The therapeutic benefits of acupoint injection of vitamin K in spleen-6 (SP6) for the treatment of primary dysmenorrhea have been observed in limited clinical settings. However, menadione, the form of vitamin K most studied for treating dysmenorrhea, is not routinely used in clinical practice in North America. As part of a larger clinical trial among women aged 18-25 years with primary dysmenorrhea, we conducted a substudy to test the plasma concentration of phylloquinone (vitamin K1). We collected blood samples from four women before and 24-48 hours after an acupoint injection of phylloquinone in SP6. Despite the rapid turnover of phylloquinone observed in previous studies, we found that the plasma phylloquinone concentrations increased significantly from preinjection to 1-2 days after the injection. Interestingly, higher phylloquinone concentrations were correlated with less pain intensity among women with dysmenorrhea. Additional research is needed to understand the association between vitamin K and menstrual pain, including the role of vitamin K deficiency in inflammation and pain, and on the possible mechanisms of acupoint injection of vitamin K for the treatment of primary dysmenorrhea.

Context

Dysmenorrhea, the occurrence of painful menstrual cramping of the uterus, is a major cause of activity restriction and absences from school and work among young women. Standard pharmaceuticals used to treat dysmenorrhea are not effective for all women and have side effects that limit their use. Studies elsewhere have shown beneficial effects for use of vitamin K1 as an acupoint treatment, but the acceptability of this treatment to women in the United States has been unknown.

Objective

The study intended to examine the feasibility, acceptability, and preliminary effects of acupuncture point injection of vitamin K1 as an alternative treatment for primary dysmenorrhea among US women.

Design

The research team conducted a pilot study using a blinded, randomized, crossover trial design.

Setting

The study took place at the University of California, San Francisco (UCSF).

Participants

The study was conducted in the San Francisco Bay Area among women 18 to 25 y of age who had been diagnosed with primary dysmenorrhea. Fourteen women completed all of the study's visits.

Intervention

Women with primary dysmenorrhea were randomized into 2 groups to receive bilateral injections of vitamin K1 in the Spleen-6 (SP-6) acupuncture point at the start of menstruation and then, following a 2-mo washout period, saline in a nonacupuncture point at the start of menstruation. One group received the vitamin K1 injection first, while the other group received the saline injection first.

Outcome measure

Dysmenorrhea pain intensity was measured using a 0-10 numeric rating scale (NRS), before and after injections.

Results

Women had an average 2.5-point decrease in pain after a vitamin K1 injection in the SP-6 acupoint (P < .001), as compared with a 1.8-point decrease after a saline injection (P < .001). Change scores for vitamin K1, as compared with a saline injection, approached statistical significance (P < .10). Intensity and duration of menstrual symptoms, as measured by the Cox retrospective symptom scale, also decreased following injections. After participating, 94% of the women remained agreeable to receiving the injection therapy, and 77% reported they would come every month were the treatment available.

Conclusions

Findings suggested high acceptability for an acupuncture point injection of vitamin K1 as treatment for primary dysmenorrhea among young women in San Francisco. Pain decreased with both treatments, with a trend toward greater pain reduction for the vitamin K1/SP-6 injection. This finding is consistent with outcomes from the Obstetrics and Gynecology Hospital in Shanghai, China, where the protocol was developed.

Study objective

The transfusion of older packed RBCs may be harmful in critically ill patients. We seek to determine the association between packed RBC age and mortality among trauma patients requiring massive packed RBC transfusion.

Methods

We analyzed data from the Pragmatic, Randomized Optimal Platelet and Plasma Ratios trial. Subjects in the parent trial included critically injured adult patients admitted to 1 of 12 North American Level I trauma centers who received at least 1 unit of packed RBCs and were predicted to require massive blood transfusion. The primary exposure was volume of packed RBC units transfused during the first 24 hours of hospitalization, stratified by packed RBC age category: 0 to 7 days, 8 to 14 days, 15 to 21 days, and greater than or equal to 22 days. The primary outcome was 24-hour mortality. We evaluated the association between transfused volume of each packed RBC age category and 24-hour survival, using random-effects logistic regression, adjusting for total packed RBC volume, patient age, sex, race, mechanism of injury, Injury Severity Score, Revised Trauma Score, clinical site, and trial treatment group.

Results

The 678 patients included in the analysis received a total of 8,830 packed RBC units. One hundred patients (14.8%) died within the first 24 hours. On multivariable analysis, the number of packed RBCs greater than or equal to 22 days old was independently associated with increased 24-hour mortality (adjusted odds ratio [OR] 1.05 per packed RBC unit; 95% confidence interval [CI] 1.01 to 1.08): OR 0.97 for 0 to 7 days old (95% CI 0.88 to 1.08), OR 1.04 for 8 to 14 days old (95% CI 0.99 to 1.09), and OR 1.02 for 15 to 21 days old (95% CI 0.98 to 1.06). Results of sensitivity analyses were similar only among patients who received greater than or equal to 10 packed RBC units.

Conclusion

Increasing quantities of older packed RBCs are associated with increased likelihood of 24-hour mortality in trauma patients receiving massive packed RBC transfusion (≥10 units), but not in those who receive fewer than 10 units.

Background

Altered coagulation function after trauma can contribute to development of venous thromboembolism (VTE). Severe trauma impairs coagulation function, but the trajectory for recovery is not known. We hypothesized that enhanced, early recovery of coagulation function increases VTE risk in severely injured trauma patients.

Study design

Secondary analysis was performed on data from the Pragmatic Randomized Optimal Platelet and Plasma Ratio (PROPPR) trial, excluding patients who died within 24 hours or were on pre-injury anticoagulants. Patient characteristics, adverse outcomes, and parameters of platelet function and coagulation (thromboelastography) were compared from admission to 72 hours between VTE (n = 83) and non-VTE (n = 475) patients. A p value < 0.05 indicates significance.

Results

Despite similar patient demographics, VTE patients exhibited hypercoagulable thromboelastography parameters and enhanced platelet function at admission (p < 0.05). Both groups exhibited hypocoagulable thromboelastography parameters, platelet dysfunction, and suppressed clot lysis (low clot lysis at 30 minutes) 2 hours after admission (p < 0.05). The VTE patients exhibited delayed coagulation recovery (a significant change compared with 2 hours) of K-value (48 vs 24 hours), α-angle (no recovery), maximum amplitude (24 vs 12 hours), and clot lysis at 30 minutes (48 vs 12 hours). Platelet function recovery mediated by arachidonic acid (72 vs 4 hours), ADP (72 vs 12 hours), and collagen (48 vs 12 hours) was delayed in VTE patients. The VTE patients had lower mortality (4% vs 13%; p < 0.05), but fewer hospital-free days (0 days [interquartile range 0 to 8 days] vs 10 days [interquartile range 0 to 20 days]; p < 0.05) and higher complication rates (p < 0.05).

Conclusions

Recovery from platelet dysfunction and coagulopathy after severe trauma were delayed in VTE patients. Suppressed clot lysis and compensatory mechanisms associated with altered coagulation that can potentiate VTE formation require additional investigation.