Vietnam Human Study - DuoVital Joint Health & Mobility

STUDY METHODOLOGY

• Diabetes diagnosed according to the WHO 2006 diagnostic criteria, knee osteoarthritis diagnosis made in accordance to the ACR 1991
• Patients received conventional radiography of the damaged knee, diagnosis of the degree of knee osteoarthritis made via X-ray images in accordance with Kellgren – Lawrence disease classification
• WOMAC (Western Ontario and McMaster Universities) used to assess the osteoarthritis, WOMAC A – pain (5 parameters assessed), WOMAC B – knee stiffness (2 parameters assessed) and WOMAC C – knee function (17 parameters assessed)
• WOMAC scale 0-4 (none to very high)
• Minimum WOMAC score 0 and maximum score 96 per patient
• WOMAC scores taken at the start of the study (T0), after 30 days (T1) and after 60 days (T2)
• 60 patients entered the study with Stage II osteoarthritis determined by the Kellgren – Lawrence disease classification
• Patients divided into 2 groups of 30 patients each, Experimental group received hyaluronic acid and chondroitin complex (Duo Vital) once daily after meals for 30 days, 30ml/day, Control group received no treatment

DETAILS OF PATIENT POPULATION

• There was no statistically significant difference between the two groups for any of the above parameters

RESULTS

COMPARISONS OF WOMAC INDEX OF THE TWO GROUPS AT THE BEGINNING OF THE STUDY

• There was no statistically significant difference between the two groups at the commencement of the study, (p > 0.05) for all WOMAC indexes

WOMAC INDEX OF EXPERIMENTAL GROUP – AVERAGE OF GROUP WITH STANDARD DEVIATION

• There is a statistically significant reduction in the WOMAC score in the Experimental group taking the hyaluronic acid and chondroitin complex at both days 30 and 60 compared with the WOMAC score at the start of the study

WOMAC INDEX OF CONTROL GROUP – AVERAGE OF GROUP WITH STANDARD DEVIATION

• There was no statistical significant improvement in the WOMAC scores at either day 30 or day 60 compared to the WOMAC score at the start of the study

COMPARISON OF WOMAC INDEX OF THE TWO GROUPS AFTER 30 DAYS

• After using the hyaluronic acid and chondroitin complex for 30 days the total average WOMAC index and WOMAC A were significantly reduced compared with the control group (P< 0.05)
• Change of pain symptoms (WOMAC A) decreased 47.8% in the experimental group and only 8.6% in the control group compared with the study start indexes
• Knee stiffness (WOMAC B) was reduced 60.9% in the experimental group compared with the study start index with the control group showing only a 25% reduction
• Knee function (WOMAC C) had a greater percentage reduction in the experimental group (39.4%) compared to the control group (10.5%) from the study start index

COMPARISON OF WOMAC INDEX OF THE TWO GROUPS AFTER 60 DAYS

• After using the hyaluronic acid and chondroitin complex for 30 days, an evaluation of the patients was made 60 days from the start of the study. The total average WOMAC, WOMAC A and WOMAC B were significantly reduced compared with the control group (P<0.05)
• Change in pain symptoms (WOMAC A) decreased 55.7% in the experimental group and only 14.1% in the control group compared with the study start index
• Knee stiffness (WOMAC B) was reduced 73.9% in the experimental group compared to the study start index and only 16.7% in the control group
• Knee function (WOMAC C) had a greater percentage reduction in the experimental group (42.2%) compared to the control group (11.6%) from the study start index

ADVERSE EVENTS

• The Hyaluronic acid was well tolerated with only two adverse events reported
• One patient reported weight gain (2kg in two weeks)
• One patient reported a mild allergy which was reversed after the treatment was discontinued (the patient has a history of allergy to a product component)

CONCLUSIONS

IMPROVEMENT IN CLINICAL SYMPTOMS DAY 60 COMPARED TO START OF STUDY                                    (N = NUMBER OF PATIENTS)

• In all clinical symptoms evaluated the experimental group has a much greater percentage of improvement than the control group
• The statistically significant improvements in the WOMAC scores have been achieved in a difficult treatment group, elderly diabetic patients
• Clinical benefits can be achieved treating osteoarthritis patients with a hyaluronic acid and chondroitin complex