2 Minute Medicine Rewind January 1, 2024
1. Patients randomized to receive both behavioural therapy (BT) and zolpidem were found to have a significant improvement in anxiety symptoms, fatigue, functional impairments, and mental health scores.
2. The addition of a second-stage treatment offered further improvements in daytime functions.
Evidence Rating Level: 1 (Excellent)
Insomnia is a common sleep disorder characterized by difficulty initiating and/or maintaining sleep. It is associated with a significant disease burden including daytime functional impairment. This randomized clinical trial aimed to evaluate the efficacy of four treatment sequences using psychological (behavioral and cognitive) and pharmacologic therapies (zolpidem and trazodone) for insomnia. A total of 211 adults with insomnia (63% female; mean [SD] age, 45.6 [14.9] years) were randomly assigned in a 1:1 ratio to BT (n = 104) or zolpidem treatment (n = 107). After first-stage therapy, 36 participants in the BT group and 29 in the zolpidem group reached insomnia remission. Of the available participants whose insomnia did not remit, 108 accepted randomization to a second-stage psychological therapy (BT or cognitive therapy [CT]) or medication therapy (zolpidem or trazodone). Both first-stage therapies similarly and significantly improved depressive symptoms, fatigue, functional impairments, and mental health scores. BT led to a significant reduction in anxiety symptoms (mean change, −4.1 [95% CI, −5.8 to −2.4]), while zolpidem (−1.2 [95% CI, −3.0 to 0.5]; d = 0.24) did not (P = .02). After second-stage therapies both zolpidem-containing sequences (zolpidem plus BT, zolpidem plus trazodone) showed further significant reductions in anxiety, fatigue, functional impairments, and improved mental health scores at 3 months. While the BT sequences did not exhibit additional changes except for functional impairments at 3 months, at 12-month follow-up both sequences starting with BT (BT plus zolpidem, BT plus CT) demonstrated significant improvements in anxiety, fatigue, functional impairments, and mental health scores. Study findings suggest that both BT and zolpidem are effective first-stage treatments for reducing daytime symptoms of insomnia, with no significant differences between them. Adding a second-stage therapy enhanced daytime functions, particularly showing immediate effects for sequences starting with zolpidem and delayed effects for those starting with BT.
1. In a population of men with hypogonadism and PSA concentrations less than 3 ng/mL, patients randomized to receive testosterone replacement therapy (TRT) did not have an associated increased incidence of prostate cancer compared with the placebo.
Evidence Rating Level: 1 (Excellent)
The association between TRT and prostate cancer risk is not fully understood. The Testosterone Replacement Therapy for Assessment of Long-Term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) study aims to compare the effects of TRT and placebo on the incidences of prostate cancer, acute urinary retention, invasive prostate surgical procedures for BPH, and initiation of pharmacologic therapy for BPH. The study included 5204 patients (mean [SD] age, 63.3 [7.9] years; mean (SD) follow-up duration, 33.0 (12.1) months) with 1 or more symptoms of hypogonadism and a PSA level of less than 3 ng/mL. Subjects were randomly assigned in a 1:1 ratio to either receive a 1.62% transdermal testosterone gel or a placebo gel. During 14 304 person-years of follow-up, there was no significant difference in the incidence of high-grade prostate cancer between groups (5 of 2596 [0.19%] in the TRT group vs 3 of 2602 [0.12%] in the placebo group; hazard ratio, 1.62; 95% CI, 0.39-6.77; P = .51). The rate of any prostate cancer did not differ between the placebo and TRT groups (HR, 1.07; 95% CI, 0.47-2.42; P = .87). The incidence of acute urinary retention, invasive prostate surgical procedures, and new pharmacologic treatment for lower urinary tract symptoms did not differ significantly between groups. Compared with the placebo group, the TRT group exhibited significantly greater increases in PSA levels at 3, 12, 24, 36, and 48 months irrespective of baseline PSA (P < .001), but there was no significant between-group difference in PSA levels after month 12. The findings of the study suggest that TRT in men with hypogonadism was associated with a low risk of adverse prostate events, including cancer.
Self-Reported Frequency of Adding Salt to Food and Risk of Incident Chronic Kidney Disease
1. This large cohort study found that in the general population, a higher self-reported frequency of adding salt to foods was significantly associated with increased chronic kidney disease (CKD) risk.
Evidence Rating Level: 2 (Good)
Sodium intake is essential for various physiological functions, but high consumption has been associated with hypertension and CKD. Self-reported frequency of adding salt to foods is associated with an increased risk of cardiovascular diseases, premature mortality, and type 2 diabetes, but there are no studies investigating its relation with CKD. This large cohort study analyzed data from 465 288 adults (mean [SD] age 56.32 [8.08] years; 54.83% female; median [IQR] follow-up, 11.8 [1.4] years) from the UK Biobank (UKB) study to determine the association of self-reported frequency of adding salt to foods with incident CKD. There were 22,031 incident events of CKD during the study period. Individuals who reported a higher frequency of adding salt to their foods had a higher BMI, higher Townsend Deprivation Index (a composite measure of deprivation based on unemployment, noncar ownership, nonhome ownership, and household overcrowding)m and a decreased baseline eGFR. Even after adjusting for potential cofounders, compared with those who reported never or rarely adding salt to food, those who reported sometimes adding salt to food (aHR, 1.04; 95 % CI, 1.00-1.07), those who reported usually adding salt to food (aHR, 1.07; 95% CI, 1.02-1.11), and those who reported always adding salt to food (aHR, 1.11; 95% CI, 1.05-1.18) demonstrated a significantly higher risk of CKD (P < .001). Overall, these findings indicate that a higher self-reported frequency of adding salt to food is significantly associated with an increased risk of CKD, warranting the consideration of reducing the addition of salt to foods as a viable strategy for the prevention of CKD.
1. In emergency patients with hip fracture and severe pain, patients randomize to receive early ultrasound-guided femoral nerve block (FNB) were observed with reduced preoperative opioid consumption without delaying time to optimal pain control, compared with standard care.
Evidence Rating Level: 1 (Excellent)
Hip fractures are common painful injuries among elderly patients. 50 to 70% of patients experience severe pain, while 40% may receive sub-optimal pain management. While opioids are frequently employed for initial pain management, the prevalence of adverse effects associated with opioid use underscores the necessity for exploring alternative approaches. This randomized trial aims to assess the impact of early ultrasound-guided FNB, initiated upon diagnosis, on preoperative opioid consumption. Between September and December 2022, patients with a radiographically proven hip fracture and a pain score of ≥ 7 (on a verbal numerical scale ranging from 0 to 10 points) at emergency department triage were identified and randomized in 1:1 ratio to receive ultrasound-guided FNB (n=15) or standard care (n=15). Compared with the standard group, ultrasound-guided FNB reduced median preoperative opioid consumption by 60%, with a 9 morphine milligram intravenous equivalents (MME) reduction (95% CI: 3–14, P < 0.001). The average time for ultrasound-guided FNB was 13.6 ± 6.5 minutes and there was no significant difference in time to pain relief between groups. During the hospital stay, the ultrasound-guided FNB group experienced a 56% reduction in opioid consumption, with a difference of 11.5 MME (95% CI: 0.5–22). Opioid adverse events were 40% lower (95% CI: 5.1–74.9) in the ultrasound-guided FNB group, and no FNB-related adverse effects were reported. Overall, these findings suggest that early in elderly patients with a hip fracture, ultrasound-guided FNB reduces preoperative opioid consumption without delaying the time to pain relief, supporting the adoption of early single ultrasound-guided FNB performed by trained emergency physicians as an alternative to intravenous opioids.
Dual Plate Fixation of Periprosthetic Distal Femur Fractures
1. In patients with distal femoral periprosthetic fractures (DFPF), patients treated with dual plating (DP) were more likely to be weight-bearing in the twelve-week postoperative period, compared with those treated with distal femoral locking plates (DFLP).
2. Compared with the DFLP group, the DP patients were more likely return to their baseline ambulatory status.
Evidence Rating Level: 3 (Average)
With an aging population and increasing rates of knee arthroplasty, the incidence of DFPF is expected to grow. Historically, treatments for distal femur fractures used large fragment plates, but complication rates were high due to inadequate angular stability and distal fixation. Recent trends favor dual implants, such as plate-nail or DP combinations. This is the largest comparative case series that aims to determine the efficacy of DP compared with single implant (DFLP) fixation of DFPF. Between 2015-2021 38 patients (mean age [SD], 75.9 [11.3] years; mean follow up, 19.8 [16.1] months; 81.5% female; mean BMI, 29.5 [6.3] kg/m2) with DFPF treated with DP and 34 patients (mean age [SD], 74.8 [7.3] years; mean follow up, 18.2 [13.8 months]; 81.5% female; mean BMI, 33.2 [7.7] kg/m2) treated with DFLP were identified and included in the analysis. There was a significant difference in fracture morphology based on the Su classification (P < 0.001), with a higher prevalence of Su type 1 fractures in the DFLP group and more type 3 fractures in the DP group. However, no significant difference in morphology was observed based on the OTA/AO classification (P = 0.273). There was no significant difference in reoperation rate, coronal alignment change, nonunion, malunion, infection, or hardware failure between groups. Significantly more DP patients were allowed to immediately weight bear compared with DFLP (87% vs. 9%, P < 0.001). The DP group achieved a return to baseline ambulation in 73% of cases, in contrast to 38% in the DFLP group (P = 0.004). In effect, this study suggests that compared with DFLP, DP of DFPF enables immediate weight-bearing with effective maintenance of coronal alignment, non-inferior reoperation rate, and a more reliable return to baseline ambulation.
Image: PD
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