Lumbrokinase: Is It Safe? Study Results Explained

observational-study PMID: 27011386

Quick Summary: A study looked at whether Lumbrokinase DLBS1033 is safe for healthy adults. The good news? It appears safe and well-tolerated at the tested dose, with no major side effects like bleeding or allergic reactions.

What The Research Found

Researchers wanted to know if taking Lumbrokinase DLBS1033 would cause any problems for healthy people. They found that taking the supplement for a short time didn't seem to cause any significant issues. This means it was "safe" and "tolerable" – meaning people didn't experience any serious side effects.

Study Details

Who was studied: 20 healthy adults.

How long: Participants took either Lumbrokinase or a placebo (a sugar pill) for 14 days. Then, after a break, they switched to the other one for another 14 days.

What they took: 490 mg of Lumbrokinase DLBS1033 three times a day.

What This Means For You

This study suggests that Lumbrokinase DLBS1033, at the tested dose, is likely safe for healthy adults over a short period. However, it's important to remember:

This study doesn't prove it works. It only looked at safety, not whether it helps with any health conditions.

Talk to your doctor. Always discuss any supplements with your doctor, especially if you have any health conditions or take other medications.

Study Limitations

It's important to know what the study didn't tell us:

Small group: The study only included 20 people, so we can't be sure the results apply to everyone.

Short-term: The study only looked at the effects over a couple of weeks. We don't know about long-term safety.

Healthy people only: The study only included healthy adults. It's not clear if the results would be the same for people with health problems.

No proof of effectiveness: The study only looked at safety, not whether Lumbrokinase actually helps with anything.

Key Findings

The study concluded that Lumbrokinase DLBS1033 at 490 mg thrice daily was safe and tolerable in healthy adults. No significant differences were observed between DLBS1033 and placebo in hemostasis parameters (e.g., prothrombin time, activated partial thromboplastin time), vital signs, electrocardiography (ECG), or laboratory markers (liver/renal function, lipid profile, fasting glucose). Additionally, no hemorrhagic symptoms (e.g., petechiae, epistaxis) or allergic reactions occurred during treatment. One participant dropped out during the second period, but overall adherence was high.

Study Design

This was a 2-arm, randomized, double-blind, placebo-controlled crossover observational study conducted in 2016. Twenty healthy adults were enrolled, with each subject receiving both DLBS1033 and placebo across two 14-day treatment periods separated by a 2-week washout. Safety assessments included clinical evaluations, lab tests, and ECGs at baseline and post-treatment.

Dosage & Administration

DLBS1033 was administered at 490 mg three times daily (total 1,470 mg/day) orally for 14 days. Placebo was matched in appearance and administration schedule. The crossover design ensured all participants acted as their own controls, reducing inter-individual variability.

Results & Efficacy

Hemostasis: No significant changes in coagulation parameters (p > 0.05).
Hematology/Blood Chemistry: No differences in hemoglobin, platelet count, liver enzymes (ALT, AST), creatinine, or lipid levels.
Safety: No hemorrhagic events or allergic reactions reported.
ECG/Vitals: No clinically relevant abnormalities in heart rate, blood pressure, or ECG readings.
Dropout: One subject withdrew during Period 2, but reasons were unspecified.

Statistical significance (p-values) was reported for all comparisons, with no notable differences between DLBS1033 and placebo.

Limitations

Small sample size (n=20) limits generalizability and power to detect rare adverse events.
Short duration (14 days per period) precludes assessment of long-term safety.
Healthy adult bias: Results may not apply to diseased populations or elderly individuals.
Observational design: While structured as a crossover trial, the study’s classification as observational (rather than interventional) may limit causal inference.
Washout period adequacy: The 2-week washout was assumed sufficient, but no pharmacokinetic data supported this.
Lack of demographic details: Age, gender, or ethnicity of participants were not specified in the summary.

Clinical Relevance

DLBS1033 at 490 mg thrice daily appears safe for short-term use in healthy adults, with no evidence of bleeding risk or organ toxicity. However, the absence of efficacy data means these findings only support safety, not therapeutic benefits. Supplement users should consider:
- Use case: May be suitable for short-term applications (e.g., acute fibrinolytic support) but long-term safety requires further study.
- Monitoring: No routine lab monitoring needed in healthy individuals, but caution is advised for those on anticoagulants or with bleeding disorders.
- Future research: Larger trials in diverse populations (e.g., elderly, cardiovascular patients) are warranted to confirm safety in broader contexts.

The study provides foundational evidence for DLBS1033’s safety profile but does not address its efficacy for conditions like thrombosis or inflammation.