Skip to main content
SpringerLink
Log in

Prednisolone or hydrocortisone replacement in patients with corticotrope deficiency fasting during Ramadan result in similar risks of complications and quality of life: a randomized double-blind controlled trial

  • Original Article
  • Published:
Endocrine Aims and scope Submit manuscript

Abstract

Purpose

The aims of the study were to compare the risk of complications and the quality of life in patients with corticotrope deficiency, who fasted during Ramadan. Both hydrocortisone and prednisolone were compared as treatments.

Methods

A randomized double-blind crossover clinical trial conducted in the department of Endocrinology of the University Hospital la Rabta in Tunis, during Ramadan 2018, on 53 patients with known corticotrope deficiency treated with hydrocortisone 20 mg per day and who were willing to fast during Ramadan. Patients were randomized into two groups; AB that received hydrocortisone twice daily for 14 days then prednisolone once daily with a placebo for 14 days and group BA that received the two treatments in the reverse order. Patients had to complete a daily follow-up sheet about their eating and sleeping habits, the occurrence of complications and blood glucose monitoring and also to respond to the AddiQoL questionnaire at the end of each treatment period.

Results

Fifty patients’ data were analyzed; 29 men, mean age: 42.4 ± 13.3 years, mean duration of the disease: 8.1 ± 7.6 years. The frequency of complications, mean blood glucose levels and the quality of life did not differ on hydrocortisone compared to prednisolone after adjustment for the sequence of the treatment.

Conclusions

the risks of Ramadan fasting in patients with corticotrope deficiency were the same on hydrocortisone or prednisolone.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

References

  1. M. Chihaoui, F. Chaker, M. Yazidi, W. Grira, Z. Ben Amor et al. Ramadan fasting in patients with adrenal insufficiency. Endocrine (2017). https://doi.org/10.1007/s12020-016-1186-0.

    Article  Google Scholar 

  2. M. Chihaoui, W. Grira, J. Bettaieb, M. Yzidi, F. Chaker et al. The risk for hypoglycemia during Ramadan fasting in patients with adrenal insufficiency. Nutrition. (2018). https://doi.org/10.1016/j.nut.2017.07.014.

    Article  CAS  Google Scholar 

  3. S.R. Bornstein, B. Allolio, W. Arlt, A. Barthel, A. Don-Wauchope et al. Diagnosis and treatment of primary adrenal insufficiency: an Endocrine Society Clinical Practice Guideline. J. Clin. Endocrinol. Metab. (2016). https://doi.org/10.1210/jc.2015-1710. 13.

    Article  CAS  Google Scholar 

  4. A. Oprea, N.C.G. Bonnet, O. Pollé, P.H. Lysy. A: novel insights into glucocorticoid replacement therapy for pediatric and adult adrenal insufficiency. Ther. Adv. Endocrinol. Metab. (2019). https://doi.org/10.1177/2042018818821294.

    Article  Google Scholar 

  5. M. Øksnes, S. Bensing, A.L. Hulting, O. Kämpe, A. Hackemann et al. Quality of life in European patients with Addison’s disease: validity of the disease-specific questionnaire AddiQoL. J. Clin. Endocrinol. Metab. (2012). https://doi.org/10.1210/jc.2011-1901

    Article  Google Scholar 

  6. B. Bleicken, S. Hahner, M. Loeffler, M. Ventz, B. Allolio et al. Impaired subjective health status in chronic adrenal insufficiency: impact of different glucocorticoid replacement regimens. Eur. J. Endocrinol. (2008). https://doi.org/10.1530/EJE-08-0578.

    Article  CAS  Google Scholar 

  7. B.A. Khalid, C.W. Burke, D.M. Hurley, J.W. Funder, J.R. Stockigt. Steroid replacement in Addison’s disease and in subjects adrenalectomized for Cushing’s disease: comparison of various glucocorticoids. J. Clin. Endocrinol. Metab. (1982). https://doi.org/10.1210/jcem-55-3-551.

    Article  CAS  Google Scholar 

  8. E.L. Williams, S. Choudhury, T. Tan, K. Meeran. Prednisolone replacement therapy mimics the circadian rhythm more closely than other glucocorticoids. J. Appl. Lab. Med. (2016). https://doi.org/10.1373/jalm.2016.020206.

    Article  CAS  Google Scholar 

  9. D.J.F. Smith, H. Prabhudev, S. Choudhury, K. Meeran. Prednisolone has the same cardiovascular risk profile as hydrocortisone in glucocorticoid replacement. Endocr. Connect. (2017). https://doi.org/10.1530/EC-17-0257.

    Article  CAS  Google Scholar 

  10. M. Quinkler, B. Ekman, C. Marelli, S. Uddin, P. Zelissen et al. Prednisolone is associated with a worse lipid profile than hydrocortisone in patients with adrenal insufficiency. Endocr. Connect. 6, 1–8 (2017)

    Article  CAS  Google Scholar 

  11. D.D. Chandy, E. Bhatia. Bone mineral density in patients with Addison disease on replacement therapy with prednisolone. Endocr. pract. (2016). https://doi.org/10.4158/EP151014.OR.

    Article  Google Scholar 

  12. J. Schulz, K.R. Frey, M.S. Cooper, K. Zopf, Ventz et al. Reduction in daily hydrocortisone dose improves bone health in primary adrenal insufficiency. Eur. J. Endocrinol. (2016). https://doi.org/10.1530/EJE-15-1096.

    Article  CAS  Google Scholar 

  13. Z. Nikolova, B. Peng, M. Hubert, M. Sieberling, U. Keller et al. Bioequivalence, safety, and tolerability of imatinib tablets compared with capsules. Cancer Chemother. Pharmacol. 53, 433–438 (2004)

    Article  CAS  Google Scholar 

  14. M. Forss, G. Batcheller, S. Skrtic, G. Johannsson. Current practice of glucocorticoid replacement therapy and patient-perceived health outcomes in adrenal insufficiency—a worldwide patient survey. BMC. Endocr. Disord. (2012). https://doi.org/10.1186/1472-6823-12-8.

  15. M. Haouari, F. Haouari-Oukerro, A. Sfaxi, M.C. Ben Rayana, N. Kâabachi et al. How Ramadan fasting affects caloric consumption, body weight, and circadian evolution of cortisol serum levels in young, healthy male volunteers. Horm. Metab. Res. (2008). https://doi.org/10.1055/s-2008-1065321.

    Article  CAS  Google Scholar 

  16. S. Bahijri, A. Borai, G. Ajabnoor, A. Abdul Khaliq, I. AlQassas. Relative metabolic stability, but disrupted circadian cortisol secretion during the fasting month of Ramadan. PLoS. One. (2013). https://doi.org/10.1371/journal.pone.0060917.

    Article  CAS  Google Scholar 

  17. L. Ben Salem, S. Bchir, R. Bouguerra, C. Ben Slama, Cortisol rhythm during the month of Ramadan. East. Mediterr. Health J. 9, 1093–1098 (2003)

    PubMed  Google Scholar 

  18. M. Whitaker, M. Debono, H. Huatan, D. Merke, W. Arlt et al. An oral multi-particulate, modified release, hydrocortisone replacement therapy that provides physiological cortisol exposure. Clin. Endocrinol. (2014). https://doi.org/10.1111/cen.12316.

    Article  Google Scholar 

Download references

Acknowledgements

The authors thank Prof. Bechir Zouari for helpful statistical analysis, and Prof. Alaya Kacem for language assistance.

Funding

This research received no specific grant from any funding agency, public or commercial, or from nonprofit sectors, and was fully covered by the hospital and the researchers. We declare no financial relationship with any organizations or industry.

Author information

Authors and Affiliations

  1. Department of Endocrinology, University Hospital La Rabta, Faculty of Medicine of Tunis, University of Tunis El Manar, Tunis, Tunisia

    Melika Chihaoui, Wafa Mimita, Ibtissem Oueslati, Ons Rejeb, Zohra Ben Amor, Wafa Grira, Meriem Yazidi & Fatma Chaker

Authors
  1. Melika Chihaoui
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Wafa Mimita
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Ibtissem Oueslati
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Ons Rejeb
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Zohra Ben Amor
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Wafa Grira
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Meriem Yazidi
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Fatma Chaker
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Melika Chihaoui.

Ethics declarations

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the National Northern Committee for the Protection of Persons (reference number: CPPN_30_2018_SI0818_JEUN_I-CORT) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Additional information

Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Chihaoui, M., Mimita, W., Oueslati, I. et al. Prednisolone or hydrocortisone replacement in patients with corticotrope deficiency fasting during Ramadan result in similar risks of complications and quality of life: a randomized double-blind controlled trial. Endocrine 67, 155–160 (2020). https://doi.org/10.1007/s12020-019-02082-w

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s12020-019-02082-w

Keywords

Search

Navigation