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| Name | Class |
|---|---|
| Tanta University | OTHER |
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Muscle cramps are common in patients with liver disease and associated with significantly diminished quality of life. Patients with cirrhosis often experience muscle cramps with varied frequency and severity. The exact mechanisms by which they occur remain unclear, although a number of pathophysiological events unique to liver disease may contribute. Clinical studies have identified alterations in 3 areas: nerve function, energy metabolism, and plasma volume/electrolytes (1) Orphenadrine is an anticholinergic drug with prominent central nervous system (CNS) and peripheral actions used to treat painful muscle spasms and other similar conditions. The combination of anticholinergic effects and CNS penetration make orphenadrine useful for pain of all etiologies, including from: radiculopathy, muscles, and headaches. [3,4]
Muscle cramps are common in patients with liver disease and associated with significantly diminished quality of life. Patients with cirrhosis often experience muscle cramps with varied frequency and severity. The exact mechanisms by which they occur remain unclear, although a number of pathophysiological events unique to liver disease may contribute. Clinical studies have identified alterations in 3 areas: nerve function, energy metabolism, and plasma volume/electrolytes [1].
Although a number of mechanisms for cramps in liver disease have been postulated and have been targeted by medical therapies, a clear picture of the causal events has not emerged. Several agents as vitamin E, human albumin, zinc, taurine, eperisone hydrochloride and branched-chain amino acids have shown some benefit in small uncontrolled studies, although large randomized controlled trials are lacking [2].
Orphenadrine is an anticholinergic drug with prominent central nervous system (CNS) and peripheral actions used to treat painful muscle spasms and other similar conditions. The combination of anticholinergic effects and CNS penetration make orphenadrine useful for pain of all etiologies, including from: radiculopathy, muscles, and headaches. [3,4] Orphenadrine is structurally related to diphenhydramine and carries relatively stronger anticholinergic and weaker sedative properties, It is mostly excreted through the kidneys.[5]
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orphenadrine(Norflex) | Experimental | 50 patients will be treated with orphenadrine 100 mg twice daily for 1 month |
|
| Placebo | Placebo Comparator | 50 patients will be given placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| orphenadrine | Drug | Orphenadrine in muscle cramps in cirrhotic patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of muscle cramps | questionnaire | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life of these patients | questionnaire | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
• Allergy to orphenadrine
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sherief M Abd-Elsalam, lecturer | Contact | 01000058842 | 002 | Sherif_tropical@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Asem A Elfert, Professor | TUH | Principal Investigator |
| Samah Mosaad, Lecturer | TUH | Study Chair |
| Lobna Aboaly, Professor |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta university hospital | Recruiting | Tanta | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31834056 | Derived | Abd-Elsalam S, Ebrahim S, Soliman S, Alkhalawany W, Elfert A, Hawash N, Elkadeem M, Badawi R. Orphenadrine in treatment of muscle cramps in cirrhotic patients: a randomized study. Eur J Gastroenterol Hepatol. 2020 Aug;32(8):1042-1045. doi: 10.1097/MEG.0000000000001622. |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D009120 | Muscle Cramp |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D009966 | Orphenadrine |
| D002118 | Calcium |
| ID | Term |
|---|---|
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D001559 | Benzhydryl Compounds |
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| Placebo | Drug | calcium in muscle cramps in cirrhotic patients |
|
|
| TUH |
| Study Chair |
| Walaa ElKhalawany, Lecturer | TUH | Study Chair |
| Sherief Abd-Elsalam, Lecturer | TUH | Study Director |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |