Abstract

Background and Objectives: To determine and compare the effects of the timing of oxytocin administration (routinely used for intraoperative uterotonic purposes in cesarean section (CS) deliveries in our clinic) on the severity of postpartum hemorrhage following CS. Materials and Methods: All study participants (n = 216) had previous cesarean deliveries, were 38-40 weeks pregnant, and had CS planned under elective conditions. The cases were randomly divided into two groups: one group (n = 108) receiving oxytocin administration before the removal of the placenta (AOBRP) and another group (n = 108) receiving oxytocin administration after the removal of the placenta (AOARP). In all cases, the placenta was removed using the manual traction method. The standard dose of oxytocin is administered as an intravenous (IV) push of 3 international units (IU); simultaneously, 10 IU of oxytocin is added to 1000 cc isotonic fluid and given as an IV infusion at a rate of 250 cc/h. All methods and procedures applied to both groups were identical, except for the timing of administration of the standard oxytocin dose. Age, body mass index (BMI), parity, gestational week, preoperative hemoglobin (HB) and hematocrit (HTC), postoperative 6th and 24th hour HB-HTC, intraoperative hemorrhage, additional uterotonic need during cesarean section, postoperative hemorrhage (number of pads), need for blood transfusion during or after cesarean section, cesarean section time, and postpartum newborn baby weight were evaluated. Results: Age (year), BMI (kg/m(2)), parity, gestational week, surgical time, and newborn weight (g) did not differ between the groups (p > 0.05). The AOBRP group had significantly higher postoperative 6th hour HB and HTC and postoperative 24th hour HB and HTC values (p < 0.05). The intraoperative hemorrhage level was higher in the AOARP group (p = 0.000). Conclusions: The administration of oxytocin before placenta removal did not change the volume of bleeding in the postoperative period but significantly reduced the volume of bleeding in the intraoperative period. Therefore, in the postoperative period, the HB and HTC values of the AOBRP group were higher than those of the AOARP group.

Abstract

BACKGROUND Blood operators screen donors to reduce the risk of transfusion-transmitted infections (TTIs). Many are evolving screening procedures from those that defer all who have had a sexual interaction with gay, bisexual, or other men who have sex with men (gbMSM) to an approach that assesses individual donors' recent sexual risk behavior with any partner. STUDY DESIGN AND METHODS A representative sample of current blood donors (N = 1194) was recruited online and randomized to complete either the existing (at the time of the study) Canadian Blood Services' donor questionnaire (DQ) that screens out those with recent gbMSM sexual experience, a modified donor questionnaire (MDQ) that assesses individuals' recent sexual behavior with any partner, or an MDQ that assesses individual sexual behavior with any partner and explains why these questions are asked. Respondents were asked for their perceptions concerning difficulty, comfort, and acceptability of these screening questionnaires. RESULTS Across experimental conditions, current donors regarded screening questionnaire difficulty to be low; discomfort in responding was minimal; screening questionnaires were perceived to be relatively inoffensive and justified, and very few donors would cease donating if the screening questionnaire they responded to became the one in general use. Some minor sex differences were observed, and in some cases, perceptions of the MDQ with explanation were somewhat more positive than those of the DQ and MDQ without explanation. DISCUSSION An individual risk behavior screening approach appears to be acceptable to current blood donors as an alternative to screening out all who have recently engaged in gbMSM sexual interactions.

Abstract

BACKGROUND It has been shown that ferric carboxymaltose (FCM) improves symptoms and quality of life in iron-deficient patients with heart failure (HF). AIM: We aimed to systematically review studies conducted on the cost-effectiveness of FCM compared to placebo in iron-deficient patients with HF. METHOD We searched PubMed, EMBASE, Scopus, and Web of Science to find the relevant studies. After removing duplicates, two authors independently evaluated the titles, abstracts, and full texts. We included studies that investigated the full economic evaluations of FCM in HF patients with iron deficiency (cost-effectiveness analysis, cost-utility analysis, and cost-benefit analysis) and used the CHEERS tool to evaluate the quality of the studies. RESULTS Seven studies were included which evaluated the economic analysis of treatments with FCM in iron-deficient patients with HF. The CHEERS scores for most of the studies (n = 6) were 0.77 or higher (very good quality). The lowest incremental cost-effectiveness ratio (ICER) per quality-adjusted life years (QALY) of FCM ($1801.96) was from Italy, and the highest ICER per QALY of FCM ($25,981.28) South Korea. Results of the studies showed that FCM, compared to placebo, was cost-effective in iron-deficient patients with HF. CONCLUSION FCM is a cost-effective treatment for iron-deficient patients with HF. Considering the fact that all the included studies in the present systematic review took place in high-income countries, we recommend further studies investigating the cost-effectiveness of FCM in low- and middle-income countries.

Abstract

BACKGROUND Osteonecrosis of the jaw (ONJ) has a frequent adverse effect after the administration of nitrogenous bisphosphonates, as non-nitrogenous bisphosphonates are metabolized more rapidly and would produce this effect to a lesser extent. The objective of this study is to analyze the results obtained in the literature with the use of L-PRF in the treatment of ONJ through a systematic review and meta-analysis. MATERIAL AND METHODS Medline (via PubMed), Cochrane, Web of Science and Grey Literature Database was screened from which 10 were selected. RESULTS In the meta-analysis with full resolution, combining the use of L-PRF in the treatment of ONJ, a weighted proportion (PP) of 94.3% of complete resolution is obtained (95% CI: 91.2-97.4, p<0.001), with a low degree of heterogeneity, statistically significant (I2 = 29.02%; p<0.001). When analyzing the non-resolution data, a weighted proportion (PP) of 7.7% (95% CI: 3.6-11.9; p<0.001) was obtained with moderate heterogeneity (I2: 41.87%; p=0.112). In the meta-regression, no significant correlation was found between complete resolution and year of publication (intercept = 2.88, p=0.829). In consistency analysis no major changes in PP are identified when any of the studies are eliminated, demonstrating a high reliability in the combined results. CONCLUSION L-PRF alone or in combination with other therapies in treatment of ONJ achieved high percentages of complete lesion resolution (94.3%). In studies where L-PRF is combined with other therapies, and where the effectiveness of the other therapy alone is analyzed, L-PRF has been shown higher percentages of resolution.

Abstract

PURPOSE To evaluate the role of platelet-rich plasma (PRP) for adhesive capsulitis (AC) as compared to other injectables. METHODS A literature search was performed on PubMed and Embase online databases identifying articles evaluating injection therapy for the treatment of AC. Inclusion criteria included prospective studies comparing PRP against alternative injectables with a minimum 15 patients in each treatment arm and a minimum 12-week follow-up. Pain scores, range of motion, and function scores were the primary outcomes assessed. RESULTS Five articles met inclusion criteria comparing PRP to corticosteroid or saline injections. There were 157 patients treated with PRP with follow-up duration ranging from three to six months. All five studies demonstrated statistically significant improvement in pain scores, motion, and function scores for patients receiving PRP, corticosteroid, and saline injections. However, PRP was consistently superior on intergroup analyses in all but one study. In four studies, pain and function scores favored PRP over control at final follow-up (range in mean difference for VAS pain score: -2.2 - 0.69, n=5 and SPADI score: -50.5 - -4.0, n=3) while three studies found greater improvement in shoulder motion after PRP (range in mean difference for forward flexion: 0.7 - 34.3 degrees and external rotation -2.3 - 20.4 degrees, n=4). One study found no significant difference between PRP and corticosteroid injections, but noted results were comparable. CONCLUSIONS According to a limited number of prospective studies, PRP injections for AC is at least equivalent to corticosteroid or saline injections and often leads to improved pain, motion, and functional outcomes at 3-6-month follow-up. Given the small number of studies, with design heterogeneity, there is insufficient evidence to routinely recommend PRP for AC. However, the results are promising and do support considering PRP as an adjunct treatment option for AC, especially for patients refractory and/or averse to corticosteroids or alternative treatment modalities.

Abstract

BACKGROUND Industry funding and corporate sponsorship have played a significant role in the advancement of orthopaedic research and technology. However, this relationship raises concerns for how industry association may bias research findings and influence clinical practice. PURPOSE To determine whether industry affiliation plays a role in the outcomes of randomized controlled trials (RCTs) investigating platelet-rich plasma (PRP). STUDY DESIGN Meta-analysis; Level of evidence, 2. METHODS A search of the PubMed, Cochrane, and MEDLINE databases for RCTs published between 2011 and the present comparing PRP versus hyaluronic acid, corticosteroid, or placebo for the treatment of knee osteoarthritis was performed. To determine industry affiliation, the conflict of interest, funding, and disclosure sections of publications were assessed, and all authors were assessed through the American Academy of Orthopaedic Surgeons disclosure database and the Centers for Medicare & Medicaid Services open payments database. Studies were classified as industry affiliated (IA) or non-industry affiliated (NIA). The outcomes of each study were rated as favorable, analogous, or unfavorable according to predefined criteria. RESULTS A total of 37 studies (6 IA and 31 NIA) were available for analysis. Overall, 19 studies (51.4%) reported PRP as favorable compared with other treatment options, while 18 studies (48.6%) showed no significant differences between PRP and other treatment methods. There was no significant difference in qualitative conclusions between the IA and NIA groups, with the IA group having 3 favorable studies and 3 analogous studies and the NIA group having 16 favorable studies and 15 analogous studies (P = .8881). When comparing IA versus NIA studies using 6- and 12-month Western Ontario and McMaster Universities Arthritis Index and International Knee Documentation Committee scores, there were no significant differences in outcomes. CONCLUSION The results of this study demonstrated that qualitative conclusions and outcome scores were found to not be associated with industry affiliation. Although the results of this study suggest that there is no influence of industry involvement on RCTs examining PRP, it is still necessary to carefully evaluate pertinent commercial affiliations when reviewing recommendations from studies before adopting new treatment approaches, such as the use of PRP for knee osteoarthritis.

Abstract

PURPOSE Temporomandibular joint (TMJ) sub-luxation can have a significant psycho-social impact on a patients' well-being. Several treatment modalities have been described in the literature for the same. The present study was undertaken to investigate the efficacy of heavy bupivacaine-dextrose prolotherapy (HDP) for the peri-articular tissues, superior joint space and the retro-discal area in the patients with symptomatic chronic sub-luxation. MATERIALS AND METHODS A preliminary clinical study was conducted among 60 patients diagnosed with chronic painful sub-luxation of the TMJ. Patients were divided into control group (CG), n = 30, where autologous blood was injected in the superior joint space, peri-capsular tissues and retro-discal area bilaterally as per the predetermined protocol; and the study group (SG), n = 30 patients were administered heavy bupivacaine-dextrose injection bilaterally in the peri-articular tissues, superior joint space and retro-discal area. The efficacy of the treatment was evaluated by assessing pain, maximum inter-incisal opening (MIO), changes in computed tomography scan, magnetic resonance imaging study, number and need for subsequent injections in both the groups. RESULT Among the 60 patients, majority of the patients exhibited successful outcome after both the interventions, ABI and HDP. There was statistically significant reduction in recorded pain score with reduced MIO post-treatment. No morphological changes were noted in the condyle in both the groups. No complications were recorded among the study population. CONCLUSION HDP is a safe and simple modality for treating symptomatic sub-luxation with predictable clinical outcome. Heavy bupivacaine-dextrose can be considered as a prolotherapeutic agent for symptomatic chronic temporomandibular joint sub-luxation with the pharmacological benefit of local anaesthesia and proliferent delivery through the same injection.

Abstract

BACKGROUND Over the past few years, many studies have been conducted to evaluate the effectiveness of platelet-rich plasma (PRP) in treating musculoskeletal conditions. However, there is controversy about its benefits for patients with Achilles tendinopathy. OBJECTIVE This study aimed to investigate whether platelet-rich plasma injections can improve outcomes in patients with Achilles tendinopathy. METHODS A comprehensive literature search was conducted in PubMed, Embase, Cochrane Library, Web of Science, China Biomedical CD-ROM, and Chinese Science and Technology Journal databases to identify randomised controlled clinical trials that compared the efficacy of PRP injection in patients with Achilles tendinopathy (AT) versus placebo, published between 1 January 1966 and 1 December 2022. Review Manager 5.4.1 software was used for the statistical analysis, and the Jadad score was used to assess the included literature. Only 8 of the 288 articles found met the inclusion criteria. RESULTS Our work suggests that: The PRP treatment group had a slightly higher VISA-A score than the placebo group at 6 weeks [MD = 1.92, 95% CI (-0.54, 4.38), I(2) = 34%], at 12 weeks [MD = 0.20, 95% CI (-2.65 3.05), I(2) = 60%], and 24 weeks [MD = 2.75, 95% CI (-2.76, 8.26), I(2) = 87%]). However, the difference was not statistically significant. The Achilles tendon thickness was higher at 12 weeks of treatment in the PRP treatment group compared to the control group [MD = 0.34, 95% CI (-0.04, 0.71), p = 0.08], but the difference was not statistically significant. The VAS-improvement results showed no significant difference at 6 and 24 weeks between the two groups, respectively (MD = 6.75, 95% CI = (-6.12, 19.62), I(2) = 69%, p = 0.30), and (MD = 10.46, 95% CI = (-2.44 to 23.37), I(2) = 69%, p = 0.11). However, at 12 weeks of treatment, the PRP injection group showed a substantial VAS improvement compared to the control group (MD = 11.30, 95% CI = (7.33 to 15.27), I(2) = 0%, p < 0.00001). The difference was statistically significant. The return to exercise rate results showed a higher return to exercise rate in the PRP treatment group than the placebo group [RR = 1.11, 95% CI (0.87, 1.42), p = 0.40]; the difference was not statistically significant. CONCLUSION There is no proof that PRP injections can enhance patient functional and clinical outcomes for Achilles tendinopathy. Augmenting the frequency of PRP injections may boost the outcomes, and additionally, more rigorous designs and standardised clinical randomised controlled trials are needed to produce more reliable and accurate results.

Abstract

Hydroxyurea and low dose thalidomide are low-cost, easily accessible Hb F inducing agents that have been found to decrease transfusion dependency among transfusion-dependent thalassemia patients. However, these drugs have not much been explored in a randomized controlled setting. The objective of this study was to determine the efficacy and safety of hydroxyurea and low dose thalidomide in adult transfusion dependent β thalassemia. A total of 39 transfusion dependent β thalassemia patients were randomized into three arms: Arm A (Hydroxyurea 500 mg/day), Arm B (thalidomide 50 mg/day), and Control Arm. The primary outcome was rise in haemoglobin at 24-weeks from the baseline levels. The mean age of the cohort was 26.9 ± 4.7 years. Total 13 patients (33.3%) were splenectomised. The mean rise of haemoglobin at the end of 24 weeks was 0.18 ± 0.645 g/dl, 0.56 ± 1.343 g/dl, and - 0.31 ± 0.942 g/dl in Arm A, Arm B and control arm, respectively, p = 0.127. The mean volume of blood transfused per unit body weight in 24 weeks was significantly less in the thalidomide arm compared with the control arm (p = 0.035). Abdominal pain (Grade 1-2, 23.1%) and pruritus (Grade 1, 15.4%) were the main adverse events in hydroxyurea arm, whereas somnolence was the main side effect noted in the thalidomide arm (Grade 1-2, 78.3%). Single agent hydroxyurea or thalidomide is ineffective in increasing haemoglobin and decreasing transfusion burden among majority of the adult transfusion dependent thalassemia patients. SUPPLEMENTARY INFORMATION The online version contains supplementary material available at 10.1007/s12288-022-01620-3.

Abstract

BACKGROUND Non-transfusion-dependent β-thalassaemia (NTDβT) is a subset of inherited haemoglobin disorders characterised by reduced production of the β-globin chain of haemoglobin leading to anaemia of varying severity. Although blood transfusion is not a necessity for survival, it may be required to prevent complications of chronic anaemia, such as impaired growth and hypercoagulability. People with NTDβT also experience iron overload due to increased iron absorption from food sources which becomes more pronounced in those requiring blood transfusion. People with a higher foetal haemoglobin (HbF) level have been found to require fewer blood transfusions, thus leading to the emergence of treatments that could increase its level. HbF inducers stimulate HbF production without altering any gene structures. Evidence for the possible benefits and harms of these inducers is important for making an informed decision on their use. OBJECTIVES To compare the effectiveness and safety of the following for reducing blood transfusion for people with NTDβT: 1. HbF inducers versus usual care or placebo; 2. single HbF inducer with another HbF inducer, and single dose with another dose; and 3. combination of HbF inducers versus usual care or placebo, or single HbF inducer. SEARCH METHODS We used standard, extensive Cochrane search methods. The latest search date was 21 August 2022. SELECTION CRITERIA We included randomised controlled trials (RCTs) or quasi-RCTs comparing single HbF inducer with placebo or usual care, with another single HbF inducer or with a combination of HbF inducers; or comparing different doses of the same HbF inducer. DATA COLLECTION AND ANALYSIS We used standard Cochrane methods. Our primary outcomes were blood transfusion and haemoglobin levels. Our secondary outcomes were HbF levels, the long-term sequelae of NTDβT, quality of life and adverse events. MAIN RESULTS We included seven RCTs involving 291 people with NTDβT, aged two to 49 years, from five countries. We reported 10 comparisons using eight different HbF inducers (four pharmacological and four natural): three RCTs compared a single HbF inducer to placebo and seven to another HbF inducer. The duration of the intervention lasted from 56 days to six months. Most studies did not adequately report the randomisation procedures or whether and how blinding was achieved. HbF inducer against placebo or usual care Three HbF inducers, HQK-1001, Radix Astragali or a 3-in-1 combined natural preparation (CNP), were compared with a placebo. None of the comparisons reported the frequency of blood transfusion. We are uncertain whether Radix Astragali and CNP increase haemoglobin at three months (mean difference (MD) 1.33 g/dL, 95% confidence interval (CI) 0.54 to 2.11; 1 study, 2 interventions, 35 participants; very low-certainty evidence). We are uncertain whether Radix Astragali and CNP have any effect on HbF (MD 12%, 95% CI -0.74% to 24.75%; 1 study, 2 interventions, 35 participants; very low-certainty evidence). Only medians on haemoglobin and HbF levels were reported for HQK-1001. Adverse effects reported for HQK-1001 were nausea, vomiting, dizziness and suprapubic pain. There were no prespecified adverse effects for Radix Astragali and CNP. HbF inducer versus another HbF inducer Four studies compared a single inducer with another over three to six months. Comparisons included hydroxyurea versus resveratrol, hydroxyurea versus thalidomide, hydroxyurea versus decitabine and Radix Astragali versus CNP. No study reported our prespecified outcomes on blood transfusion. Haemoglobin and HbF were reported for the comparison Radix Astragali versus CNP, but we are uncertain whether there were any differences (1 study, 24 participants; low-certainty evidence). Different doses of the same HbF inducer Two studies compared two different types of HbF inducers at different doses over two to six months. Comparisons included hydroxyurea 20 mg/kg/day versus 10 mg/kg/day and HQK-1001 10 mg/kg/day, 20 mg/kg/day, 30 mg/kg/day and 40 mg/kg/day. Blood transfusion, as prespecified, was not reported. In one study (61 participants) we are uncertain whether the lower levels of both haemoglobin and HbF at 24 weeks were due to the higher dose of hydroxyurea (haemoglobin: MD -2.39 g/dL, 95% CI -2.80 to -1.98; very low-certainty evidence; HbF: MD -10.20%, 95% CI -16.28% to -4.12%; very low-certainty evidence). The study of the four different doses of HQK-1001 did not report results for either haemoglobin or HbF. We are not certain if major adverse effects may be more common with higher hydroxyurea doses (neutropenia: risk ratio (RR) 9.93, 95% CI 1.34 to 73.97; thrombocytopenia: RR 3.68, 95% CI 1.12 to 12.07; very low-certainty evidence). Taking HQK-1001 20 mg/kg/day may result in the fewest adverse effects. A combination of HbF inducers versus a single HbF inducer Two studies compared three combinations of two inducers with a single inducer over six months: hydroxyurea plus resveratrol versus resveratrol or hydroxyurea alone, and hydroxyurea plus l-carnitine versus hydroxyurea alone. Blood transfusion was not reported. Hydroxyurea plus resveratrol may reduce haemoglobin compared with either resveratrol or hydroxyurea alone (MD -0.74 g/dL, 95% CI -1.45 to -0.03; 1 study, 54 participants; low-certainty evidence). We are not certain whether the gastrointestinal disturbances, headache and malaise more commonly reported with hydroxyurea plus resveratrol than resveratrol alone were due to the interventions. We are uncertain whether hydroxyurea plus l-carnitine compared with hydroxyurea alone may increase mean haemoglobin, and reduce pulmonary hypertension (1 study, 60 participants; very low-certainty evidence). Adverse events were reported but not in the intervention group. None of the comparisons reported the outcome of HbF. AUTHORS' CONCLUSIONS We are uncertain whether any of the eight HbF inducers in this review have a beneficial effect on people with NTDβT. For each of these HbF inducers, we found only one or at the most two small studies. There is no information on whether any of these HbF inducers have an effect on our primary outcome, blood transfusion. For the second primary outcome, haemoglobin, there may be small differences between intervention groups, but these may not be clinically meaningful and are of low- to very low-certainty evidence. Data on adverse effects and optimal doses are limited. Five studies are awaiting classification, but none are ongoing.