Double-blind, Placebo Controlled, Randomized Crossover Pilot Study Evaluating the Impacts of Sodium Bicarbonate in a Transdermal Delivery System on Delayed Muscle Onset Soreness: 2403 Board #239 June 1 11

Full text

Lisa M. Misell1, Mark Kern2, Andrew Ordille2, Madeline Alm2, Brookell Salewske2
1Ampersand Biopharmaceuticals, LLC, Thousand Oaks, CA, 2San Diego State University, San Diego, CA (Sponsor: Michael Buono, FACSM)
DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, CROSSOVER PILOT STUDY EVALUATING THE IMPACT OF
SODIUM BICARBONATE IN A TRANSDERMAL DELIVERY SYSTEM ON DELAYED MUSCLE ONSET SORENESS (DOMS)
Warm up 10 - 20-min 5-min 30-sec 5-min 5-min Recovery
Incremental Ramp Test
RPE of 17
is reached
30-sec Sprint
5-min Time Trial
Warm up 60-min Recovery
1-hour Time Trial
FIGURE 1-BFIGURE 1-A
Author Disclosure Information: M. Kern: Contracted Research - Including Principle Investigator; Ampersand Biopharmaceuticals LLC (DBA AmpHP)
ABSTRACT
Sodium bicarbonate/alkalinization may reduce muscle mitochondrial damage caused by
reactive oxygen species during intense exercise. Such damage can induce post-exercise
inammation and pain, which may be linked to delayed onset muscle soreness, or DOMS.
However gastrointestinal side effects limit the use of oral sodium bicarbonate.
PURPOSE: This study evaluated the efcacy of a commercially available, topical transdermal
sodium bicarbonate (TSB) lotion (Topical EdgeTM), which is claimed to be delivered through the
skin using a novel patent-pending transdermal delivery system for impacting DOMS.
METHODS: 20 trained cyclists (Category 1-3) and professional triathletes participated in this
randomized, cross-over, double-blinded, placebo-controlled study. After application of TSB or a
placebo, subjects completed a variety of exercise and performance tests varying in duration.
On one day, subjects completed a series of high-intensity exercises which included a ramped
protocol to a rating of perceived exertion (RPE) of 17 out of 20, a 30-sec sprint performance test,
and a 5-min time trial with 5 minutes of recovery between tests. On a separate day, subjects
completed a 1-hr time trial. Subjects completed DOMS questionnaires 24- and 48-hours after
exercise sessions. Muscle soreness was rated on a scale of 0-100 where 0 = “no soreness”, 25 =
“mild pain”, 50 = “moderate pain”, 75 = “severe pain” and 100 = “the worst pain you can imagine”.
RESULTS: DOMS was reduced following the high-intensity series with TSB compared to placebo.
Similar effects were not observed following the 1-hr exercise bout. From the rst to second day
following the high-intensity exercise series, subjects using TSB experienced a 54% reduction in
DOMS versus an increase in DOMS of 34% with placebo (p=0.007).
CONCLUSIONS: Findings from this study suggest that TSB can signicantly shorten recovery
from DOMS following high-intensity exercise. Findings also support the effectiveness of the
transdermal system in delivering sodium bicarbonate topically and may allow athletes to achieve
these results while avoiding the side-effects of oral bicarbonate. Furthermore, we believe this
study is the rst to provide a direct link between sodium bicarbonate use and DOMS in athletes.
Additional research is underway to further substantiate these ndings.
INTRODUCTION
DOMS is characterized by discomfort of muscles peaking 24-48 hours following exercise. A body
of evidence is mounting that suggests that generation of reactive oxygen species (ROS) after
strenuous exercise may be involved in DOMS. The signicant increase in ROS (superoxide,
nitric oxide, hydrogen peroxide and hydroxyl radical) release, following muscle contractions,
leads to oxidative stress. Research has recently shown that alkalization reduces ROS release.
Therefore, theoretically, since oxidative stress-related muscle damage may be a key contributor
to DOMS, the use of sodium bicarbonate may reduce DOMS following intense exercise. However
gastrointestinal side effects limit the use of oral sodium bicarbonate.
HYPOTHESIS: We hypothesized that the topical transdermal sodium bicarbonate (TSB) lotion
(Topical Edge PR™) would positively impact DOMS. Specically it would lower the DOMS score
at ~24 hours after exercise and would result in faster recovery from DOMS as observed by a
larger decrease in DOMS scores from ~24 hours to ~48 hours after exercise.
METHODS
• 20 trained cyclists (Category 1-3) and professional triathletes with an average VO2 Peak
(VO2mL/kg/min) of 58.9+/-7.2 participated in this randomized, cross-over, double-blinded,
placebo-controlled study.
• After application of Transdermal Sodium Bicarbonate (TSB) or placebo lotions, subjects
completed a variety of exercise and performance tests (Figure 1).
• Subjects completed delayed-onset muscle soreness (DOMS) questionnaires ~24 and ~48
hours after exercise sessions. Muscle soreness was rated on a scale of 0-100 where 0 = “no
soreness”, 25 = “mild pain”, 50 = “moderate pain”, 75 = “severe pain” and 100 = “the worst pain
you can imagine”.
• Statistical analyses were performed using a mixed effects linear model with subject as a
random effect and DOMS as a xed effect. DOMS results are reported as least-squares means
± SE. Post hoc analyses were completed to analyze DOMS results for the subset of subjects
reporting scores >0 at day 1 after exercise. Signicant differences are p≤0.05.
Figure 1. Schematic of Study Protocol. Subjects completed both tests; A) High-intensity series
of exercise tests, and B) 1 hour time trial, on separate days, and for each study product (placebo
or active).
RESULTS
• DOMS, measured over a 2-day period following exercise testing, showed faster recovery from
muscle soreness with TSB lotion use versus placebo lotion after the series of high-intensity
exercise tests, but not after the longer duration 1-hour time trial.
• A post hoc analysis of DOMS reporters (those who reported scores >0) and non-reporters
(those consistently reporting scores of 0 points) at ~24 hours after testing, was also
completed. In DOMS reporters (n=9 placebo and n=11 TSB) the reduction in DOMS was
signicantly greater (p=0.02) for TSB versus placebo (Figure 3).
• In this sub-population, although baseline scores were similar, there was a signicantly different
(p=0.02) mean (±SD) scores of 10.5 ±2.9 for TSB, and 21.0 ±3.3 for placebo at 48 hours.
• Additionally, for DOMS reporters, when evaluating % change from 24 hours to 48 hours while
adjusting for ~24 hour observed values, TSB use resulted in a 54% reduction in DOMS scores
versus an increase in DOMS scores of 34% when using placebo (p=0.007).
Figure 2. Delayed-onset muscle soreness (DOMS) was measured on a 0-100 point scale.
*Subjects had a signicantly greater reduction in DOMS when using the transdermal sodium
bicarbonate lotion compared to the placebo lotion (p=0.045).
Figure 3. Delayed-onset muscle soreness (DOMS) was measured on a 0-100 point scale.
In subjects who reported scores of >0 (n=9 placebo and n=11) the % change in DOMS scores
from 24 to 48 hours was had a signicantly greater reduction when using the transdermal sodium
bicarbonate lotion compared to the placebo lotion (p=0.007, indicated by *).
CONCLUSIONS
• Findings from this study suggest that TSB can signicantly shorten recovery from DOMS
following high-intensity exercise.
• Findings also support the effectiveness of the transdermal system in delivering sodium
bicarbonate topically and may allow athletes to achieve these results while avoiding the
side-effects of oral bicarbonate.
• Furthermore, we believe this study is the rst to provide a direct link between sodium
bicarbonate use and DOMS in athletes.
• Additional research is underway using an objective measure of DOMS to further substantiate these
ndings and to further elucidate the mechanisms that may be responsible for this observation.
ACKNOWLEDGMENTS
Ampersand Biopharmaceuticals, LLC (DBA AmpHP), the manufacturers of Topical Edge PR
sodium bicarbonate sports lotion, provided an unrestricted research grant and placebo and active
products for testing.
0
-2
-4
-6
-8
-10
-12
-14
-16
-18
-20
% Change in DOMS Score
Placebo TSB
*
60
40
20
0
-20
-40
-60
% Change in DOMS Score
(24 to 48 hours)
Placebo
TSB *
FIGURE 2
FIGURE 3