Impact of serum-derived bovine immunoglobulin/protein isolate therapy on irritable bowel syndrome and inflammatory bowel disease: a survey of patient perspective
Authors Shaw AL, Tomanelli A, Bradshaw TP, Petschow BW, Burnett BP
Received 16 February 2017
Accepted for publication 22 April 2017
Published 31 May 2017 Volume 2017:11 Pages 1001—1007
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Amy Norman
Peer reviewer comments 2
Editor who approved publication: Dr Johnny Chen
Audrey L Shaw,1 Adam Tomanelli,2 Timothy P Bradshaw,1 Bryon W Petschow,1 Bruce P Burnett3
1Clinical Research, Entera Health, Inc., Cary, NC, 2Market Research, Praxis Research Partners, Fairfield, CT, 3Medical Affairs, Entera Health, Inc., Cary, NC, USA
Background: Patients with irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD) commonly experience diarrhea, abdominal pain, bloating, and urgency. These symptoms significantly compromise the patient’s quality of life (QoL) by limiting participation in normal daily activities and adversely affect work productivity and performance.
Purpose: The aim of this study was to understand from the patient’s perspective how oral serum-derived bovine immunoglobulin/protein isolate (SBI) impacts bowel habits, management of condition, and basic QoL.
Methods: A 1-page questionnaire was distributed randomly to >14,000 patients who were prescribed SBI (EnteraGam®) for relevant intended uses. The survey was designed to collect data related to the influence of IBS or IBD on daily life activities and the impact of SBI usage on daily stool frequency, management of their condition, and QoL. Patient-reported responses were analyzed using a paired t-test to compare mean change in daily stool output and descriptive statistics for continuous variables.
Results: A total of 1,377 patients returned the surveys. Results from 595 surveys were analyzed with a focus on patients with IBS or IBD who had provided numeric responses regarding daily stool frequency. Respondents with IBS who reported having a normal stool frequency (≤4 stools per day) increased from 35% prior to using SBI to 91% while using SBI. A similar change toward normal stool frequency was reported by IBD respondents. Mean daily stool numbers decreased for respondents in the combined IBS and IBD groups (P=0.0001) from 6.5±4.3 before SBI to 2.6±1.9 following SBI use. The majority of respondents agreed strongly or very strongly that SBI helped them manage their condition (66.9%) and helped them return to the activities they enjoyed (59.1%).
Conclusion: Results from this patient survey suggest that SBI use can lead to clinically relevant decreases in daily stool frequency in patients with IBS or IBD along with improvements in the overall management of their condition and aspects of QoL.
Keywords: IBD, IBS, patient satisfaction, stool frequency, quality of life
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Shaw AL, Mathews DW, Hinkle JE, Petschow BW, Weaver EM, Detzel CJ, Klein GL, Bradshaw TP
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