Wednesday, July 25, 2018

The Danger of Complementary and Alternative Medicine

Researchers at Yale did two database analyses. They looked at the National Cancer Database and found 1,901,805 patients who were treated for either nonmetastatic prostate, breast, lung or colorectal cancer between 2004 and 2013. In one analysis they looked at use of complementary medicine; in the other, they looked at use of alternative medicine.

Complementary medicine was defined as use of “other-unproven: cancer treatments administered by nonmedical personnel” in addition to at least one conventional cancer treatment modality, defined as surgery, radiotherapy, chemotherapy, and/or hormone therapy. 258 patients who chose a complementary therapy were matched to 1032 patients who did not use any complementary medicine on age, clinical group stage, Charlson-Deyo comorbidity score (CDCS), insurance type, race/ethnicity, year of diagnosis, and cancer type using the propensity score matching technique.

After 5 years of follow-up, comparing users of complementary medicine to matched non-users:
  • There was no difference in delay of treatment, but there was a greater probability of refusal of surgery (7% vs 0.1%), chemo (34% vs 3%), radiotherapy (53% vs 2%), and hormone therapy (34% vs 3%).
  • 82% survived for 5 years vs 87% among non-users, and were 2.1 times more likely to die after adjustment.
  • The differences in survival were attributable to refusal of conventional treatment.
  • Differences in 5-year survival were significant for breast cancer (85% vs 90%), and colorectal cancer  (82% vs 84%), but not for lung cancer  or prostate cancer. 
Alternative medicine was defined as “other-unproven: cancer treatments administered by nonmedical personnel” and who also did not receive conventional cancer therapy, defined as chemotherapy, radiotherapy, surgery, and/or hormone therapy. 281 patients who used alternative medicine were matched to 560 patients with similar characteristics (cancer type, age, clinical group stage, CDCS, insurance type, race, and year of diagnosis) who did not use alternative therapies using propensity score matching.

After 66 months median follow-up, comparing users of alternative medicine to matched non-users:
  • 55% survived for 5 years vs 78% among non-users, and were 2.5 times more likely to die after adjustment.
  • Differences in 5-year survival were significant for breast cancer (58% vs 87%), lung cancer (20% vs 41%), colorectal cancer  (33% vs 88%), but not prostate cancer  (86% vs 95%)
  • The survival curves for prostate cancer had just begun to diverge at 5 years (75% were low or intermediate risk).
Complementary and alternative medicines consisted of herbs and botanicals, vitamins and minerals, probiotics, Ayurvedic medicine, traditional Chinese medicine, homeopathy and naturopathy, deep breathing, yoga, Tai Chi, Qi Gong, acupuncture, chiropractic or osteopathic manipulation, meditation, massage, prayer, special diets, progressive relaxation, and/or guided imagery.

Although these observational studies did not follow prostate cancer patients long enough to detect differences in survival, we see the damage that use of both complementary and alternative medicines had on patients with more virulent cancers. Patients who get complementary medicine are more likely to refuse conventional treatments (even though they received at least one conventional treatment) and are about twice as likely to die because of that decision.

(update 5/2019) The CAPSURE database shows that the use of complementary and alternative medicines among men with prostate cancer is increasing. Comparing the period of 2006-2010 to 2011-2016. They report that:

  • Use of complementary medicines increase +128% (from 24% to 54%)
  • Vitamin D use has more than doubled in spite of Level 1 evidence that supplementing confers no benefit.
  • Happily, Vitamin E use has decreased based on Level 1 evidence from the SELECT trial.
  • Almost a quarter of men with prostate cancer take omega-3 fatty acids. A secondary analysis of omega-3 use in the SELECT trial, confirming an earlier study, found an association between high omega-3 fatty acid serum levels and increased risk of prostate cancer. Level 1 evidence showed no association with prostate cancer incidence or prostate cancer death.

note: Level 1 evidence means that a cause/effect relationship was proven by a large randomized clinical trial (RCT). Interested readers may consult the Oxford definition, which is widely accepted. Many patients rely on mouse and lab studies which are almost always disproven when tried in clinical trials. They constitute the lowest quality of evidence (Level 5), and should only be used for hypothesis generation for clinical trials or to demonstrate plausibility for a cause/effect relationship found in an RCT. Additionally, the Bradford Hill checklist is used.

15 comments:

  1. That shows because cancer patients have lost trust of coventional treatments...

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  2. The title seems to be misleading, at least so far as prostate cancer is concerned. The studies do not show any "danger" in using alternative or complementary medicine.

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    1. In fact, that's exactly what the authors suggest. Survival was reduced by half when complementary medicine was used, even more when alternative medicine was used.

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  3. This research comes with the inherent assumption that longer survival is the most important factor for cancer patients (and their doctors). For many, any increased survival derived from conventional treatment comes with a heavy price tag of unfavorable health side effects, medical uncertainty, emotional anxiety, financial stress and other factors that contribute to decreased quality of life. IMHO, a more interesting and revealing study would be one that inquires into the self-assessed quality of life of patients whose treatment choices were strictly conventional, strictly complementary or alternative, and those who chose a combination of both. Such a study could possibly include the observational assessments by the patients' respective oncologists or primary care physicians as to the patients' overall well-being and/or QofL during the course of the chosen treatment paths.

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    1. If survival is not a goal of therapy, then why bother with any therapy at all? All standard-of-care therapies are evaluated on their effect on QOL as well as survival. In fact, all therapies for prostate cancer extend life AND improve QOL. For example, the original trial of docetaxel for prostate cancer found that it reduced pain and improved QOL.

      Cancer itself is the biggest detriment to QOL. All of the conventional therapies improve QOL.

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    2. Use of alternative therapies may be accompanied by a rush of feelings accompanying making choices based on their beliefs: that they 'know the TRUTH!', that they will be healed by (ancient herbs, the power of [insert religious figure], the 'miracle cure' discovered by [insert book author's name here], etc.).
      Followed by death, or their beliefs all come crashing down, or being one of the patients who survive such choices and then leading others to choose the same treatment.
      If they're going to make such choices, that is their privilege. However they remain more likely to die early.

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  4. Speaking for myself and knowing the lived experiences of other men with PCa with whom I've communicated, cancer itself was not the biggest detriment to QofL. In fact, for many like myself, while cancer may threaten longevity, it was not detrimental to my everyday QofL, but the conventional treatments were. As for stating that "All of the conventional therapies improve QOL" I have several friends who underwent ADT, surgery, radiation and/or chemo who would beg to differ with such a blanket statement.

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    1. I can only tell you what is true among thousands of men, but it may not be true for you or some friends of yours. Your anecdotes notwithstanding, across the population of men with advanced prostate cancer, ALL of the standard therapies improve QOL in the long run. I can prove that is true. If you are convinced they don't for you, you are, as you correctly stated, "speaking for yourself."

      Prostate cancer can be a painful and debilitating disease.

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    2. @novatimo what is your source of information about QofL for those who don't undergo treatment?
      None of the therapies are things we would do voluntarily; we try to choose the least-bad option. Treatment hurts us as a side-effect of killing the cancer.
      If the harm of treatment will exceed the benefit (see Active Surveillance for example), then the treatment will generally not be recommended (subject as usual to human failures) or chosen.

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  5. Thank you for acknowledging the lived experiences of men who choose different treatment paths for their PCa. But I think what we have here is a difference in the definition of 'QofL'. In my case, the (untreatable) drenching hourly nightsweats that came with ADT deprived me of sleep and made me irritable, depressed, physically weakened, and with no libido. This was hardly an 'improved QofL' for me. I stopped ADT four years ago and have almost returned to normal. As for "prostate cancer can be a painful and debilitating disease' this is undoubtedly true, but perhaps no more so than other types of cancer or other diseases in general. 'QofL' is a very subjective measure that, like many complex issues, cannot always be fully understood by disembodied statistics.

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    1. I'm glad you raised the point of QOL as a subjective measure. In fact, the "disembodied statististics," as you call them, depend on the patient's subjective POV. They ask each patient for his own assessment of QOL. It captures the "lived experience of each patient." Once again, your "lived experience" may be different from the average.

      Ass for hot flashes, some men find relief in acupuncture, estrogen patches, Megace, or venlafaxine.

      The point about "painful and debilitating" effects of no treatment is certainly true of almost all cancers. That is exactly the point. Avoiding treatments does not allow one to escape the morbidity associated with the disease. Treatment significantly improves QOL on the average.

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  6. Yes but available treatments do prolong life but in the end the "painful and debilitating disease" stage comes anyway. It is inevitable. We all are just buying some time. We buy years, some of us just months. For some, the cost of extra time expressed in QoL is too high. I know individuals who - before they died - regretted taking chemotherapy. The said they compared themselves to others who refused - and their last months were identical.

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    1. I know individuals, probably many more than you know, who before they died, regretted NOT taking chemotherapy sooner. Chemo has much fewer side effects and works better if taken EARLIER. Patient evaluations prove that it IMPROVES QOL.

      The illogic is that if a therapy has side effects then a complementary or alternative therapy allows one to forgo all side effects. SOC therapies all IMPROVE QOL over the alternatives.

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  7. I have been taken Omega-3 1g/BID for almost 20 years and it did not do anything for my Chronic Renal Insufficiency Grade 3. I was diagnosed Marginal Zone Lymphoma in the Bone Marrow in 2019 and Prostate Ca G4+3=7 Grade 3.
    I am still taking them and I am getting Lupron Depot 22.5 mg/12 weeks X 2 and VMAT hypofractionnated 3 Gy X 20 Rxs.
    So after 12 weeks of ADT and 9 weeks post-radiotherapy, my PSA is 0.18ng/L

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  8. Thank you Allen. Is it possible that some of the disagreement/confusion results from men's accepting anecdotal evidence versus scientific evidence? some men who have Gleason 3+4 or 4+3, for instance, elect a SOC treatment and live 10 years without recurrence, but some of those men do suffer very irritating side effects. Other men, also with 3+4 or 4+3 , elect just non-SOC complementary medicine and/or supplements, and many of these men who so choose may also live 10 years without cancer causing significant problems/side effects....then a particular man who survived 10 years with side effects after SOC treatment compares himself to another man, who deferred SOC treatment and claims no problems/SEs after 10 years, and decides he should have done the same, thus forgoing the SEs of the unnecessary SOC treatment...what that man fails to consider to consider is that he may be one of those who would have experienced metastases during those 10 years without the use of SOC treatment? Thus, at some time during that 10 years, the metastasis and associated problems the first man escaped because of SOC treatment are ignored...though a scientific statistical analysis would reveal the overall QOL improvement from accepting SOC treatment? Or is this not the primary reason for misunderstanding of the benefit of QOL?

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