Efficacy and safety of the Bushen Tiaochong recipe combined with alendronate sodium for the treatment of postmenopausal senile degenerative osteoporosis: study protocol and preliminary results of a randomized controlled trial

Background and objectives: Alendronate sodium is a commonly used western medicine for the treatment of osteoporosis, but it has many adverse reactions. The main component of the traditional Chinese medicine, known as the Bushen Tiaochong recipe, is Epimedium brevicornu Maxim. (epimedium). Pharmacological studies have shown that the main active ingredient of Epimedium is icariin. Icariin has an estrogen-like effect, can prevent against bone loss and improve bone strength, and has a definite effect on the treatment of postmenopausal senile degenerative osteoporosis. We hypothesize that the Bushen Tiaochong recipe combined with alendronate sodium will be more effective, as well as safer and more reliable than alendronate sodium alone for the treatment of postmenopausal senile degenerative osteoporosis. Design: A prospective, single-center, randomized, controlled, trial. Methods: Two hundred patients with postmenopausal senile degenerative osteoporosis will be randomly assigned to an observation group and a control group. In the control group, patients will be given alendronate sodium tablets 10 mg/d and calcium carbonate D3 chewable tablets 0.6 g/d. In the observation group, patients will receive the same treatment as the control group and the Bushen Tiaochong recipe, simmering, twice per day (once in the morning and once in the evening). The duration of treatment will be 6 months in both groups. Outcome measures and preliminary results: The primary outcome measure is total efficacy 6 months after treatment in both groups. The secondary outcome measures are Visual Analogue Scale scores for waist and back pain; lumbar spine (L2–4) bone mineral density; serum levels of calcium, phosphorus, alkaline phosphatase, osteocalcin, estradiol, follicle stimulating hormone, luteinizing hormone, interleukin-1, and interleukin-6 before and 6 months after treatment; and incidence of adverse reactions 6 months after treatment. The results of a peliminary experiment including 124 patients with postmenopausal senile degenerative osteoporosis who received the same treatment as in the present study revealed that at 6 months after treatment, the total efficacy, L2–4 bone mineral density, serum levels of calcium and estradiol were higher in the observation group than in the control group (P < 0.05). Visual Analogue Scale scores, serum levels of alkaline phosphatase, osteocalcin, interleukin-1, and interleukin-6 were lower in the observation group than in the control group (P < 0.05). Discussion: We hope to verify that the Bushen Tiaochong recipe combined with alendronate sodium provides better results than alendronate sodium alone for the treatment of postmenopausal senile degenerative osteoporosis. Ethics and dissemination: This trial has been approved by the Ethics Committee of the Affiliated Hospital of Qinghai University of China (approval number: QHY1703F). The study protocol will be conducted in accordance with the Declaration of Helsinki, formulated by the World Medical Association. Written informed consent will be obtained from all participants. The recruitment of subjects will begin in January 2018. Samples and data will be collected from January to December 2018. Outcome measures will be analyzed in March 2019. This trial will be completed in April 2019. The results of the trial will be reported in a scientific conference or disseminated in a peer-reviewed journal. Trial registration: This trial was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR-ONC-17013947).