OBJECTIVES: Some of the most common climacteric symptoms are somatic symptoms, such as muscle and joint pain, which cause limitations in performing daily tasks. This study aimed to assess whether oral porcine placental extract (PPE) affects patients with shoulder stiffness, one of the most common types of muscle-tendon stiffness, in climacteric women and postmenopausal women with hormone therapy (HT). METHODS:Sixty-six climacteric women (33 each in the control and study groups) with shoulder stiffness and 54 postmenopausal women (27 each in the control and study groups) with HT-resistant shoulder stiffness were enrolled into this open-label, randomized, controlled study. The control subjects received Toki-shakuyaku-san (TJ23; 7.5 g/day, daily per os), an oral herbal remedy used to alleviate climacteric symptoms, and study subjects received PPE orally for 24 weeks in climacteric women and for 12 weeks in postmenopausal women with HT. Changes in the degree of shoulder stiffness were evaluated by the Visual Analog Scale (VAS). RESULTS: Treatment with PPE was significantly effective in reducing the VAS score for shoulder stiffness during the study period compared with the control group in both climacteric and postmenopausal women with HT. The VAS score at the end of treatment was significantly reduced (p < 0.01 vs. baseline) by 76.4% for climacteric women and 64.8% for postmenopausal women with HT compared with baseline. CONCLUSIONS:PPE is useful as an oral supplement for shoulder stiffness in climacteric women without HT or in postmenopausal women with HT-resistant, long-term shoulder stiffness.
RCT Entities:
OBJECTIVES: Some of the most common climacteric symptoms are somatic symptoms, such as muscle and joint pain, which cause limitations in performing daily tasks. This study aimed to assess whether oral porcine placental extract (PPE) affects patients with shoulder stiffness, one of the most common types of muscle-tendon stiffness, in climacteric women and postmenopausal women with hormone therapy (HT). METHODS: Sixty-six climacteric women (33 each in the control and study groups) with shoulder stiffness and 54 postmenopausal women (27 each in the control and study groups) with HT-resistant shoulder stiffness were enrolled into this open-label, randomized, controlled study. The control subjects received Toki-shakuyaku-san (TJ23; 7.5 g/day, daily per os), an oral herbal remedy used to alleviate climacteric symptoms, and study subjects received PPE orally for 24 weeks in climacteric women and for 12 weeks in postmenopausal women with HT. Changes in the degree of shoulder stiffness were evaluated by the Visual Analog Scale (VAS). RESULTS: Treatment with PPE was significantly effective in reducing the VAS score for shoulder stiffness during the study period compared with the control group in both climacteric and postmenopausal women with HT. The VAS score at the end of treatment was significantly reduced (p < 0.01 vs. baseline) by 76.4% for climacteric women and 64.8% for postmenopausal women with HT compared with baseline. CONCLUSIONS: PPE is useful as an oral supplement for shoulder stiffness in climacteric women without HT or in postmenopausal women with HT-resistant, long-term shoulder stiffness.