Efficacy and safety of medroxyprogesterone acetate on noninvasive ventilation -treated exacerbated COPD patients: a double-blind randomized clinical trial

Abstract Background In acute exacerbation periods of chronic obstructive pulmonary disease (COPD), patients may experience hypoxemia or hypercapnia. Noninvasive ventilation (NIV) and respiratory stimulant drugs are used to treat this condition. Medroxyprogesterone acetate (MPA) can cross the blood-b...

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Main Authors: Mohsen Gholinataj Jelodar, Mohammadreza Malek-Ahmadi, Adeleh Sahebnasagh, Farhad Mohammadi, Fatemeh Saghafi
Format: Article
Language:English
Published: BMC 2025-03-01
Series:BMC Pulmonary Medicine
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Online Access:https://doi.org/10.1186/s12890-024-03462-3
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author Mohsen Gholinataj Jelodar
Mohammadreza Malek-Ahmadi
Adeleh Sahebnasagh
Farhad Mohammadi
Fatemeh Saghafi
author_facet Mohsen Gholinataj Jelodar
Mohammadreza Malek-Ahmadi
Adeleh Sahebnasagh
Farhad Mohammadi
Fatemeh Saghafi
author_sort Mohsen Gholinataj Jelodar
collection DOAJ
description Abstract Background In acute exacerbation periods of chronic obstructive pulmonary disease (COPD), patients may experience hypoxemia or hypercapnia. Noninvasive ventilation (NIV) and respiratory stimulant drugs are used to treat this condition. Medroxyprogesterone acetate (MPA) can cross the blood-brain barrier and cause breathing stimulation and hyperventilation. This study was conducted to investigate the effectiveness of MPA in hypercapnic exacerbated COPD patients and the possibility of faster weaning of patients from NIV. Materials and methods This double-blind clinical trial was conducted on consecutive exacerbated COD patients referred to Shahid Rahnemoun Hospital, Yazd, Iran, from February 2022 to August 2022. Through a block randomized sampling method with a 1:1 allocation ratio, 58 eligible patients with hypercapnic exacerbated COPD on NIV were divided into two study groups: the intervention (treated with MPA 10 mg every 8 h) and the control (treated with placebo). The clinical and arterial blood gas (ABG) parameters were investigated in both groups. Results Out of 50 patients, 27 and 23 intervention and control arms cases were analyzed. Although there was a significant difference in the amount of ABG parameters during the study in each group, there was no statistically significant difference between the two groups. Also, There was no significant difference in the total weaning rate of the patients in the two groups. Despite the higher number of early weaning in the MPA group, no significant difference was reported between the two groups in this regard. In addition, there was no difference between the two groups in the rate of ICU hospitalization, the length of stay of hospitalization and ICU, and the mortality rate. Conclusion The administration of MPA has not improved clinical and laboratory results, and MPA is not superior to placebo in the weaning process of patients undergoing NIV. Trial registration IRCT20190810044500N21 (01/02/2022), (https//irct.behdasht.gov.ir/user/trial/59402/view)
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spelling doaj-art-94ab8b8b547a41f6a29e3aa2eea85cf12025-08-20T03:01:34ZengBMCBMC Pulmonary Medicine1471-24662025-03-012511910.1186/s12890-024-03462-3Efficacy and safety of medroxyprogesterone acetate on noninvasive ventilation -treated exacerbated COPD patients: a double-blind randomized clinical trialMohsen Gholinataj Jelodar0Mohammadreza Malek-Ahmadi1Adeleh Sahebnasagh2Farhad Mohammadi3Fatemeh Saghafi4Department of Internal Medicine, Faculty of Medicine, Shahid Sadoughi University of Medical SciencesPharmaceutical Sciences Research Center, School of Pharmacy, Student Research Committee, Shahid Sadoughi University of Medical SciencesDepartment of Internal Medicine, Clinical Research Center, Faculty of Medicine, North Khorasan University of Medical SciencesDepartment of Pharmaceutics, School of Pharmacy, Shahid Sadoughi University of Medical Sciences and Health ServicesDepartment of Clinical Pharmacy, School of Pharmacy and Pharmaceutical Sciences Research Center, Shahid Sadoughi University of Medical SciencesAbstract Background In acute exacerbation periods of chronic obstructive pulmonary disease (COPD), patients may experience hypoxemia or hypercapnia. Noninvasive ventilation (NIV) and respiratory stimulant drugs are used to treat this condition. Medroxyprogesterone acetate (MPA) can cross the blood-brain barrier and cause breathing stimulation and hyperventilation. This study was conducted to investigate the effectiveness of MPA in hypercapnic exacerbated COPD patients and the possibility of faster weaning of patients from NIV. Materials and methods This double-blind clinical trial was conducted on consecutive exacerbated COD patients referred to Shahid Rahnemoun Hospital, Yazd, Iran, from February 2022 to August 2022. Through a block randomized sampling method with a 1:1 allocation ratio, 58 eligible patients with hypercapnic exacerbated COPD on NIV were divided into two study groups: the intervention (treated with MPA 10 mg every 8 h) and the control (treated with placebo). The clinical and arterial blood gas (ABG) parameters were investigated in both groups. Results Out of 50 patients, 27 and 23 intervention and control arms cases were analyzed. Although there was a significant difference in the amount of ABG parameters during the study in each group, there was no statistically significant difference between the two groups. Also, There was no significant difference in the total weaning rate of the patients in the two groups. Despite the higher number of early weaning in the MPA group, no significant difference was reported between the two groups in this regard. In addition, there was no difference between the two groups in the rate of ICU hospitalization, the length of stay of hospitalization and ICU, and the mortality rate. Conclusion The administration of MPA has not improved clinical and laboratory results, and MPA is not superior to placebo in the weaning process of patients undergoing NIV. Trial registration IRCT20190810044500N21 (01/02/2022), (https//irct.behdasht.gov.ir/user/trial/59402/view)https://doi.org/10.1186/s12890-024-03462-3COPDExacerbationHypercapniaNIVMedroxyprogesterone acetateRCT
spellingShingle Mohsen Gholinataj Jelodar
Mohammadreza Malek-Ahmadi
Adeleh Sahebnasagh
Farhad Mohammadi
Fatemeh Saghafi
Efficacy and safety of medroxyprogesterone acetate on noninvasive ventilation -treated exacerbated COPD patients: a double-blind randomized clinical trial
BMC Pulmonary Medicine
COPD
Exacerbation
Hypercapnia
NIV
Medroxyprogesterone acetate
RCT
title Efficacy and safety of medroxyprogesterone acetate on noninvasive ventilation -treated exacerbated COPD patients: a double-blind randomized clinical trial
title_full Efficacy and safety of medroxyprogesterone acetate on noninvasive ventilation -treated exacerbated COPD patients: a double-blind randomized clinical trial
title_fullStr Efficacy and safety of medroxyprogesterone acetate on noninvasive ventilation -treated exacerbated COPD patients: a double-blind randomized clinical trial
title_full_unstemmed Efficacy and safety of medroxyprogesterone acetate on noninvasive ventilation -treated exacerbated COPD patients: a double-blind randomized clinical trial
title_short Efficacy and safety of medroxyprogesterone acetate on noninvasive ventilation -treated exacerbated COPD patients: a double-blind randomized clinical trial
title_sort efficacy and safety of medroxyprogesterone acetate on noninvasive ventilation treated exacerbated copd patients a double blind randomized clinical trial
topic COPD
Exacerbation
Hypercapnia
NIV
Medroxyprogesterone acetate
RCT
url https://doi.org/10.1186/s12890-024-03462-3
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