Juniper Online Journal of Case Studies
Temperature (°C) Systolic BP (mmHg) Distolic BP (mmHg) Pulse (bpm) Weight (kg) Height (m) BMI (kg/m²)
36.3± 0.47 [35.5, 37.0] 121.0 ± 16.02 [93, 148] 73.9± 10.11 [63, 88] 68.3± 13.01 [44, 86] 1.6 ± 0.03 [1.6, 1.7] 26.9 ± 4.26 [21.9, 34.3]
36.4± 0.29 [36.0, 37.0] 125.1 ± 16.65 [91, 148] 78.9± 10.32 [61, 95] 65.4± 6.92 [53, 79] 1.6 ± 0.10 [1.5, 1.8] 28.4± 4.93 [20.0, 37.2]
0.24 0.53 0.218 0.522 0.224 0.296 0.44
69.8± 10.71 [54.7, 85.5] 75.5± 12.50 [51.1, 100.0]
*Binomial-test conducted (Active group only). Table 3: Classification of reported adverse events.
Relationship to Study
Action Taken
Group Subject ID
Description
Visit
Intensity
Outcome
SAE
Active 076-002 Subject got nausea and feltill after consuming the product Baseline Moderate Probable d Ti srceoant tmi neunet d Recovered No 076-007 Clinically significant blood pressure Baseline Moderate Unrelated Referred to GP Resolved; Recovering No 076-013 Nausea, diarrhoea Week 08 Moderate Unlikely None Recovered No 076-014 Head-cold Week 08 Mild Unrelated None Recovered No 076-029 Chest infection Week 08 Moderate Unlikely None Recovered No Placebo 076-009 s lbi pr upies de da ns idd fee al lnadt thhoi mg he , Week 08 Moderate Unrelated None Resolved; Recovering No 076-020 Allergic reaction to the product. rash on skin red and blistered Baseline Moderate Probable d Ti srceoant tmi neunet d Resolving; Not recovered No 076-030 Mild Head-cold & Dry Cough Week 08 Mild Unlikely None Resolved; Recovering No 076-033 Bruised ribs, chin, nose and wrist after a fall. Week 08 Moderate Unrelated None Resolved; Recovering No p-value 1.000* 1.000* 0.894** 0.638** 0.051** N/E * Fisher’s exact test; ** Chi-squared test. baseline to 8 weeks, with a larger difference, in magnitude op fl atcheeb oe f fgercot uspi z ae c sr toastsi s tt hi ces , mf oauj on rdi t iyn ot hf emaecat si vuer egmr oeunpt s .t hDa un e t ht oe tchoemepxapr li onrga teof rf eyc nt astiuz rees oafr et hae sr teul idayb laen adptphreo as cmha ltlos ai nmf oprl em s itzhee, statistical power of future studies, [22]. Table 4: Effect of 8 weeks’ supplementation of Naticol®, on osteoarthritis related measurements, for subjects that completed the study. Placebo (n = 9) Active (n = 19) p-value Baseline* Week 08 Baseline* Week 08 WOMAC Pain sub-scores 6.9 ± 3.55 4.8 ± 5.04 7.1 ± 3.05 4.3 ± 2.98 0.583 WOMAC Physical Function sub-scores 25.8 ± 10.72 18.4± 15.15 28.6± 10.34 19.3± 10.30 0.606 WOMAC Composite score during the study 36.3± 15.53 25.8± 21.06 38.9± 13.55 26.6± 13.61 0.726 SF-36v2 Role Limitations due to Physical Problems 56.3± 23.59 70.1± 22.273 58.9± 16.05 71.1± 20.75 0.867 SF-36v2 Role Limitations due to Emotional Problems 69.4± 22.44 80.6± 17.18 73.7± 21.91 78.3± 21.72 0.548 SF-36v2 Emotional Well-Being score 70.2± 10.97 69.3± 23.75 69.9± 11.11 71.4± 12.09 0.564 SF-36v2 Social Functioning scores 76.4± 26.84 76.4± 23.75 68.4± 26.80 77.6± 23.78 0.392 SF-36v2 Pain score 56.7± 23.08 56.7± 31.62 51.6± 16.33 61.4± 22.57 0.272 SF-36v2 General Health score 72.2± 22.65 70± 18.03 70.8± 16.44 71.8± 14.83 0.541 SPPB Balance Score 4.0 ± 0.00 4.0 ± 0.00 4.0 ± 0.00 4.0 ± 0.00 SPPB Chair Test Score 1.9 ± 1.17 2.2 ± 1.20 2.1 ± 1.09 2.5 ± 1.01 0.769 SPPB Total score 10± 1.20 10.1± 1.25 10.1± 1.09 10.4± 1.18 0.639 *No difference between groups at baseline. Upon investigation it was apparent that subjects in the active go rf omu epaesxupr ee rmi eennct es dt hma on r seuobf j ea cnt si mi np rt oh ve epml aecnet baoc rgor sosu tph oe vme ra jtohrei t 8y wo f e tehkes od fi ftfheer es nt uc de sy , os ebes eTravbel de 4w, Te ra eb l ceo5m&p Fa irgeudr eu s1i. nTgh ee fmf eac gt nsiitzued –e i.e., the standardized mean difference in measurements from
How to cite this article: Seán Lacey, Christelle Bonnet, Kelly Seamans, Andrea Doolan. Effect Size Statistics to Inform an Exploratory Analysis of a Double-Blinded, Randomised, Placebo Controlled Pilot Clinical Study to Evaluate the Efficacy of Naticol ® , Specific Fish Collagen Peptides to Alleviate Symptoms of Osteoarthritis in the Knee . JOJ Case Stud. 2019; 10(2): 555783. DOI: 10.19080/JOJCS.2019.10.555783 0033
Powered by FlippingBook