New Research Published: Results from a multi-Site, Prospective, Double-Blind Randomized Placebo-Controlled Trial

Did you see the latest research about the implementation of complementary disease management strategies to reduce IPF symptoms and enhance quality of life and well-being? This study – which enrolled 100 IPF patients from six different institutions – was a prospective, double-blind randomized placebo-controlled trial. This is considered the “gold standard” for research! It was led and ultimately authored by our Director Neha Shah, PhD. 

• To read the publication online, visit the journal Diseases: https://www.mdpi.com/2079-9721/12/7/155
• If you’d prefer making a paper copy before reading, you can download and print here: https://www.mdpi.com/2079-9721/12/7/155/pdf
• For a summary of the research design and findings, continue reading below.

About the Study

Here are more details about the study’s design:

• The study was considered “double-blind” and randomized because people were ‘blinded’ to who received the supplement vs the placebo. This includes research participants as well as research coordinators, investigators, or others directly involved in the study’s conduct and implementation. While all 100 participants met the same inclusion criteria qualifying them for the study, the 50 people who received the supplement were selected at random from the various sites.
• This study was prospective, meaning that it collected data real-time and tracked the development of potential future outcomes (rather than a retrospective study, which evaluates data that’s already been collected in the past). 
• It was also placebo-controlled, which means that it not only tested the effects of the intervention (in this case, the systemic enzymes Serracor-NK® and Serra Rx260) but also tested the effects of no intervention. For 6 months, half of the participants received the dietary supplements in addition to what’s considered ‘standard’ care, and the other half received ‘standard’ care but not the dietary supplements. 

The study had these objectives:

1. The primary objective was to evaluate the regimen’s impact on symptoms, quality of life (also known as QOL), and well-being. In order to quantitatively measure those health-related areas, a few different kinds of validated surveys were distributed:
   • the UCSD shortness of breath (UCSD-SOB) questionnaire, 
   • St. George’s respiratory questionnaire (SGRQ), and 
   • WHO well-being index (WHO-5) 
2. The secondary objective was to evaluate the regimen’s safety. Safety assessments included the monitoring of liver function tests and vital signs. To see research that focused on safety as a primary objective, please visit our research page here.

Results and Conclusions

• A significantly higher proportion of patients in the supplement group demonstrated meaningful improvement in symptoms as compared to the placebo group.
• A significantly greater proportion of patients in the supplement group showed improved QOL and well-being.
• A significantly greater proportion of patients in the supplement group showed reduced health impairment.
• Interestingly, physical activity did not differ significantly between the groups. 
• Safety assessments indicated that the supplement regimen was well tolerated.

In summary, the results of this study suggest that the systemic enzyme supplements safely improved symptoms and health-related QOL in IPF patients. For additional ideas to address commonly reported IPF symptoms, visit these blogs about chronic coughing, fatigue, and brain fog. 

Ready to Learn More?

If this research seemed interesting or inspiring to you, please refer to our resources that help you find published research, understand published research, and build self-advocacy skills. Talk to your doctor about your unique circumstances and any research you find interesting; there may be a clinical trial you’d qualify for, or disease management strategies to consider too. Be sure to also sign up for our upcoming support group meetups and to join our online community forum for 24/7 support.

Stay In Touch

PF NOW! hosts virtual support groups on Teams multiple times each month. Not only will you strengthen your network of connections but you’ll learn firsthand how those with PF best look after themselves. PF NOW! also has a Facebook group whose active community shares their PF journey and their tips with others. New to online support groups? Download our free step-by-step guide for online advocacy here.

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