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Boluoke® FAQ

How long before surgery should patient stop taking Boluoke®?
The conservative approach is to stop Boluoke® 1 week prior to surgery. The patient may resume taking Boluoke® 15 days after surgery if there is no complication, or earlier if the physician deems appropriate. Some physicians may recommend certain high-risk patients to start or resume Boluoke® immediately post surgery.

Can Boluoke® be safely taken if the patient is on blood thinning agents?
Lumbrokinase has been safely used together with blood thinning agents in various clinical studies, and does not have any adverse interaction nor increase the chance of bleeding other than what is inherent to the blood thinners (Park S, Kye KC, Sumi H, et al. 1989). Boluoke® has been shown not to significantly affect PT and aPTT (thus it does not affect INR). However, physicians and patients should be aware that other lumbrokinase products may significantly affect PT and/or aPTT. Patients should always consult their physicians before taking Boluoke® while on any prescriptions.

Can the content of Boluoke® capsules be emptied out and taken without the capsules?
The capsules used in Boluoke® are acid-resistant capsules. They are designed to resist stomach acid and dissolve in the small intestines, because lumbrokinase may be inactivated by stomach acid. Preliminary coagulation tests using Sonoclot® machine (manufactured by Sienco, Inc.) indicate that Boluoke® is still effective when taken without the capsules on an empty stomach. However, it is highly recommended that the patients take Boluoke® in its original capsulated format whenever possible.

Can Boluoke® be safely taken with anti-platelet agents?
Lumbrokinase has been shown to be safe when taken together with anti-platelet medications (e.g. aspirin, Plavix) in a few studies. However, because Boluoke® can affect platelet aggregation (Zhang GP, Qian RZ, et al. 1998), it should be used cautiously with strong anti-platelets like Plavix or Ticlid and only under the supervision of a physician.

Can Boluoke® be safely taken with aspirin?
Boluoke® has been shown to be safe when taken with aspirin in clinical studies (Wang XL, Yan DC. 2000; Wang H, Yan DC, et al. 2000). However, patients should consult with their physicians before taking Boluoke® with aspirin or other NSAIDs.

Can Boluoke® be used on pregnant women?
Teratogenicity studies of Boluoke® on animals showed no effect on pregnancy weight, fetal growth, abortion rate, still birth rate, and fetal resorption rate in mice compared to the placebo group. There was also no birth defect detected. However, pregnant patients should not take Boluoke® unless it is done under a physician’s approval and supervision.

What are the contra-indications for taking Boluoke®?
Contra-indications for Boluoke® are: allergy to lumbrokinase or earthworm; recent surgery; pre-surgery; lumbar puncture or arterial puncture; trauma; high risk aneurysm; active internal bleeding or GI ulceration; any other bleeding disorders/tendencies. People who are taking any anti-coagulants (e.g. heparin, warfarin, dabigatran) or anti-platelet drugs (e.g. aspirin, Plavix or Ticlid) should consult their physicians before taking Boluoke®.

Does Boluoke® have any side effects?
The earthworm has been used in Traditional Chinese Medicine for a few thousand years, and is considered to be one of the safest medicines in the traditional pharmacopoeias. In one of the largest clinic trial of Boluoke® involving 16 hospitals and 1560 patients in China, the overall adverse reaction rate was 1.92% (30 cases). 0.58% had skin itching, 0.19% had skin rash, and 1.15% had nausea or diarrhea; no hemorrhage or major side effect was reported.

Does Boluoke® affect ESR or C-RP? What about PAI-1(Plasminogern Activator Inhibitor 1)?
Lumbrokinase has been shown to reduce ESR up to 30% in 4 weeks and C-RP up to 40% in 3 weeks. It has also been shown to reduce PAI-1 in a human clinical trial with prostaglandin E1 injection. PAI-1 is believed to be a risk factor for the development of Type 2 Diabetes.

How fast and how much can Boluoke® lower the patient’s plasma fibrinogen level?
On average, a reduction rate of 10-20% (or more) in 4 weeks can be expected when patients are on the full dosage of 2 capsules three times daily. Boluoke® does not reduce plasma fibrinogen level to below normal. Fibrinogen is an inflammatory marker, and physicians should seek the underlying causes of the inflammation and correct them, and not simply treating the elevated fibrinogen level.

How fast and how much can Boluoke® lower the patient’s whole blood viscosity?
Preliminary data shows that Boluoke® could reduce low-shear whole blood viscosity up to 38% in 4 hours (using Rheolog® machine by Rheologics). However, in some patients with high baseline whole blood viscosity, the viscosity at 4-6 hours after oral dosing may increase temporarily (possibly due to increased generation of FDP & D-Dimers). If the patient continues with the dosage (1-2 caps tid), the viscosity should come down nicely at 24 hours.

Can Boluoke® be taken with other enzyme products?
There is a theoretical possibility that Boluoke may be cleaved and rendered ineffective by other proteolytic enzymes, so we currently do not recommend taking Boluoke® with another proteolytic enzyme product. If you do have to take another proteolytic enzyme product, please take Boluoke® on an empty stomach first, and then take the other enzyme product 30 minutes later.

What is lumbrokinase’s effect on FDP (Fibrin Degradation Product) or D-Dimer?
FDP and D-Dimer levels have been shown to increase significantly from the baseline within 24-48 hours of lumbrokinase administration in healthy and hyperfibrinosis individuals. FDP and D-Dimer are indications of fibrinogen and fibrin breakdown in the body.

I have heard that Boluoke® can help Peyronie’s disease, is it true?
There is no evidence indicating that Boluoke® or other similar enzymes have any effect in helping Peyronie’s disease. Knowing the mechanisms of Boluoke®, it is unlikely that it will be helpful for Peyronie’s disease, thus it is not recommended for those patients.

What about uterine fibroids? Is Boluoke® useful?
Again, this is another myth that’s been propagated on the Internet. Boluoke® is not likely to help those patients unless there is coexisting hypercoagulation.

Can Boluoke® be used to help lower cholesterol?
There is some evidence indicating that lumbrokinase may have a mild cholesterol lowering effect. However, we believe there are other more effective ways to lower cholesterols. Thus, Boluoke® should not be recommended for cholesterol lowering purpose, but for the overall health of the circulatory system.

Can Boluoke® be used to replace coumadin?
Boluoke® is a nutraceutical product and should not be used to replace warfarin. However, if a patient refuses to take warfarin or new anti-coagulant as recommended, then the physician shall find the best alternative for the patient. Regardless what agent the physician decides on, the patient should be properly monitored. If Boluoke® was chosen as the alternative, the patient should be checked for alpha-2-anti-plasmin, prothrombin fragment 1+2, thrombin/antithrombin complex, and soluble fibrin monomer on a regular basis to make sure the thromboembolism risk is being managed well. A discussion with specialized coagulation lab as to what might be the best way to monitor the patient’s status is highly recommended.

What is the suggested protocol for taking Boluoke®?
Boluoke® is best taken under a physician’s guidance in accordance to the patient’s individual condition. For most chronic conditions and maintenance, 1 capsule once to three times daily on empty stomach should be sufficient. In acute conditions and severe hypercoagulable states, Boluoke® should be dosed at 2 capsules three times daily on an empty stomach for 3 to 6 weeks or as long as the doctor recommends.

What kind of tests can be used to see if patients are on appropriate doses of Boluoke®?
Tests like alpha-2-anti-plasmin, prothrombin fragment 1+2, thrombin/antithrombin complex, and soluble fibrin monomer levels are some tests to help physicians determine if patients are on appropriate doses of Boluoke®. We have also found that the gbACT+ test performed on Sonoclot® machine (manufactured by Sienco, Inc.) is a very helpful tool for in-office monitoring of patient’s coagulation status. However, a discussion with specialized coagulation lab as to what might be the best way to monitor patient status is highly recommended.

How quickly does Boluoke® start to act on the body and how to best maintain the maximal effect?
Pharmacokinetic studies showed that the fibrinolytic effect of Boluoke® kicks in about 3 hours and peaks at 6-8 hours after oral administration. At about 12 hours after oral dosing, the fibrinolytic activity is back to baseline level. Thus, the best way to obtain and maintain maximal benefit from Boluoke® is to take each dose about 8 hours apart.

How is Boluoke® different from other products that contain lumbrokinase?
Boluoke® is the only lumbrokinase that has been through Phase I-III clinical trials in China and has an excellent clinical safety and efficacy profile since 1992 (over 20 years). Its enzymatic strength is standardized to no less than 12,000 lumbrokinase units per milligram (often much higher) and no less than 2.4 million tPA units per capsule (tested by independent lab in Canada). Other lumbrokinase products often are citing Boluoke®’s credentials and research, and may not be held to as vigorous quality control measures as Boluoke®. On the raw material market, the price of lumbrokinase can vary by up to 15 folds, and the enzymatic strengths of various lumbrokinase also differ greatly. In addition, lumbrokinase is a preparation containing multiple enzyme fractions, and the extraction and purification method determines the composition of the various enzyme fractions. Thus different extraction method will produce different sub-fractions of lumbrokinase. This is the reason why Boluoke® does not significantly change prothrombin time (PT) or activated partial thromboplastin time (aPTT), while other lumbrokinase sources may significantly alter PT or aPTT as shown in some studies (Jin L, Jin H, Zhang G, Xu G. 2000).

The statements above have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.