Cirrhosis, Muscle Cramp, Quality of Life
Conditions
Keywords
Muscle Cramp, cirrhosis
Brief summary
The goal of this randomized controlled trial is to compare the efficacy and safety of branched-chain amino acids (BCAA) versus placebo for treating muscle cramps in cirrhotic patients. The main questions it aims to answer are: * Compared the effect of BCAA versus placebo on muscle cramp frequency in cirrhotic patients * Compared the effect of BCAA versus placebo on muscle cramp duration and severity in cirrhotic patients * Compared the effect of BCAA versus placebo on quality of life in cirrhotic patients with muscle cramps Participants with cirrhosis who have experienced muscle cramps at least once per week will be randomized to receive either a placebo or 12.45 grams of BCAA orally per day for 12 weeks.
Detailed description
Cirrhosis is a late-stage of fibrosis of the liver caused by many forms of liver disease. Muscle cramps are visible or palpable involuntary contraction part of the muscle. The prevalence of cramps in cirrhosis varied range from 31-78%. The pathophysiology of cramps in cirrhosis was explained by multiple mechanisms such as energy metabolism, nerve function, and plasma volume. Cramps significantly diminished the quality of life in cirrhotic patients. Many drugs, vitamins, and minerals were studied for treating cramps in cirrhosis in previous studies but no clinical improvement, good randomized control studies, or side effects. Branched-chain amino acids (BCAA) had been developed to correct this amino acid imbalance and helped to decrease the frequency of cramps and improve the quality of life in cirrhotic patients from previous studies but there were no control groups and a small number of patients were included. The aim of this study was to evaluate the efficacy and safety of BCAA for controlling muscle cramps in cirrhotic patients.
Interventions
12.45 grams of BCAA orally per day before bedtime
DRUGPlacebo
12.45 grams of Maltodextrin orally per day before bedtime
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
All participants will be randomized to receive BCAA or placebo. The BCAA and placebo were prepared by pharmacists who contained both 12.45 grams of BCAA and placebo in the same quantity, the same containing sachet, and labeled enveloped from No.1 to No.50. The sequence of labels was randomized by computer generator block of 4 randomizations with conceal allocation to investigators, participants, care providers, and outcomes assessor.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age ≥ 18 years * Muscle cramp ≥ 1 time per week * Confirmed cirrhotic status (radiologic finding compatible with cirrhosis or liver stiffness measurement ≥ 12.5 kPa by transient elastography method or pathological confirm of cirrhosis)
Exclusion criteria
* Allergy to BCAA * Overt hepatic encephalopathy * Hepatorenal syndrome * Severe renal insufficiency; eGFR \< 30 * Heart failure * Peripheral arterial disease * Active malignancies beyond hepatocellular carcinoma * Heavy alcohol drinking (\> 21g/day for men and \>14g/day for women) * Pregnancy or lactation * Current use of BCAA within 3 months * Recent adding or titrating diuretics within 4 weeks * On current medications for muscle cramp relief such as vitamin E, taurine, carnitine, narcotic pain medications, baclofen, methocarbamol, other muscle relaxers, NSAIDs, or other antispastic agents.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of muscle cramp frequency | 12 weeks | Change from baseline in muscle cramp frequency by patient's diary record |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of muscle cramp severity | 12 weeks | Change from baseline in muscle cramp severity by patient's diary record as the visual analog scale that reported from 0 (no pain) to 10 (worst pain). |
| Quality of life in cirrhotic patients with muscle cramps | 12 weeks | Change of quality of life in cirrhotic patients with muscle cramps at the end of the study compared to baseline by chronic liver disease questionnaire (CLDQ) that includes 29 items in the following domains: abdominal symptoms, fatigue, systemic symptoms, activity, emotional function, and worry. The response of CLDQ results in 1 to 7 scales: ranging from all of the time to none of the time. |
| Muscle mass in cirrhotic patients with muscle cramps | 12 weeks | Change of muscle mass in cirrhotic patients with muscle cramps at the end of the study compared to baseline by bioelectrical impedance analysis (BIA) |
| Change of muscle cramp duration | 12 weeks | Change from baseline in muscle cramp duration by patient's diary record as minutes per muscle cramp events |
| Serum albumin | 12 weeks | Change of serum albumin (g/dL) in cirrhotic patients with muscle cramps at the end of the study compared to baseline |
| Serum alanine aminotransferase | 12 weeks | Change of serum alanine aminotransferase in cirrhotic patients with muscle cramps at the end of the study compared to baseline |
| Serum aspartate aminotransferase | 12 weeks | Change of serum aspartate aminotransferase in cirrhotic patients with muscle cramps at the end of the study compared to baseline |
| Muscle strengthening in cirrhotic patients with muscle cramps | 12 weeks | Change of muscle strength in cirrhotic patients with muscle cramps at the end of the study compared to baseline by hand grip strength measurement |
Countries
Thailand
Outcome results
None listed