病人在使用DCA之前,需要了解有关DCA的效果, 安全性和有关法律

来源: 御用文人 2015-02-01 11:29:17 [] [旧帖] [给我悄悄话] 本文已被阅读: 次 (27605 bytes)
DCA (dichloroacetate) Frequently Asked Questions
Updated Oct 2014

Common dichloroacetate (DCA) Frequently Asked Questions and answers are listed below. Please contact us if you have questions that are not fully addressed here. This page is also available as a PDF.



DCA FAQ's
Background
What types of cancers does DCA work on?
Observational DCA Data
Is DCA natural?
Is DCA safe?
Oral vs. Intravenous DCA
Online DCA sale – is it of good quality and safe?
DCA and Renal Failure
DCA and Heart Failure
DCA and Heart Rhythm Disturbance
DCA and Liver Failure / Jaundice
DCA and Diabetes
DCA-Drug Interactions
DCA and Caffeine
DCA and Chemotherapy
TLS (Tumour Lysis Syndrome)
What is the status of DCA clinical trials?
A publication says DCA increases the growth of colon cancer. Is that correct?
Do I Qualify for DCA Treatment?
How is DCA administered?
What is the duration of treatment?
Is DCA Available?
I don’t live near Toronto, can I still be treated?
How do I become a Medicor patient?


Background
Video Overview – All patients interested in DCA therapy are encouraged to first watch this educational video: https://www.youtube.com/watch?v=9o12uT_d-Co
This is a video of Dr. Khan presenting a lecture to patients and healthcare practitioners filmed at Hippocrates Health Institute in Florida in May 2014.

In 2007 a research team at the University of Alberta discovered that the drug DCA (dichloroacetate sodium) induced the death of human breast, lung and brain cancer cells that were implanted into rats, while being non-toxic to healthy cells.

This research was published in Cancer Cell, 11, 37–51, January 2007. DCA has been found to kill cancer cells by a newly discovered mechanism that appears to be common to several types of cancer. DCA works by turning on the natural cell suicide system (called apoptosis) which is suppressed in cancerous cells, thus allowing them to die naturally. DCA does not poison the cells like cytotoxic chemotherapy drugs. DCA also interferes with the cancer cell’s use of glucose, starving the cell of energy. At the same time, it does not starve healthy cells in the body.

This discovery alone was not enough to allow DCA to be used in humans as a cancer therapy. The work of Dr. Peter Stacpoole and his colleagues at University of Florida was instrumental in establishing human dosing and side effect profile of DCA, and provided a starting point for its use in cancer patients.

DCA research has accelerated in the last few years. The latest research shows that DCA kills many types of cancer cells, and can boost the cancer-killing effects of chemo, radiation and targeted cancer drugs. The first formal human cancer research using DCA was published in May 2010. This small study confirmed that DCA is an effective anti-cancer drug for treating glioblastoma patients (Metabolic Modulation of Glioblastoma with Dichloroacetate, Science Translational Medicine, Vol 2, Issue 31).

We have published 2 papers demonstrating significant responses to DCA for various cancer types. These are linked on our website: http://medicorcancer.com/treatments/dca-therapy/ We have also received acceptance for publication of the world’s first paper on intravenous DCA as a cancer therapy (check website for the latest update).

MEDLINE is the largest medical database in the world, and contains information on published DCA research. This database can be searched free of charge for those interested in finding other DCA publications. Further research to determine how well DCA works against various cancers within the human body is ongoing, but studies are small and proceeding slowly.

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What types of cancers does DCA work on?
Several publications demonstrate that DCA works in a variety of cancers. These include human studies, case reports and lab studies (rat and in vitro). The cancer types studied so far are: colon, breast, prostate, ovarian, gastric, brain (neuroblastoma), brain (glioblastoma), lung (carcinoid), uterus (cervix), uterus (endometrial), melanoma (including BRAF V600E mutation), lymphoma (non-Hodgkin’s), sarcoma, multiple myeloma and cancer of unknown primary. In our experience, DCA may work on any cancer type, including various rare tumours.

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Observational DCA Data
For the first time in the world, on Dec 7, 2007 we publicly shared our observational data from the treatment of our first 118 cancer patients with oral DCA. We updated our data in 2009 from treating over 347 patients. This can be found here. We are focusing our efforts on publishing our findings in reputable peer-reviewed medical journals.

Our first publication is: “Use of Oral Dichloroacetate for Palliation of Leg Pain Arising from Metastatic Poorly Differentiated Carcinoma: A Case Report.” This can be viewed here.

Our second DCA publication showed how DCA can enhance radiation to achieve remarkable results in stage 4 cancer, can be read here.

We also were the first to demonstrate the potential synergism of DCA with the diabetes drug metformin. We co-published a paper in which one can see an example of a glioblastoma tumour with 99% cell kill from a combination of DCA + metformin, but <10% cell kill from either drug alone. Read the paper here.

We have other papers currently being written on various cancer types. Due to our priority of treating patients, finding time to prepare papers for publication remains a challenge.

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Is DCA natural?
DCA is a synthetic drug, but it is a very simple compound similar to a chemical combination of salt and vinegar. It works against cancer in a natural way (by triggering natural cell suicide or “apoptosis”).

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Is DCA safe?
DCA has been used in humans to treat a rare disease called “congenital lactic acidosis”, and found to have some mild to moderate side effects, based on extensive research published by Stacpoole and his colleagues. Our experience so far suggests that DCA is safe to use in cancer patients under close medical supervision. DCA is not to be used without the supervision of a doctor. Some animal studies show that DCA can itself cause liver cancer. These studies used doses which are much higher than what would be prescribed for cancer treatment. Also, no research has every demonstrated liver tumour formation in humans as a result of DCA therapy. We have observed that DCA can have 2 main categories of side effects.

Neurological:

Nerve injury (“peripheral neuropathy”). Neuropathy typically develops in the hands and feet (but not always), takes several weeks to months to develop, and is reversible if it is caught early. In the existing literature, neuropathy from DCA has always been shown to be reversible. We use vitamin B1 (benfotiamine or thiamine), acetyl L-carnitine and R alpha lipoic acid to prevent and reduce the severity of peripheral neuropathy. These medicines can be given orally or intravenously depending on the degree of neuropathy. Published data clearly demonstrates all of these medicines can help chemo and/or diabetic neuropathy, and our own extensive experience confirms that these supplements are effective for DCA neuropathy as well. We have co-published a review article on natural therapies for neuropathy, here.

Anecdotal reports suggest certain cannabis-derived products may also reduce neuropathy.

Sedation, confusion, hallucinations, memory problems, mood changes, hand tremors. These side effects are temporary and appear to be dose-dependent and age-dependent. A small number of patients metabolize DCA very slowly, and will develop significant side effects rapidly at standard doses. In these patients, DCA can still be used, but a low dose will be needed. These findings are consistent with existing human research on DCA that we have reviewed. We use benfotiamine (a type of vitamin B1), acetyl L-carnitine and R alpha lipoic acid to prevent/reduce these side effects. If you are a Medicor patient, you will receive our latest dosing guidelines for these supplements. Due to potential interference with other ongoing treatments like radiation or chemotherapy, certain supplements such as lipoic acid may not be recommended, or may have to be skipped during part of the radiation or chemo treatment. For patients with seizures that are not fully controlled, acetyl L-carnitine should be used with caution or avoided. Medicor patient will receive detailed information specific to their treatment plan.

Gastrointestinal:

Heartburn, nausea, vomiting, indigestion. These side effects may occur with DCA, and we prescribe a “proton pump inhibitor” antacid medication (e.g. pantoprazole) as needed to treat them.

Other Side Effects:

Some patients experience pain at the sites of their tumour(s) within the first few days of starting DCA. This may be an indicator of the effectiveness of DCA. About 1-2% of patients have mild liver toxicity (increase in liver enzymes noted without symptoms). We have not observed a fall in blood cell counts due to bone marrow toxicity, or any other significant organ toxicity. Note that leukemia or lymphoma patients may see a fall in their high white blood cell count, indicating destruction of the cancerous white cells. Reduction of blood pressure is uncommon, but possible. We have never seen a true allergic reaction to DCA, but we have rarely seen “anaphylactoid” reactions to iv DCA. This is caused by histamine release in the bloodstream. It is easily treated with antihistamine medication. We have seen 2 cases of tumour lysis syndrome (discussed below).

Most side effects reported so far have been mild or moderate. Patients experiencing moderate side effects are usually taken off DCA as a precaution. Most side effects typically resolve within days after stopping DCA. Neuropathy can take weeks or months to resolve.

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Oral vs. Intravenous DCA
We now have extensive experience using iv DCA. Our normal protocol involves twice per week iv DCA treatment, with doses that are about 2-3 times higher than our oral DCA protocol. The theory is that the higher DCA doses may be able to attack the cancer more effectively. Our experience indicates that side effects can be reduced and resolve faster when DCA is given in this manner. For example, patients responding well to oral DCA who develop neuropathy can be switched to iv DCA, and therapy can continue while the neuropathy heals. Elderly patients wanting DCA therapy, who are concerned about side effects may decide to try iv DCA instead of oral DCA. Also, iv DCA can be used where swallowing is difficult, or medication absorption is poor or unreliable. We generally recommend high dose iv vitamin C along with iv DCA, since these 2 therapies appear to work well together.

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Online DCA sale – is it of good quality and safe?
DCA is a prescription drug in Canada, USA and through most of Europe. It cannot legally be sold as a medication unless it is under a doctor’s prescription (medical doctor or naturopathic doctor). Lab grade DCA powder is sold legally online from various chemical manufacturers and is not suitable or approved for human consumption.

Various online merchants have attempted to bypass FDA and Health Canada regulation by selling DCA capsules online to anyone without a prescription. This is not permitted by law in North America. Buyers should be aware that these companies are not regulated and may be selling fake DCA, or DCA that has not been properly manufactured or has not gone through the rigorous quality controls of manufacturing at a proper GMP-certified drug manufacturer.

Regardless of claims their DCA is “certified” or “pharm grade” or “tested”, these merchants have no accountability to patients if the DCA is faulty or the patient experiences side effects. Claims of independent purity testing are difficult to verify. One online merchant has already been convicted of fraud and is serving a jail term for selling fake DCA to cancer patients.

Three simple questions to consider in order to confirm the problems with online DCA merchants are:

1) Do they have a valid physical commercial address listed on their website? (If not, why are they hiding? If yes, is it someone’s house?)
2) Is the DCA surprisingly cheap? (Why?)
3) Do they have medical doctors or naturopathic doctors on staff? (Why not?)

Please do not ask Medicor staff for advice about DCA purchased online! Various websites are using our name without authorization, and we are not able to answer questions about unknown products. We strongly advise all patients to steer clear of these merchants, whose focus is quick profit, not patient care.

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DCA and Renal Failure
DCA is not toxic to the kidneys. DCA can safely be used in patients with moderately severe renal failure based on our experience.

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DCA and Heart Failure
DCA is safe to use in patients with heart failure. DCA improves the pumping efficiency of the heart without increasing oxygen demand. As a result, it can improve heart failure and/or angina.

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DCA and Heart Rhythm Disturbance
DCA shortens the QT interval which is an electrical measurement of the heart determined by ECG. Combination with drugs that prolong the QT interval is therefore unlikely to cause abnormal heart rhythms. Rather, DCA may even prevent abnormal heart rhythms.

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DCA and Liver Failure / Jaundice
DCA is metabolized by the liver, so dose adjustment is needed for patients with liver failure. Also a different cycle may be needed. Intravenous DCA is likely safer than oral DCA for patients in liver failure.

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DCA and Diabetes
Diabetics may notice a slight improvement in blood glucose control. Diabetes medications generally do not have to be changed, but blood glucose monitoring will determine if a small reduction of diabetes medication (like insulin) is required.

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DCA-Drug Interactions
We have observed that drugs that can cause confusion or hallucinations have a potential to interact with DCA. This may include cannabinoids, benzodiazepines and other CNS drugs, especially if they are already causing some neurological side effects. Patients on stable doses of opiate pain medications or benzodiazepines who are not having side effects from these drugs rarely have such issues. Use of intravenous DCA may reduce the issue of confusion / memory problems when taking other drugs that can cause these side effects.

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DCA and Caffeine
We have received a large number of inquiries about caffeine following some anecdotal reports of enhanced DCA effect with excessive tea/caffeine intake. After conducting a limited review of our DCA patients, we have noted that a few patients with high tea/caffeine consumption (> 10 cups per day) have shown no response to DCA. Also many patients who have shown an excellent response to DCA do not take tea/coffee or caffeine or take it in minimal amounts.

There are a number of potential harmful effects of consuming high doses of caffeine including increased likelihood of seizures in brain tumour patients, abnormal heart rhythms, anxiety, and insomnia. Even though there is research showing that intravenous high dose caffeine can enhance chemotherapy, the potential for caffeine to enhance DCA therapy is unverified. We are presently recommending against the use of high dose caffeine, unless it is done with medical supervision. Patients should use moderation with consumption of caffeinated drinks and check with their own doctor, naturopath or dietician for specific advice.

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DCA and Chemotherapy
For the first time in North America, Medicor and AccuTheranostics (previously known as ORT) began conducting ChemoFit tests with DCA and chemo combined (2008). Eligible patients were able to have a sample of their own tumor analyzed to see if combinations of DCA and chemo were effective, and if they worked better than chemo or DCA alone. The accuracy of the ChemoFit test ranges from 85-95%.

We have already had some exciting results showing that DCA can, in some cases, dramatically enhance the cancer-killing effects of chemo, rarely to the point of remission (estimated 1-2% chance of complete remission). However, there is a possibility that DCA can interfere with chemo as well. This is similar to treatment with a single chemo being better than combination chemo for some patients. Published lab research now confirms our findings.

If you are a patient who is thinking of combining DCA and chemotherapy, we recommend you contact Dr. Bradford or Dr. Thakur at AccuTheranostics www.accutheranostics.com for information.

The best time for a ChemoFit test to be done is at the time of cancer surgery. If you have already had surgery, but you have an accessible tumour, it can be biopsied by your surgeon for the ChemoFit test. Malignant ascites fluid samples and malignant pleural effusion samples can now be tested with ChemoFit, eliminating the need for a biopsy in some patients. If you are not able to have the ChemoFit test, a treatment plan can be developed to safely combine DCA with most chemotherapy drugs with minimal risk of interference (depending on the chemotherapy schedule).

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TLS (Tumour Lysis Syndrome)
This is a condition in which a large number of tumour cells are rapidly killed, causing a sudden release of the contents of the dead cells into the bloodstream. It can result in abnormal heart rhythms, salt imbalance in the blood and kidney failure. A detailed reference article can be found here. TLS occurs most commonly in patients with a large mass of tumour cells in the body who receive chemotherapy, especially with lymphomas or acute leukemia. We have not had a single case of TLS in our patients treated with DCA alone. Since DCA can enhance the effect of chemotherapy in certain cases, it may be more likely to occur if DCA is combined with chemotherapy, especially without medical supervision. We have noticed that intravenous DCA can work more quickly than oral DCA in some cases, so there is theoretically more risk of TLS. Still, we have not observed any cases of TLS with iv DCA alone. We have noted 2 cases of TLS, 1 where oral DCA was combined with chemotherapy in a lymphoma patient (mild case) and 1 where iv DCA was combined with oral cannabis oil in a lymphoma patient (moderately severe TLS).

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What is the status of DCA clinical trials?
The first phase 2 clinical trial of DCA in glioblastoma was completed but was not published as a trial, possibly because the DCA doses were too high and resulted in a large number of patients dropping out (our opinion, actual reason not disclosed by the authors). A few DCA clinical trials are ongoing, or completed. These can be reviewed here.

Since DCA is not a patented drug, it cannot be sold at a high price to repay the expense of a large scale clinical trial. Therefore, pharmaceutical manufacturers are not interested in funding DCA trials.

Even though we have seen clear evidence of DCA’s effectiveness in several types of cancer, Medicor physicians believe that it is necessary for formal clinical trials to be conducted. DCA is different from other drugs that undergo clinical trials because it is not a “new” drug. It has already been used for decades in humans, and has a relatively safe profile. This means that the trials may take less time, but may still take years. Many cancer patients cannot wait this length of time. We are hopeful that information obtained from our experiences with DCA will supplement clinical trials, and help patients and the medical community determine that DCA does have significant anti-cancer activity in humans.

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A publication says DCA increases the growth of colon cancer. Is that correct?
There is a publication which reports that DCA enhances the survival of colon cancer cells. This paper is flawed because the researchers looked at the effects of DCA on cancer cells with a complete absence of oxygen (anoxia). While hypoxia (low oxygen) may be common in tumours, anoxia (complete lack of oxygen) is not a normal situation. In very rapidly growing tumours, there will be areas of anoxia, however colon cancer generally does not behave that way.

In addition, a subsequent study has been published which shows the opposite effect: DCA improving cancer cell killing under hypoxic conditions: read here.

In summary, we believe our clinical findings from treating actual patients are more meaningful than a lab study done under artificial conditions. DCA (both oral and intravenous) can be an effective treatment for colon cancer based on our extensive clinical experience. DCA can cause symptom improvement, tumour shrinkage, tumour stability, or reduction in the colon cancer blood marker CEA. DCA can be effective even in patients who are chemo-resistant.

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Do I Qualify for DCA Treatment?
Patients with a documented diagnosis of cancer (any type) under the following categories qualify for treatment:

failed conventional, scientifically proven treatments
told by their doctor that there is no safe or effective treatment for their cancer
waiting to start conventional treatment, and would like to do something in the interim
treated for cancer, and would like to prevent recurrence (where no proven recurrence prevention is available)
receiving therapy which has a poor chance of success and would like to strengthen their treatment
reviewed conventional therapies with the oncologist (or other specialist) and declined them voluntarily after fully understanding the risks and benefits
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How is DCA administered?
DCA is currently available in 3 formulations: oral liquid, oral capsules, intravenous. Oral DCA can be taken at home, DCA i.v. can be administered at the Medicor office or at the office of a naturopathic doctor who is certified to administer iv medications. We no longer recommend DCA cream.

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What is the duration of treatment?
In order to determine if DCA is effective in treating your cancer, we recommend at least 2 to 3 months of treatment. For slow growing cancers, longer treatment is needed, perhaps 3 – 6 months. Sometimes we can determine if there is a favourable response within 4 weeks however. If your cancer responds to DCA, therapy may continue indefinitely. If you experience significant side effects, treatment will be stopped and may be restarted later, or changed to something else.

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Is DCA Available?
Yes. We obtain certified pharmaceutical grade DCA for our patients from a reputable GMP certified multi-national chemical and drug manufacturer. We never obtain DCA made in China or India despite the lower price, and claims of GMP / pharmaceutical quality.

Recently there have been media reports of drugs on pharmacy shelves made in India or China, which fail to meet the quality control standards: Canadians kept in dark about defective drugs

For this reason, we prefer to keep strict control of quality by using only DCA which is made in USA.

We will not routinely write prescriptions for DCA to be obtained from pharmacies, since we cannot be certain of the country of manufacture, or of the quality. Further information is available in Medicor’s Drug Prescribing Policy.

We have clearance from the relevant Federal and Provincial regulatory bodies to obtain and dispense DCA. It is compounded into capsules, injectable liquid or oral liquid for us by a licensed pharmacist, using our own DCA powder. DCA can only be dispensed to patients who come under the care of our medical team.

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I don’t live near Toronto, can I still be treated?
Yes, you can come to our clinic to be evaluated, and begin treatment. After that, you may return home to continue treatment under supervision by your naturopathic doctor, family doctor or oncologist. If you are unable to travel, please call or email us to discuss your options. Telemedicine consultation and ongoing care are available.

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How do I become a Medicor patient?
Please obtain your pathology report confirming the diagnosis of cancer type (if applicable), your latest CT scan or MRI (if applicable), and your latest blood test report. If you do not have a pathology report (e.g. if you did not have a biopsy), we require some documentation confirming the diagnosis of cancer.

You can call us at 416 227 0037 or email us to make an appointment to discuss your individual case. We will do our best to respond to your request promptly. A valid Health Card from any province (except Quebec) is required for a free consultation. Patients from Quebec must pre-pay for consultation since the Minstère de la Santé does not properly pay Ontario doctors for insured services. Insured patients are only required to pay for the medication, as it is not covered by Ontario Drug Benefits.

Please note that due to Ontario College of Pharmacists regulations, we are presently treating patients using our own verified source of compounded pharmaceutical grade DCA. Regrettably, we cannot take responsibility for treatment of patients wishing to bring their own DCA. In this case, we can only provide one-time consultation services to assist you or your physician(s).

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