant human GH in adults with GH deficiency in relation to impact on quality of life. Trials were identified from searching electronic databases, bibliographies of related articles and consulting experts. There was reporting of withdrawals due to adverse effects and specific adverse effects. Rates of oedema and arthralgia were reported in included trials. Seventeen randomised controlled trials, published between 1990 and 1999, met the inclusion criteria for the review. Nine trials reported data on the effectiveness of GH on quality of life in adults. Only five trials (29%) reported both withdrawals from the study because of adverse events and specific adverse events with numbers per study arm and per type. Six further trials (35%) reported either withdrawal details or specific adverse event details or partial data on specific adverse events. Six trials (35%), however, did not report information on either withdrawals or specific adverse events. Ten of the 17 studies (59%) reported the number of patients who withdrew from the study due to adverse events per study arm and type of adverse event per study arm. Seven of the 17 trials (41%) reported the number of specific adverse events per study arm and six (35%) reported the type per study arm. The reporting of adverse events in randomised controlled trials of GH is variable and not consistent across trials. It is not possible to assess the impact that adverse events may have had on unblinding patients, and therefore the extent to which the effects of GH may have been overestimated. Therefore those conducting endocrinology trials in the future need to pay attention to the reporting of withdrawals due to adverse events and specific adverse events.

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A case-controlled study on the quality of life in a cohort of patients with history of differentiated thyroid carcinoma

Giusti

Sibilla

Cappi

et al. 2005

J Endocrinol Invest

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Although quality of life (QoL) has become an important aspect of cancer rehabilitation, psychometric studies on thyroid cancer patients are rare. We performed a case-controlled study on QoL in patients with differentiated thyroid carcinoma (DTC). QoL was evaluated in 61 patients with a history of DTC diagnosed from < 1 to 23 yr earlier. An undetectable thyroglobulin (Tg) level after recombinant human TSH (rhTSH) testing was considered the best predictor of cure. QoL was evaluated by means of a general psychiatric interview, the self-rating Kellner Symptoms Questionnaire (KSQ) and the Hamilton Depression Scale (HDS). QoL was also evaluated in a control group of subjects on L-T4 therapy with a non-toxic multinodular goiter diagnosed from < 1 to 25 yr earlier. DTC and control subjects were similar in age, male-female distribution and concomitant psychiatric therapies. Per-week dosage of L-T4 was higher in DTC patients than in controls (p < 0.01). In neither group of subjects was there any correlation between current TSH levels or interval from diagnosis and KSQ or HDS scores. Only in DTC patients was there a positive correlation between age and KSQ (p < 0.05) or HDS (p < 0.01) scores. There was a significant difference in overall KSQ scores between DTC (33.4 +/- 2.1) and control (24.5 +/- 1.9; p < 0.01) subjects. The subscales of KSQ showed a significant inter-group difference. HDS scores were higher in DTC subjects (35.8 +/- 1.0) than in controls (30.0 +/- 1.1; p < 0.01). HDS score was significantly (p = 0.02) higher in female than in male DTC patients. In patients with papillary carcinoma there was a positive correlation between the MACIS (metastases, age, completeness, invasiveness, size) score and KSQ (p = 0.01) or HDS (p < 0.01) scores. After rhTSH testing, detectable Tg levels were found in 13% of DTC patients. In Tg-positive patients, KSQ and HDS scores were not different from those of Tg-negative patients. After an 8-14 month period, a significant decrease in the KSQ scale somatization (p = 0.02) was found in a sub-set of 31 DTC patients. In conclusion, even in the age of rhTSH testing, DTC patients suffer an impairment of their QoL, as noted when short-term L-T4 withdrawal was the gold standard. Longitudinal evaluation seems to indicate a slight improvement in QoL when safe rhTSH testing is extensively used in the management of the disease.

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Impact of recombinant human growth hormone treatment on psychological profiles in hypopituitary patients with adult‐onset growth hormone deficiency

Cited by 32 publications

References 33 publications

Prevalence of Pituitary Hormone Dysfunction, Metabolic Syndrome, and Impaired Quality of Life in Retired Professional Football Players: A Prospective Study

Prevalence of Pituitary Hormone Dysfunction, Metabolic Syndrome, and Impaired Quality of Life in Retired Professional Football Players: A Prospective Study

Endocrinology trial design: adverse event reporting in randomised controlled trials of recombinant human GH in GH-deficient adults

A case-controlled study on the quality of life in a cohort of patients with history of differentiated thyroid carcinoma

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