Risk-Benefit Profile of Commonly Used Herbs - Legal & Otherwise by Dr. Rick Bayer
Physicians and consumers need reliable information on medical herbs. The popularity of such therapy in the US is growing rapidly but the science is not progressing as rapidly as sales. In the January 1st, 2002 Annals of Internal Medicine, Dr. Edzard Ernst (from the UK) wrote The Risk-Benefit Profile of Commonly Used Herbal Therapies: Ginkgo, St. John’s Wort, Ginseng, Echinacea, Saw Palmetto, and Kava. The Annals has a history of conservative politics (for example, they oppose the Oregon Death With Dignity Act and have written scathing half-truths about the medical use of marijuana). With those conservative politics in mind, I have provided the following review of Dr. Ernst’s article.
The seven top selling legal herbal medicines are ginkgo biloba, St. John’s wort, ginseng, garlic, echinacea, saw palmetto, and kava. Dr. Ernst looked for the best scientific articles he could find and graded them as to how well they answered questions such as, “Are objectives of the study clearly stated”, “Are the data sources stated”, and “Are inclusion and exclusion criteria stated?”. Readers are welcome to review the scientific abstract at PubMed www.ncbi.nlm.nih.gov/entrez/.
Ginkgo is mostly used for memory impairment, dementia, tinnitus (ringing ears), and intermittent claudication (legs hurt when walking because of clogged arteries). In persons with memory impairment and dementia, ginkgo is superior to placebo but in normal persons, ginkgo does not enhance normal function. Ginkgo may help with ringing ears but there is insufficient data to make any consistent claims. Ginkgo is just as effective as the allopathic drug company competitor, pentoxifylline, for intermittent claudication but the best treatment is to stop smoking and to start walking exercise. Ginkgo is generally safe but inhibits clotting (like aspirin does) so may interact with other medicines such as warfarin blood thinners.
St. John’s wort is used almost exclusively as an herbal antidepressant. Its mechanisms of actions appear similar to drug company products like imipramine. St. John’s wort is more effective than placebo in the treatment of mild to moderate depression and is similar in effect to moderate doses of drug company products. My experience is that no antidepressant drug works all the time and that persons with severe and/or recurring depression usually benefit more from talk therapy plus chemical treatment rather than either treatment alone. St. John’s wort can cause sensitivity to sunlight and can interact with other drugs such as blood thinners and oral contraceptives. Because of drug interactions, all of your doctors should know if you are taking this herb.
Ginseng is a confusing herb looking for a home in allopathic circles. The studies are poor and conclusions are not reliable. Sold as an ergogenic (energy giving) booster or an aphrodisiac or “other”, the reviews do not show ginseng to enhance performance. It does interact with warfarin blood thinners.
Echinacea preparations contain many potentially active ingredients but no single active constituent has been found. The best-researched indications are prevention and treatment of uncomplicated upper respiratory infections. In prevention trials, the results were not conclusive but suggested that groups receiving echinacea received benefit compared to control groups. In treatment trials, most groups showed benefit with echinacea compared to placebo. Dr. Ernst states, “Echinacea (particularly E. purpurea) may be efficacious, but the trial data are weak and inconclusive”. Side effects from echinacea are rare. I use echinacea during high-risk settings (like air travel) to prevent a cold. It seems to help and there is no alternative because antibiotics are ineffective and dangerous in this setting.
Saw palmetto is almost exclusively used to treat benign prostatic hyperplasia, a condition of aging men when the prostate grows and interferes with normal urinary flow. The results show superiority of saw palmetto over placebo in terms of urination frequency and peak flow and suggest similar effectiveness to finasteride (the drug company competitor). In some European countries, saw palmetto is considered first-line therapy over finasteride. Side effects are rare but long-term studies are lacking.
Kava is mainly used for its anti-anxiety effects and short-term administration of kava appears to be effective. Unfortunately, several cases of toxic liver damage requiring liver transplants have been reported. Kava also interacts with other drugs, including alcohol, that impair the central nervous system. A skin condition can occur with long-term use of kava at high doses.
Garlic was reported on by Dr. Ernst in a prior Annals article (19 Sept 2000). Garlic was reported to be superior to placebo in decreasing cholesterol levels. However, the impact was small (around 5% compared to the drug company “statins” impact of about 20% or more). About 20% of garlic users complained of indigestion and odor.
General Findings It is encouraging that we know this much about the best-selling legal herbal remedies. Some herbs demonstrate attractive risk-benefit profiles, particularly ginkgo (for dementia and intermittent claudication), St. John’s wort (for mild to moderate depression), and saw palmetto (for benign prostatic hyperplasia). Echinacea appears to have modest benefits. Claims for ginseng appear to be more myth than fact. Kava and garlic are superior to placebo but inferior to other pharmaceutical options when treating severe anxiety or elevated cholesterol levels.
Dr. Ernst concludes, “trials of herbal medicine products have been too few, too small, and too short”. This limits our abilities to predict drug interactions and yields inadequate information to consumers or doctors.
In my opinion, though he didn’t say it, Dr. Ernst’s caution may be applied equally to allopathic drug company products. Pharmaceutical drugs are often recalled after severe events (liver failure, kidney failure, gastrointestinal bleeding, and death). Consumers and doctors can never know too much about any drug. Finally, choices should be made on scientific merit rather than dogmatic viewpoints shaped by profit motives, our country’s War on Drugs, or bigotry against certain types of medical practitioners.
The 8th Herb: Medicinal Marijuana What would happen if we took an enlightened pro-patient approach and applied the same risk-benefit profile to medical cannabis/marijuana as was applied to the previous seven herbs?
Towards that end, addictions specialist nurse, Mary Lynn Mathre, from the University of Virginia, and her nonprofit group, Patients Out of Time (www.MedicalCannabis.com/) presented The Second National Clinical Conference on Cannabis Therapeutics on May 3 & 4, in Portland. The conference theme was Analgesia and Other Indications and was co-sponsored by the Oregon Department of Human Services, Oregon Nurses Association, Mothers Against Misuse and Abuse, and the Portland Community College (PCC) Institute of Health Professionals.* Patients Out of Time presented their first conference at the University of Iowa in 2000.
Cannabinoids are the scientific name for the natural agents found uniquely in the cannabis plant but includes the synthetic compounds made in the lab (synthetic cannabinoids) and naturally occurring hormones in our body that are similar to cannabis (endogenous cannabinoids). The main psychoactive ingredient in cannabis is THC (tetrahydrocannabinol) although there are many other cannabinoids in cannabis such as cannabidiol. The only cannabinoid that doctors can prescribe is synthetic oral THC called dronabinol and sold under the brand name Marinol&Mac226; which under the Controlled Substances Act is a schedule III drug (same group as acetaminophen with codeine).
Conference Findings On Friday, May 3, Dr. Esther Fride from Israel reviewed the molecular biology of cannabinoids and how they work in the body. She explained how cannabinoids and opioid pain medicine (like morphine) work together in a synergistic fashion. New research shows there are at least three different endogenous cannabinoids. One of these has been shown to be essential for suckling in newborn rat pups. If the action of the cannabinoid is blocked with an antagonist drug, the newborn pups do not suckle and thus die. Therefore, not only is the internal cannabinoid system important for pain control but it also regulates important appetite areas in the brain that are essential for life in newborn mammals.
Later in the morning, Dr. David Bearman provided a historical review of medical cannabis that has been used as medicine for thousands of years. Dr. Rick Musty reviewed the studies that showed pain relief with cannabinoids in patients with multiple sclerosis. Dr. Juan Sanchez-Ramos talked about how cannabinoids might help some persons with movement disorders such as Parkinson’s disease.
Dr. Donald Abrams discussed his odyssey of having to spend years trying to study cannabis in persons with AIDS/HIV. The federal government blocked his study on the possible benefit of cannabis until he changed his study around to look for the bad effects rather than the good effects of cannabis. In spite of this federal stonewalling that lasted for years, Dr. Abrams finally completed a study and published it last year showing that smoking cannabis has no negative effect on the immune system of persons with AIDS and actually helps patients improve appetite and gain weight. He is looking forward to more clinical studies to include using cannabis for pain management in persons with prostate cancer and breast cancer whose cancer has spread to the bones.
Dr. Stuart Rosenblum, the director of the Legacy Emanuel Pain Clinic in Portland, reviewed clinical case studies from Oregonians who are participating in the Oregon Medical Marijuana Act (OMMA) and who volunteered to fill out questionnaires and pain diaries. Dr. Rosenblum reported, “Patient comments emphasize efficacy and functional improvement”. Dr. Wenner from Hawaii also discussed positive clinical experience with more than 250 patients in Hawaii.
At lunch, Oregon State Health Officer, Dr. Grant Higginson, discussed The Oregon Medical Marijuana Act—Three Years of Experience. He reported there are currently some 3003 patients and 628 doctors participating in the OMMA. The average age of the patients is 46 years old and most are men. The most common reason for using cannabis in Oregon is to control pain.
In the afternoon, the editor of Journal of Cannabis Therapeutics, Dr. Ethan Russo, and other researchers discussed a study in which they looked at the effects of cannabis on four patients who have been using cannabis daily for many years under the now-discontinued federal Investigational New Drug (IND) trials. Three of the four patients attended the conference and told their stories. One of the patients has smoked 10 joints (7 to 9 grams of cannabis) daily for 31 years and the other two have used cannabis medically for nearly as long. Sadly, George Bush (the elder) shut the program down to new applicants in 1992 because there were “too many applicants”. Dr. Russo’s conclusion is that cannabis works for pain, spasms, and reducing eye pressure while the major risk is some inflammation of the airways. No evidence of liver damage, kidney damage, brain damage, or malignancy has been found. The authors strongly encouraged our federal government to re-open the IND program for sick and dying persons.
On Saturday May 4, persons from Hawaii, California, and Colorado discussed the state programs. The Hawaii program is the only program in the country that was created by the legislature and governor and it was modeled after the OMMA. Like Oregon, all the other states with medical marijuana programs had to bypass an ignorant or uncompassionate legislature and governor who forced the citizens to seek justice through the Initiative process.
Oregon patients under the OMMA told their stories at the conference reporting on the benefit they receive and the improvement they seek in the laws. Medical cannabis providers from Oregon, Washington, California, and British Columbia also spoke on issues of access to medical cannabis for patients. Interestingly, the Americans uniformly described our federal government as the major obstacle for patient access to medical cannabis; while the speaker from British Columbia praised her federal government and said that in Canada, it is the doctors who slow down federal political gains. Dr. Mark Ware from Quebec discussed Canadian clinical trials of Cannabis for chronic pain. He confirmed that by the time that patients got to pain clinics a significant percentage have already tried cannabis. Doctors are taught that cannabis is not medicine so tend not to ask if the patient is using cannabis to control pain. Our medical educators need to get with the program. He also confirmed that there is no causal relationship between cannabis smoking and the development of head and neck cancer. The positive image of the Canadian federal government depicted by its citizens contrasted dramatically with the endless condemnation of the US drug policy by all American participants.
Dr. Geoffrey Guy, founder of GW Pharmaceuticals in the UK, spoke on matching medicinal cannabis strains with symptoms. His company is testing cannabis extracts that are higher in THC and lower in cannabidiol versus extracts that are lower in THC and higher in cannabidiol versus extracts that have an equal THC to cannabidiol ratio. This is some of the most exciting research headed our way because under-the-tongue spray preparations are currently undergoing clinical trials in the UK and may be on the market next year, plus GW Pharmaceuticals is committed to using a whole plant extract rather than synthetic products.
I have concerns that if the only products available to patients are synthetics then there may be an escalation of the War on Drugs aimed at cannabis, sick patients and their doctors (see my article in the Fall 2000 issue of Alternatives)
Using medical herbs as an alternative to medical pharmaceuticals must be a patient’s choice. Having many preparations of therapeutic agents to tailor therapy is good but patients should not be arrested for using the “politically incorrect” medi-cine. Right now, in spite of polls showing that most Americans support allowing patients medical access to cannabis, the major health risk of using marijuana in the US is being arrested. This is inhumane in a civilized society. Period.
Dr. Audra Stinchcomb from the University of Kentucky shared interesting research on the transdermal (skin) patch. The good news is that the American Cancer Society funded her study to deliver a cannabinoid through a patch but the bad news is the research has just started on lab animals and human trials may be years away.
Dr. Sumner Burstein, from the University of Massachusetts, discussed very early research on a synthetic cannabinoid called ajulemic acid or CT3. He has removed the section of the THC molecule that causes psychoactivity (the “high”). His reports in mice indicate it is equivalent to morphine in pain control but has no psychoactive effects and it is equally effective as the potent anti-inflammatory medicine, indomethacin (Indocin). To have a drug that would control pain like morphine, cool off joints without the bleeding risk of most anti-inflammatory drugs, and still allow one to drive a car or work crossword puzzles sounds almost too good to be true. My recommendation is to be cautiously optimistic and stay tuned.
Finally, Professor Mathre moderated a panel for questions and answers.
Prescription: Sane Public Policy This conference shows what can happen when health care professionals and others apply the same risk-benefit analysis to cannabis and cannabinoids that we apply to other medicines, whether complex herbs or space-age designer drugs. Ideally, if everyone was in the same business to practice safe medicine and protect consumers/patients, we could use science to break through the bigotry and propaganda that clouds all herbal drug discussion but especially the medical use of the ancient herb cannabis.
There will never be enough information to satisfy some people. Some persons will always oppose medical access to cannabis for reasons unrelated to science. This includes those who are committing senseless violations of constitutional rights while enriching the huge drug testing industry. This includes most law enforcement and the prison industrial complex, which has become a major political force and needs a steady stream of “customers” (prisoners) to satisfy its profit quota driven by shareholder expectations. Private industry entering the prison business is especially scary.
But most of all, this includes the barbarians in the current Bush Administration such as Attorney General Ashcroft and his cronies at the Drug Enforcement Administration (DEA) and the Office of National Drug Control Policy (ONDCP). Doesn’t US Justice, DEA, and ONDCP have better things to do than raid medical cannabis clubs in California, take medicine from dying and suffering patients, block medical research, convolute administrative rules concerning controlled drugs and threaten doctors? Their War on Drugs is a war on good American citizens whose crime is “illness” and it must stop. Americans must stand up for our fellow citizens who are chronically and terminally ill. This is an issue of personal choice for them and, after all, we may be sick someday and want the same choices available to us. In spite of the harsh reality of the “War on Drugs” and the “War to Make Money”, common sense must prevail and patient advocacy must come first.
Dr. Bayer is board-certified in internal medicine, a fellow in the American College of Physicians – American Society of Internal Medicine, and practiced in Lake Oswego for many years. He is co-author of Is Marijuana the Right Medicine For You? A Factual Guide to Medical Uses of Marijuana. He was a chief petitioner for the Oregon Medical Marijuana Act in 1998 and manages the website www.omma1998.org that includes a medical bibliography with referenced scientific books and articles on medical use of cannabis and cannabinoids.