First Randomized, Blinded Study Published on Vitamin C as Treatment for Severe Sepsis
October 2, 2019
For several years researchers have been looking at many ways to treat sepsis, but a cure has been elusive so far. Since the actual cause of sepsis isn’t yet completely understood, it’s hard to find the right target for treatment. In 2017, Dr. Paul Marik, an ICU physician at Sentara Norfolk General Hospital in Norfolk, Virginia, had an idea. He used a combination of intravenous (IV) vitamin C, steroids, and thiamine to treat three patients with severe sepsis. They responded well, so he continued to give patients the vitamin C regimen. After he treated 50 patients with his IV combination, he wrote a paper for the journal Chest.
The media picked up on his story and gave it a lot of coverage. If such a simple solution could cure people with sepsis, this would be amazing. However, there hadn’t been any clinical trials to verify the claims that the vitamin C regimen was truly helpful, so while some physicians were on board with trying it, others were cautious. All too often, hopes have been raised and then dashed when it comes to finding treatments for potentially fatal illnesses, so their caution is understandable.
More studies were proposed to test Marik’s theory. The first is complete and its findings were published this week in JAMA. Researchers from Virginia, Wisconsin, Ohio, Kentucky, and Georgia studied 167 patients with sepsis and acute respiratory distress syndrome (ARDS); 84 patients received vitamin C plus fluid (5% dextrose in water) by IV and 83 received only the dextrose and water (placebo) in their IV. This was the control group. The study was randomized and blinded, so the researchers did not know which patients were in which group. Both groups were treated for 96 hours and blood tests were taken at the start of treatment, and again at 48, 96, and 168 hours later.
The study had three primary outcomes: organ failure, and blood tests showing either inflammation or injury markers. The findings showed no differences between patients in either group with these three outcomes. In addition, the researchers looked at 46 secondary outcomes to compare the patients. Of these, three outcomes were better in the treated group. Fewer people who received the vitamin C died than those who received the placebo. The treated patients also spent less time in the ICU overall (7 days versus 10) and fewer days in the hospital (15 days versus 22). However, it must be kept in mind that these are the only three outcomes where the treated patients did better than the control group – out of 46.
Fewer deaths and shorter hospital stays are encouraging, but caution must be taken when interpreting these results. For example, studies make adjustments to their findings to ensure the facts are seen equally in multiple comparisons. There were no adjustments in this case, which means there could be other reasons unrelated to the treatment why fewer people who received the vitamin died or why they recovered faster. The researchers concluded with the following statement: “In this preliminary study of patients with sepsis and ARDS, a 96-hour infusion of vitamin C compared with placebo did not significantly improve organ dysfunction scores or alter markers of inflammation and vascular injury. Further research would be needed to evaluate the potential role of vitamin C for other outcomes in sepsis and ARDS.”
Sepsis Alliance is encouraged by the increasing number of studies dedicated to solving the sepsis puzzle. There are now 16 trials world-wide that are studying various combinations of vitamin C, thiamine, and steroids. To learn more about ongoing studies, visit the vitamin C and sepsis ClinicalTrials.gov page.