ABSTRACT
Objectives Knee pain related to osteoarthritis increases with age and is more common in middle-aged women. Although hormone replacement therapy (HRT) improves knee pain, women unresponsive to HRT need an effective adjunctive therapy. The aim of this study was to assess whether oral porcine placental extracts (PPE) have an impact on patients with knee pain as an adjunctive therapy combined with HRT.
Methods Forty-eight postmenopausal women with knee pain receiving HRT were enrolled into this open-label, randomized, controlled study. Subjects were randomized into Group 1 (n= 24) or Group 2 (n=24). Subjects in Group 1 were given 3 months open treatment with calcium (260 mg/day) as adjunctive therapy combined with HRT. Group 2 received PPE (9 capsules/day) as adjunctive therapy combined with HRT. Changes in the degree of knee pain were evaluated by the Visual Analog Scale (VAS).
Results Treatment with PPE was significantly effective in reducing the VAS score for knee pain at 4 weeks (p < 0.05), at 8 weeks (p< 0.01) and at 12 weeks (p<0.01), compared with the control group. Interestingly, the effects continued for 4 weeks after cessation of treatment in the PPE group (p< 0.01) compared with the control group. The PPE treatment had no significant adverse effects on blood biochemical and metabolic profiles, especially related to the risk factors for cardiovascular disease.
Conclusion PPE is a possible option as an adjunctive oral supplement in the case of HRT-resistant, long-lasting knee pain.
ACKNOWLEDGEMENT
The authors wish to thank Mr Taiichi Kaku (Japan Bio Products Co., Ltd. Tokyo, Japan) for providing porcine placental extracts (JBP porcine 100).
Conflict of interest The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.
Source of funding This work was partially supported and funded by the NPO Science Research Center for Alternative Medicine, Kanazawa, Ishikawa, Japan.