German Human Study - DuoVital Joint Health & Mobility

Dr. rer. nat. Dieter Lazik

1978-1981 professional education, 1983-1988 Studies Diploma teacher for sports and history in Potsdam, 1989-1992 PhD student at the Institute of Sports Medicine and Prevention (Direktor- Prof. Dr. med. G. Badtke) Potsdam University, 1992 PhD Dr . rer. (Sports Biology - focus Spine Research), 1994 masseur, employee since 1995 Scientific Institute of Sports Medicine and Prevention, in 1997 graduating as Naturopaths, 1998 Medical training Thera-peut, since 1996 real estate management of top athletes and participate in the World Cup, the World Cup Rowing / Munich of 2007. the 2008 Olympic Games (Beijing / China) and 2010 (Whistler / Canada), 2001-2003 Head INPAT at the University of Potsdam (innovations and patents at German universities - an initiative of the BMWi) research visits Canada, Egypt, Russia, 2003 - 2010 Member of FNK Commission / promotion Committee of Human Sciences Faculty of the University of Potsdam, employees and management of various research projects, 2007 Head of Slow Medicine research Institute Potsdam, 2007 publication of the first textbook on therapeutic climbing (Thieme-Verlag), 1998 spin-off of InnoTrend GmbH (spin Off of the University of Potsdam), since 2009 a member of the teaching team of the European University Viadrina Frankfurt / Oder for the first Masters Course (Germany) for physicians and pharmacists in complementary medicine and head of the Berlin office in Potsdam for the degree course previous mentioned, July 2010 termination of activity at the University of Potsdam and focus on the professional tasks in the field of complementary medicine.

  

STUDY DESIGN AND RESEARCH METHODS

  • The clinical study was designed to evaluate the effectiveness of a new supplement containing a complex of hyaluronic acid and chondroitin (Duo Vital)
  • Patients were assessed using the standard WOMAC (Western Ontario and McMaster University) questionnaire, a standardized self-assessment method which is designed and validated specifically for patients diagnosed with osteoarthritis of the knee and hip joints
  • 50 patients were enrolled in the study – 25 in the control group (average age 36.7) and 25 in the experimental group (average age 40.7)
  • Patients had first stage cartilage degeneration in the form of surface cracks and fissures and softening of the cartilage as well as second stage cartilage damage with a maximum depth of lesion less than 50% of the cartilage layer
  • All patients underwent arthroscopic surgery to smooth the cartilage and after surgery underwent physiotherapy. In addition, the experimental group received a complex of hyaluronic acid and chondroitin over a period of 8 weeks commencing the first day after surgery
  • The patients were assessed prior to surgery, 60 days post-surgery and 90 days post-surgery. Comparison of health status prior and post-surgery was performed 60 days after surgery and a follow up examination and analysis was conducted 90 days post-surgery
  • 3 analyses were conducted
    • Part A – Changes in the incidence of pain
    • Part B – Stiffness assessment
    • Part C – Discomfort occurring with physical activities of daily living

 

RESULTS PART A

Changes in the incidence of pain

 

60 Days Post Surgery

90 Day Post Surgery

 

Experimental Group

Control Group

Experimental Group

Control Group

Improvement

87.5% (21)

64% (16)

95.7% (22)

52% (13)

Deterioration

8.3% (2)

20% (5)

4.3% (1)

36% (9)

No Change

4.2% (1)

16% (4)

______

12% (3)

 

  • For the experimental and control group, the pain reduction compared to pre surgery was statistically significant at 60 days post-surgery, experimental group (p=0.001) Control Group (p=0.036)
  • The percentage of patients showing improvement over pre surgery in the experimental group has increased since the day 60 evaluation which indicates a long term lowering of pain
  • In the control group, the percentage of patients exhibiting improved pain compared to pre surgery declined from the 60-day level (64%-52%) and there was an increase in patients reporting pain increase (20%-36%)
  • The improvement in pain in the experimental group compared to pre surgery is statistically significant (p<0.001) but not for the control group (p=0.504)

 

RESULTS PART B

Stiffness assessment

 

60 Days Post Surgery

90 Day Post Surgery

 

Experimental Group

Control Group

Experimental Group

Control Group

Improvement

84% (21)

44% (11)

91.7% (22)

52% (13)

Deterioration

4% (1)

32% (8)

4.2% (1)

36% (9)

No Change

12% (3)

24% (6)

4.2% (1)

12% (3)

 

  • At 60 days post-surgery for the experimental group, there was a statistically significant improvement over pre surgery (p<0.001) while there was no difference in the control group
  • There was a statistically significant difference between the experiment and control group (p=0.004). Therefore, it could be concluded that the hyaluronic acid and chondroitin complex contributed to a decrease or elimination of knee joint stiffness in the majority of patients after 60 days of product administration post-surgery
  • At 90 days post-surgery, patients reporting an improvement in pain for the experimental group has further increased from the 60 day evaluation (84%-91.7%) while only 52% of the control group reported improvement in mobility of the knee after 90 days
  • The change in the average group value for the experimental group was significant (p<0.001) but not for the control group (p=0.82) at 90 days post-surgery
  • A high rate of recurrences of pain in the control group was reported at the 90 day post-surgery evaluation.

  

RESULTS PART C

Discomfort occurring with physical activities of daily living

 

60 Days Post Surgery

90 Day Post Surgery

 

Experimental Group

Control Group

Experimental Group

Control Group

Improvement

95.8% (23)

72% (18)

100% (23)

66.7% (16)

Deterioration

4.2% (1)

20% (5)

________

29.2% (7)

No Change

________

8% (2)

________

4.2% (1)

 

  • Considering the absolute numbers (except for one patient in the experimental group) 60 days post-surgery, this group was able to spend their day pain free or with much lower levels of discomfort
  • This compared to the control group where 28% of patients symptoms were worse or unchanged which led to statistically significant pain relief associated with physical activity in the experimental group compared to the control group (p=0.012)
  • At the 90 day post-surgery evaluation, the difference between the experimental and control groups is significant (p<0.001)
  • In the control group at 90 days post-surgery, improvement compared to the 60 day evaluation declined from 72% to 66.7%

  

DISCUSSIONS AND CONCLUSIONS

  • The study proves that patients treated with a complex of hyaluronic acid and chondroitin after arthroscopic surgery experienced a statistically significant reduction in pain and discomfort compared with patients not receiving the complex
  • Patients receiving the hyaluronic acid and chondroitin complex more frequently reported pain relief compared to the control group
  • In the experimental group, the study clearly demonstrates the knee stiffness and the limitations of daily physical activity decreased compared to the control group
  • In conclusion, the combination of arthroscopic surgery, rehabilitation and administration of a hyaluronic acid and chondroitin complex contributes to the achievement of superior results in terms of pain relief, knee stiffness and limitations of daily physical activity compared with treatment by arthroscopic surgery and rehabilitation