October 2005

Expert says valid clinical research takes millions

by Dr. David A. Jackson

A recent article by Dr. Robert Matthews, in New Scientist magazine revealed a surprising and ultimately shocking fact about medical research. According to Dr. Matthews, "to detect side effects affecting 1 in 1000 patients ‑‑ enough to spark a major health alert with mass‑market drugs like Vioxx ‑‑ you would need to recruit several million people to take part in your trial."

He based this conclusion on standard statistical theory that, "to be sure of having a decent chance of detecting side effects that occur in 1 in n people, you need a clinical trial involving around 8 times n2 people."

Yet, most clinical trials don't come close to those numbers. In fact, most involve fewer than 1,000 subjects and some have only a few dozen. A clinical trial conducted by the Multiple Sclerosis Institute in Philadelphia, to see if the drugs Avonex and Topamax (topiramate) could affect immune function, had 30 subjects. A proposal for a trial sponsored by the National Center for Complementary and Alternative Medicine to test the link between dietary magnesium intake and asthma listed an expected total enrollment of 240.

A recent press release distributed by the Mayo Clinic optimistically announced "Radiation, Chemotherapy With Liver Transplant Improves Cancer Survival," yet the research was based on a study of only 90 patients.

Another release, from the Johns Hopkins Medical Institutions, declared, "Transplant Rejection Drug Holds Promise for Inflammatory Eye Disease." The research was based on a clinical trial in which the drug was given to 84 patients (seven of whom had to drop out because of negative side effects).

No wonder so many drugs have to be pulled off the market after people start dying from them. Researchers are increasingly admitting that, in order to draw valid conclusions about the effectiveness or risks of a procedure or drug, the number of subjects studied must increase drastically.

"These statistical facts of life can no longer be waved away as mere theory," Matthews warned. "It took a huge study involving almost 17,000 women, abruptly terminated in 2002, to reveal convincing evidence of the risks to women from hormone replacement therapy. The dark side of the class of antidepressants known as SSRIs, long suspected of increasing the risk of suicide attempts, is also becoming clear following results from more than 87,000 patients."

Chiropractic has the opportunity to pioneer the large scale clinical trials through the RCS (Research & Clinical Science) program, which aims at recruiting well over one million subjects worldwide. Using a network of several thousands field doctors simultaneously collecting data on thousands of volunteers each, the research database will be able to correlate numerous variables on millions of people. Volunteers will include a wide spectrum of the public ‑‑ from those who have never received chiropractic adjustments to those undergoing long‑term wellness care.

By analyzing the lengthy Self‑Reported Quality of Life assessment study completed by each volunteer, the RCS International Scientific Advisory Panel will be able to determine with extreme specificity the impact of vertebral subluxation ‑‑ and the affect of chiropractic care ‑‑ on various aspects of health and wellness.

Correlations the researchers are looking for include chiropractic's affect on immune function, its ability to reduce the negative impact of stress on health, and the benefits of chiropractic on children and seniors.

Several years ago, Robert Blanks, PhD, conducted a study of more than 2,800 chiropractic patients, with data collected by 156 Network Chiropractic practitioners in the United States, Canada, Australia, and Puerto Rico. Results indicated that patients reported significant, positive perceived change in all four domains of health (physical, mental/emotional, stress, and life enjoyment) as well as overall quality of life.

Wellness was assessed by totaling the scores for the four health domains into a combined wellness scale, and comparing this combined scale before and after chiropractic care. The difference, or "wellness coefficient" spanning a range of ‑1 to +1, with zero representing no change, showed positive, progressive increases over the duration of care intervals ranging from 1‑3 months to over three years.

The benefits became evident as early as one‑to‑three months under care, and subjects continued to show clinical improvements with additional care ‑‑ with no indication of a maximum clinical benefit.

Imagine if a major drug manufacturer conducted a study of a new drug on 2,800 people and found that nearly all of them reported an improvement in four major categories of health as well as overall quality of life ‑‑ and no negative side effects. I might even be tempted to start taking such a pill!

Now, imagine a study conducted by highly respected researchers (most of whom are not connected to the chiropractic profession) in which several MILLION people reported an improvement in the quality of their lives after receiving chiropractic care.

This would surely be enough to convince our critics that chiropractic is not suffering from a "dearth of good research to prove efficacy" (as Newsweek put it earlier this year). And it should satisfy even the most skeptical of our own colleagues.

There is a fairly universal consensus that chiropractic requires additional research to provide the scientifically acceptable evidence of the damaging affects of subluxation. Stephen Perle, DC, justly noted in an article for Dynamic Chiropractic that, "The problem is that there are no prospective studies, that I am aware of, showing that people without subluxations are healthier than those with subluxations. Further, in my experience, the clinical trials that have examined spinal adjusting have not tracked changes in health with changes in indicators for the presence of subluxations. So, while we have evidence that chiropractic care can be an effective treatment for certain conditions, I am not aware of any evidence showing that what helped the patient was the removal of subluxations."

The mission of RCS  is to provide those studies and that evidence by conducting the largest population‑based clinical research trial ever performed, involving thousands of doctors and millions of subjects. RCS will continue and expand upon Dr. Blanks' initial research effort and use the same types of methodology utilized by the Mayo Clinic, Johns Hopkins and every other credible research institute. We have already submitted our research proposal and been fully approved by an independent Institutional Review Board (IRB). We've even gone to the extent of making sure that every one of the field doctors compiling data for the program also are screened and IRB approved!

The project is incredibly complex ‑‑ and expensive. While the Federal government routinely funds multi‑million dollar research projects for drugs and medical procedures, very little of this money ever reaches chiropractic. No chiropractic college or research organization is going to be able to raise the money required for a study on this massive of a scale. To do this research, we have to rely on the private sector.

The most effective way for RCS to raise the kind of money needed for research of this type is to charge doctors to participate in the program, knowing that they would receive many tangible and intangible benefits from that involvement. Hundreds of doctors have already expressed an interest in RCS and others are calling or visiting the RCS website (www.rscprogram.com) every day. Although a few are deterred by the cost (approximately $400/month for a three‑year commitment) most realize that this is a small investment in the future of their profession. It will pay not only for the most important research ever conducted in our profession, but will help position them as the standard bearers of scientific, evidence‑based chiropractic. They understand the meaning of "More research ... more patients ... more credibility ... MORE CHIROPRACTIC!" They also would agree with the conclusion Matthews came to in his New Scientist article: "If acquiring knowledge seems expensive, try ignorance."

(David A. Jackson, DC is chief executive officer of Research and Clinical Science ‑‑ RCS ‑‑ a private sector research program exploring issues of subluxation correction and chiropractic care as they relate to health and wellness. Previously, he served as president of the Chiropractic Leadership Alliance and Creating Wellness Alliance and was owner/operator of several private practice offices in California and Idaho that specialized in high‑volume, family wellness‑based care. For a free, no‑obligation information packet about RCS, call 800‑909‑1354 or 480‑303‑1694, or visit the RCS website at www.rcsprogram.com. Doctors of chiropractic may log on to a special limited‑access area of the site by using the username DC2 and password RESEARCH.)