Orphenadrine Versus Baclofen in Treatment of Muscle Cramps in Cirrhotic Patients

Mansoura University5 enrolled

Overview

Muscle cramps are commonly affects patients with cirrhosis. It adversely influences the quality of life of cirrhotic patients. Treatment of muscle cramps still challenging owing to the diversity of the responsible pathophysiological mechanisms.The effectiveness of baclofen and orphenadrine in controlling muscle cramps in cirrhotic patients has been presented in recent randomised controlled clinical trials;however, the comparative efficacy and safety between these two therapeutic options has not been previously investigated.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cirrhosis

Interventions

OrphenadrineDRUG

100 mg twice daily

BaclofenDRUG

initial dose of 10 mg tablet once daily, dose will be gradually increased according to the patients responses

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 18-70 years 2. Cirrhotic patients complaining of frequent muscle cramps (\>3 per week) for at least a month Exclusion Criteria: 1. Patients with allergy to study drugs 2. Renal impairment 3. Peripheral vascular disease 4. Peripheral neuropathy 5. Glaucoma 6. Prostatic enlargement 7. Pregnancy and lactation 8. Patients taking calcium channel blockers, and conjugated estrogens 9. Patients taking vitamin E, taurine, carnitine, narcotic pain medications, muscle relaxants, nonsteroidal anti-inflammatory drugs, or antispastic agents during and for 2 weeks following the study 10. Patients with alcoholic cirrhosis

Locations (1)

Tanta University Hospitals

Tanta, Egypt

Outcomes

Primary Outcomes

the difference in the number of muscle cramps between the orphenadrine and baclofen groups at the end of treatment

Questionnaire

Time frame: 12 weeks

Secondary Outcomes

The difference in severity of cramps between orphenadrine and baclofen groups at the end of treatment

Visual analogue scale (VAS)

Time frame: 12 weeks

Data from ClinicalTrials.gov

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