Shexiang Baoxin Pill (MUSKARDIA) for Stable Coronary Artery Disease: Safety, Angina Relief, and Cardiovascular Risk Trends from a Large Chinese Trial
Coronary artery disease (CAD) is the leading cause of death worldwide, affecting over 200 million people—even when treated with standard therapies like aspirin (to prevent blood clots) and statins (to lower cholesterol). Yet for many, residual risk remains: up to 12% of patients with stable CAD still experience major adverse cardiovascular events (MACE)—including heart-related death, non-fatal heart attack, or stroke—within four years of treatment. For people in China, especially women, aspirin intolerance (due to stomach issues, asthma, or gout) adds another layer of challenge. This is where traditional Chinese medicine (TCM) like Shexiang Baoxin Pill (MUSKARDIA) comes in: a pill used for over 35 years to treat CAD, but until recently, lacking rigorous scientific evidence.
In 2021, a landmark study published in the Chinese Medical Journal tested whether MUSKARDIA could safely reduce risk and improve symptoms in people with stable CAD. Led by Dr. Jun-Bo Ge from Zhongshan Hospital, Fudan University, and colleagues from 97 hospitals across China, the trial is one of the largest to evaluate a TCM for CAD.
What Is Shexiang Baoxin Pill?
MUSKARDIA is a TCM formula containing muscone (from musk, which supports heart healing), ginsenosides (from ginseng, anti-inflammatory and blood vessel-protective), borneol (reduces tissue damage from low oxygen), and other plant- and animal-derived compounds. For decades, it has been used to treat angina and improve coronary blood flow—but until this trial, its long-term safety and efficacy in stable CAD were unproven.
The Study Design: Rigorous and Large-Scale
Researchers enrolled 2674 patients with stable CAD—defined as consistent symptoms (like angina) for at least one month, plus a history of heart attack, bypass surgery, stenting (over 6 months prior), or coronary artery narrowing of 50% or more. Participants were randomly assigned to take either MUSKARDIA (two pills three times daily) or a placebo for 24 months, alongside their usual care (99.7% took aspirin, 93% took statins).
The trial was double-blind (neither patients nor doctors knew who got the real pill) and placebo-controlled (a “dummy” pill ensured results weren’t due to bias). The main goal was to measure MACE risk; secondary goals included reducing angina frequency (assessed via the Seattle Angina Questionnaire) and checking safety.
Key Results: Safety, Angina Relief, and a Promising Trend for MACE
After two years, the data revealed three critical findings:
1. MUSKARDIA is safe
Side effect rates were nearly identical between groups: 17.7% of MUSKARDIA users and 17.4% of placebo users reported adverse events (AEs). Severe AEs (like hospitalization) were rare—3.5% in the MUSKARDIA group vs. 3.1% in placebo. Lab tests (liver and kidney function) showed no meaningful differences, addressing a major concern with long-term TCM use.
2. MUSKARDIA reduces angina frequency
At 18 months, patients taking MUSKARDIA reported significantly less frequent angina than those on placebo (P=0.0362). Angina stability (how well symptoms are controlled) was also better in the MUSKARDIA group (P=0.0458). While the difference faded slightly at 24 months (P=0.0742), the 18-month result is meaningful: angina limits daily activities, so reducing its frequency directly improves quality of life.
3. A trend toward fewer MACEs—with room for more research
MUSKARDIA users had a 26.9% lower risk of MACE than placebo users (1.9% vs. 2.6%). However, this difference wasn’t statistically significant (P=0.2869), meaning it could have been due to chance. The researchers noted two key reasons:
- The MACE rate was much lower than expected (they’d planned for 5% per year in the placebo group), making the study “underpowered” to detect a significant difference.
- The Kaplan-Meier curve (which tracks when events occur) showed the MUSKARDIA group’s risk started to diverge from placebo after 18 months—suggesting the pill’s benefits take time to appear, a common trait of TCM.
Why This Matters for Patients and Doctors
MUSKARDIA’s benefits align with its ingredients:
- Muscone helps repair heart tissue after injury.
- Ginsenosides reduce inflammation and protect blood vessels.
- Borneol minimizes damage from low oxygen (ischemia) in the heart.
For patients with aspirin intolerance (a big issue in China), MUSKARDIA offers a safe add-on to statins. For everyone with stable CAD, the angina relief is a tangible win—even if the MACE trend needs more confirmation.
Treatment compliance was also high: 84.5% of MUSKARDIA users and 82% of placebo users took at least 70% of their pills, so results aren’t skewed by missed doses.
Limitations to Consider
The study isn’t perfect:
- Late registration: It was registered on chictr.org.cn (ChiCTR-TRC-12003513) after the first patient enrolled—though this was a historical quirk (China didn’t mandate trial registration until later) and no protocol changes were made.
- Short follow-up: Two years may not be long enough to see MUSKARDIA’s full cardiovascular benefits, as TCM often works gradually.
- Underpowered sample: The lower-than-expected MACE rate meant the study didn’t have enough events to prove the pill reduces serious risks.
- Unmeasured factors: The team didn’t track inflammation or oxidative stress—key drivers of CAD—that could explain how MUSKARDIA works.
Conclusion: A Valuable Add-On for Stable CAD
This trial provides strong evidence that MUSKARDIA is a safe, effective add-on to standard CAD treatment. It clearly reduces angina frequency—a major quality-of-life win— and shows a promising trend toward fewer MACEs (even if not statistically significant).
For patients with stable CAD, especially those with aspirin intolerance or residual risk, MUSKARDIA offers a complementary option backed by large-scale research. For doctors, it’s a tool to address both symptoms and long-term risk—without compromising safety.
More research (longer follow-up, larger samples) is needed to confirm if MUSKARDIA reduces MACE risk. But for now, the results suggest this 35-year-old TCM could play a vital role in modern CAD care.
Ge JB, Fan WH, Zhou JM, et al. Efficacy and safety of Shexiang Baoxin pill (MUSKARDIA) in patients with stable coronary artery disease: a multicenter, double-blind, placebo-controlled phase IV randomized clinical trial. Chinese Medical Journal. 2021;134(2):185–192. doi:10.1097/CM9.0000000000001257
Trial registration: chictr.org.cn, No. ChiCTR-TRC-12003513
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