Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Compare the effect of treatment of midodrine and pyridostigmine in neurogenic orthostatic hypotension and investigate the quality of life of treatment of neurogenic orthostatic hypotension.
In patients with neurogenic orthostatic hypotension, the appropriate treatment was identified by comparing the treatment effects and side effects for each treatment drug. In addition, by confirming the effect of orthostatic hypotension on lowering the quality of life, it is expected that the improvement of the quality of life will help.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midodrine | Experimental | Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary. |
|
| Pyridostigmine | Experimental | Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary. |
|
| Midodrine + Pyridostigmine | Experimental | Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midodrine | Drug |
|
| |
| Pyridostigmine Bromide |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Orthostatic BP Drop | Change of orthostatic SBP and DBP drop after 3-month medical treatment compared to initial results. | after 3-month medical treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the Orthostatic Hypotension Associated Symptom Questionnaire (OH Questionnaire (OHQ)). | Change of the OH associated symptom survey result after 3-month medical treatment compared to initial results. OHQ questionnaire has two components: the OH daily activity scale (OHDAS), which contains 4 items measuring the impact of OH on daily activities, and the OH symptom assessment (OHSA), which contains 6 items measuring the symptoms of OH (dizziness/light headedness, vision disturbance, weakness, fatigue, trouble concentrating, and head/neck discomfort).This questionnaire reflects the severity of OH-related symptoms on a 10-point scale, with 0 indicating the absence of a symptom and 10 indicating maximal severity. ** OHQ total score minimal 0 ~ maximal 100 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kon Chu | Seoul National University Hospital, Seoul, South Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24388946 | Background | Arbique D, Cheek D, Welliver M, Vongpatanasin W. Management of neurogenic orthostatic hypotension. J Am Med Dir Assoc. 2014 Apr;15(4):234-9. doi: 10.1016/j.jamda.2013.10.014. Epub 2014 Jan 2. | |
| Background | Smith ND. Orthostatic Hypotension in the Patient with Diabetes: A Broad Review of Pharmacologic Treatment Options. Journal of Pharmacy Technology. 2013 January 1, 2013;29(1):23-34. | ||
| 18420158 |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Midodrine Only | Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary. |
| FG001 | Pyridostigmine Only | Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary. |
| FG002 | Midodrine + Pyridostigmine | Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Midodrine Only | Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary. |
| BG001 | Pyridostigmine Only | Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Orthostatic BP Drop | Change of orthostatic SBP and DBP drop after 3-month medical treatment compared to initial results. | At 3 months after treatment, 65 patients were evaluated (Midodrine only; 23, Pyridostigmine only; 21, Midodrine + Pyridostigmine; 21). 22 additional patients missed visit (Midodrine only; 6, Pyridostigmine only; 8, Midodrine + Pyridostigmine; 8) | Posted | Mean | Standard Deviation | mmHg | after 3-month medical treatment |
|
Possible side effects were checked by direct questioning at each visit at 1 and 3 months after treatment. Expected adverse reactions were listed in the protocol.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Midodrine Only | Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
This study lacked a placebo group and a blinding process Compared with previous studies, which focused on primary autonomic degenerative disorders, our study included more patients with peripheral autonomic neuropathy.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jung-Ick Byun | SNUH | +8224406254 | mr830611@gmail.com |
Not provided
| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008879 | Midodrine |
| D011729 | Pyridostigmine Bromide |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
|
| Midodrine + pyridostigmine | Drug |
|
|
| after 3-month medical treatment. |
| Change of the Depression Score (Beck Depression Inventory-II ) | Change of the depression score after 3-month medical treatment compared to initial results. 21 multiple-choice questions, each of which can be scored from 0 to 3. Higher score represent higher degree of depression. Score Normal; 0-13, Mild depression; 14-19, Moderate depression; 20-28, Severe depression; 29-63 | after 3-month medical treatment. |
| Short-form 36 Version 2 | changes in Short Form (36) Health Survey version 2 (SF-36v2) physical component summary scale (PCS) compared to the baseline SF-36v2 measures eight HRQOL domains (physical functioning, role limitation caused by physical problems, bodily pain, general health, vitality, social functioning, role limitation caused by emotional problems, and mental health) summarized into two summary scales that are normalized to the population (mean=50, standard deviation=10): the physical component summary scale (PCS) and the mental component summary scale (MCS).20 Better HRQOL is reflected by higher SF-36v2 scores. | changes at 3 months after treatment |
| Changes in Health-related Quality of Life | changes in Short Form (36) Health Survey version 2 (SF-36v2) mental component summary scale (MCS) SF-36v2 measures eight HRQOL domains (physical functioning, role limitation caused by physical problems, bodily pain, general health, vitality, social functioning, role limitation caused by emotional problems, and mental health) summarized into two summary scales that are normalized to the population (mean=50, standard deviation=10): the physical component summary scale (PCS) and the mental component summary scale (MCS).20 Better HRQOL is reflected by higher SF-36v2 scores. | changes at 3 months after treatment |
| Background |
| Low PA, Singer W. Management of neurogenic orthostatic hypotension: an update. Lancet Neurol. 2008 May;7(5):451-8. doi: 10.1016/S1474-4422(08)70088-7. |
| 17976425 | Background | Shibao C, Grijalva CG, Raj SR, Biaggioni I, Griffin MR. Orthostatic hypotension-related hospitalizations in the United States. Am J Med. 2007 Nov;120(11):975-80. doi: 10.1016/j.amjmed.2007.05.009. |
| 19124673 | Background | Goldstein DS, Sharabi Y. Neurogenic orthostatic hypotension: a pathophysiological approach. Circulation. 2009 Jan 6;119(1):139-46. doi: 10.1161/CIRCULATIONAHA.108.805887. No abstract available. |
| 16930356 | Background | Lahrmann H, Cortelli P, Hilz M, Mathias CJ, Struhal W, Tassinari M. EFNS guidelines on the diagnosis and management of orthostatic hypotension. Eur J Neurol. 2006 Sep;13(9):930-6. doi: 10.1111/j.1468-1331.2006.01512.x. |
| 23775146 | Background | Parsaik AK, Singh B, Altayar O, Mascarenhas SS, Singh SK, Erwin PJ, Murad MH. Midodrine for orthostatic hypotension: a systematic review and meta-analysis of clinical trials. J Gen Intern Med. 2013 Nov;28(11):1496-503. doi: 10.1007/s11606-013-2520-3. Epub 2013 Jun 18. |
| 9674789 | Background | Wright RA, Kaufmann HC, Perera R, Opfer-Gehrking TL, McElligott MA, Sheng KN, Low PA. A double-blind, dose-response study of midodrine in neurogenic orthostatic hypotension. Neurology. 1998 Jul;51(1):120-4. doi: 10.1212/wnl.51.1.120. |
| 22045363 | Background | Kaufmann H, Malamut R, Norcliffe-Kaufmann L, Rosa K, Freeman R. The Orthostatic Hypotension Questionnaire (OHQ): validation of a novel symptom assessment scale. Clin Auton Res. 2012 Apr;22(2):79-90. doi: 10.1007/s10286-011-0146-2. Epub 2011 Nov 2. |
| 7687093 | Background | Jankovic J, Gilden JL, Hiner BC, Kaufmann H, Brown DC, Coghlan CH, Rubin M, Fouad-Tarazi FM; New Collective Author. Neurogenic orthostatic hypotension: a double-blind, placebo-controlled study with midodrine. Am J Med. 1993 Jul;95(1):38-48. doi: 10.1016/0002-9343(93)90230-m. |
| 9091692 | Background | Low PA, Gilden JL, Freeman R, Sheng KN, McElligott MA. Efficacy of midodrine vs placebo in neurogenic orthostatic hypotension. A randomized, double-blind multicenter study. Midodrine Study Group. JAMA. 1997 Apr 2;277(13):1046-51. |
| 12933939 | Background | Singer W, Opfer-Gehrking TL, McPhee BR, Hilz MJ, Bharucha AE, Low PA. Acetylcholinesterase inhibition: a novel approach in the treatment of neurogenic orthostatic hypotension. J Neurol Neurosurg Psychiatry. 2003 Sep;74(9):1294-8. doi: 10.1136/jnnp.74.9.1294. |
| 16476804 | Background | Singer W, Sandroni P, Opfer-Gehrking TL, Suarez GA, Klein CM, Hines S, O'Brien PC, Slezak J, Low PA. Pyridostigmine treatment trial in neurogenic orthostatic hypotension. Arch Neurol. 2006 Apr;63(4):513-8. doi: 10.1001/archneur.63.4.noc50340. Epub 2006 Feb 13. |
| 28794253 | Derived | Byun JI, Moon J, Kim DY, Shin H, Sunwoo JS, Lim JA, Kim TJ, Lee WJ, Lee HS, Jun JS, Park KI, Lee ST, Jung KH, Jung KY, Lee SK, Chu K. Efficacy of single or combined midodrine and pyridostigmine in orthostatic hypotension. Neurology. 2017 Sep 5;89(10):1078-1086. doi: 10.1212/WNL.0000000000004340. Epub 2017 Aug 9. |
| BG002 | Midodrine + Pyridostigmine | Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Supine systolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Supine diastolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Supine heart rate | Mean | Standard Deviation | Beats per Minute |
|
| Orthostatic systolic blood pressure change | Maximum decrements in SBP within 3 minutes of standing were recorded. | Mean | Standard Deviation | mmHg |
|
| Orthostatic diastolic blood pressure change | Maximum decrements in DBP within 3 minutes of standing were recorded. | Mean | Standard Deviation | mmHg |
|
| OG002 | Midodrine + Pyridostigmine | Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary. |
|
|
| Secondary | Change of the Orthostatic Hypotension Associated Symptom Questionnaire (OH Questionnaire (OHQ)). | Change of the OH associated symptom survey result after 3-month medical treatment compared to initial results. OHQ questionnaire has two components: the OH daily activity scale (OHDAS), which contains 4 items measuring the impact of OH on daily activities, and the OH symptom assessment (OHSA), which contains 6 items measuring the symptoms of OH (dizziness/light headedness, vision disturbance, weakness, fatigue, trouble concentrating, and head/neck discomfort).This questionnaire reflects the severity of OH-related symptoms on a 10-point scale, with 0 indicating the absence of a symptom and 10 indicating maximal severity. ** OHQ total score minimal 0 ~ maximal 100 | At 3 months after treatment, 65 patients were evaluated (Midodrine only; 23, Pyridostigmine only; 21, Midodrine + Pyridostigmine; 21). 22 additional patients missed visit (Midodrine only; 6, Pyridostigmine only; 8, Midodrine + Pyridostigmine; 8) | Posted | Mean | Standard Deviation | points | after 3-month medical treatment. |
|
|
|
| Secondary | Change of the Depression Score (Beck Depression Inventory-II ) | Change of the depression score after 3-month medical treatment compared to initial results. 21 multiple-choice questions, each of which can be scored from 0 to 3. Higher score represent higher degree of depression. Score Normal; 0-13, Mild depression; 14-19, Moderate depression; 20-28, Severe depression; 29-63 | At 3 months after treatment, 65 patients were evaluated (Midodrine only; 23, Pyridostigmine only; 21, Midodrine + Pyridostigmine; 21). 22 additional patients missed visit (Midodrine only; 6, Pyridostigmine only; 8, Midodrine + Pyridostigmine; 8) | Posted | Mean | Standard Deviation | points | after 3-month medical treatment. |
|
|
|
| Secondary | Short-form 36 Version 2 | changes in Short Form (36) Health Survey version 2 (SF-36v2) physical component summary scale (PCS) compared to the baseline SF-36v2 measures eight HRQOL domains (physical functioning, role limitation caused by physical problems, bodily pain, general health, vitality, social functioning, role limitation caused by emotional problems, and mental health) summarized into two summary scales that are normalized to the population (mean=50, standard deviation=10): the physical component summary scale (PCS) and the mental component summary scale (MCS).20 Better HRQOL is reflected by higher SF-36v2 scores. | At 3 months after treatment, 65 patients were evaluated (Midodrine only; 23, Pyridostigmine only; 21, Midodrine + Pyridostigmine; 21). 22 additional patients missed visit (Midodrine only; 6, Pyridostigmine only; 8, Midodrine + Pyridostigmine; 8) | Posted | Mean | Standard Deviation | points | changes at 3 months after treatment |
|
|
|
| Secondary | Changes in Health-related Quality of Life | changes in Short Form (36) Health Survey version 2 (SF-36v2) mental component summary scale (MCS) SF-36v2 measures eight HRQOL domains (physical functioning, role limitation caused by physical problems, bodily pain, general health, vitality, social functioning, role limitation caused by emotional problems, and mental health) summarized into two summary scales that are normalized to the population (mean=50, standard deviation=10): the physical component summary scale (PCS) and the mental component summary scale (MCS).20 Better HRQOL is reflected by higher SF-36v2 scores. | At 3 months after treatment, 65 patients were evaluated (Midodrine only; 23, Pyridostigmine only; 21, Midodrine + Pyridostigmine; 21). 22 additional patients missed visit (Midodrine only; 6, Pyridostigmine only; 8, Midodrine + Pyridostigmine; 8) | Posted | Mean | Standard Deviation | points | changes at 3 months after treatment |
|
|
|
| 0 |
| 29 |
| 1 |
| 29 |
| EG001 | Pyridostigmine Only | Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary. | 0 | 29 | 6 | 29 |
| EG002 | Midodrine + Pyridostigmine | Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary. | 0 | 29 | 3 | 29 |
| dizziness | Nervous system disorders | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| tremor | Nervous system disorders | Systematic Assessment |
|
Not provided
Not provided
| D000588 |
| Amines |
| D011726 | Pyridinium Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |