Page 26 - IMCJ April 2020

permeability, cell adhesion, cell growth, cell differentiation, Statistical Analysis
cell signaling, apoptosis, signal transcription, and Baseline variables (sex, age and triglyceride level)
transduction in intestinal mucosa were modulated by were summarized using count/percentage for sex and
B. Clausii. 49 mean/sd for continuous variables. This was done for the
This randomized, double-blind, placebo-controlled entire cohort and also by treatment. Outcome variables
trial demonstrates that probiotics consisting of five spore (triglyceride level at 6 and 12 weeks) were compared
forming bacilli effectively lowered triglyceride levels in between treatment groups using two-sample t tests and
participants with mild to moderate HT. linear regression models that adjust for baseline variables.
Possible interactions between treatment and baseline
Methods variables were tested under linear regression models.
Inclusion criteria P values less than .05 (two-sided) were considered statistically
• In good general health as evidenced by medical significant. All analyses were performed in R 3.4.2.
history and physical examination.
• Willingness to comply with all the study procedures. Results
• Male or Female, age >25 and <70 years old. A total of 80 participants were eligible to enter into
• For females of reproductive potential: use of highly the study. All were randomized into the intervention and
effective contraception. placebo groups. All 80 participant were reevaluated at
• Triglyceride levels >150 md/dl 6 weeks and 12 weeks, with no adverse effects reported in
• Ability and willingness to take oral supplements either the intervention or placebo groups.
and adhere to regimen. Table 1 summarizes the baseline characteristics of the
80 subjects, overall and by treatment. The study subjects
Exclusion criteria were mostly female (80%), with an average age of 49 years
• Pregnancy or lactation. and an average triglyceride level of 207 mg/dl. The treated
• Surgical procedure within the last 120 days. group had a slightly larger proportion of male subjects, a
• Use of recreational drugs or addictions. slightly higher average age and a slightly higher average
• Alcoholism. triglyceride level at baseline. However, these differences
• Hepatitis were not statistically significant.
• Currently on or having taken statin drugs within Figure 1 shows the trajectory of triglyceride level in
the last 90 days. each treatment group. In the treated group, triglyceride
• Currently on cortisol based medications or having level declined sharply from baseline to 6 weeks and further
taken these in the last 60 days. to 12 weeks, whereas the control group did not experience
• On non-steroidal anti-inflammatory drugs. a substantial change in triglyceride level. At 6 weeks, a
• Taking or having taken an antibiotic drug within direct (i.e., unadjusted) comparison of the two treatment
the last 30 days. groups indicates that probiotic treatment decreases the
• Currently under the care of a doctor for any type of mean triglyceride level by 37.3 (95% CI: 1.4 to 73.3) mg/dl,
medical problem deemed unacceptable for which is statistically significant (P = .042). In a linear
participation in this clinical trial. regression analysis that adjusts for sex, age and triglyceride
at baseline, the effect of probiotic treatment at 6 weeks
Randomizing and blinding becomes larger (51.7 mg/dl; 95% CI: 22.3 to 80.1) and
All the randomized assignments were concealed in more significant (P = .0009). At 12 weeks, the unadjusted
opaque, sealed envelopes. All participants, doctors, difference in mean triglyceride level between the two
researchers, outcome assessors, were blinded to the treatment groups (placebo – probiotic) increases to
research protocol and the random assignment. 64.9 (95% CI: 33.5 to 96.2) mg/dl, which is highly
significant (P < .0001). After adjusting for sex, age and
Participants and Recruitment baseline triglyceride in a linear regression model, the
All participants were recruited from newspaper effect of probiotic treatment at 12 weeks becomes even
advertising and from posted flyers. They were assessed larger (77.7 mg/dl; 95% CI: 52.5 to 102.9) and more
clinically. After evaluation, 80 participants were significant (P < .0001). There are no significant interactions
randomized to either the intervention or the placebo at either time point (6 or 12 weeks) between treatment and
group. All physicians were trained regarding the the three baseline variables (P > .4), indicating that the
administration of the intervention and placebo before the treatment effect is consistent across different subgroups
study. All participants were subsequently informed about defined by sex, age and baseline triglyceride.
the research and given an information sheet. All
participants were required to provide a signed informed Discussion
consent that contained the aim and nature of this study. To the best of our knowledge, this study is the first
12 week randomized, double-blind, placebo-controlled

24 Integrative Medicine • Vol. 19, No. 2 • April 2020 Campbell—Spore Forming Bacilli Supplementation for HT