A low-tech toothbrush and so much more
Believe it or not, I grew up without ever using a regular toothbrush until I was about 9 years old. You see, we had a couple of “neem” trees (botanical name: Azadirachta Indica) growing in the backyard of our home in South India. My grandfather would cut little twigs – about the size of toothbrushes – and keep a bunch of them handy. First thing in the morning, I would pop one of these twigs into my mouth and wander around chewing the tip to a pulpy, fibrous brush. No need for toothpaste either. The taste is slightly bitter and astringent but not unpleasant, causing a lot of saliva. By the time I had chewed the tip enough, the stiff fibers of the twig had cleaned out my mouth and teeth as well. The chewed twig is pitched, a fully recyclable and non-polluting, low cost brushing option.
That is just a bit of traditional color from my childhood. The medicinal value of neem extracts in traditional ayurvedic medicine is immense. Depending on who you talk to, the neem trea is a veritable treasure trove that can cure just about everything. All parts of the neem tree (seeds, flowers, bark, leaves) are used in medicinal preparations. Among the better documented uses of the neem tree are:
- Neem oils and extracts are used as pesticides against a wide variety of insects, ticks, worms and mites.
- Neem oil is an effective mosquito repellent.
- Neem extracts are thought to be useful in combating malaria – but this has yet to be proven in rigorous clinical studies.
- It is used as a spermicide, for prevention of pregnancy.
- Many local brands of cosmetics (soap, shampoo, face creams) advertise they have neem extracts in them since it is considered to be good for maintaining skin elasticity and acne prevention. It is also thought to be effective in the treatment of scabies.
- Traditional Indian medicine uses a decoction of neem tree roots to relieve fever. But just like aspirin, its use in children is contra-indicated!
- Chewing the leaves or twigs of the neem tree is thought to help control gingivitis, freshen breath and clean teeth.
- Extracts of neem leaves may be useful in controlling diabetes.
- Of particular interest to me, neem extracts are thought to be of use in controlling GERD (gastric acid reflux disease).
This list is just the tip of the iceberg. Traditional Ayurvedic medicine considers the neem tree a veritable cornucopia of medicinal uses. I have no doubt that with a little web surfing you will be able to find much more detailed information regarding the potential uses of this remarkable tree.
If I stuck around in India until “Ugadi” the South Indian version of lunar New Year rolls around, my mom would feed me a spoonful of a very special traditional chutney first thing on New Year’s day. It would have in it freshly minced neem flowers, along with tamarind, brown sugar, salt and hot chillies. The idea is to capture all five taste groups – bitter, sour, sweet, salty and hot – a reflection of the many facets of life to come in the New Year, each to be welcomed and cherished for its own sake.
Roswel Park Clinical Trial
Title: Azadirachta Indica (neem leaf extract) in Treating Patients With Chronic Lymphocytic Leukemia
This is a Phase-I clinical trial. It is not yet ready for recruiting patients, but when it is open 30 or so chemo-naive CLL patients will be recruited. The main aims of the trial are to determine the appropriate dose and establish efficacy, safety and toxicity profiles for neem leaf extract.
Notice the trial excludes patients with high risk cytogenetics, those with 11q or 17p deletions (by FISH test). Rightly so, in my humble opinion. People with high risk disease are not likely to respond to “kinder and gentler” approaches and they are better served by considering more conventional therapy options with proven track records.
“Patients with advance stage disease (Rai Stage II-IV) may be included in this clinical trial if they refuse to take standard chemotherapeutic regimens“. In my opinion, this is not just a cautionary CYA statement to be glossed over. Patients in late stage disease are risking something quite real when they participate in early stage trials such as this one. It is called a window of opportunity. Time spent in participating in early stage trials is time taken away from undergoing established therapy options, letting your lymph nodes get larger as you wait and giving your bone marrow that much more time to get clogged up. Judging the right time to treat CLL and the right therapy option that best serves the patient’s needs are exquisitely important decisions.
As usual, the inclusion criteria require adequate liver and kidney function. If you have particular concerns along these lines you should discuss them ahead of time with the investigators. Jaundice (liver toxicity) has been observed in some people ingesting neem oil. Perhaps that concern is not there with neem leaf extract – I do not know. However, if you have had bouts of hepatitis and therefore concerned about the less than robust good health of your liver, this too is something to discuss with the researchers.
This article was prompted when several patients wrote to me asking about this clinical trial. If you fulfill the inclusion criteria listed for this clinical trial, I hope you will consider participating in it. Many interesting clinical trials are facing great difficulties in recruiting participants and this has become a serious bottleneck for continuing medical research.
However, I am also a strong believer in the concept of informed consent and people signing up for stuff with their eyes wide open. Patients need to understand what the trial involves, the potential risks of stepping out into uncharted territory. In the case of very early stage trials, there is also the problem of selling ourselves on unproven and overly optimistic expectations.
So, it boils down to this. Why do you wish to participate in an early stage trial?
Given long history of use of many parts of the neem tree in traditional medicine, chances are reasonably good that this neem leaf extract is not likely to have over-the-top-toxicity or adverse effect profile. Are you looking to help clinical research in a situation where there is not likely to be huge personal cost to you, because you have done your due diligence about the drug in question? If so, I salute you. Many future generations of CLL patients will benefit from the altruism and generosity of people like you participating in clinical trials.
But if you are considering an early stage clinical trial as a realistic alternative to proven therapy options, I would like you to keep the following check-list in mind as you consider clinical trial participation:
- Early stage clinical trials are designed for the explicit purpose of figuring out if the drug in question works at all in real patients (as opposed to lab rats or CLL cells in a glass dish), how it should be administered and at what dosage. Defining the “dose limiting toxicity” (DLT) is an important aim, since this would used in designing later stage of the drug’s trials.
- Explicitly stated in many of the early stage trial consent forms is the statement that these trials are not meant to be of therapeutic benefit to the participants. These early stage trials are truly for the purpose of learning more about the drug in question, they are not meant to replace conventional therapy options for patients and they are certainly not thought to be able to cure anyone.
- Maybe, if we are lucky, the trial in question will yield enough interesting data and more confident steps can be taken down the road. But a lot of hard work needs to be done before early stage trials can lead to fully developed therapy options. Less than 1% of early stage clinical trial concepts go on to become realistic success stories.
- Just because something is “herbal” does not mean it has no toxicity. Some of our most valuable chemotherapy drugs have herbal origins, and a lot of them also have toxicity to match. Vincristine, one of the ingredients of CHOP therapy regimen used in NHL, comes from the vinca plant. No one who has used vincristine would tell you using it is like walking in the park admiring flowers.
How likely are cancer patients to sell themselves a bill of goods, overestimate the benefits and underestimate the risks involved in early stage clinical trials? “ScienceDaily” reports on the findings of an interesting study:
The study included 72 patients with cancer who were enrolled in early-phase oncology trials in the New York metropolitan area between August 2008 and October 2009.
Study respondents exhibited unrealistic optimism in response to three of five questions about the likelihood of particular events happening to them compared with other trial participants: having their cancer controlled by drugs administered in the trials, experiencing a health benefit from the drugs in the trials, and not experiencing a health problem from the drugs in the trials. The authors said that unrealistic optimism has the potential to compromise informed consent “by interfering with the ability to apply information realistically.”
All of us indulge in wishful thinking in our lives. Go ahead, buy that lottery ticket (and if you win big, be sure to share your winnings with me for giving you the suggestion!) But cancer patients considering clinical trial participation should not make their decisions based on wishful thinking. This should be done with clear understanding of the risks and rewards and even more important, with an honest understanding of your own motives for your participation. Do it for the right reasons, do it because it matters, do it because you have thought it through.