- Harsh Criticism of Study Showing Lower Cancer Survival With CM
- Study Details
- The Truth About Alternative Medical Treatments
- Alternative and complementary therapy can pose dangers
- How complementary medicine can be helpful and safe
- Warning signs
- Complementary medicine for cancer can decrease survival
- Alternative Medicine for Cancer Treatment Raises Mortality Risk – National Cancer Institute
- Unproven Therapies, Worse Survival
- A Limited Window of Opportunity
- Talking about Concerns and Consequences
- Complementary and Alternative Medicine Use and Breast Cancer Prognosis: A Pooled Analysis of Four Population-Based Studies of Breast Cancer Survivors
Harsh Criticism of Study Showing Lower Cancer Survival With CM
Harsh criticism is being directed at a study that concluded cancer patients who used complementary medicine (CM) were more ly to refuse standard care, and as a result, faced a higher risk of death.
The use of CM in this study was associated with worse 5-year overall survival compared with patients who didn't use CM (82.2% vs 86.6%; P = .001) and a twofold greater risk of death. The study was published last year in JAMA Oncology, and reported at the time by Medscape Medical News.
The authors now are facing a firestorm of criticism, detailed in letters to the journal from five separate groups, and the criticism has been amplified on .
One of the critics, Lars Haakon Soraas, MSc, from the Norwegian University of Life Sciences and Nordic Cochrane Centre, Copenhagen, Denmark, says in a long thread on his feed that the five letters to the journal are “completely destroying the pseudoscience article.”
He also hopes that the journal and/or authors retract the study “as its presence online will continue to misinform cancer patients worldwide.”
Lead author of the study Skyler Johnson, MD, Yale School of Medicine, New Haven, Connecticut, argues on that these letters to the editor “do not 'completely destroy' our work, as any thoughtful, objective reader or scientist familiar with these processes can attest.” He points out that concerns about the study have been previously addressed on , in the discussion section of the article, and again in their response to the letters to the journal.
“There is a HUGE difference between unproven anticancer therapies noted by docs (our study) and the most common complementary medicines self-reported by patients,” he adds.
For the study, Johnson and colleagues conducted a retrospective review of data on 1,901,815 patients from the National Cancer Database. The cohort included patients diagnosed with nonmetastatic breast, prostate, lung, or colorectal cancer.
From this large cohort, 258 patients (0.01%) were identified as using CM, loosely defined as “other-unproven: cancer treatments administered by nonmedical personnel” that were given in addition to at least one conventional modality, defined as surgery, radiotherapy, chemotherapy, and/or hormone therapy.
Patients who received CM were then matched with 1032 patients who had received conventional therapy.
However, the association of CM with increased mortality was largely treatment delay or refusal. After adjustment for treatment refusal and delay from diagnosis to treatment, CM was no longer significantly associated with the risk for death (HR, 1.39).
At the time, Medscape Medical News solicited comments from Donald Abrams, MD, professor of clinical medicine at the University of California San Francisco and a general oncologist at Zuckerberg San Francisco General Hospital. He noted that because the study is retrospective, it is not the “highest level of evidence” and has many limitations related to its design.
Controlling for delayed or refusal of treatment eliminated survival disparities between the groups, he pointed out. But importantly, “there is no information available on why patients refused therapy, and no information on what complementary therapies were used by the patients or how many types of therapies they may have used.”
Some of these same limitations are now outlined in the letters published in JAMA Oncology, but there are also other concerns about methodological flaws.
In one letter, Ana Muñoz van den Eynde, PhD, Research Unit on Scientific Culture, CIEMAT, Madrid, Spain, writes that the study has three problems: “Two are genuinely methodological, whereas the third is more related with the ethics of research. The three problems severely undermine the study's scientific rigor.”
The authors found that CM is an independent variable associated with a greater risk of death, but the “problem arises when, after also adjusting for treatment refusal and delay from diagnosis to treatment, CM no longer has a statistically significant association with the risk of death,” she writes. “This means that the supposed association between CM use and survival is a spurious one, ie, a false correlation between two variables that is caused by a third variable.”
She also highlights the small number of patients using CM identified in the database (only 258 patients [0.01%] of nearly 2 million). This is not a representative sample, she argues, as other studies have found that an estimated 48% to 88% of cancer patients report the use of complementary and alternative medicine as part of their therapy.
The third problem was the lack of objectivity on the part of the authors. “Ignoring that the relationship between CM use and risk of death is spurious, they establish a causal association between the higher rate of conventional cancer therapy refusals in the CM group and a higher risk of death,” writes Muñoz van den Eynde.
She adds that when she looked at the “real figures of survival that were provided by the authors, instead of an estimate obtained by an equation lacking the relevant variables,” there was no difference in survival rates between patients using and not using CM.
In another letter, Kevin Lee, MD, PhD, and Nathan Douthit, MD, both from Brookwood Baptist Health, Birmingham, Alabama, also highlight the small number of patients using CM and argue that this “conservatively represents a 1000-fold under-ascertainment.”
In addition, “the current definition of CM is so broad, including prayer, diets, vitamins, and supplements, as to be ungeneralizable.”
They also worry that studies such as this will be “used to further drive a wedge between traditional healthcare practitioners and patients interested in CM.”
Some healthcare practitioners are already skeptical and even hostile towards the use of CM, and this study “could further reinforce the cognitive biases of these physicians, leading to decreased understanding and openness of communication with patients with cancer.”
In another letter, Linda E. Carlson, PhD, RPsych, Cumming School of Medicine, University of Calgary, Alberta, Canada, and colleagues, point out that for a cancer patient to be coded as a CM user in the study the treating oncologist had to check a box titled, “Other-unproven: Cancer treatments administered by nonmedical personnel.”
Thus, it is ly that only the “most extreme examples of treatment refusal or use of unrecommended approaches were included in the 258 people who were classified as CM users,” they write. Not only is this an under-representation of the target population, it is also ly that half or more of those classified as “nonusers” were in fact using CM. This renders the study results invalid, they argue.
Carlson and colleagues also take issue with the study definition of CM, which is said to be “used in addition to conventional cancer therapy and may be used as a substitute for adjuvant therapies.”
“Within the specialty of integrative oncology, there is a clear distinction between therapies that are 'complementary' — used along with conventional care — and those that are 'alternative' — used instead of conventional care,” they write.
The definition used in the study differs from the one used by the Society for Integrative Oncology, in which there is no suggestion “that patients should delay or refuse conventional cancer care; rather, patients are encouraged to seek care that draws on both conventional and complementary approaches,” they note.
In yet another letter, Ozan Bahcivan, MSc, University of Barcelona, Spain, reiterates the point that CM was not clearly defined, but also highlights the fact that the finding on survival outcomes with CM were significant only for a subgroup of patients with breast cancer. This finding was of “borderline significance for patients with colorectal cancer” and was “not true for patients with prostate and lung cancer.”
Also homing in on this issue in a letter is Soraas, who on highlighted the letters to the journal, as mentioned earlier. Writing with colleagues from the Nordic Cochrane Centre, they argue that the study was influenced by selection bias.
“In our opinion, a sample of only 258 patients is unly to be representative of the large population of patients with cancer using CM,” they write. This small group was dominated by breast cancer patients (n = 186), so the conclusions for some of the other cancer types were “subgroups containing as few as 15 patients.”
Johnson and colleagues respond to the criticism of their study in a short letter, and have also responded on to some of the comments made by Soraas.
The authors point out that in their study CM had a very precise definition: “cancer treatment administered by nonmedical personnel.
” Hence, it is ly that CM defined as such includes treatments for cancer with a proposed, albeit unproven, biological mechanism, safety, and effectiveness, they note in their letter.
This is quite distinct from therapies used for improvement of quality of life, such as mind-body therapies (yoga, meditation) or acupuncture.
On , lead author Johnson points out their study did not, as Soraas claims, show “that cancer patients using CM had twice the risk of dying as non-users.”
The study conclusion was “…patients who received CM were more ly to refuse additional conventional cancer therapy and had a higher risk of death. The results suggest that mortality risk associated with CM was mediated by the refusal of conventional therapy,” Johnson points out.
JAMA Oncol. Published online January 24, 2019. Abstract
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The Truth About Alternative Medical Treatments
Almost 40% of Americans believe cancer can be cured through alternative therapies alone, according to a survey conducted by the American Society of Clinical Oncology. This is alarming because evidence shows that people who use alternative therapies in place of standard cancer treatments have much higher death rates.
The terms “alternative,” “complementary,” and “lifestyle” medicine are used to describe many kinds of products, practices, and treatments that are not part of standard or traditional medicine.
Alternative therapy refers to non-standard treatment used in place of standard treatment, while complementary therapy usually means methods used along with standard treatment.
Lifestyle medicine is a newer field that describes its approach as preventing and treating illness through healthy eating, physical activity, and other healthy behaviors without the use of medicine.
In some cases, complementary methods can help cancer patients feel better when used alongside standard treatment and with the advice of a health care provider.
Alternative and complementary therapies are often appealing because they use your own body, your own mind, or things that may be found in nature.
But sometimes these methods wrongly claim to prevent, diagnose, or treat cancer even when they have not been proven to work through scientific testing.
And in the worst cases, some alternative or complementary therapies may be dangerous or even deadly. Some may also interfere with how standard cancer treatment works. If you’re thinking about using any non-traditional therapy, it’s important to first discuss it with your health care team.
Alternative and complementary therapy can pose dangers
Some of these therapies promise wellness using a method that sounds simple, wholesome, and without harmful side effects. But this is not always true. Some concerns include:
- Delaying surgery, radiation, chemotherapy, or other traditional treatment by using an alternative therapy can allow the cancer to grow and spread to other parts of the body.
- Some complementary and alternative therapies have been reported to cause serious problems or even deaths.
- Certain vitamins and minerals can increase the risk of cancer or other illnesses, especially if too much is taken. Some companies don’t follow Food and Drug Administration (FDA) rules about making claims and labeling supplements properly. In some cases, harmful contaminants can get into dietary supplements because of how they are manufactured or handled.
How complementary medicine can be helpful and safe
Some complementary methods have been studied and shown to help people feel better while they’re undergoing standard cancer treatment under a doctor’s care. Examples might include meditation to reduce stress, peppermint or ginger tea for nausea, or guided imagery to help relieve stress and pain during medical procedures.
Many complementary treatments are unly to cause harm and won’t interfere with your cancer treatment. Here are some examples:
- Acupuncture may help with mild pain and some types of nausea.
- Art or music therapy may promote healing and enhance quality of life.
- Biofeedback uses monitoring devices to help people gain conscious control over physical processes that are usually controlled automatically, such as heart rate, blood pressure, temperature, sweating, and muscle tension.
- Massage therapy can decrease stress, anxiety, depression, and pain and increase alertness, according to some studies.
- Prayer and spirituality help many people with the emotional side effects from cancer.
- Tai chi and yoga have been shown to improve strength and balance in some people.
If you are thinking about using any method instead of standard evidence-based medical treatment, it is important to talk to your health care team first. And watch out for these warning signs:
- Be suspicious of any treatment that says it can cure cancer or other difficult-to-treat diseases (such as chronic fatigue, multiple sclerosis, AIDS, etc.). It’s important to remember that those claims have not been proven.
- Be suspicious of any treatment that claims to offer benefits with no side effects. Even herbs and vitamins have possible side effects. If the treatment is marketed as having no side effects, it has ly not been studied in rigorous clinical trials, where side effects would be seen.
- Be suspicious of promoters who attack the medical or scientific community or who tell you not to use standard or traditional medical treatment.
- Beware of treatments you can get in only one clinic, especially if that clinic is in a country with less strict patient protection laws than those in the United States or the European Union.
- Beware of terms such as “scientific breakthrough,” “miracle cure,” “secret ingredient,” or “ancient remedy.” Beware of personal stories that claim amazing results but provide no actual scientific evidence.
- Find out about the training and education of anyone supporting the treatment or using it to treat you. Find out if they are medical doctors and whether they are experts in cancer care or complementary medicines.
- Find out whether scientific studies or clinical trials have studied this treatment in people (not just animals), and what side effects have been reported. Find out if the treatment could harm you or interact badly with your other medicines or supplements.
- Learn whether the findings have been published in trustworthy journals after being reviewed by other scientists who are experts in the same field, or if they have been promoted only in the mass media, such as books, magazines, the internet, TV, infomercials, and radio talk shows.
Complementary medicine for cancer can decrease survival
People who received complementary therapy for curable cancers were more ly to refuse at least one component of their conventional cancer treatment, and were more ly to die as a result, according to researchers from Yale Cancer Center and the Cancer Outcomes, Public Policy and Effectiveness Research Center (COPPER) at Yale School of Medicine. The findings were reported today online in JAMA Oncology.
Use of complementary medicine — medical therapies that fall beyond the scope of scientific medicine — is growing in the United States and often used by patients with cancer.
Although many patients believe that a combination of complementary medicine and conventional cancer treatment will provide the greatest chance at a cure, there is limited research evaluating the effectiveness of complementary medicines.
It is also unknown whether patients who use complementary medicines use them to improve their response to conventional medical therapies, or use them in lieu of recommended conventional therapies.
“Past research into why patients use non-medical complementary treatments has shown the majority of cancer patients who use complementary medicines believe their use will result in improved survival,” said the study's senior author, James Yu, M.D., associate professor of therapeutic radiology at Yale Cancer Center. “We became interested in this topic after we reviewed the literature, and found that there was scant evidence to support this belief.”
To investigate complementary medicine use and its impact on survival and treatment adherence, the researchers studied 1,290 patients with breast, prostate, lung, or colorectal cancer in the National Cancer Database (NCDB) — a joint project of the Commission on Cancer of the American College of Surgeons and the American Cancer Society. The NCDB represents approximately 70% of newly diagnosed cancers nationwide. Researchers compared 258 patients who used complementary medicine to 1,032 who did not.
The researchers studied de-identified patients diagnosed over a 10-year period, from 2004 to 2013. By collecting the outcomes of patients who received complementary medicine in addition to conventional cancer treatments, they found a greater risk of death.
Interestingly, they noted, despite having received some conventional cancer therapy, these patients were more ly to refuse other aspects of recommended care chemotherapy, surgery, radiation and/or hormone therapy.
The researchers concluded patients who chose to use complementary medicines as cancer treatment, were more ly to refuse other conventional cancer treatments and as a result, had a higher risk of death than those who used no complementary medicine.
“The fact that complementary medicine use is associated with higher refusal of proven cancer treatments as well as increased risk of death should give providers and patients pause,” said lead author Skyler Johnson, M.D., chief resident in radiation oncology at Yale School of Medicine.
“Unfortunately, there is a great deal of confusion about the role of complementary therapies. Although they may be used to support patients experiencing symptoms from cancer treatment, it looks as though they are either being marketed or understood to be effective cancer treatments.
Cary Gross, M.D., co-author of the study, called for further research, “The sources of misinformation need to be better understood, so that patients aren't being sold a false bill of goods.”
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Materials provided by Yale University. Note: Content may be edited for style and length.
- Skyler B. Johnson, Henry S. Park, Cary P. Gross, James B. Yu. Complementary Medicine, Refusal of Conventional Cancer Therapy, and Survival Among Patients With Curable Cancers. JAMA Oncology, 2018; DOI: 10.1001/jamaoncol.2018.2487
Alternative Medicine for Cancer Treatment Raises Mortality Risk – National Cancer Institute
September 12, 2017, by NCI Staff
In a large study, patients with nonmetastatic breast, lung, or colorectal cancer who chose alternative therapies had substantially worse survival than patients who received conventional cancer treatments.
After a median of 5 years, patients with breast or colorectal cancer were nearly five times as ly to die if they had used an alternative therapy as their initial treatment than if they had received conventional treatment.
“Our findings highlight the importance of timely, proven medical care for cancer,” said Skyler Johnson, M.D., of the Yale School of Medicine, who led the study. “There’s an increased risk of death with choosing alternative medicine, and that’s something patients should consider when making their treatment decisions.”
The study results were published August 10 in the Journal of the National Cancer Institute.
Unproven Therapies, Worse Survival
Although doctors know that many cancer patients try alternative therapies, limited data exist on how this use affects survival, the Yale researchers said.
To conduct their study, Dr. Johnson and his colleagues used the National Cancer Database, a resource maintained by the American College of Surgeons and the American Cancer Society that contains information on outcomes after cancer treatment from more than 1,500 hospitals across the United States.
1.68 million patients whose initial treatment for nonmetastatic breast, prostate, colorectal, or lung cancer was recorded in the database between 2004 and 2013, 281 refused conventional treatments in favor of one or more alternative therapies.
The definition of alternative therapy used by the database included any “unproven therapies from a nonmedical provider,” he said.
Although specific alternative therapies used were not recorded in the database, they may have included approaches as diverse as herbs, botanicals, vitamins, minerals, traditional Chinese medicines, homeopathy, acupuncture, diets, mind–body techniques, or even intravenous infusions, Dr. Johnson explained.
To conduct their analysis, the researchers matched each of the patients who had used alternative therapies with two similar patients who had received conventional treatments—surgery, chemotherapy, radiation therapy, or hormone therapy—during the same time period.
In addition to finding that patients with breast or colorectal cancer were about five times more ly to die over the following 5 years if they had used alternative therapies, the researchers found that patients with nonmetastatic lung cancer who used alternative therapies were more than twice as ly to die as patients who underwent conventional treatment.
By contrast, men with nonmetastatic prostate cancer who used alternative therapies did not have reduced survival over the follow-up period. This finding highlights the growing understanding that many men with early-stage prostate cancer can live a long time with only active surveillance of their disease instead of immediate treatment, explained Dr. Johnson.
Overall, the patients who chose alternative treatments were more ly to be younger, female, healthier, and have higher incomes and education levels. Some of these traits, such as overall better health, would normally improve the odds of survival after a cancer diagnosis, he said.
A Limited Window of Opportunity
The study has several important caveats, according to Jeffrey White, M.D., director of the National Cancer Institute’s Office of Cancer Complementary and Alternative Medicine.
One is that this study looked only at patients who refused any type of conventional treatment after a cancer diagnosis, not at people who used alternative approaches alongside conventional treatments—a more common scenario.
Whether combined use of conventional and alternative therapies affects survival, either positively or negatively, cannot be determined from this study, he added.
Also, the researchers could not tell if patients went on to receive conventional therapies after their cancer progressed, because only initial treatments were recorded in the database.
It is also important to note that patients with metastatic disease were not included in the study, explained Dr. White.
For many types of metastatic cancer, such as pancreatic cancer, any treatment is palliative, not potentially curative.
Therefore, patients with metastatic disease who decline or delay conventional treatment because of concerns about toxicity are different from the population examined in the current study, he added.
However, “in this analysis, they focused specifically on patients with early-stage [cancer], who should have a good chance for a cure with conventional therapy,” said Dr. White.
“If you go the route of unconventional approaches and end up advancing your [cancer] stage to the point that there’s no longer a conventional option with curative potential, then that window is closed.
You can’t re-open it.”
Talking about Concerns and Consequences
Patients with nonmetastatic cancer may feel that they have time to try an alternative approach before undergoing conventional treatment, but the results from this study highlight that “while that may seem a choice that doesn’t have any particular repercussions, it really does,” said Dr. White.
The high stakes of patients’ treatment decisions make it important for doctors and patients to be able to have an open dialog about unconventional approaches to cancer treatment, without patients feeling judged or having their questions and concerns dismissed, he added. These conversations can address patients’ concerns about the potential side effects of conventional treatments and available ways to treat those side effects, as well as how to balance quality of life with maximizing survival after a cancer diagnosis.
“A lot of patients conceal their use of alternative approaches…because they don’t think that physicians are open to [talking about them], or have been told in a dismissive way not to use them,” he said. “You can turn people off [from a discussion] very quickly if they think you’re not willing to work with them.”
Complementary and Alternative Medicine Use and Breast Cancer Prognosis: A Pooled Analysis of Four Population-Based Studies of Breast Cancer Survivors
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