Adverse effects of xenogenic scaffolding in the context of a randomized double-blind placebo-controlled study for repairing full-thickness rotator cuff tears

Background.We for the first time examined the effects of a multiherb formula containingCrataegus pinnatifida(1 g daily),Alisma orientalis,Stigma maydis,Ganoderma lucidum,Polygonum multiflorum, andMorus albaon plasma lipid and glucose levels in Chinese patients with dyslipidemia.Methods.In this randomized, double-blind, placebo-controlled study, 42 patients were randomized at a ratio of 1 : 1 to receive the herbal formula or placebo for 12 weeks and 40 patients completed the study. Lipid profiles, glucose, glycated haemoglobin (HbA1c), and laboratory safety parameters were performed before and after treatment.Results.The difference in the changes in low-density lipoprotein cholesterol (LDL-C) levels between placebo and active treatment (−9%) was significantly(P<0.05)better with active treatment. HbA1c levels significantly decreased by −3.9% in the active treatment group, but the change was not significantly different from that with placebo (−1.1%)(P=0.098). There were no apparent adverse effects or changes in laboratory safety parameters with either treatment.Conclusions.The multiherb formula had mild beneficial effects on plasma LDL-C after 12-weeks treatment in subjects with dyslipidemia without any noticeable adverse effects.

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Clinical Function Improves After Subacromial Injection of Local Anesthetic in Full-Thickness Rotator Cuff Tears: A Randomized Control Trial

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967119892331 ◽

2020 ◽

Vol 8 (1) ◽

pp. 232596711989233

Author(s):

Brian Forsythe ◽

Avinesh Agarwalla ◽

Richard N. Puzzitiello ◽

Bhavik H. Patel ◽

Yining Lu ◽

...

Keyword(s):

Rotator Cuff ◽

Physical Examination ◽

Range Of Motion ◽

Rotator Cuff Tears ◽

Controlled Study ◽

Full Thickness ◽

Randomized Controlled ◽

Subacromial Injection ◽

Constant Murley Score ◽

Lidocaine Injection

Background: Rotator cuff pathology is the most common cause of shoulder pain in adults, accounting for nearly 70% of shoulder-related visits to clinicians. However, physical examination findings may be limited because of pain or patient inhibition. Purpose: To establish whether a relationship exists between pain, range of motion, and strength in patients with a full-thickness rotator cuff tear. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A single-blind, randomized controlled study of 40 patients undergoing rotator cuff repair for full-thickness rotator cuff tears was performed. Patients were randomized to receive either a subacromial 10-mL 2% lidocaine injection or a sham injection, with no contents being injected into the subacromial space. Before the injection, patients were assessed using a visual analog scale for pain (VAS-Pain) as well as the Constant-Murley subjective questionnaire and objective physical examination. The examination was repeated 10 minutes after injection and 6 months postoperatively. VAS-Pain after injection was not assessed. The assessment at 6 months was performed to demonstrate improvement of rotator cuff function after operative management. Statistical analysis included Student t and chi-square tests as well as multivariate binomial logistic regression analyses to identify predictors for improvement after injection. Results were considered significant if P < .05. Results: Range of motion, strength, and Constant-Murley score significantly improved after a subacromial lidocaine injection ( P < .05). Range of motion, strength, Constant-Murley score, and VAS-Pain significantly improved at final follow-up compared with the preinjection assessment for both groups ( P < .05); however, there was no difference ( P > .05) between groups at 6 months postoperatively. Conclusion: After subacromial lidocaine injections, patients exhibited modest but significant improvements in range of motion, strength, and the Constant-Murley score. Pain may limit range of motion and strength in patients with full-thickness rotator cuff tears independent of the mechanical impact of the tear itself. Registration: NCT02693444 ( ClinicalTrials.gov identifier).

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