Treatment and Prognosis of Neurogenic Orthostatic Hypotension : A Prospective Randomized Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Treatment and Prognosis of Neurogenic Orthostatic Hypotension : A Prospective Randomized Study

Conditions
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Orthostatic; Hypotension, Neurogenic

Intervention / Treatment
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* Drug: Midodrine
* Drug: Pyridostigmine Bromide
* Drug: Midodrine + pyridostigmine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age >=18 patients who complained of dizziness Orthostatic hypotension after 3-minute standing (systolic blood pressure drop >=20 or diastolic blood pressure drop >=10 Exclusion Criteria: Drug-induced hypotension, if necessary, evaluate patient after discontinuing the causative drug for one month Heart failure or Chronic renal failure Patients who cannot or do not want to write questionaires. Poor drug compliance

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Midodrine<br>Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary. | Drug: Midodrine<br> <br> * Other names: Midodrine only;|
| Experimental: Pyridostigmine<br>Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary. | Drug: Pyridostigmine Bromide<br> <br> * Other names: Pyridostigmine only;|
| Experimental: Midodrine + Pyridostigmine<br>Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary. | Drug: Midodrine + pyridostigmine<br> <br> * Other names: Combination;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |