Table 7Studies excluded from the clinical review

StudyReasons for exclusion
Agha, A., Liew, A., Finucane, F. et al. (2004) Conventional glucocorticoid replacement overtreats adult hypopituitary patients with partial ACTH deficiency. Clinical Endocrinology 60(6): 688–93 [PubMed: 15163331]

- Outcomes do not meet review protocol

- Study objective does not meet review protocol

Although this study evaluates the effects of glucocorticoid therapy for the management of adrenal insufficiency and includes QoL outcomes, it does not provide insight into the ability of GC therapy to benefit patients during periods of psychological distress.

Al Nofal, A., Bancos, I., Benkhadra, K. et al. (2015) The effect of various glucocorticoid replacement regimens on health outcomes in patients with adrenal insufficiency: A systematic review and meta-analysis. Endocrine Reviews. Conference: 97th Annual Meeting and Expo of the Endocrine Society, ENDO 36(supplement2)

- Systematic review used as source of primary studies.

All included studies have already been reviewed for relevance to review protocol.

Al Nofal, A., Bancos, I., Benkhadra, K. et al. (2017) Glucocorticoid Replacement Regimens in Chronic Adrenal Insufficiency: A Systematic Review and Meta-Analysis. Endocrine Practice 23(1): 17–31 [PubMed: 27631672]

- Systematic review used as source of primary studies.

All included studies have already been reviewed for relevance to review protocol.

Andela, Cornelie D, Staufenbiel, Sabine M, Joustra, Sjoerd D et al. (2016) Quality of life in patients with adrenal insufficiency correlates stronger with hydrocortisone dosage, than with long-term systemic cortisol levels. Psychoneuroendocrinology 72: 80–86 [PubMed: 27388687]

- Study objective does not meet review protocol.

Cross-sectional study investigates association between hair cortisol levels, HC intake and QoL. Does not provide insight into management of periods of psychological stress with HC.

Bannon, C. A., Gallacher, D., Hanson, P. et al. (2020) Systematic review and meta-analysis of the metabolic effects of modified-release hydrocortisone versus standard glucocorticoid replacement therapy in adults with adrenal insufficiency. Clinical Endocrinology 93(6): 637–651 [PubMed: 32621327]

- Systematic review used as source of primary studies.

- Outcomes do not meet review protocol

No psychological outcomes evaluated.

Behan, L. A., Kelleher, G., Hannon, M. J. et al. (2014) Low-dose hydrocortisone replacement therapy is associated with improved bone remodelling balance in hypopituitary male patients. European Journal of Endocrinology 170(1): 141–50 [PubMed: 24123094] - Outcomes do not meet review protocol.
Behan, L. A., Kelleherc, G., Hannon, M. J. et al. (2011) Low-dose hydrocortisone (HC) replacement therapy is associated with improved bone remodeling balance in hypopituitary subjects. Endocrine Reviews. Conference: 93rd Annual Meeting and Expo of the Endocrine Society, ENDO 32(3meetingabstracts) - Outcomes do not meet review protocol.
Benson, S., Neumann, P., Unger, N. et al. (2012) Effects of standard glucocorticoid replacement therapies on subjective well-being: a randomized, double-blind, crossover study in patients with secondary adrenal insufficiency. European Journal of Endocrinology 167(5): 679–85 [PubMed: 22930487]

- Study objective does not meet review protocol.

Although this study evaluates the effects of glucocorticoid therapy for the management of adrenal insufficiency and includes QoL outcomes, it does not provide insight into the ability of GC therapy to benefit patients during periods of psychological distress.

Dineen, R., Martin-Grace, J., Ahmed, K. M. S. et al. (2021) Cardiometabolic and psychological effects of dual-release hydrocortisone: A cross-over study. European Journal of Endocrinology 184(2): 253–265 [PubMed: 33513125]

- Study objective does not meet review protocol.

Although this study evaluates the effects of glucocorticoid therapy for the management of adrenal insufficiency and includes QoL outcomes, it does not provide insight into the ability of GC therapy to benefit patients during periods of psychological distress.

Ekman, B., Bachrach-Lindstrom, M., Lindstrom, T. et al. (2012) A randomized, double-blind, crossover study comparing two- and four-dose hydrocortisone regimen with regard to quality of life, cortisol, and ACTH profiles in patients with primary adrenal insufficiency. Clinical Endocrinology 77(1): 18–25 [PubMed: 22288685]

- Study objective does not meet review protocol.

Although this study evaluates the effects of glucocorticoid therapy for the management of adrenal insufficiency and includes QoL outcomes, it does not provide insight into the ability of GC therapy to benefit patients during periods of psychological distress.

Gagliardi, L., Nenke, M. A., Thynne, T. R. et al. (2014) Continuous subcutaneous hydrocortisone infusion therapy in Addison’s disease: a randomized, placebo-controlled clinical trial. Journal of Clinical Endocrinology & Metabolism 99(11): 4149–57 [PubMed: 25127090]

- Study objective does not meet review protocol.

Although this study evaluates the effects of glucocorticoid therapy for the management of adrenal insufficiency and includes QoL outcomes, it does not provide insight into the ability of GC therapy to benefit patients during periods of psychological distress.

Hahner, S.; Burger-Stritt, S.; Allolio, B. (2013) Subcutaneous hydrocortisone administration for emergency use in adrenal insufficiency. European Journal of Endocrinology 169(2): 147–54 [PubMed: 23672956] - Study objective does not meet review protocol.
Harbeck, Birgit, Danneberg, Sven, Rahvar, Amir-Hossein et al. (2016) Exploring the impact of short- and long-term hydrocortisone replacement on cognitive function, quality of life and catecholamine secretion: A pilot study. Applied Psychophysiology and Biofeedback 41(3): 341–347 [PubMed: 27170300] - Study objective does not meet review protocol.
Isidori, A. M., Venneri, M. A., Graziadio, C. et al. (2018) Effect of once-daily, modified-release hydrocortisone versus standard glucocorticoid therapy on metabolism and innate immunity in patients with adrenal insufficiency (DREAM): a single-blind, randomised controlled trial. The Lancet Diabetes & Endocrinology 6(3): 173–185 [PubMed: 29229498]

- Study objective does not meet review protocol

Although this study evaluates the effects of glucocorticoid therapy for the management of adrenal insufficiency and includes QoL outcomes, it does not provide insight into the ability of GC therapy to benefit patients during periods of psychological distress.

Johannsson, G., Nilsson, A. G., Bergthorsdottir, R. et al. (2012) Improved cortisol exposure-time profile and outcome in patients with adrenal insufficiency: a prospective randomized trial of a novel hydrocortisone dual-release formulation. Journal of Clinical Endocrinology & Metabolism 97(2): 473–81 [PubMed: 22112807] - Outcomes do not meet review protocol.
Kim, M. S.; Ryabets-Lienhard, A.; Geffner, M. E. (2012) Management of congenital adrenal hyperplasia in childhood. Current Opinion in Endocrinology, Diabetes & Obesity 19(6): 483–8 [PubMed: 23037928]

- Outcomes do not meet review protocol.

- Data not reported in an extractable format or a format that can be analysed.

Nilsson, A. G., Marelli, C., Fitts, D. et al. (2014) Prospective evaluation of long-term safety of dual-release hydrocortisone replacement administered once daily in patients with adrenal insufficiency. European Journal of Endocrinology 171(3): 369–77 [PubMed: 24944332]

- Study objective does not meet review protocol.

Although this study evaluates the effects of glucocorticoid therapy for the management of adrenal insufficiency and includes QoL outcomes, it does not provide insight into the ability of GC therapy to benefit patients during periods of psychological distress.

Oksnes, M., Bjornsdottir, S., Isaksson, M. et al. (2014) Continuous subcutaneous hydrocortisone infusion versus oral hydrocortisone replacement for treatment of addison’s disease: a randomized clinical trial. Journal of Clinical Endocrinology & Metabolism 99(5): 1665–74 [PubMed: 24517155] - Outcomes do not meet review protocol.
Riedel, M., Wiese, A., Schurmeyer, T. H. et al. (1993) Quality of life in patients with Addison’s disease: effects of different cortisol replacement modes. Experimental & Clinical Endocrinology 101(2): 106–11 [PubMed: 8405139]

- Study objective does not meet review protocol.

Although this study evaluates the effects of glucocorticoid therapy for the management of adrenal insufficiency and includes QoL outcomes, it does not provide insight into the ability of GC therapy to benefit patients during periods of psychological distress.

Schultebraucks, Katharina, Wingenfeld, Katja, Heimes, Jana et al. (2015) Cognitive function in patients with primary adrenal insufficiency (Addison’s disease). Psychoneuroendocrinology 55: 1–7 [PubMed: 25705797]

- Study objective does not meet review protocol.

Although this study evaluates the effects of glucocorticoid therapy for the management of adrenal insufficiency and includes QoL outcomes, it does not provide insight into the ability of GC therapy to benefit patients during periods of psychological distress.

Staufenbiel, S. M., Penninx, B. W., Spijker, A. T. et al. (2013) Hair cortisol, stress exposure, and mental health in humans: a systematic review. Psychoneuroendocrinology 38(8): 1220–35 [PubMed: 23253896]

- Study objective does not meet review protocol

Although this study evaluates the effects of glucocorticoid therapy for the management of adrenal insufficiency and includes QoL outcomes, it does not provide insight into the ability of GC therapy to benefit patients during periods of psychological distress.

Vreeburg, Sophie A, Hoogendijk, Witte J. G, Pelt, Johannes van et al. (2009) Major depressive disorder and hypothalamic-pituitary-adrenal axis activity: Results from a large cohort study. Archives of General Psychiatry 66(6): 617–626 [PubMed: 19487626]

- Population not relevant to this review protocol.

Population does not focus on people with adrenal insufficiency or provide sub-group analysis for this group.

Werumeus Buning, J., van Faassen, M., Brummelman, P. et al. (2016) Effects of Hydrocortisone on the Regulation of Blood Pressure: Results From a Randomized Controlled Trial. Journal of Clinical Endocrinology & Metabolism 101(10): 3691–3699 [PubMed: 27490921] - Outcomes do not meet review protocol.

From: Pharmacological management during psychological stress

Cover of Pharmacological management during psychological stress
Pharmacological management during psychological stress: Adrenal insufficiency: identification and management: Evidence review K.
NICE Guideline, No. 243.
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