Jintiange combined with alfacalcidol improves muscle strength and balance in primary osteoporosis: A randomized, double-blind, double-dummy, positive-controlled, multicenter clinical trial.

Objective: To investigate the effectiveness of a Chinese patent medicine, Jintiange capsules with the main component of artificial tiger bone powder, combined with alfacalcidol on muscle strength and balance of the lower extremities in patients with primary osteoporosis. Design: A randomized, double-blind, double-dummy, positive-controlled, multicenter clinical trial. Subjects and methods: A total of 400 patients diagnosed with primary osteoporosis or osteopenia were recruited and randomized into the Jintiange or control groups. During the 52-week treatment, the participants in the Jintiange group were treated with Jintiange capsules (1.2 â€‹g each time, 3 times per day) and calcium carbonate simulant, while those in the control group were treated with calcium carbonate (element calcium 0.3 â€‹g, twice a day) and a Jintiange capsule simulant. Alfacalcidol (0.25 â€‹µg/d) was applied in both groups. The timed up and go test (TUG), chair rising test (CRT), and tandem gait test (TGT) were performed to evaluate balance, muscle strength and fall risk of the participants. Results: There were 154 participants in the Jintiange group, and 157 participants in the control group were included in the per-protocol set. Comparing the data at week 52 from those at baseline, the TUG time decreased from 9.60 â€‹± â€‹2.25 â€‹s to 8.53 â€‹± â€‹2.06 â€‹s (p â€‹< â€‹0.001) in the Jintiange group and decreased from 9.50 â€‹± â€‹1.91 â€‹s to 9.11 â€‹± â€‹1.95 â€‹s (p â€‹< â€‹0.001) in the control group; the CRT time decreased from 11.49 â€‹± â€‹4.05 â€‹s to 8.57 â€‹± â€‹2.13 â€‹s (p â€‹< â€‹0.001) and 11.17 â€‹± â€‹3.21 â€‹s to 9.74 â€‹± â€‹1.98 â€‹s (p â€‹< â€‹0.001) in the Jintiange and control groups, respectively; the number of correct steps in the TGT increased significantly in both the control (7.40 â€‹± â€‹1.27 vs. 7.69 â€‹± â€‹0.87, p â€‹< â€‹0.01) and Jintiange groups (7.21 â€‹± â€‹1.58 vs. 7.60 â€‹± â€‹1.12, p â€‹< â€‹0.001). At the end of the study, the TUG and CRT results in the Jintiange group were superior to those in the control group (all p value â€‹< â€‹0.05), while no obvious difference was found in the TGT between the two groups. At week 52, the high fall risk proportions in the Jintiange group were significantly lower than those in the control group according to TUG (3.25% vs. 9.55%, p â€‹= â€‹0.023) and CRT (20.78% vs. 33.76%, p â€‹= â€‹0.01). Conclusion: Jintiange capsules combined with alfacalcidol can effectively improve muscle strength and the balance of the lower extremities and reduce fall risk in patients with primary osteoporosis/osteopenia. The translational potential of this article: Artificial tiger bone powder, a traditional Chinese patent medicine, can improve muscle strength and balance and reduce fall risks effectively among patients with primary osteoporosis. It might be a therapeutic option for osteoporosis individuals combined with sarcopenia to improve their muscle function.

Open-label, randomized, multiple-center, parallel study comparing glycemic responses and safety profiles of Glucerna versus Fresubin in subjects of type 2 diabetes mellitus.

Since the increase of prevalence of type 2 diabetes mellitus (T-2DM), the replacing quickly absorbed carbohydrates with a fat source rich in monounsaturated fatty acid to provide improved glycemic control in these patients has become an important assistant therapy. In the present study, we compared glycemic response and safety of two nutritional products, Glucerna and Fresubin, in Chinese subjects with T-2DM. Overall, 203 T-2DM subjects were randomly assigned (1:1) to either Glucerna or Fresubin. The primary endpoint was the adjusted area under the curve (adj-AUC) for plasma glucose at 0-240 min. Blood samples were collected at 0, 30, 60, 90, 120, 180, and 240 min to compare the adjusted area under the curve (AUC) for the change in plasma glucose or insulin from 0 to 240 min. Adjusted peak values and times of glucose and insulin responses and adjusted glucose and insulin values were collected at the same time points. Safety parameters were also evaluated. The adjusted AUC for the change in plasma glucose in the Glucerna group was significantly lower than in Fresubin group (5.60 +/- 5.88 mmol/l*h vs. 7.97 +/- 6.32 mmol/l*h, P = 0.0061), as was the adjusted peak value of glucose (3.51 +/- 2.04 mmol/l vs. 4.69 +/- 1.99 mmol/l, P < 0.0001). Glucerna subjects had a longer adjusted peak time to insulin response compared to Fresubin subjects (105.00 +/- 43.4 min vs. 88.81 +/- 37.69 min, P = 0.0050). Glucerna subjects also experienced more gradual changes in glucose and insulin values. In conclusion, Glucerna provided better control of postprandial plasma glucose and insulin levels in Chinese subjects with T-2DM. Variation of postprandial glucose tended to be relatively stable after patients took Glucerna. Study results suggest that Glucerna may be beneficial in the reduction of postprandial glycemia.

[Effects of Tongluo recipe on experimental diabetic peripheral neuropathy in rats].

OBJECTIVE: To investigate the effects of Tongluo Recipe (TLR), a compound Chinese herbal medicine, on experimental diabetic peripheral neuropathy in rats. METHODS: Diabetes was induced by streptozocin in rats. Eight weeks later, the diabetic rats were assigned to 3 groups according to different body weights: untreated group, low-dose TLR-treated group and high-dose TLR-treated group. Eight normal rats were assigned to normal control group. Systemic and sciatic nerve intrinsic antioxidant enzyme activities, lipid peroxide levels, hemorheology and sciatic nerve conduction velocity and ultrastructure changes were evaluated. RESULTS: Glutathione peroxidase (GSH-Px) and superoxide dismutase (SOD) activities were lower, and lipid peroxide levels were higher in plasma and sciatic nerve of the untreated group than those in the normal control group (P<0.05). Blood glucose and viscosity in the untreated group were higher than those in the normal control group. Sciatic nerve showed demyelination changes and decrease of conduction velocity. Vasa nervorum expanded and erythrocyte deposited in the capillary in the untreated group. TLR obviously improved sciatic nerve conduction velocity and ameliorated morphology changes, decreased blood viscosity, improved SOD and GSH-Px activities. CONCLUSION: TLR can obviously improve sciatic nerve function and ameliorate morphology changes in rats with diabetic peripheral neuropathy, probably through depleting free radical production, improving endothelial cell function and ameliorating hemorheology changes.