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Vertigo is defined as the hallucination of spinning sensation or rotatory movement and is frequently combined with severe nausea and vomiting. In Taiwan, an average of 3.13 cases per 100 persons suffer from acute vertigo attack per year. And 1 in 3 patients with vertigo will have recurrent attack within a year. The sensation of disequilibrium and severe nausea and vomiting urge patients visit emergent department (ED) for help. Therefore, vertigo is one of the most common complaints in ED.
Vertigo can be divided into central type and peripheral type. Central type vertigo included life threatening disease like brainstem hemorrhage or infraction. Although peripheral vertigo is mostly benign, the acute symptoms relief are usually needed. The first line therapy of acute peripheral vertigo is using antihistamine or benzodiazepine with other anti-emetic agents. However, these agents usually have side effects of fatigue and lethargy, which will cause increasing patients' length of stay or elders' risk of falling.
Sodium bicarbonate is widely used in treating hyperkalemia or metabolic acidosis. Its safety and no side effect have also been proved. There were few reports of using sodium for treatment of acute vertigo in Taiwan and Japan. However, there is no strong evidence of comparing this therapy with other medication.
This study hypothesized that there is an equivalence of efficacy between sodium bicarbonate and diphenhydramine for treatment of vertigo. Using sodium can cause less fatigue or lethargy and can decrease ED length of stay. This study aims to perform a double-blinded randomized controlled trial to evaluate the efficacy of sodium bicarbonate for treatment of acute peripheral vertigo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diphenhydramine | Active Comparator | Diphenhydramine 30 mg in 100 mL normal saline intravenous dripping |
|
| Sodium Bicarbonate | Experimental | Sodium bicarbonate 66.4 mEq in 100 mL normal saline intravenous dripping |
|
| Diphenhydramine with Sodium Bicarbonate | Experimental | Diphenhydramine 30 mg in 100 mL normal saline intravenous dripping with Sodium bicarbonate 66.4 mEq intravenous push |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diphenhydramine | Drug | Diphenhydramine 30 mg in 100 mL normal saline intravenous dripping when vertigo patients visit Emergency Department |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in vertigo intensity | Reduction in Vertigo Visual Analog Scale (VAS 0~10, higher scores mean higher intensity) from baseline | Baseline and 60 minutes after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in nausea intensity | Reduction in Nausea Visual Analog Scale (VAS 0~10, higher scores mean higher intensity) from baseline | Baseline and 60 minutes after drug administration |
| Improvement of ambulatory ability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chien-Yu Chi, MD | Contact | +886 0972655833 | Y06108@ms1.ylh.gov.tw |
| Name | Affiliation | Role |
|---|---|---|
| Chien-Yu Chi, MD | Emergency Department, National Taiwan University, Yunlin Branch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Yunlin Branch | Recruiting | Yunlin County | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35849408 | Background | Hunter BR, Wang AZ, Bucca AW, Musey PI Jr, Strachan CC, Roumpf SK, Propst SL, Croft A, Menard LM, Kirschner JM. Efficacy of Benzodiazepines or Antihistamines for Patients With Acute Vertigo: A Systematic Review and Meta-analysis. JAMA Neurol. 2022 Sep 1;79(9):846-855. doi: 10.1001/jamaneurol.2022.1858. | |
| 30845218 | Background |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 15, 2025 | |
| Reset | May 1, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 15, 2025 | May 1, 2025 |
| ID | Term |
|---|---|
| D014717 | Vertigo |
| ID | Term |
|---|---|
| D015837 | Vestibular Diseases |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D004155 | Diphenhydramine |
| D017693 | Sodium Bicarbonate |
| ID | Term |
|---|---|
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D001559 | Benzhydryl Compounds |
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| Sodium Bicarbonate | Drug | Sodium bicarbonate 66.4 mEq in 100 mL normal saline intravenous dripping when vertigo patients visit Emergency Department |
|
| Diphenhydramine + Sodium Bicarbonate | Drug | Diphenhydramine 30 mg in 100 mL normal saline intravenous dripping with Sodium bicarbonate 66.4 mEq intravenous push when vertigo patients visit Emergency Department |
|
Change in objective ambulatory ability (score 1~4, higher scores mean a worse outcome) from baseline
| Baseline and 60 minutes after drug administration |
| Lethargy | Lethargy score (score 1~4, 1 indicates no lethargy and 4 indicates very lethargy) | 60 minutes after drug administration |
| Emergency Department staying time | From patients admit to Emergency Department until patients discharge (up to 24 hours) | up to 24 hours |
| Numata K, Shiga T, Omura K, Umibe A, Hiraoka E, Yamanaka S, Azuma H, Yamada Y, Kobayashi D. Comparison of acute vertigo diagnosis and treatment practices between otolaryngologists and non-otolaryngologists: A multicenter scenario-based survey. PLoS One. 2019 Mar 7;14(3):e0213196. doi: 10.1371/journal.pone.0213196. eCollection 2019. |
| 41196596 | Derived | Chi CY, Chen YC, Cheng MT, Chang KC, Chen YP, Tsai MS, Chang WT, Ma MH, Huang CH, Chiang WC. Diphenhydramine, Sodium Bicarbonate, or Combination for Acute Peripheral Vertigo: A Randomized Clinical Trial. JAMA Netw Open. 2025 Nov 3;8(11):e2541472. doi: 10.1001/jamanetworkopen.2025.41472. |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |