1. Background
2. Objectives
3. Methods
3.1. Participants and Study Context
3.2. Informed Consent and Confidentiality
3.3. Sampling
3.4. Data Collection Method
3.5. Data Analysis
4. Results
| Variables | CAM Negative | CAM Positive | Total |
|---|---|---|---|
| Age, y | 58.46 ± 9.38 | 57.76 ± 9.60 | 58.35 ± 9.39 |
| Gender | |||
| Male | 149 (58.7) | 37 (80.4) | 186 (62.0) |
| Education | |||
| Illiterate | 27 (10.6) | 10 (21.7) | 37 (12.3) |
| Under diploma | 102 (40.2) | 9 (19.6) | 111 (37) |
| Diploma & associate’s degree | 106 (41.7) | 27 (58.7) | 133 (44.3) |
| Bachelor’s & master’s degree | 19 (7.5) | 0 | 19 (6.3) |
| Doctorate and above | 0 | 0 | 0 |
| Residential place | |||
| City | 240 (94.5) | 32 (69.6) | 272 (90.7) |
| Village | 14 (5.5) | 14 (30.4) | 28 (9.3) |
| BMI, kg/m2 | 26.31 ± 0.50 | 27.23 ± 1.86 | 26.45 ± 2.43 |
| Measurements | |||
| ESR | 58.68 ± 49.27 | 46.52 ± 29.37 | 56.82 ± 46.94 |
| FBS | 191.57 ± 123.15 | 170.13 ± 58.30 | 186.12 ± 110.51 |
| CRP | |||
| Negative | 111 (43.7) | 5 (10.9) | 116 (40.3) |
| 1+ | 24 (9.4) | 0 | 172 (59.7) |
| 2+ | 55 (21.7) | 12 (26.1) | |
| 3+ | 32 (12.6) | 9 (19.6) | |
| > 3+ | 30 (11.8) | 10 (21.7) | |
| Missed | 2 (0.8) | 10 (21.7) | |
| HBAIC | 7.45 ± 1.81 | 7.77 ± 1.46 | 7.49 ± 1.76 |
| HBAIC | |||
| < 7 | 118 (46.5) | 14 (30.4) | 132 (44) |
| ≥ 7 | 136 (53.5) | 32 (69.6) | 168 (56) |
| Duration of the disease, y | |||
| < 5 | 48 (18.9) | 9 (19.6) | 57 (19) |
| 5 - 15 | 127 (50.0) | 19 (41.3) | 146 (48.7) |
| 15 - 25 | 58 (22.8) | 17 (37.0) | 75 (25) |
| > 25 | 21 (8.3) | 1 (2.2) | 22 (7.3) |
| History of other diseases | |||
| Hypertension | 149 (58.7) | 26 (56.5) | 175 (58.3) |
| Cardiovascular | 104 (40.9) | 22 (47.8) | 126 (42.0) |
| Hyperlipidemia | 148 (58.3) | 35 (76.1) | 183 (61.0) |
| Thyroid disease | 19 (7.5) | 13 (28.3) | 32 (10.7) |
| Liver disease | 89 (35.0) | 22 (47.8) | 111 (37) |
| Nephropathy | 85 (33.5) | 13 (28.3) | 98 (32.7) |
| Neuropathy | 212 (83.5) | 37 (80.4) | 249 (83) |
| Retinopathy | 65 (25.6) | 6 (13.0) | 71 (23.7) |
| Treatment | |||
| Oral medication | 108 (42.5) | 17 (37.0) | 125 (41.7) |
| Insulin | 9 (3.5) | 8 (17.4) | 17 (5.7) |
| Insulin + oral medication | 111 (43.7) | 5 (10.9) | 116 (38.7) |
| Insulin + herbal medicine c | 5 (2.0) | 5 (10.9) | 10 (3.3) |
| Oral medication + herbal medicine | 15 (5.9) | 6 (13.0) | 21 (7.0) |
| Insulin + oral medication + herbal medicine | 6 (2.4) | 5 (10.9) | 11 (3.7) |
| Wagner's classification | |||
| Grade 0 | 5 (2.0) | 0 | 5 (1.7) |
| Grade 1 | 93 (36.6) | 24 (52.2) | 117 (39) |
| Grade 2 | 140 (55.1) | 22 (47.8) | 162 (54) |
| Grade 3 | 14 (5.5) | 0 | 14 (4.7) |
| Grade 4 | 1 (0.4) | 0 | 1 (0.3) |
| Grade 5 | 1 (0.4) | 0 | 1 (0.3) |
Abbreviations: Cr, creatinine; HB, hemoglobin; CRP, C-reactive protein; HbA1C, hemoglobin A1C; BMI, Body Mass Index; ESR, erythrocyte sedimentation rate; CAM,
a Values are expressed as mean ± SD or No. (%).
b Wagner’s classification: Grade 0: Skin intact, but bony deformities lead to "foot at risk."; grade 1: Superficial ulcer; grade 2: Deeper, full-thickness extension; grade 3: Deep abscess formation or osteomyelitis; grade 4: Partial gangrene of the forefoot; grade 5: Extensive gangrene.
c Herbal medication in this study refers to any kind of plant-based medication intake, such as tablets or direct use of plants, according to grocer perception.
a Significant at 0.05.
| Variables | Estimate | Confidence Interval | SE | P-Value |
|---|---|---|---|---|
| Age | -0.001 | -0.02 to 0.02 | 0.01 | 0.935 |
| Gender | ||||
| Male | 0.22 | -0.23 to 0.68 | 0.23 | 0.335 |
| Female | Ref | - | - | - |
| Duration of the disease, y | 0.12 | -0.15 to 0.39 | 0.14 | 0.379 |
| Principles of lifestyle management | -0.57 | -1.18 to 0.04 | 0.31 | 0.070 |
| Leech therapy | -0.62 | -1.29 to 0.05 | 0.34 | 0.071 |
| Wet cupping | 0.07 | -0.54 to 0.67 | 0.31 | 0.826 |
| Phlebotomy | -1.42 | -2.20 to -0.64 | 0.39 | 0.001 b |
| Massage | -2.39 | -3.97 to -0.82 | 0.80 | 0.003 b |
| Acupuncture | -2.41 | -3.93 to -0.90 | 0.77 | 0.002 b |
| Spiritual treatments | -2.32 | -4.35 to -0.28 | 1.04 | 0.026 b |
| Fenugreek | 0.28 | -0.23 to 0.79 | 0.26 | 0.280 |
| Citrulluscolocynthis (bitter apple) | 0.39 | -0.37 to 1.15 | 0.39 | 0.319 |
| Silybummarianum (Mary thistle) | 0.35 | -0.42 to 1.12 | 0.39 | 0.375 |
| Green tea | -0.51 | -0.97 to -0.06 | 0.23 | 0.026 b |
| Urtica | -0.64 | -1.21 to -0.08 | 0.29 | 0.025 b |
| Chamomile | -0.09 | -0.53 to 0.35 | 0.22 | 0.697 |
| Dill | -0.03 | -0.53 to 0.49 | 0.26 | 0.914 |
| Poppy seeds | 1.31 | -0.09 to 2.71 | 0.71 | 0.068 |
| Lettuce seeds | 1.28 | -0.57 to 3.14 | 0.95 | 0.176 |
| Sumac | -0.47 | -0.99 to 0.05 | 0.26 | 0.080 |
| Walnut leaf | 1.31 | -0.09 to 2.71 | 0.71 | 0.068 |
| Eryngo tincture | 0.82 | 0.21 to 1.42 | 0.31 | 0.008 b |
| Thyme | 0.62 | 0.06 to 1.18 | 0.28 | 0.031 b |
a Wagner's classification was considered as the outcome variable; an ordinal regression model was used.
b Significant at 0.05.
| Variables | OR | Confidence Interval for OR | P-Value |
|---|---|---|---|
| Age | 1.04 | 1.01 - 1.06 | 0.001 b |
| Gender | |||
| Male | Ref | - | - |
| Female | 1.81 | 1.12 - 2.92 | 0.015 b |
| Duration of the disease, y | 1.47 | 1.11 - 1.96 | 0.008 b |
| Principles of lifestyle management | 1.98 | 1.01 - 3.89 | 0.047 b |
| Leech therapy | 2.33 | 1.08 - 5.02 | 0.030 b |
| Wet cupping | 2.13 | 1.09 - 4.17 | 0.026 b |
| Phlebotomy | 0.95 | 0.44 - 2.01 | 0.891 |
| Massage | 0.98 | 0.26 - 3.73 | 0.978 |
| Fenugreek | 2.37 | 1.36 - 4.11 | 0.002 b |
| Citrulluscolocynthis (bitter apple) | 0.96 | 0.44 - 2.08 | 0.925 |
| Silybummarianum (Mary thistle) | 1.46 | 0.65 - 3.28 | 0.356 |
| Green Tea | 1.67 | 1.04 - 2.68 | 0.032 b |
| Urtica | 4.73 | 2.29 - 9.80 | 0.001 b |
| Chamomile | 0.81 | 0.51 - 1.28 | 0.382 |
| Dill | 4.44 | 2.34 - 8.42 | 0.001 b |
| Poppy seeds | 6.55 | 0.81 - 53.04 | 0.078 |
| Sumac | 0.39 | 0.23 - 0.68 | 0.001 b |
| Walnut leaf | 6.55 | 0.81 - 53.04 | 0.078 |
| Eryngo tincture | 0.51 | 0.28 - 0.93 | 0.030 b |
| Thyme | 0.71 | 0.44 - 1.31 | 0.326 |
a A1C ≥ 7 was considered as the outcome; a logistic regression model was used.
b Significant at the 0.05 level.
| Variables | B | SE | P-Value |
|---|---|---|---|
| Age | -0.55 | 0.29 | 0.056 |
| Gender | |||
| Male | - | - | - |
| Female | 0.01 | 5.59 | 0.998 |
| Duration of the disease, y | 3.25 | 3.26 | 0.320 |
| Principles of lifestyle management | -12.16 | 7.50 | 0.106 |
| Leech therapy | 10.53 | 8.23 | 0.202 |
| Wet cupping | -25.91 | 7.25 | 0.001 b |
| Phlebotomy | 15.27 | 8.87 | 0.086 |
| Massage | 7.28 | 15.91 | 0.647 |
| Principles of lifestyle management | -10.57 | 15.11 | 0.485 |
| Leech therapy | 30.69 | 21.13 | 0.147 |
| Fenugreek | -15.41 | 6.10 | 0.012 b |
| Citrulluscolocynthis (bitter apple) | 5.50 | 9.18 | 0.549 |
| Silybummarianum (Mary thistle) | -15.21 | 9.29 | 0.103 |
| Green tea | -12.27 | 5.47 | 0.026 b |
| Urtica | -12.80 | 6.88 | 0.064 |
| Chamomile | -16.77 | 5.34 | 0.002 b |
| Dill | 1.67 | 6.35 | 0.792 |
| Poppy seeds | -4.63 | 15.91 | 0.771 |
| Lettuce seeds | -9.99 | 21.20 | 0.638 |
| Sumac | -2.97 | 6.41 | 0.643 |
| Walnut leaf | -4.63 | 15.91 | 0.771 |
| Eryngo tincture | -9.27 | 7.04 | 0.189 |
| Thyme | 11.76 | 6.48 | 0.071 |
a Erythrocyte sedimentation rate was considered as the outcome variable; a linear regression model was used.
b Significant at 0.05.