Abstract

BACKGROUND Some users of the etonogestrel contraceptive implant experience bothersome bleeding which can reduce contraceptive satisfaction and continuation. Few strategies exist to manage this bleeding. The exact mechanism of progestin-induced bleeding is unknown but it is likely multi-factorial (e.g. impaired angiogenesis, 'leaky' fragile vasculature, and inflammation). Curcumin, the active ingredient in turmeric, has anti-inflammatory, anti-proliferative, and anti-angiogenic proprieties which may make it a useful agent for implant-associated bothersome bleeding. OBJECTIVE To evaluate whether curcumin decreases frequent or prolonged bleeding or spotting in contraceptive implant users. STUDY DESIGN The study was a randomized, double blind, placebo-controlled trial. We enrolled etonogestrel implant users with frequent or prolonged bleeding or spotting and randomized them to either 600 mg Theracumin HP (Immunovites, Las Vegas, NV) or placebo daily for 30 days. We defined "frequent" as two or more independent bleeding or spotting episodes and "prolonged" as 7 or more consecutive days of bleeding or spotting in a 30-day interval. Implant use was confirmed by clinical exam as well as a negative gonorrhea/chlamydia and pregnancy test. Enrolled participants initiated study treatmentfollowing three consecutive days of bleeding or spotting; if no bleeding or spotting occurred within 30-days of enrollment, subjects were withdrawn from the study. Study treatments were encapsulated to maintain a similar appearance. Participants used text messages to record daily bleeding patterns and study drug compliance. We defined bleeding as a day that required the use of protection with a pad, tampon, or liner, and spotting as a day with minimal blood loss that did not require the use of any protection. Our primary outcome was the total number of days without bleeding or spotting during the 30 days of study drug or placebo exposure. Secondary outcomes including total number of bleeding-free days, bleeding episodes, and satisfaction. A sample size of 22 per group provided 80% power at an alpha 0.05 to demonstrate a 6-day difference between groups. RESULTS From February 2021 to November 2022, 58 individuals enrolled in the study with 93% (n=54) completing 30 days of treatment (curcumin 26, placebo 28). One individual in the curcumin arm did not experience a qualifying bleeding event and thus never initiated treatment and, per protocol, was withdrawn from the study. Participant characteristics did not differ between groups including length of implant use at study enrollment [placebo: 521 days (SD 305), curcumin 419 days (SD 264)]. Study groups did not differ in regard to any bleeding-related outcome [mean days without bleeding or spotting: curcumin 16.7 (SD 6.9), placebo 17.5 (SD 4.8), p = 0.62; mean bleeding-free days: curcumin 23.4 (SD 4.9), placebo 22.4 (SD 4.5), p = 0.44; bleeding episodes: curcumin 2.0 (SD 0.8), placebo 2.1 (SD 0.8), p = 0.63]. Satisfaction with the implant as contraception and acceptability of bleeding over the study period also did not differ by study group (p = 0.54 and p = 0.30, respectively). CONCLUSION Daily use of curcumin did not improve bleeding patterns in users of the etonorgestrel contraceptive implant experiencing frequent or prolonged bleeding patterns.

Abstract

PURPOSE To investigate the efficacy of non-tranexamic acid (TXA) on reducing blood loss and requirements of allogeneic blood transfusion (ABT) in total knee arthroplasty (TKA). METHODS The PubMed, EMBASE, and the Cochrane Library databases were researched since incipiency to June 2018. Only randomized controlled trials (RCTs) involved with non-TXA hemostatic techniques in TKA met the inclusion criteria. RESULTS A total of 36 RCTs, including 1511 patients, were recruited for analysis. The results of subgroup analysis revealed that hemostatic techniques, which could substantially decrease the rate of ABT, were cell salvage with the transfusion trigger of 9 mg/dl, fibrin sealant with a dosage of 10 ml, and postoperative flexion position. CONCLUSION The available evidence in this meta-analysis suggests that postoperative flexion position, fibrin sealant, and cell salvage can substantially decrease the rate of ABT in TKA. Further studies, including more hemostatic methods and high-quality research, are expected.

Abstract

PURPOSE The purpose of the present study was to compare patient-specific instrumentation (PSI) with standard instrumentation (SI) in patients undergoing total knee arthroplasty (TKA). PSI is hypothesized to have advantages with respect to component alignment; number of outliers (defined as alignment > 3 degrees from the target alignment); operative time; perioperative blood loss; and length of hospital stay. This new surgical technique is expected to exhibit superior performance. METHODS A total of 23 randomized controlled trials (RCTs) involving 2058 knees that compared the clinical outcomes of TKA between PSI and SI were included in the present analysis; these RCTs were identified via a literature search of the PubMed, Embase, and Cochrane Library databases through March 1, 2018. The outcomes of interest included coronal, sagittal and axial component alignment (presented as the angle of deviation from the transcondylar line); number of outliers; operative time; perioperative blood loss; and length of hospital stay. RESULTS There was a significant difference in postoperative femoral axial alignment between PSI and SI patients (95% CI - 0.71 to - 0.21, p = 0.0004, I(2) = 48%). PSI resulted in approximately 0.4 degrees less deviation from the transcondylar line than SI. Based on our results, PSI reduced operative time by a mean of 7 min compared with SI (95% CI - 10.95 to - 3.75, p < 0.0001, I(2) = 78%). According to the included literature, PSI reduced perioperative blood loss by approximately 90 ml compared with SI (95% CI - 146.65 to - 20.18, p = 0.01, I(2) = 74%). We did not find any differences between PSI and SI with respect to any other parameters. CONCLUSIONS PSI has advantages in axial alignment of the femoral component, operative time, and perioperative blood loss relative to SI. No significant differences were found between PSI and SI with respect to alignment of the remaining components, number of outliers, or length of hospital stay. LEVEL OF EVIDENCE Therapeutic study (systematic review and meta-analysis), Level I.