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Safety of Red Yeast Rice for High Cholesterol in Individuals With Statin Intolerance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00639223
Recruitment Status : Completed
First Posted : March 20, 2008
Results First Posted : January 18, 2010
Last Update Posted : January 18, 2010
Chestnut Hill Health System
Information provided by:
University of Pennsylvania

Brief Summary:
This study will examine the effect of red yeast rice extract compared to pravastatin on muscle related complaints in individuals with high cholesterol who have previously been unable to tolerate statin medications due to muscle pain. The study will determine whether red yeast is associated with a lower level of muscle related complaints compared to pravastatin.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Statin-Associated Myopathy Dietary Supplement: Red Yeast Rice Drug: Pravastatin Behavioral: Lifestyle modification program Phase 2

Detailed Description:

20 million Americans are actively treated with statins at an annual cost of 16 billion dollars. Statins are effective therapeutic agents for reducing LDL cholesterol and have documented effectiveness. However, a significant subset of patients (5-18%), cannot tolerate lipid lowering statin therapy due to intolerable muscle-related symptoms characterized by muscle pain and/or weakness. These symptoms affect quality of life and lead to poor adherence.

Patients may seek alternative therapies to manage hypercholesterolemia if they have been intolerant of statin therapy. One commonly used alternative treatment option is the Chinese herb red yeast rice extract. Several small studies performed in China, have suggested this treatment is efficacious and well tolerated. In the U.S. red yeast rice is sold over the counter a dietary supplement.

The objective of this study is to critically examine the safety and efficacy of the Chinese herb red yeast rice as an alternative lipid lowering therapy, in a statin intolerant population.

This objective will be operationalized by a double-blind randomized trial, comparing the effect of red yeast rice extract, to that of pravastatin on the level of myalgia in subjects with a prior history of statin-induced myalgias.

The specific aims include:

  1. Determine the relative rates of withdrawal from treatment in subjects receiving red yeast rice compared to pravastatin.
  2. Determine if red yeast rice is associated with a lower level of muscle pain (myalgia) symptoms compared to pravastatin as measured by the Brief Pain Inventory, a validated pain questionnaire.
  3. Determine if red yeast rice is associated with a lower level of muscle weakness compared to pravastatin as measured by a dynamometry, a validated muscle strength testing method.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Red Yeast Rice vs. Pravastatin: A Double-Blind Randomized Comparative Study of Myopathic Symptoms
Study Start Date : January 2008
Actual Primary Completion Date : July 2008
Actual Study Completion Date : October 2008

Arm Intervention/treatment
Active Comparator: Pravastatin Drug: Pravastatin
One 20mg capsule twice daily for 12 weeks
Other Name: Pravachol

Behavioral: Lifestyle modification program
Weekly sessions each lasting 3 1/2 hours for 12 weeks

Experimental: Red yeast Rice Dietary Supplement: Red Yeast Rice
Four 600mg capsules twice daily for 12 weeks

Behavioral: Lifestyle modification program
Weekly sessions each lasting 3 1/2 hours for 12 weeks

Primary Outcome Measures :
  1. Withdrawal of Therapy Due to Muscle Symptoms That Are Either Intolerable and/or Associated With a Creatine Kinase(CK) >500 [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Change in LDL-Cholesterol Measured at the Beginning and End of the Study [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject reports stopping at least one statin drug due to complaints of muscle pain or weakness which his/her physician thinks was attributable to the drug.
  • Subject has never taken pravastatin.
  • Subject willing to remain off the dietary supplements CoQ10, L-carnitine, fish oil, policosanol, and guggulipid, garlic, and phytosterols in margarines (e.g. Benecol, Promise activ), milk or cereal products, for one month prior to the trial and for the duration of the trial.

Exclusion Criteria:

  • A history of muscle damage (CK>1000 IU) on statin therapy.
  • A history of generalized chronic pain such as fibromyalgia, or generalized arthritis.
  • Any active cardiac problem including chest pain, angina, heart attack, bypass surgery, angioplasty/stent or unstable angina/acute coronary syndrome within the past 6 months.
  • Taking other lipid lowering drugs including: ezetimibe, gemfibrozil, niacin, fibrates or bile acid sequestrants.
  • Triglyceride level more than 400 mg/dl.
  • Taking weight loss medication including orlistat, sibutramine, diethylpropion, phendimetrazine, phentermine.
  • Taking pain medication or systemic steroids on a chronic basis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00639223

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United States, Pennsylvania
Chestnut Hill Hospital
Philadelphia, Pennsylvania, United States, 19118
Sponsors and Collaborators
University of Pennsylvania
Chestnut Hill Health System
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Study Director: Steven C Halbert, MD University of Pennsylvania

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Responsible Party: David Becker MD Principal Investigator, Chestnut Hill Health System Identifier: NCT00639223    
Other Study ID Numbers: 806827
First Posted: March 20, 2008    Key Record Dates
Results First Posted: January 18, 2010
Last Update Posted: January 18, 2010
Last Verified: December 2009
Keywords provided by University of Pennsylvania:
Statin related myalgia
Red yeast rice
Cardiovascular Diseases
Nutritional and Metabolic Diseases
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases
Red yeast rice
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors