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Table 1 Baseline clinical and demographic characteristics in PP population

From: Treatment of knee osteoarthritis with a new formulation of a fixed-dose combination of glucosamine sulfate and bovine chondroitin: a multicenter, randomized, single-blind, non-inferiority clinical trial

Baseline characteristics

GS/CS (N = 209)

RP (N = 223)

Female, n (%)

184 (88)

193 (86.6)

Age, mean (sd), years

62.8 (8.9)

63 (8)

Caucasian, n (%)

133 (63.6)

133 (59.6)

Osteoarthritis duration, mean (sd), years

7.7 (6.9)

7.4 (5.7)

BMI, mean (sd), kg/m2

30.4 (4.7)

30.7 (4.4)

Kellgren-Lawrence grading, n (%)

II

146 (69.9)

151 (67.7)

III

63 (30.1)

72 (32.3)

Overall assessment of OA by the patient, mean (sd), VAS 0-100 mm

66.7 (18.1)

65 (19.2)

Overall assessment of OA by the physician, mean (sd), VAS 0-100 mm

61.8 (12.5)

62.9 (14.1)

WOMAC, mean (sd), mm

Pain subscale

66.3 (13.2)

68.1 (13.5)

Stiffness subscale

64.9 (21.1)

65.4 (20.9)

Physical function subscale

65.7 (13.7)

65.4 (14.6)

Total score

196.9 (39.9)

198.9 (41.7)

SF-12, mean (sd)

  

Physical component

34.9 (7.4)

35.7 (7.5)

Mental component

49 (10.6)

46.9 (11.3)

Comorbidities (reported by ≥ 5% of patients), n (%)

Back pain

56 (25.8)

61 (27.4)

Musculoskeletal pain / Arthralgia / Pain in the extremities

46 (22)

46 (20.6)

Osteoporosis/ Osteopenia

34 (16.3)

30 (13.5)

Dyslipidemia / Hypercholesterolemia

69 (33)

70 (31.4)

Impaired glucose tolerance

33 (15.8)

40 (17.9)

Headache / Migraine

60 (28.7)

77 (34.5)

Hypothyroidism

40 (19.1)

39 (17.5)

Gastritis

26 (12.4)

30 (13.5)

Gastroesophageal reflux disease

9 (4.3)

14 (6.3)

Depression

13 (6.2)

17 (7.6)

Insomnia

11 (5.3)

15 (6.7)

Systemic arterial hypertension

128 (61.2)

130 (58.3)

Lower limbs varices

44 (21.1)

69 (30.9)

  1. P < 0,05 between groups for all characteristics. BMI body mass index, kg/m2 kilogram per square meter, GS/CS glucosamine sulfate/ chondroitin sulfate, n (%) number and percentage of patients in relation to the total number of patients in PP population, OA osteoarthritis, PP per protocol, RP reference product, sd standard deviation, SF-12 short-form 12 questionnaire, VAS visual analogue scale, WOMAC Western Ontario and McMaster Universities index