Rheumafort – Clinical Evaluation

 

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Przemyslaw Lisinski, Wlodzimierz Samborski

 

Plant Extracts in Osteoarthritis


Faculty and Clinic of Rheumatology and Rehabilitation
Medical University in Poznan

Background

The investigated preparation was a dietary supplement specially designed for people with joint problems. Its formula provides carefully selected plants, which active constituents have been extracted in special technology ensuring better bioavailability and hence efficacy. Each capsule provides 6 plant extracts that possibly have positive action on synoviocytes1 (cells that form inner layer of synovial membrane and chondrocytes2 (cells forming joint cartilage).

The purpose of this study was an evaluation of the efficacy and tolerance of the preparation providing plant extracts in patients with osteoarthritis (OA).

Subjects and Methods

There were 60 subjects qualified for the study with osteoarthritis stage II/III acc. to Kellgren-Lawrence Radiological Assessment3. The investigation was conducted as double blind study4. Subjects were divided into two randomised5 parallel groups. After one week of wash-out period6, one group received active (investigated) preparation (verum group) and the other group received placebo7 (placebo group) for 6 weeks. Investigated patients received an average daily dosage of one capsule twice a day. Patients with very big body mass (BMI ≥ 30) took doubled daily dose.

Patients were evaluated before starting the study, and after 3 and 6 weeks. Following parameters were evaluated:

  • general condition by the help of Likert scale8
  • quality of life by questionnaire SF-129
  • intensity of pain in last 24 hours
  • intensity of pain after 15 meters walk
  • integrated WOMAC Index 10

Intensity of pain was evaluated with use of the visual-analogue scale – so called VAS11.

Patients that had interrupted the study were evaluated till the moment they stopped the study.

All side and/or undesired effects were registered. Furthermore, each time were taken blood samples for testing the basic biochemical parameters and liver and kidney function.

Results

Pain Assessment

The pain that patient has experienced at rest was evaluated 24 hours before the study and after 3 and 6 weeks. The placebo group showed a reduction in pain intensity by an average of 7 mm after 3 weeks and 8 mm after 6 weeks[8]. In the group receiving the active preparation a decrease in the intensity of pain was observed by 18 and 30 mm after 3 and 6 weeks, respectively.

These differences were highly statistically significant in favor of the active formulation; confidence interval p ≤ 0.05 after 3 weeks and p ≤ 0.002 after 6 weeks. It is assumed that the reduction of pain intensity by the value of 15 mm according to VAS is of significant clinical importance. After 6 weeks of taking the test preparation, the reduction of pain intensity by 30 mm and more (i.e. twice more than the assumed clinically significant value) was found in 79% of the respondents.


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Changes in pain intensity after a 15-yards walk were also assessed. In the group receiving the investigated preparation, a clinically significant reduction in pain intensity after walking was found compared to the placebo group. The mean value of pain intensity for the whole group receiving the preparation containing plant extracts decreased by 40 mm according to the VAS scale after 6 weeks. In the control group (placebo), this value was reduced by only 6 mm.


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The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales:[1]

  • Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright
  • Stiffness (2 items): after first waking and later in the day
  • Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties
WOMAC Index was developed in 1982 at Western Ontario and McMaster Universities. WOMAC is available in over 65 languages and has been linguistically validated.[2][1]

click this graph to magnify it




click this graph to magnify it



References

  1. American College of Rheumatology. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). http://www.rheumatology.org/practice/clinical/clinicianresearchers/outcomes-instrumentation/WOMAC.asp. (accessed 12 July 2013).
  2. WOMAC Osteoarthritis Index. http://www.womac.org/womac/index.htm. (accessed 12 July 2013).
  3. Theiler R, Spielberger J, Bischoff H.A., Bellamy N, Huber J, Kroesen S. Clinical evaluation of the WOMAC 3.0 OA Index in numeric rating scale format using a computerized touch screen version [abstract]. OSTEOARTHR CARTILAGE 2002;10(6):479-481
  4. Bellamy N, Wilson C, Hendrikz J, Whitehouse S.L., Patel B, Dennison S, Davis T. Osteoarthritis Index delivered by mobile phone (m-WOMAC) is valid, reliable, and responsive [abstract]. J CLIN EPIDEMIOL 2011;64(2):182-190




1 Synoviocytes - are key-cells for joint health. Synoviocytes form the inner lining of joint. They produce synovial liquid that reduce friction between the joint cartilages during movement. Synovium is also important to maintain proper joint function by providing the structural support and supply of the necessary nutrients to the surrounding cartilage.
2 Chondrocytes - are the only cells found in healthy cartilage. They produce and maintain the cartilaginous matrix, which consists mainly of collagen and proteoglycanscell producing joint cartilage. Chondrocytes do not have blood vessels they receive nourishment from synovial liquid exclusively.
3Radiological Assessment of Osteoarthritis described by Kellgren-Lawrence evaluation of OA progression acc to radiological criteria. Stage II - small progression of changes: visible osteophytes, no change or discreet narrowing of the joint space; stage III - moderate escalation of changes: moderate osteophytes, visible narrowing of the joint space, possible joint deformation.
4 Double blind study - a medical study in which both the subjects participating and the researchers are unaware of when the experimental medication or procedure has been given. Double-blinded studies are often used when initial studies shows particular promise.
5 Wash-out period
6 Randomisation – random classification of subjects into comparative groups in order to eliminate the influence of uncontrolled variables on the study results.
7 Placebo - it is a product / procedure that looks identical to the investigated one but does not provide active ingredients / therapeutic action. In medical research, placebo is applied as control and depends on the use of measured suggestion. Sometimes patients given a placebo treatment will perceive an improvement - a phenomenon commonly called the placebo effect. Properly made study that evaluates subjective symptoms like e.g. pain always shows betterment after placebo administration - so called placebo effect. Missing placebo effects suggests methodological error.
8 Likerta scale – is a psychometric scale commonly involved in research. This is five-level scale where a tested person choose this value, which corresponds with his feeling best.
9 Questionnaire SF-12 is a selected part of questionnaire SF-36 for assessement of general health and quality of life related to physical activity.
10 WOMAC Index - Western Ontario and McMaster Osteoarthritis Index, also named WOMAC scale na integrated is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints.
11 Visual Analog Scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.

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