Efficacy of a comfrey root (Symphyti offic. radix) extract ointment in the treatment of patients with painful osteoarthritis of the knee: Results of a double-blind, randomised, bicenter, placebo-controlled trial
Introduction
Rheumatic disorders have different causes (inflammatory, infectious, degenerative, metabolic), are located at different parts of the body (joints, tendons, muscles, spine) and have different symptoms. Among them are several chronic tissue diseases and painful disorders of the locomotor system, including osteoarthritis of the joints.
Osteoarthritis characterises a primarily non-inflammatory, degenerative change of the structure of the cartilage and bones of one or more joints, involving an increasing deformation of the joint. On principle, all joints can be affected; frequently knee and hip joints, hands and the spine are affected. The frequency of osteoarthritis rises with age, approximately 80% of people over 75 are affected (Cooper, 1998). Osteoarthritis of the knee is described by the Deutsche Gesellschaft für Rheumatologie (German Rheumatology Association) as a disease primarily of the joint cartilage which coincides clinically with pain (pain upon walking, pain on exercise), limited movement and walking impairment, and can result in instability, false position and concomitant synovialitis (active athrosis) (Deutsche Gesellschaft für Rheumatologie, 2000).
The multitude of diseases and complaints is faced by an equally large number of therapeutic drug-based and non-drug based treatment options (Walker-Bone et al., 2000, Hunter and Felson, 2006). Due, in particular, to the symptoms: pain, joint stiffness and restriction of movement, patients seek therapeutical advice. As a result, symptomatic improvement represents an important therapeutic objective. The reduction of pain, the preservation and the restoration of the joint's function and thus the restoration of quality of life are therefore important target parameters in clinical trial (Förster, 2005).
The phytopharmaceutical drugs used in Germany are made, for instance, from willow bark and comfrey root. Since antiquity, the medicinal plant comfrey has been used both internally and externally in different forms of administration, for the treatment of a variety of diseases, e.g. bone fractures, wounds and ulcers (Englert et al., 2005).
In recent times, several clinical trials have proven the efficacy of comfrey in the treatment of distorsions, strains and sprains and other muscle and joint complaints (Koll et al., 2004; Predel et al., 2005; Kucera et al., 2005, Staiger, 2005).
In recent observation studies a reduction of pain of approx. 50% in respect of joint pain and a virtually complete decline of morning stiffness was observed after approximately two weeks of treatment with preparations containing comfrey root extract (Klingenburg, 2004; Tschaikin, 2004).
The efficacy of comfrey is essentially due to its anti-inflammatory, analgesic, granulation promoting and antiexsudative properties (Kommission E, 1990, Schmidtke-Schrezenmeier et al., 1992). Allantoin, rosmarinic acid and other hydroxycinamon acid derivatives as well as muco-polysaccharides are likely to be of critical importance for the pharmacodynamics of the root drug (Andres et al., 1989; Gracza et al., 1985).
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Patients and methods
The clinical trial was performed in accordance with the ICH-GCP guidelines and the Declaration of Helsinki. The patients were informed prior to commencement of the trial and provided written confirmation of their participation in the trial.
This double-blind, randomised, bicenter, placebo-controlled trial involved a total of 220 patients with painful osteoarthritis of the knee. Both ambulatory centres were located in Berlin, Germany. Principal investigator was Barbara Grube, Kurfürstendamm
General information
A total of 220 patients (153 female, 67 male) were randomised and received trial medication after providing written agreement of their participation in the trial (FAS and Safety population). The patients were of an average age of 57.9 years. The complaints relating to osteoarthritis of the knee had on an average persisted for 6.5 years.
There was no significant group difference with regard to distribution of sex, age, height, and body weight. 44 of the 220 patients (20%) suffered from
Discussion
Osteoarthritis of the knee is among the most frequent degenerative joint diseases within the rheumatic disorders. This is due primarily to the complexity of the knee's structure, the high level of stress it is under from body weight but also to the increasing age of the population of industrialised countries. The primary, conservative treatment of osteoarthritis of the knee is symptomatic, as monotherapy or in combination with physical, physiotherapeutical and drug-based measures.
The most
Conclusions
The fact that the verum medication is significantly superior to the placebo medication with regard to all target values proves the therapeutic efficacy of the comfrey root extract ointment in the treatment of painful osteoarthritis of the knee.
At the end of the trial, pain in the verum group had, on an average, reduced five times more than in the placebo group. The primary target value (VAS total score) improved by 54.7% in the verum group, but only by 10.7% in the placebo group.
With regard to
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