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N C C A M Research Blog

The Many Positives in Negative Study Findings

December 09, 2013
Josephine P. Briggs, M.D.
Josephine P. Briggs, M.D.

Director
National Center for Complementary and Alternative Medicine

View Dr. Briggs' biographical sketch

A recent study in the New England Journal of Medicine, authored by six researchers at the National Heart, Lung, and Blood Institute (NHLBI), prompts some thoughts about studies with negative outcomes—and their importance in the entire research process.

In this report Dr. David Gordon, Dr. Michael Lauer, and their colleagues analyzed the 244 extramural, randomized clinical trials supported by NHLBI and completed between the years 2000 and 2011. The primary outcome was the time between completion of trials and publication of the main results in a peer-reviewed journal; the secondary outcome was the annual citation rates for these articles—i.e., how many times each article was cited in a given time period. The team also examined a number of trial characteristics that related to these questions, such as budget, number of participants, and whether the result was positive or negative.

Among the many interesting findings are that more than half of the studies analyzed (58 percent) yielded negative results. And intriguingly, of the 31 trials having the highest citation rates, only 8 (26 percent) had positive results. Studies supported by NHLBI, and indeed, studies supported by NCCAM, generally start with enthusiasm of the investigators, peer reviewers, and NIH. They generally start with the expectation (and indeed preliminary data) that the intervention being studied has the potential to improve patient outcomes. By and large, when no benefit is demonstrated, research teams are understandably disappointed. And Gordon and co-authors found that investigators completing negative studies are indeed significantly slower to publish.

Nevertheless, we do the research because we don’t know the answer! Negative studies are just as important to consumers as positive studies. They are essential blocks in the evidence base. They help everyone—consumers and health care providers—avoid interventions that don’t help.

There is an additional “silver lining.” Negative studies are extremely important in the research process. And the high-quality data produced during our well-performed, carefully monitored studies are of enormous value in deciding on follow-on questions and in the design of subsequent studies.

We learn from surprises—from discovering that we don’t always know what we think we know.

Comments

Oh how true this is.  Holistic health is something that had been of great importance to me as I continue to search for answers for my own health.  I read and learn from professionals in the field of health and wellness as often as I can. It is extremely beneficial for someone like me to be able to learn about the negative affects of a treatment, “TRUTHFULLY’  rather than believe what is advertized. In addition, having the negative information available in a timely manner would definately save money.

For better or worse, the majority of modern-day medical practices have been proven to be ineffective.  The BMJ estimates that only around 11% (!) of medical treatment have been found to be effective.  http://clinicalevidence.bmj.com/x/set/static/cms/efficacy-categorisations.htmlA recent review published in the Mayo Clinic Proceedings further confirms, “Of the 363 articles testing standard of care, 146 (40.2%) reversed that practice, whereas 138 (38.0%) reaffirmed it.”  http://www.mayoclinicproceedings.org/article/S0025-6196(13)00405-9/abstractPerhaps most damning of all is the fact that the vast majority of patients today are prescribed two or more drugs, often 5 to 10 drugs!  Needless to say, there is virtually no evidence of safety or efficacy of this common practice of polypharmacy.  It is time to STOP referring to conventional medical practices as “scientific” or “proven” unless they have been proven in the way that they are commonly used in medical care today.

Dear Sheer Julious,The “negative findings” referenced in the article above refer specifically to the results of a study as they relate to the hypothesis of the study; for instance, if a study hypothesized that acupuncture would relieve pain caused by arthritis, and the study found that acupuncture did not in fact relieve pain (the pain did not get better), then the results of the study would be considered “negative”. This in no way refers to “negative effects” of the treatment, which in clinical research are referred to as “adverse events”, where the research participant is actually harmed by the treatment being studied. Hope this clears things up for you! All the best. Dan

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