Table 2 Intervention effects on clinical measures, intention-to-treat analysis
From: A dietary intervention for chronic diabetic neuropathy pain: a randomized controlled pilot study
Intervention group | Supplement group | Effect size | P-value* | |||||
|---|---|---|---|---|---|---|---|---|
Baseline | 20 weeks | Change scores | Baseline | 20 weeks | Change scores | Mean (95% CI) | ||
Mean (s.d.) | Mean (s.d.) | Mean (s.d.) | Mean (s.d.) | Mean (s.d.) | Mean (s.d.) | |||
Body weight (kg) (N=34) | 102.5 (22.7) | 95.5 (20.1) | −7.0 (5.0)† | 105.6 (23.6) | 105.1 (22.9) | −0.6 (3.5) | −6.4 (−9.4 to −3.4) | <0.001 |
BMI (N=34) | 35.9 (6.0) | 33.5 (5.7) | −2.4 (1.5)† | 36.2 (7.1) | 36.0 (7.1) | −0.2 (1.2) | −2.2 (−3.2 to −1.2) | <0.001 |
Total cholesterol (mg dl−1) (N=34) | 171.2 (48.4) | 159.1 (42.6) | −12.1 (37.8) | 173.4 (41.4) | 175.6 (34.0) | 2.2 (25.6) | −14.4 (−36.9 to 8.2) | 0.20 |
HDL (N=34) | 52.1 (15.1) | 46.8 (11.4) | −5.2 (10.1)‡ | 47.4 (18.9) | 45.0 (16.9) | −2.4 (6.9) | −2.9 (−8.9 to 3.2) | 0.34 |
LDL (N=34) | 89.0 (38.3) | 81.2 (34.2) | −7.8 (28.9) | 95.4 (43.6) | 95.8 (34.5) | 0.4 (21.0) | −8.2 (−25.8 to 9.5) | 0.35 |
Ratio (N=34) | 3.4 (1.1) | 3.5 (0.9) | 0.1 (0.7) | 4.0 (1.4) | 4.3 (1.5) | 0.3 (0.6) | −0.2 (−0.6 to 0.2) | 0.36 |
Triglycerides (N=34) | 151.0 (66.3) | 155.7 (61.6) | 4.7 (56.2) | 152.6 (88.8) | 174.5 (110.6) | 21.9 (68.9)a | −17.2 (−61.2 to 26.8) | 0.43 |
Log triglycerides (N=34) | 2.14 (0.19) | 2.16 (0.19) | 0.01 (0.17) | 2.12 (0.23) | 2.17 (0.24) | 0.05 (0.17)a | −0.04 (−0.16 to 0.08) | 0.51 |
Fasting glucose (N=34) | 160.6 (73.5) | 134.6 (51.6) | −25.9 (65.0) | 157.4 (60.5) | 138.2 (51.3) | −19.2 (55.6)a | −6.8 (−49.0 to 35.5) | 0.75 |
HbA1c, % (N=34) | 8.0 (1.7) | 7.2 (1.4) | −0.8 (1.2)‡ | 7.8 (1.6) | 7.8 (1.4) | 0.0 (0.9) | −0.7 (−1.5 to 0.1) | 0.07 |
HbA1c, mmol ml−1 (N=34) | 64 (19) | 55 (15) | −9 (13)‡ | 62 (18) | 62 (15) | 0 (10) | −8 (−16 to 1) | 0.07 |
Systolic BP (N=34) | 139.3 (17.0) | 127.9 (22.6) | −11.5 (22.5)a | 144.4 (21.6) | 140.1 (19.3) | -4.3 (15.0) | −7.2 (−20.6 to 6.2) | 0.28 |
Diastolic BP (N=34) | 81.5 (9.7) | 75.8 (9.0) | −5.7 (9.4)‡ | 87.2 (14.5) | 84.4 (10.4) | −2.8 (8.8) | −2.9 (−9.2 to 3.5) | 0.36 |
Foot conductance, avg (N=20)b | 64.5 (29.5) | 65.2 (24.1) | 0.7 (10.5) | 73.4 (16.8) | 61.7 (24.4) | −11.7 (13.2)‡ | 12.4 (1.2 to 23.6) | 0.03 |
Hand conductance, avg (N=20) | 53.2 (28.0) | 55.7 (21.6) | 2.5 (13.9) | 67.6 (23.4) | 61.2 (25.5) | −6.4 (11.7) | 8.9 (−3.2 to 21.0) | 0.14 |
MNSI-PA (N=34) | 4.8 (2.4) | 4.3 (2.3) | −0.5 (1.9)a | 3.4 (2.2) | 2.6 (1.8) | −0.8 (1.7)a | 0.3 (−1.0 to 1.5) | 0.67 |
NIS-LL (N=34) | 11.3 (8.0) | 8.7 (6.8) | −2.6 (7.3) | 6.6 (4.6) | 6.8 (5.3) | 0.2 (4.9) | −2.8 (−7.1 to 1.6) | 0.20 |
VAS (N=34) | 5.3 (2.7) | 4.0 (2.4) | −1.2 (2.8) | 5.8 (2.4) | 3.8 (2.7) | −2.0 (3.0)‡ | 0.8 (−1.3 to 2.8) | 0.45 |
PGIC (N=33)c | 4.6 (1.9) | 3.3 (1.6) | 0.05 | |||||
Quality of life total (N=34) | 27.9 (14.3) | 19.6 (17.9) | −8.4 (13.6)‡ | 29.6 (15.7) | 24.6 (17.5) | −5.1 (10.5)a | −4.0 (−15.1 to 7.1) | 0.43 |
SF McGill Pain Questionnaire Total (N=34) | 22.6 (11.0) | 13.5 (10.0) | −9.1 (11.4)§ | 21.0 (10.0) | 20.1 (12.2) | -0.9 (11.3) | −8.2 (−16.1 to −0.3) | 0.04 |
MNSI-Q (N=34) | 7.5 (2.5) | 5.3 (2.5) | −2.2 (2.4)§ | 7.7 (2.8) | 7.1 (2.8) | −0.6 (1.5) | −1.6 (−3.0 to −0.2) | 0.03 |
NTSS-6 Total (N=34) | 10.7 (4.9) | 6.8 (4.5) | −3.9 (4.2)§ | 12.3 (5.1) | 9.1 (4.0) | −3.2 (3.6)§ | −0.7 (−3.4 to 2.0) | 0.59 |
BDI (N=34) | 12.8 (8.1) | 8.6 (10.6) | −4.2 (8.8) | 11.0 (8.4) | 9.5 (7.4) | −1.5 (4.5) | −2.8 (−7.6 to 2.1) | 0.26 |
CESD-R (N=34) | 11.9 (10.1) | 11.2 (13.0) | −0.8 (6.6) | 10.8 (7.3) | 8.7 (9.2) | −2.1 (7.8) | 1.4 (−3.7 to 6.4) | 0.59 |
