Should you take part in clinical trials for HNPP?

Jul 17, 2017Jul 17, 2017 suswatibasuLeave a comment

“Clinical trials” is phrase that’s always bandied about for illnesses such as cancer, and you may wonder what it actually is and whether it’s worth taking part. The use of human volunteers to collect data is not always for everyone. It is wrapped in the enigma of experimentation and feeling exploited. But what is it all about?

“Fear is a greater barrier than the reality.”

Robert L. Comis, M.D

The National Heart, Lung and Blood Institute, run by the US Health Department, describes a clinical trial as research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. These studies enable medical professionals to follow the best path for certain illnesses or groups of people. The NHLBI say: “Clinical trials produce the best data available for health care decision-making.”

So why are people reluctant to take part?

A survey by Harris Interactive, Inc., showed that of the patients who knew about clinical trials, 71 per cent still chose not to participate.

Uncertainty of treatment – Fear of being treated as a guinea pig and getting a placebo is the most common factor that pulls patients away from clinical trials. In fact, placebos are rarely used in cancer treatment trials, and never in lieu of standard treatment, according to Robert L. Comis, M.D., president of the Coalition of National Cancer Cooperative Groups and chairman of the Eastern Cooperative Oncology Group in Philadelphia. Ninety-seven percent said they were treated with dignity and respect, and received excellent or good quality care.
Worry about insurance – For our US friends, one in five participants were concerned that their insurance companies may not pay out. But for those who enrolled in clinical trials, 79 per cent said their insurance company ultimately paid for the care they received.
Uncertainty of results/adverse effects – People are afraid whether the new therapy will work to improve their health or worsen their disease. Although researchers cannot guarantee outcomes, patient safety is apparently top priority. Each trial has enforced oversight, and patients also have rights that help protect them. Currently participant’s right are protected by regulatory bodies like the Institutional Review Board (IRB) in the US, and Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. There will be an equivalent to your native country, usually through the government.
Inconveniences. Some people can’t commit to the time required to participate in a clinical trial. Others may find the available hours incompatible with their schedule. Travel is an issue for some, whether they’re unable to transport themselves or find a geographic location close enough. Other social and economic disadvantages contribute to some populations being underrepresented. Some trials even pay the participants for enrolling in a trial. However, FDA suggests people must learn thoroughly about the risks involved in a study before enrolling, and not get lured by the free treatment or money being offered.
Missed opportunities – Low enrolment is attributed to many factors and varies on a per study basis, but if more people knew about clinical trials there would certainly be more participation. One study found that only one in three US adults knew about clinical trials, of the 1,000 surveyed.

The NHLBI state: “The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards protect patients and help produce reliable study results.”

But does that ease our fears?

To be fair, it’s unusual for clinical trials to try something completely experimental. They usually go through a lot of scientific research before getting to this stage. That being said it is important to check the credentials if you do wish to take part.

It is one of the final stages of a long and careful research process. The process often begins in a laboratory, where scientists first develop and test new ideas.

If an approach seems promising, the next step may involve animal testing. This shows how the approach affects a living body and whether it’s harmful. However, an approach that works well in the lab or animals doesn’t always work well in people. Hence, research in humans is needed. It may start off with only a few patients, in order to ensure safety, while in later phases of clinical trials, researchers learn more about the new approach’s risks and benefits.

Why do they need volunteers?

Volunteers can play an important role at this stage of development, which is crucial for new treatments to reach pharmacy shelves. Without sufficient numbers of trial participants, the drug development process stalls and a trial must be repeated, scaled back or, even worse, the potential new therapy is abandoned. This lengthens the time it takes for new treatments to come to market. No amount of funding or other resources can compensate for the lack of clinical research volunteers.

According to the Foundation of Peripheral Neuropathy, across all diseases, 85 per cent across of clinical trials finish late due to difficulties enrolling participants and nearly one-third of trials fail to recruit a single subject and cannot ever begin.

Phases of the trial

Clinical trials are conducted in phases designed to answer a separate research question.

Phase 1 Safety testing of a small batch of healthy volunteers – recruiting only a few patients, usually less than 100. The first few patients to take part (called a cohort or group) are given a very small dose of the drug. If all goes well, the next group have a slightly higher dose. The dose is gradually increased with each group. The researchers monitor the effect of the drug until they find the best dose to give. Doctors/researchers look at how the drug affects the volunteer: How is it absorbed? How is it metabolised and eliminated from the body? Does it cause side effects?
Phase 2 Testing effectiveness and safety on small batch of patients – doctors evaluate the candidate drug’s effectiveness in a larger group of patient volunteers. In this case, researchers compare the efficacy of the drug on the patient compared to a different treatment. Patients are either given a placebo or a drug that is already used for treatment. Some phase 2 trials are randomised. This means the researchers put the people taking part into treatment groups at random. Doctors/ also analyse optimal dose strength and possible side effects.
Phase 3 Testing effectiveness and safety on a much larger group of patient volunteers – Phase 3 trials usually involve many more patients than phase 1 or 2. This is because differences in success rates may be small. So, the trial needs many patients to be able to show the difference. This phase of research is essential in determining whether the drug is safe and effective. Patient volunteers are divided into three groups: the group that gets the standard treatment; the group that gets the new treatment being tested; and if doctors do not know if the new treatment is better than the standard treatment, but they believe it is as good and may be better.
Phase 4 Researching long-term side effects – Phase 4 trials are usually done after a drug has been shown to work and has been granted a licence. The goal of this phase is to continue studying side effects of a new treatment.

If you take part in a clinical trial, you may be one of the first people to benefit from a new treatment.

However, there is also a chance that the new treatment turns out to be no better, or worse, than the standard treatment. It’s a chance / risk, and ultimately it’s your choice if it really is for you.

Where to find clinical trials:

Centerwatch.com – global database of clinical trials
NHS.uk – UK-based clinical trials
UK Clinical Trials Gateway – Educational side of the NHS
Global Register for Inherited Neuropathies – collects clinical and genetic information on patients from around the world diagnosed with various forms of hereditary neuropathies
ClinicalTrials.gov – US health department based clinical trials
World Health Organization – International clinical trials registry platform

Can medical marijuana help pain from HNPP?

Jul 13, 2017Mar 6, 2018 suswatibasu3 Comments

cannabis marijuana hnpp hereditary neuropathy

This is a super controversial subject, especially since it’s part of a wider global debate on whether to legalise marijuana for those with chronic illnesses. I say this as some medical professionals I’ve spoken to have recommended it to ease nerve pain from HNPP. It isn’t for everyone for a variety of personal reasons and it is obviously still illegal in most countries.

With marijuana, or cannabis, the advantages include the fact that there has been a long history of use and some evidence of benefits – many patients swear by the herb to relieve their pain, and physicians see it helping those who have few other options. To others, medical marijuana – which lacks both standardised formulations and rigorous clinical testing – represents a challenging deviation from the ideal of evidence-based medicine.

The issue is that one can generalise that medical cannabis has a higher level of testing standards required to meeting the medical standards for dispensing in areas where it has been legalised. These standards do not always apply to recreational use. But this may differ from country to country, from state to state.

This is more of a hypothetical situation for many.

Disclaimer: Everything written is based on personal and other’s testimonies, available journals and research. Please check with your doctor or practitioner before taking new medicines, and do not break your country’s laws.

So is it helpful?

According to Medical Marijuna Inc, a pro-marijuana think-tank, two major cannabinoids found in cannabis, tetrahydrocannabinol (THC) and cannabidiol (CBD), activate the two main cannabinoid receptors (CB1 and CB2) of the endocannabinoid system within the body.

These receptors regulate the release of neurotransmitter and central nervous system immune cells to manage pain levels.

Mark Ware, a pain clinician at McGill University, Montreal, Canada, explained that the CBDs act as modulators, “circuit breakers,” on numerous nervous pathways. Within these pathways, CB receptors are located at many key sensory intersections.

neuropathy

Once the nerve is stimulated by an action potential (normal nerve conduction) endocannabinoids such as anandamide flow retrograde up to the presynaptic terminal to dampen the forward flow of nervous information. This leads to less pain impulses being generated and perceived. This decrease is interpreted as pain relief.

Dr Rosemary Mazanet has done some extensive research on the use of medical marijuana on neuropathic pain. Writing for the Foundation for Peripheral Neuropathy, she said: “Although CBD and THC act differently in the body, they seem to have many of the same medical benefits. Unfortunately, most of this evidence comes from animals, since very few studies on cannabis have been carried out in human patients.”

She adds: “Patients should treat marijuana for medical use like they would any prescription and avoid operating a motor vehicle or heavy machinery, performing child or elder care, and making important decisions while under treatment.”

Unlike opioids, marijuana cannot cause someone to stop breathing, no matter how much they ingest.

What are the side effects?

Increased heart rate
Dry mouth
Reddening of the eyes
Muscle relaxation
Sensation of cold or hot
Anxiety and paranoia are the most commonly reported side effect of smoking marijuana with a high THC content
Alteration of conscious perception
Feelings of well-being, relaxation or stress reduction, increased sensuality, increased awareness of sensation, increased libido, and creativity
With very high doses, THC can induce auditory and visual hallucinations. THC should be used only under the care of a physician by anyone with a mental health history.

Effects of cannabis

Peak levels of cannabis-associated intoxication occur approximately 30 minutes after smoking. The total short-term duration of cannabis effects when smoked is based on the potency, method of smoking (vape) and how much is smoked. Any acute effects that accompany cannabis use usually abate after 6 hours.

When taken orally (in the form of capsules, food or drink), the effects take longer to manifest initially, and generally last longer, typically for 4–10 hours after consumption. Taking marijuana in the form of edibles can have unpredictable effects, since they are delayed and thus harder to predict.

Where is it legal for medicinal use?

Smoking weed is legal to some extent in 30 states in the USA, though the majority only allow consumption for medicinal purposes. So where has medicinal marijuana been legalised?

Countries where medicinal use is legal	Information on how it is used
Argentina	Decriminalised for personal use. Medical cannabis is legal in Chubut since September 2016, and in Santa Fe since November 2016.
Australia	Legal for medicinal and scientific purposes. Decriminalised for personal use in the Northern Territory, South Australia and the Australian Capital Territory.
Bosnia & Herzogovina	In 2016 it was announced that the Ministry of Civil Affairs had formed a task force to explore the legalising of cannabis and cannabinoids for medical purposes.
Canada	Legal with government issued licence for medical or industrial purposes. In April 2016, Health Minister Jane Philpott announced that new legislation would be introduced in spring 2017 to legalise and regulate cannabis in Canada.
Chile	Since 2014, Chile allows the cultivation of cannabis for medical purposes with the authorisation of The Chilean Agriculture Service (SAG). Sale of marijuana-derived medication is allowed on prescription in pharmacies, from December 2015.
Colombia	Legal for up to 22 grams for personal use. No limit for medical or scientific purpose, and if licensed by the “National Anti-narcotics Council”
Croatia	In 2015, the Ministry of Health officially legalised the use of cannabis-based drugs for medical purposes for patients with illnesses such as cancer, multiple sclerosis, or AIDS.
Czech Republic	Medical use of cannabis on prescription has been legal and regulated since 2013
Finland	Since 2006, use of medical cannabis has been possible under a special license. In 2014, 223 licenses were issued.
France	Legislation permitting the sale of medications containing cannabis derivatives was enacted in June 2013.
Germany	On May 4, 2016 the Cabinet of Germany decided to approve the measure for legal cannabis for seriously ill patients who have consulted with a doctor and “have no therapeutic alternative”. German Health Minister, Hermann Gröhe, presented the legal draft on the legalisation of medical cannabis to the cabinet, which took effect in early 2017.
India	Legal or tolerated in several states such as West Bengal, Gujarat, Bihar, Odisha and the North East.
Israel	Illegal for recreational use, but limited medical uses have been permitted since the 1990s
Italy	Licensed cultivation for medical and industrial use is strictly regulated.
Jamaica	On 25 February 2015, the Jamaican House of Representatives passed a law decriminalising possession of up to two ounces of cannabis.
Macedonia	Medical cannabis legalised in 2016.
Mexico	In December 2016, Mexico’s Senate voted to legalise marijuana for medicinal and scientific purposes – this was approved by the Chamber of Deputies in April 2017.
Netherlands	Personal possession has been decriminalised since 1976, and cannabis products are only sold openly in certain local “coffeeshops”
Philippines	Congress introduced House Bill No. 4477 in 2016, known as the Compassionate Use of Medical Cannabis Act, which would legalise the use of medical marijuana.
Poland	Legal for medicinal use only
Portugal	In 2001, Portugal became the first country in the world to decriminalise the use of all drugs
Puerto Rico	In 2015 the Governor of Puerto Rico signed a executive order to legalise cannabis for medicinal use only
Romania	Medical cannabis legalised in 2013.
Slovenia	Cannabis-based drugs are legal for medical use, but not cannabis itself.
Turkey	The cultivation of marijuana is legal in nineteen provinces in Turkey for medicincal and scientific purposes. However, with permission this can also be conducted in other provinces too.
USA	Illegal at the federal level but legal at the state level in Alaska, California, Colorado, Maine, Massachusetts, Nevada, Oregon and Washington, and in Washington, D.C.; decriminalised in eighteen states, medicinal legal in 25 states and Guam. All Indian Reservations are allowed to regulate cannabis laws; laws vary by reservation.
Uruguay	José Mujica has fully legalised any use of Cannabis in Uruguay; law does not specify quantity for “personal amount”

According to the study Medicinal Cannabis and Painful Sensory Neuropathy in the American Medical Association Journal of Ethics, Dr Igor Grant said: “Our society should be able to find ways to separate the medical benefits of making a treatment available to improve lives when indicated from broader social policy on recreational use, marijuana legalization, and unsubstantiated fears that medicinal cannabis will lead to widespread cannabis addiction.”

Nothing is 100 per cent safe, but when you weigh the benefits against the risks, and if you suffer from chronic neuropathic pain, you may find a worthwhile benefit from using medical marijuana, as long as you use it responsibly and you do it legally.

HNPP · Medication · Physical Health

HNPP and Alternative Supplements

Jul 4, 2017Jul 24, 2017 suswatibasu4 Comments

It sounds like there are a lot of good tidbits of information as well as conflicting messages in terms of taking supplements, and other foodstuffs that are said to have wonderful healing properties.

From supporting nerve regrowth to reducing inflammation, there is a whole host of additional organic as well as synthetic tablets and herbs that can be taken with regular medication.

I personally take a selection of Vitamin B tablets and Folic Acid, which was recommended to me by a neurologist, but everyone’s body is different and reacts in different ways.

So is it necessary to take supplements?

Regardless of the cause of your peripheral neuropathy, boosting the health of your nerves through proper diet and supplementation can help slow the spread of your symptoms. However, the sooner you and your doctor can pinpoint a cause, the quicker you can identify and begin the most effective treatment for your symptoms.

While this is by no means a comprehensive list, these medicinal and herbal suggestions have definitely gotten a lot of praise.

Disclaimer: Please check with your doctor or practitioner before taking new medicines. Make sure you’re not allergic.

Magnesium

Magnesium is said to help maintain nerve function, mostly by reducing pain, calming overactive nerves and relaxing your muscles. This calming effect on nerves and muscles helps reduce pain and improve mobility. According to a 2010 study, a major mechanism of pain is the excessive stimulation of a brain chemical called “NMDA.” Magnesium seems to settle down this pain-carrying neurotransmitter without the toxins of other medications.

Low levels magnesium may result in fatigue, cramping and weakness – among other symptoms.

Alternatives to supplements:

So from where else can you get your magnesium intake?

Spinach
Pumpkin seeds
Beans and peas
Fresh fruits
Quinoa

Vitamin B

One common cause of peripheral neuropathy is a deficiency of B vitamins, particularly B12. If a B12 deficiency isn’t treated in a timely fashion, the nerve damage can become permanent. It is the most important link in the chain of the various B vitamins.

However, without vitamin B2 and B6, your body’s ability to properly absorb and make use of these vitamins for the benefit of your nerves becomes significantly handicapped.

Alternatives to supplements:

The NHS website has laid out some of the foods that are high in B12:

Meat
Salmon
Cod
Milk
Cheese
Eggs
Some fortified breakfast cereals

Folic Acid

Folic acid, known as folate in its natural form, helps the body form healthy red blood cells and reduce the risk of central neural tube defects. Folic acid is needed to activate the B12. B6, B9 (folic acid) and B2 are needed for B1 to be absorbed.

If you’re taking folic acid supplements, it’s important not to take too much, as this could be harmful. Folic acid can actually be absorbed by having a healthy diet. Adults need 200mcg of folic acid a day. It can’t be stored in the body, so you need it in your diet every day.

Alternative for supplements:

Folate is found in small amounts in many foods:

Broccoli
Brussel sprouts
Liver (but avoid this during pregnancy)
Spinach
Asparagus
Peas
Chickpeas
Fortified breakfast cereals

Potassium

Potassium helps generate energy so that the nerves can transmit messages. The way it does this is called the sodium-potassium pump. Essentially, there is more potassium inside your cells and more sodium outside. When the gate that allows one or the other to leave or enter the cell opens, potassium leaves and sodium enters. This “pump” generates the energy for your nerves to transmit messages.

Alternatives to supplements:

Sweet potato
White and kidney beans
Dark leafy greens such as spinach
Avocado
Bananas
Certain fish – Wild salmon, tuna, halibut, flounder, and Pacific cod
Milk
Tomato sauces
Dried fruits -Apricots, peaches and figs

Acetyl-L-Carnitine

Acetyl-L-carnitine (ALC) is a naturally occurring amino acid and is potentially effective at preventing peripheral neuropathy as well as lessening neuropathic symptoms once they have developed. ALC has been shown to influence neurotransmitters (NTs), including acetylcholine (organic chemical that works as a neurotransmitter) and dopamine.

Disclaimer: Please check with your doctor or practitioner before taking new medicines. Make sure you’re not allergic and it doesn’t interact with other medications.

Turmeric

Turmeric is an ancient spice commonly used in Ayurvedic and Chinese medicines to treat digestive issues, inflammation, skin conditions, and wounds. Turmeric is also known as an anti-ischemic agent, which helps in regulating blood supply to peripheral nerves. Lack of blood supply to nerves is of the key reason for these nerves not working properly.

Although there is not currently much research to support its standing as an effective anti-inflammatory or that it can benefit nerve issues, there is much anecdotal evidence that it has its advantages.

For more information on how to consume it, visit TheKitchn.com.

Hemp Oil

A slightly more controversial product is Hemp Oil or Cannabidiol (CBD). For many HNPP sufferers, this is harder to come by depending on the laws of your country. However, it is said to benefit users. Two major cannabinoids found in cannabis, activate the two main cannabinoid receptors, which is said to regulate the release of neurotransmitter and central nervous system immune cells to manage pain levels. There are foods and liquids containing hemp that can also be consumed.

Some of the most popular forms of hemp foods include:

Whole hemp seeds
Shelled hemp seed (hemp hearts)
Hemp oil
Hemp protein
Hemp milk

Omega 3 Oils

Research from Queen Mary, University of London suggests that omega-3 fatty acids, which are found in fish oil, have the potential to protect nerves from injury and help them to regenerate.

Omega-3 fatty acids are vital for the body’s normal growth and development because the body cannot manufacture omega-3 fatty acids. Therefore it has to be consumed in foods such as oily fish.

Foods that include Omega 3 include:

Flaxseeds
Fatty / oily fish – wild salmon, halibut, mackerel, tuna
Walnuts

Coq 10

CoQ10 (CoEnzyme Q10) is an antioxidant naturally produced by your body. As it relates to your nerves, CoQ10 plays a role in correction mitochondrial dysfunction, a condition that can lead to a decline in nerve health and cause nerve related problems or pain. Long-term low dose CoQ-10 inhibited neuropathy induced pain, according to a study.

Coq10 can be found in:

Fish- Sardines, Mackerel, salmon, tuna, herring
Beef, Lamb, Pork- organs like heart, liver, kidneys
Eggs
Spinach
Broccoli
Cauliflower
Wheat-germ
Peanuts, Pistachio, sesame seeds
Soyabean oil, Canola oil

Zinc

Don’t go crazy with zinc supplementation because it can cause a secondary copper metabolic problem, however, there are plenty of foods that are naturally high in zinc.

Why do you need zinc for peripheral neuropathy? It turns out that zinc plays a part in modulating the brain and body’s response to stress all along the way. The highest amount of zinc in the body is found in our brains, particularly in a part of our brains called the hippocampus, and it is critical to cell signalling. But you don’t need a huge amount to fulfil your daily quota which can be done quite simply.

Foods that are high in zinc:

Oysters
Crab and lobster
Meat and poultry as well as eggs
Legumes – hummus, chickpeas, lentils, edamame, and black beans
Vegetables – mushrooms, spinach, broccoli, kale, and garlic
Nuts and seeds
Whole grains
Fortified breakfast cereals
Milk and dairy foods
Dark chocolate

If there are any more supplements you would like to add, please feel free to comment below! Do these particular products work for you?

Dark chocolate as a medical aid makes me very happy indeed.

UPDATE: Since writing the initial post, a few other supplements including Coq 10 and Omega 3 Oils has been suggested and added above.