| Background:Knee osteoarthritis, also called degenerative arthritis, proliferative knee arthritis, age-related arthritis. Until now, no ideal therapy can be adapted to treat the pain of knee OA. With theincreasing of age and complications, finding a more effectivetherapy is an essential and urgent mission currently.In China and worldwide, the recent guidelines recommend topical medications as an alternative or adjunctive therapy, or even as the first-line therapy for knee OA. Traditional Chinese medicine in the prevention and control of external treatment KOA curative effect is distinct, are still the important means of treatment of this disease.A great number of Chinese doctors have prescribed some forms of Traditional Chinese Medicine to patients with knee OA, of which the herbal patch is a common approach and has long been a standard treatment. Currently, Fufang Nanxing Zhitong Gao (FNZG) is a most prescribed herbal patches in China with the indication for the management of painful knee OA. Published literatures documented that FNZG had a better efficacy for knee OA or arthralgia. However, these reports were all focused on the effective cases and could not supply sufficient evidences for the curative effect. The results and conclusions were limited by methodological quality, including restricted demographics characteristics, absence of standardized outcome measures and poor statistical analysis. Most importantly,although Traditional Chinese herbal patch has been applied over centuries, there were no placebo controlled trials published for validating its effectiveness in treating knee OA. Therefore, we conducted a randomized, double-blind, positive-controlled, and placebo-controlled trial to explore the effectiveness and safety of FNZG, and evaluate the analgesic effect for the management of OA in a short-term design, which can provide the basis for the clinical application of external Plaster on knee osteoarthritis pain.Purpose:Investigate the analgesic effect of FufangNanxingZhitongGao (FNZG) to provide the basis of the therapy of external plaster for knee osteoarthritis pain.Methods: Clinical observation methods was used in this study.125outpatients met the inclusion criteria from rheumatology clinic of Nanfang Hospital of Nanfang Medicine University were included. They were randomly assigned to the experimental drug treatment group [Fufang Nanxing Zhitong Gao (FNZG)](n=50),positive drug control group [Shangshi Jietong Gao (SJG)](n=50), the placebo group [the acrylic pressure-sensitive adhesive tape](n=25). Sticking plaster was applied to the most pain location of the knee joint (1stick every knee) after bath or before sleep every night. The plaster could be fixed by externalknee pad and will be removed after12hours. The treatment was given once daily,6days as a course.And VAS pain scores were used to evaluate the analgesic effects and clinical efficacy.Results:The reducing score and reducing score rate of the FNZG group after treatment compared with SJG group showed a significant difference (P<0.05). The joint pain relief time of the FNZG group, SJG group and placebo group were13.0±10.4h,22.5±17.4h,25.7±15.5h respectively. There was a significant difference between the experimental group and the other two groups (P <0.05). On the other hand, the pain relief rates were92.55%,71.43%and27.27%for the three groups. And the comparison of the clinical effect between the FNZG group with the SJG group and the placebo group showed significant difference.It was shown that FNZGcould improve symptom of the joint pain effectively and had better outcome than SJG.Treating painful knee osteoarthritis with FNZG in clinical hadnotable curative effectConclusion:These results indicate that FNZG for the treatment of knee osteoarthritis pain has better results than the positive control group and the placebo control group (P<0.05).And the allergy during therapy is rare. Thus, FNZG can be used as an effective analgesic external plaster for the treatment of knee osteoarthritis. |
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