Table 3.
Adverse events among patients reporting on various constructs of potential side effects after 68 weeks
Control | Diet | Exercise | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Variable | No. | Count | % | No. | Count | % | No. | Count | % | P* |
Abdominal and intestinal symptoms | ||||||||||
Nausea | 52 | 1 | 2 | 55 | 3 | 5 | 52 | 8 | 15 | 0.036† |
Diarrhea | 51 | 4 | 8 | 55 | 3 | 5 | 52 | 6 | 12 | 0.512† |
Constipation | 52 | 8 | 15 | 55 | 9 | 16 | 52 | 7 | 13 | 0.914 |
Flatulence | 52 | 14 | 27 | 55 | 19 | 35 | 52 | 10 | 19 | 0.204 |
Epigastric pain | 52 | 1 | 2 | 55 | 6 | 11 | 52 | 7 | 13 | 0.082† |
Vomiting | 52 | 1 | 2 | 55 | 3 | 5 | 52 | 4 | 8 | 0.444† |
Abdominal pain | 52 | 3 | 6 | 55 | 6 | 11 | 52 | 6 | 12 | 0.622† |
Heartburn | 51 | 3 | 6 | 55 | 3 | 5 | 52 | 9 | 17 | 0.083† |
Biliary symptoms | 52 | 0 | 0 | 54 | 2 | 4 | 51 | 4 | 8 | 0.103† |
Musculoskeletal symptoms | ||||||||||
Cramps | 49 | 8 | 16 | 54 | 6 | 11 | 52 | 7 | 13 | 0.742 |
Joint pain | 51 | 12 | 24 | 55 | 15 | 27 | 52 | 12 | 23 | 0.858 |
Back pain | 50 | 10 | 20 | 54 | 11 | 20 | 52 | 6 | 12 | 0.403 |
Swollen joints | 51 | 11 | 22 | 55 | 11 | 20 | 52 | 10 | 19 | 0.956 |
Sciatic pain | 51 | 9 | 18 | 55 | 4 | 7 | 52 | 7 | 13 | 0.270 |
Central nervous system and psychiatric symptoms | ||||||||||
Dizziness | 52 | 8 | 15 | 55 | 7 | 13 | 52 | 10 | 19 | 0.651 |
Headache | 52 | 5 | 10 | 53 | 6 | 11 | 51 | 12 | 24 | 0.095 |
Anxiety | 52 | 2 | 4 | 53 | 3 | 6 | 50 | 5 | 10 | 0.427† |
Sleeplessness | 52 | 11 | 21 | 53 | 6 | 11 | 51 | 11 | 22 | 0.302 |
Fatigue | 52 | 12 | 23 | 53 | 8 | 15 | 51 | 13 | 25 | 0.395 |
Mood changes | 52 | 5 | 10 | 53 | 5 | 9 | 51 | 13 | 25 | 0.031 |
Depressive tendencies | 52 | 4 | 8 | 53 | 6 | 11 | 51 | 5 | 10 | 0.818 |
Skin and subcutaneous symptoms | ||||||||||
Dry skin | 52 | 6 | 12 | 53 | 4 | 8 | 51 | 6 | 12 | 0.726 |
Allergic rash | 52 | 4 | 8 | 53 | 5 | 9 | 51 | 7 | 14 | 0.584 |
Redness | 52 | 2 | 4 | 53 | 4 | 8 | 51 | 7 | 14 | 0.176† |
Eczema | 51 | 3 | 6 | 53 | 4 | 8 | 51 | 5 | 10 | 0.814† |
Perianal itching | 52 | 2 | 4 | 53 | 5 | 9 | 51 | 11 | 22 | 0.016 |
Skin irritation | 52 | 3 | 6 | 53 | 5 | 9 | 51 | 8 | 16 | 0.245 |
Urticaria | 52 | 1 | 2 | 52 | 3 | 6 | 51 | 3 | 6 | 0.634† |
Miscellaneous symptoms | ||||||||||
Sensitive to cold | 52 | 6 | 12 | 53 | 9 | 17 | 51 | 8 | 16 | 0.715 |
Influenza | 52 | 2 | 4 | 53 | 7 | 13 | 51 | 5 | 10 | 0.232† |
Hair loss | 52 | 2 | 4 | 53 | 5 | 9 | 51 | 7 | 14 | 0.217† |
Bad breath | 52 | 5 | 10 | 53 | 6 | 11 | 51 | 9 | 18 | 0.439 |
Toothache | 52 | 4 | 8 | 52 | 4 | 8 | 51 | 6 | 12 | 0.732† |
Analyzed using chi-square test (4df).
Analyzed using Fisher's exact test when cells had counts <5.