RESEARCH ARTICLE
Somatosensory function in patients with secondary adrenal insufficiency treated with two different doses of hydrocortisone— Results from a randomized controlled trial a1111111111 a1111111111 a1111111111 a1111111111 a1111111111
Jorien Werumeus Buning1*, Karl-Heinz Konopka2, Pauline Brummelman1, Janneke Koerts3, Robin P. F. Dullaart1, Gerrit van den Berg1, Melanie M. van der Klauw1, Oliver Tucha3, Bruce H. R. Wolffenbuttel1, Andre´ P. van Beek1 1 Department of Endocrinology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands, 2 Drug Discovery Science & Management-Europe, Astellas Pharma Europe B.V., Leiden, The Netherlands, 3 Department of Clinical and Developmental Neuropsychology, University of Groningen, Groningen, The Netherlands * [email protected]
OPEN ACCESS Citation: Werumeus Buning J, Konopka K-H, Brummelman P, Koerts J, Dullaart RPF, van den Berg G, et al. (2017) Somatosensory function in patients with secondary adrenal insufficiency treated with two different doses of hydrocortisone —Results from a randomized controlled trial. PLoS ONE 12(7): e0180326. https://doi.org/10.1371/ journal.pone.0180326 Editor: Kathrin Eller, Medizinische Universitat Graz, AUSTRIA Received: September 12, 2016 Accepted: June 11, 2017 Published: July 7, 2017 Copyright: © 2017 Werumeus Buning et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Data Availability Statement: Data are from the SUPREMECORT Study (Clinicaltrials.gov: NCT01546922). The dataset contains clinical data, which because of the Dutch law for Personal Data Protection cannot be shared publicly. Patients did not sign informed consent to release their data on an individual basis on the internet. For this reason, data are available upon request to the author, who may be contacted at j.werumeus.buning@umcg. nl / +31503613962.
Abstract Background Low cortisol levels are associated with several functional pain syndromes. In patients with secondary adrenal insufficiency (SAI), the lack in endogenous cortisol production is substituted by the administration of oral hydrocortisone (HC). Our previous study showed that a lower dose of HC led to an increase in reported subjective pain symptoms. Whether different doses of HC substitution alter somatosensory functioning in SAI patients has not been established yet.
Methods In this randomized double blind cross-over trial, forty-six patients with SAI participated. Patients randomly received either first a lower dose (0.2–0.3 mg HC/kg body weight/day) for 10 weeks followed by a higher dose (0.4–0.6 mg HC/kg body weight/day) for another 10 weeks, or vice versa. After each treatment period, blood samples were drawn and somatosensory functioning was assessed by determining the mechanical detection threshold (MDT), mechanical pain threshold (MPT), mechanical pain sensitivity (MPS) and the pain pressure threshold (PPT), according to the Quantitative Sensory Testing (QST) battery by the German Network on Neuropathic Pain.
Results The administration of the higher dose of HC resulted in significantly higher levels of cortisol (mean [SD] 748 [245] nmol/L) than the lower dose (537 [250] nmol/L, P
Somatosensory function in patients with secondary adrenal insufficiency treated with two different doses of hydrocortisone— Results from a randomized controlled trial a1111111111 a1111111111 a1111111111 a1111111111 a1111111111
Jorien Werumeus Buning1*, Karl-Heinz Konopka2, Pauline Brummelman1, Janneke Koerts3, Robin P. F. Dullaart1, Gerrit van den Berg1, Melanie M. van der Klauw1, Oliver Tucha3, Bruce H. R. Wolffenbuttel1, Andre´ P. van Beek1 1 Department of Endocrinology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands, 2 Drug Discovery Science & Management-Europe, Astellas Pharma Europe B.V., Leiden, The Netherlands, 3 Department of Clinical and Developmental Neuropsychology, University of Groningen, Groningen, The Netherlands * [email protected]
OPEN ACCESS Citation: Werumeus Buning J, Konopka K-H, Brummelman P, Koerts J, Dullaart RPF, van den Berg G, et al. (2017) Somatosensory function in patients with secondary adrenal insufficiency treated with two different doses of hydrocortisone —Results from a randomized controlled trial. PLoS ONE 12(7): e0180326. https://doi.org/10.1371/ journal.pone.0180326 Editor: Kathrin Eller, Medizinische Universitat Graz, AUSTRIA Received: September 12, 2016 Accepted: June 11, 2017 Published: July 7, 2017 Copyright: © 2017 Werumeus Buning et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Data Availability Statement: Data are from the SUPREMECORT Study (Clinicaltrials.gov: NCT01546922). The dataset contains clinical data, which because of the Dutch law for Personal Data Protection cannot be shared publicly. Patients did not sign informed consent to release their data on an individual basis on the internet. For this reason, data are available upon request to the author, who may be contacted at j.werumeus.buning@umcg. nl / +31503613962.
Abstract Background Low cortisol levels are associated with several functional pain syndromes. In patients with secondary adrenal insufficiency (SAI), the lack in endogenous cortisol production is substituted by the administration of oral hydrocortisone (HC). Our previous study showed that a lower dose of HC led to an increase in reported subjective pain symptoms. Whether different doses of HC substitution alter somatosensory functioning in SAI patients has not been established yet.
Methods In this randomized double blind cross-over trial, forty-six patients with SAI participated. Patients randomly received either first a lower dose (0.2–0.3 mg HC/kg body weight/day) for 10 weeks followed by a higher dose (0.4–0.6 mg HC/kg body weight/day) for another 10 weeks, or vice versa. After each treatment period, blood samples were drawn and somatosensory functioning was assessed by determining the mechanical detection threshold (MDT), mechanical pain threshold (MPT), mechanical pain sensitivity (MPS) and the pain pressure threshold (PPT), according to the Quantitative Sensory Testing (QST) battery by the German Network on Neuropathic Pain.
Results The administration of the higher dose of HC resulted in significantly higher levels of cortisol (mean [SD] 748 [245] nmol/L) than the lower dose (537 [250] nmol/L, P
