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The “gold standard” is not what they say

Mainstream medicine doctors love to disregard therapies that have not been “proven by randomized, double blinded, placebo-controlled clinical trials.” However, many therapies in mainstream and natural-therapy medicine are very safe and effective but lack clinical trials to prove them. Does this mean these therapies are not valid and should not be recommended? I’d like to share with you what the “standard of care” really is.

Questioning the gold standard in healthcare

Let me begin with a description of a term commonly used in mainstream medicine called “evidence-based medicine.” This is described as “The conscientious, explicit, judicious and reasonable use of modern, best evidence in making decisions about the care of individual patients.” [1] Evidence-based medicine aims to rely on high quality research such as systematic reviews and meta-analyses to guide clinical decision-making.

The next way to establish a standard of care in mainstream medicine is called the “randomized double-blind, placebo-controlled (RDBPC) clinical trial.” These are human studies in which neither group knows what treatment they are receiving, and each participant is randomly assigned to either the treatment group or the placebo (control) group. Some doctors foolishly hold to the belief that if it has not been proven by a RDBPC trial, it should not be recommended. I beg to differ and here’s why.

If you need to know about the effectiveness of a prescription drug, then a RDBPC study is needed. There are many examples of this. However, a substantial part of preventing or reversing illness is not the use of a drug or supplement. While most all mainstream doctors hold fast to RDBPC studies as the only “gold standard” of medicine,[2] it hasn’t always been this way. There are fundamental therapies in medicine that have deviated from this standard for decades.

For example, in a 1978 report by our government’s Office of Technology Assessment’s (OTA) advisory board made up of eminent university faculty, "…only 10 to 20 percent of all procedures [then] currently used in medical practice [had] been shown to be efficacious by controlled trial."[3] This means that 80% to 90% of “gold standard”’ medical procedures were still unproven by a scientific clinical trial!

Moreover, according to a 1988 Journal of the American Medical Association (JAMA) article, 44% of all coronary artery bypass graft (open heart) surgery was being done for inappropriate reasons.[4] You can see that pride or greed creeps into mainstream medicine.

The fact is that whenever a doctor finds that a certain therapy or medication repeatedly works well, this too can be considered “evidence-based medicine” until more evidence is obtained. Let me tell you what I mean.

Study results can be confusing

A problem with relying only on clinical trials to determine the value of a therapy is that there are studies “for” and studies “against” most all therapies I learn about.

Then we look to “meta-analyses” (a collection of studies) to better substantiate study outcomes, and to this I agree. Yet here again, the researchers are subject to the biases or quality of clinical studies available.

One such example was the use of equine (synthetic) estrogen, which I was taught to recommend to all menopausal women for improved heart health and breast cancer risk reduction. Then in 2002 the large Women’s Health Initiative (WHI)[5] revealed that synthetic oral estrogen plus progestin therapy was actually not safe, and the ongoing study in 2009[6] looked at more than 16,000 postmenopausal women taking synthetic, chemically modified prescription hormones for extended periods and showed that they had an increased incidence of breast cancer[7], a higher risk of heart attack and stroke[8], and more pulmonary embolism.

Another example is he myriad of confusion around the need for statin drugs to lower heart attack risk. While statins became the highest dollar-volume selling pharmaceutical drug in America in early 2000 due to certain RDBPC clinical trials, a landmark 2009 study revealed that nearly 75% of patients hospitalized for a heart attack had LDL cholesterol levels within the recommended target for LDL cholesterol.[9] What does this say about the predictive power of LDL-cholesterol levels on cardiovascular risk?

Or how about the studies that tell us we should avoid saturated fat for heart health? Consider the huge prospective meta-analysis reported in 2010 involving nearly 350,000 people which found no association between saturated fat and heart disease.[10] Or the Japanese study of 58,000 men followed for an average of 14 years which found no association between saturated fat intake and heart disease; plus, those who consumed more saturated fat had a lower stroke risk.[11]

Yet another example is the “gold standard” of testing someone with stomach area pains for Helicobacter pylori “infection.” It is well known that most people who test positive for Helicobacter pylori are asymptomatic.[12] I would ask, why is it the gold standard to test for it and eradicate it with antibiotics? There are other more important factors in gastritis from my experience, such as:

  • foods that you know stir up excessive stomach acid: spicy foods, carbonated drinks, coffee, sweet foods on an empty stomach, citrus such as strong orange juice, or possibly cow's milk or excessive bread

  • eating late at night or under stress

  • major stress/illness all at once or prolonged painful emotions

While we all like to think that clinical trials guide us to correct treatments, let’s be smart about what can effectively be studied by this model and what cannot. Where there is no money to be made, you will likely not see any RDBCT clinical trial. Let’s also not disregard safe and effective treatments just because we don’t “yet have” such studies to rely on!

In my next article allow me to give you some current examples in my practice of valuable therapies not (yet) proven by randomized double-blind, placebo-controlled (RDBPC) clinical trials.

To long term health and feeling good,

Michael Cutler, M.D.


[1] Masic I, Miokovic M, Muhamedagic B. Evidence based medicine - new approaches and challenges. Acta Inform Med. 2008;16(4):219-25. PubMed PMID: 24109156; PubMed Central PMCID: PMC3789163.

[2] Misra S. Randomized double blind placebo control studies, the "Gold Standard" in intervention-based studies. Indian J Sex Transm Dis AIDS. 2012 Jul;33(2):131-4. PubMed PMID: 23188942.

[3]Assessing the Efficacy and Safety of Medical Technologies. Washington, DC, Congress of the United States, Office of Technology Assessment, Publication No. 052003-00593-0. Government Printing Office, Washington, DC, 20402, 1978.

[4] Winslow CM, Kosecoff JB, Chassin M, et al: The appropriateness of performing coronary artery bypass surgery. JAMA 1988;260:505-509.

[5] Rossouw JE, Anderson GL, Prentice RL, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women’s Health Initiative randomized controlled trial. JAMA.2002 Jul 17;288(3):321-33.

[6] Chlebowski RT, et al. Breast Cancer after Use of Estrogen plus Progestin in Postmenopausal Women. N Engl J Med 2009; 360:573-587.

[7] Colditz GA, Hankinson SE, Hunter DJ, et al. The use of estrogens and progestins and the risk of breast cancer in postmenopausal women. N Engl J Med. 1995 Jun 15;332(24):1589-93.

[8] Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women JAMA. 2002;288(3):321-333.

[9] Sachdeva A, Cannon CP, Deedwania PC, Labresh KA, Smith SC Jr, Dai D, Hernandez A, Fonarow GC. Lipid levels in patients hospitalized with coronary artery disease: an analysis of 136,905 hospitalizations in Get With The Guidelines. Am Heart J. 2009 Jan;157(1):111-117.e2. Online at:

[10] Siri-Tarino PW, Sun Q, Hu FB, Krauss RM. Meta-analysis of prospective cohort studies evaluating the association of saturated fat with cardiovascular disease. Am J Clin Nutr. 2010 Mar;91(3):535-46. PubMed PMID: 20071648. Find online at:

[11] Yamagishi K, Iso H, Yatsuya H, Tanabe N, Date C, Kikuchi S, Yamamoto A, Inaba Y, Tamakoshi A; JACC Study Group. Dietary intake of saturated fatty acids and mortality from cardiovascular disease in Japanese: the Japan Collaborative Cohort Study for Evaluation of Cancer Risk (JACC) Study. Am J Clin Nutr. 2010 Oct;92(4):759-65.

Find online at:

[12] Oztürk H, Senocak ME, Uzunalimoğlu B, Hasçelik G, Büyükpamukçu N, Hiçsönmez A. Helicobacter pylori infection in symptomatic and asymptomatic children: a prospective clinical study. Eur J Pediatr Surg. 1996 Oct;6(5):265-9. PubMed PMID: 8933128.

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