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Doctors Claim to Have Effective New Treatment for Deadly Sepsis

Retrospective data must be confirmed in clinical trials

A group of doctors at Eastern Virginia Medical School in Norfolk, Virginia, has reported remarkable success in treating sepsis patients who were at high risk of sudden death, according to an article posted on the National Public Radio (NPR) website.

In a retrospective clinical study, the researchers evaluated the outcome and clinical course in septic patients treated with intravenous vitamin C, hydrocortisone, and thiamine during a seven-month period (treatment group) compared with patients treated in the intensive care unit during the preceding seven months (control group). Forty-seven patients were included in each group. The study’s primary endpoint was hospital survival.

The hospital mortality rate was 8.5% (4/47) in the treatment group compared with 40.4% (19/47) in the control group (P < 0.001). The propensity-adjusted odds of mortality among the patients treated with the vitamin C protocol was 0.13 (P = 0.002). The Sequential Organ Failure Assessment (SOFA) score was reduced in all of the patients in the treatment group, with none developing progressive organ failure.

A prospective investigation isn’t the standard way to evaluate a potential new treatment. Ordinarily, the investigational treatment would be compared head-to-head with placebo or a standard therapy using a double-blind protocol, in which neither the doctors nor the patients would know who was getting the new therapy.

But the initial results were so impressive, lead investigator Dr Paul Marik decided he would treat all of his sepsis patients with the vitamin C infusion. So far, he has treated approximately 150 patients, and only one has died of sepsis, he said. That’s a phenomenal claim, considering that of the million Americans a year who develop sepsis, approximately a third die.

“If it turns out in further studies that this is true, and we can validate it, then this will be an unbelievably huge deal,” Dr. Craig Coopermsith, a professor of surgery at the Emory University School of Medicine, told NPR. “But right now we should treat it as a preliminary deal that needs to be validated.”

Coopersmith, a top sepsis researcher, is cautious for a reason. There have been hundreds of exciting results from sepsis studies that failed in follow-up research.

Coopersmith said the extraordinary results reported from Norfolk clearly need careful scrutiny, and Marik agrees.

Drug companies could reap billions in profits if they could develop a successful sepsis treatment. But profit was not the motive for the new study, Marik says. The ingredients cost about as much as a single dose of antibiotics.

Sources: NPR Health News; March 23, 2017; and Chest; December 6, 2016.

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