Abstract

BACKGROUND Plantar fasciitis (PF) is the most common cause of heel pain and can be a source of extensive physical disability and financial burden. Platelet-rich plasma (PRP) offers a potentially definitive, regenerative treatment modality that, if effective, could change the current paradigm of PF care. However, randomized controlled trials (RCTs) on the clinical benefits of PRP for refractory PF offer inconsistent conclusions, potentially because of the broader limitations of using P value thresholds to declare statistical and clinical significance. In this study, we use the Continuous Fragility Index (CFI) and Quotient (CFQ) to appraise the statistical robustness of data from RCTs evaluating PRP for treatment of PF. METHODS RCTs comparing outcomes after PRP injection vs alternative treatment in patients with chronic PF were evaluated. Representative simulated data sets were generated for each reported outcome event using summary statistics. The CFI was determined by manipulating each data set until reversal of significance (α=0.05) was achieved. The corresponding CFQ was calculated by dividing the CFI by the sample size. RESULTS Of 259 studies screened, 20 studies (59 outcome events) were included in this analysis. From these simulations, the median CFI for all events was 9, suggesting that varying the treatment of 9 patients would be required to reverse trial significance. The corresponding CFQ was 0.177. Studies with reported P value <.05 were more statistically fragile (CFI=10, CFQ=0.122) than studies with reported P value >.05 (CFI=5, CFQ=0.179). Of 36 outcome events reporting lost to follow-up data, 10 events (27.8%) lost ≥9 patients. CONCLUSION Our findings suggest that, on average, the statistical fragility of RCTs evaluating PRP for nonoperative PF therapy is at least comparable to that of the sports medicine literature. However, several included studies had concerningly low simulated fragility scores. Orthopaedic surgeons may benefit from preferentially relying on studies with higher CFI and CFQ values when evaluating the utility of PRP for chronic PF in their own clinical practice. Given the importance of RCT data in clinical decision making, fragility indices could help give context to the stability of statistical findings. LEVEL OF EVIDENCE Level I, systematic review.

Abstract

BACKGROUND Randomized controlled trial (RCT) outcomes reaching statistical significance, frequently determined by P <.05, are often used to guide decision making. Noted lack of reproducibility of some RCTs has brought special attention to the limitations of this approach. In this meta-analysis, we assessed the robustness of RCTs evaluating platelet-rich plasma (PRP) for the treatment of chronic noninsertional Achilles tendinopathy (AT) by using fragility indices. METHODS The present study was a systematic review and meta-analysis of RCTs comparing outcomes after PRP injection vs alternative treatment in patients with AT. Representative data sets were generated for each reported continuous outcome event using summary statistics. Fragility indices refer to the minimal number of patients whose status would have to change from a nonevent to an event to turn a statistically significant result into a nonsignificant result, or vice versa. The fragility index (FI) and continuous FI (CFI) were determined for dichotomous and continuous outcomes, respectively, by manipulating each data set until reversal of significance (a=0.05) was achieved. The corresponding fragility quotient (FQ) and continuous FQ (CFQ) were calculated by dividing FI/CFI by sample size. RESULTS Of 432 studies screened, 8 studies (52 outcome events) were included in this analysis. The 12 dichotomous outcomes had a median FI of 4.5 (FQ: 0.111), and the 40 continuous outcomes had a median CFI of 5 (CFQ: 0.154). All 52 outcome events included lost-to-follow-up data, and 12 (23.1%) indicated a greater number of patients lost to follow-up than the FI or CFI. CONCLUSION Our findings suggest that RCTs evaluating PRP for AT therapy lack statistical robustness, because changing only a small number of events may alter outcome significance. LEVEL OF EVIDENCE Level II, therapeutic study.

Abstract

INTRODUCTION Platelet-rich plasma (PRP) is a commonly used therapeutic option for androgenetic alopecia (AGA). Evidence syntheses for the impact of PRP on AGA has been handicapped by non-standardized protocols for its administration. We quantitatively synthesized the evidence base to determine the relative efficacy of PRP regimens with different frequencies of administration. We defined frequency as a vector of the (i) number of sessions and (ii) time interval between the sessions. METHODS We systematically reviewed the peer-reviewed literature to obtain relevant data; we then conducted a multivariable meta-regression and network meta-analyses (NMAs). RESULTS Twenty-five trials met our eligibility criteria; 10 unique PRP regimens were ultimately identified for use in our analyses. Our NMAs produced surface under the cumulative ranking curve (SUCRA) values that corroborated the findings of our multivariable meta-regression. The frequency of PRP sessions, chemical activation, number of centrifugations, the age and sex of the patient, and the design of PRP administration (ie, whole-head vs split-scalp) are correlated with the efficacy of PRP insofar as the mean change in total hair density at 6 months from baseline. CONCLUSIONS For the most part, regimens’ SUCRA rankings and relative effects support that the efficacy of PRP administration increases when: (i) the number of sessions increases and (ii) the time interval between sessions decreases; we found that chemically-activated PRP (vs inactivated), double centrifugation (vs single), younger (vs older) age of treated patients, female (vs male) sex, and whole-head (vs split-scalp) administration is associated with improved PRP efficacy. Our approach rules out much confounding as the analysis of our outcome was exclusive to monotherapy at a singular timepoint. Our results may reconcile discrepant findings among previous studies and may be helpful in updating clinical practice guidelines. J Drugs Dermatol. 2022;21(9):943-952. doi:10.36849/JDD.6948.

Abstract

AIMS: To compare the efficacy of platelet-rich plasma (PRP) injection vs dry needling (DN) for management of trigger points in the masseter muscle in myofascial pain syndrome (MPS) patients. METHODS This randomized controlled trial included 30 clinically confirmed cases of myofascial trigger points (MTrPs) in the masseter muscle who were randomly and equally (1:1) assigned to the test (PRP) and control (DN) groups. Both groups were evaluated for pain (visual analog scale [VAS]), range of functional movements, need for pain medication, patient satisfaction (Likert scale), and sleep (VAS) at baseline and 2-week, 1-month, and 3-month follow-ups. VAS pain and Likert score were also obtained at 6-month intervals. RESULTS The use of PRP solution in MTrPs in MPS patients had a better effect on pain and patient satisfaction compared to DN. CONCLUSION PRP appears to be a more effective treatment modality compared to DN in the management of MTrPs in MPS patients.

Abstract

INTRODUCTION Contemporary published data present confounding results on use of PRF in soft- and hard-tissue healing in the oral cavity, and many authors have suggested for further studies to reach the definitive conclusion. AIM: Our main objective therefore was to evaluate soft-tissue healing and osseous regeneration (by using VIXWIN PRO software) in extraction sites of mandibular third molars with substantial sample size to understand the effect of PRF in bony defects. METHODOLOGY Sixty patients had their bilaterally impacted third molars (120 sites) extracted in the split mouth study, following which platelet-rich fibrin was placed in one of the sockets. Patients were followed up clinically and radiographically, and pain score, presence of infection, exudation of graft and VIXWIN PRO software were used to evaluate healing of soft tissue and bone. RESULT AND CONCLUSION Our study advocates the use of PRF for enhanced soft- and hard-tissue healing. Though the osseous regeneration could be differentiated in both the groups at second month interval only, pain scores were better with PRF at most instances. Subsequent phase to the research should include histopathological investigations for ancillary support.

Abstract

BACKGROUND Transurethral resection of the prostate (TURP) is the gold standard for benign prostatic enlargement; however, hemorrhage still remains one of the major complications. OBJECTIVE The primary aim of this study was to evaluate the effect of tranexamic acid (TXA) in reducing intraoperative blood loss and need for blood transfusion. Secondary parameters compared were operating time, volume of irrigation fluid used, and reduction in hemoglobin concentration. SUBJECTS AND METHODS A total of 70 eligible patients undergoing TURP were randomized based on computer generated table into two groups. The study group (1) received IV TXA 500 mg after induction of anesthesia and 500 mg in each irrigation fluid bottle (dual mode) and the control group (2) received none. RESULTS The mean age (68.20 vs. 66.5 years), prostate size (57 vs. 51 g), and preoperative hemoglobin (13.3 vs. 13.5 g/dl) were similar between the groups. Intraoperative blood loss in the TXA group was found to be significantly reduced (174.60 ± 125.38 ml vs. 232.47 ± 116.8; P = 0.04). Blood transfusion was required in 2.8% of cases as compared to 14.2% in controls. Operating time, volume of irrigation fluid, and postoperative reduction of hemoglobin were not significant between the groups. No complications were observed in both groups. CONCLUSION In this study, we observed that TXA, when used as a combination of Intravenous and topical route, effectively reduced intra-operative blood loss and the need for transfusion.

Abstract

BACKGROUND Diabetic foot ulcer (DFU) is well managed by infection control, euglycemic state, debridement of ulcer followed by appropriate dressing and off-loading of the foot. Studies have reported that when DFU is properly off-loaded, about 90% of these would heal in nearly six weeks. Platelet rich plasma (PRP) serves as a growth factor agonist and has mitogenic and chemotactic properties which help in DFU healing. To evaluate the efficacy of local application of PRP with respect to healing rate and ulcer area reduction in treating diabetic foot ulcer. MATERIALS AND METHODS Sixty non-infected DFU patients with plantar ulcer of size less than 20cm2 and Wagner's Grade 1 & 2 were randomized to receive normal saline dressing (Control group - CG) or PRP dressing (Study group - SG) in conjunction with total contact casting for 6 weeks (or till complete ulcer healing), whichever was earlier. Evaluation was done at weekly interval for healing rate and change in ulcer area. RESULTS Mean ulcer area of study participants at baseline was 4.96 {plus minus} 2.89cm2 (CG) and 5.22 {plus minus} 3.82cm2 (SG) (p=0.77) which decreased to 1.15{plus minus}1.35cm2 (CG) and 0.96{plus minus}1.53cm2 (SG) (p=0.432) at 6wks. Percent reduction in mean healing area at 6wks was 81.72{plus minus}17.2% and 85.98{plus minus}13.42% in control group and study group respectively (p=0.29). Average rate of healing achieved at 6 weeks was 0.64{plus minus}0.36cm2 and 0.71{plus minus}0.46cm2 in control group and study group respectively (p=0.734). CONCLUSIONS PRP dressing is no more efficacious than normal saline dressing in management of DFU in conjunction with total contact casting.

Abstract

BACKGROUND The use of platelet-rich plasma (PRP) combined with noninvasive, nonenergy procedures for atrophic acne scars has shown promise. To date, there has not been a systematic review or meta-analysis of the effectiveness of this therapy. AIMS To use meta-analysis to compare Goodman and Baron qualitative scores, patient satisfaction outcomes, and adverse effects in patients undergoing combination procedures with PRP, combination procedures without PRP, and noninvasive monotherapy without PRP in the treatment of patients with atrophic acne scars. PATIENTS/METHODS The Pubmed and Cochrane library databases were searched for relevant studies published before May 1, 2019. PRISMA guidelines were utilized. Studies that compared the use of PRP in combination with a noninvasive procedure and therapies without PRP for the treatment of atrophic acne scars were included. Cochrane's handbook was utilized to assess the individual biases of the included studies. Publication bias was assessed. RESULTS A total of 311 participants (153 whole-face participants and 158 split-face participants) were reviewed across eight included studies. Quantitative analysis of 241 participants across six included studies showed a statistically significant reduction in scar severity scores in favor of microneedling or subcision with PRP (P < .001). Combination therapy with intradermal or topical PRP was significantly more effective than monotherapy alone and combination therapy with an adjunct other than PRP (P < .001 and .001, respectively). CONCLUSION This systematic review and meta-analysis demonstrated that microneedling or subcision with PRP produced statistically significant improvement in validated outcomes over microneedling or subcision alone.

Abstract

OBJECTIVE To assess the effect of intravenous versus oral iron on hematologic indices and clinical outcomes for iron-deficiency anemia (IDA) in pregnancy. STUDY DESIGN Searches in Ovid Medline, Embase, SCOPUS, Cochrane Database, and ClinicalTrials.gov identified randomized-controlled trials comparing intravenous to oral iron for treating IDA in pregnancy. Primary outcomes were maternal hematologic indices at delivery. Secondary outcomes were blood transfusion, cesarean delivery, neonatal outcomes, and medication reactions. RESULTS Of 15,637 studies, 20 randomized trials met inclusion criteria and were analyzed. Mean hemoglobin at delivery (9 studies: WMD 0.66 g/dL (95% confidence Interval 0.31 -1.02 g/dL)) was significantly higher after intravenous iron therapy. Intravenous iron was associated with higher birthweight (8 studies: WMD 58.25 g (95% CI: 5.57-110.94 g)) but no significant differences in blood transfusion, cesarean delivery, or neonatal hemoglobin. There were fewer medication reactions with intravenous iron (21 studies: RR 0.34% (95% CI: 0.20-0.57)). CONCLUSION Intravenous iron therapy is associated with higher maternal hemoglobin at delivery with no difference in blood transfusion and fewer mild medication reactions.

Abstract

BACKGROUND Intravenous iron sucrose is a promising therapy for increasing haemoglobin concentration; however, its effect on clinical outcomes in pregnancy is not yet established. We aimed to assess the safety and clinical effectiveness of intravenous iron sucrose (intervention) versus standard oral iron (control) therapy in the treatment of women with moderate-to-severe iron deficiency anaemia in pregnancy. METHODS We did a multicentre, open-label, phase 3, randomised, controlled trial at four government medical colleges in India. Pregnant women, aged 18 years or older, at 20-28 weeks of gestation with a haemoglobin concentration of 5-8 g/dL, or at 29-32 weeks of gestation with a haemoglobin concentration of 5-9 g/dL, were randomly assigned (1:1) to receive intravenous iron sucrose (dose was calculated using a formula based on bodyweight and haemoglobin deficit) or standard oral iron therapy (100 mg elemental iron twice daily). Logistic regression was used to compare the primary maternal composite outcome consisting of potentially life-threatening conditions during peripartum and postpartum periods (postpartum haemorrhage, the need for blood transfusion during and after delivery, puerperal sepsis, shock, prolonged hospital stay [>3 days following vaginal delivery and >7 days after lower segment caesarean section], and intensive care unit admission or referral to higher centres) adjusted for site and severity of anaemia. The primary outcome was analysed in a modified intention-to-treat population, which excluded participants who refused to participate after randomisation, those who were lost to follow-up, and those whose outcome data were missing. Safety was assessed in both modified intention-to-treat and as-treated populations. The data safety monitoring board recommended stopping the trial after the first interim analysis because of futility (conditional power 1.14% under the null effects, 3.0% under the continued effects, and 44.83% under hypothesised effects). This trial is registered with the Clinical Trial Registry of India, CTRI/2012/05/002626. FINDINGS Between Jan 31, 2014, and July 31, 2017, 2018 women were enrolled, and 999 were randomly assigned to the intravenous iron sucrose group and 1019 to the standard therapy group. The primary maternal composite outcome was reported in 89 (9%) of 958 patients in the intravenous iron sucrose group and in 95 (10%) of 976 patients in the standard therapy group (adjusted odds ratio 0.95, 95% CI 0.70-1.29). 16 (2%) of 958 women in the intravenous iron sucrose group and 13 (1%) of 976 women in the standard therapy group had serious maternal adverse events. Serious fetal and neonatal adverse events were reported by 39 (4%) of 961 women in the intravenous iron sucrose group and 45 (5%) of 982 women in the standard therapy group. At 6 weeks post-randomisation, minor side-effects were reported by 117 (16%) of 737 women in the intravenous iron sucrose group versus 155 (21%) of 721 women in the standard therapy group. None of the serious adverse events was found to be related to the trial procedures or the interventions as per the causality assessment made by the trial investigators, ethics committees, and regulatory body. INTERPRETATION The study was stopped due to futility. There is insufficient evidence to show the effectiveness of intravenous iron sucrose in reducing clinical outcomes compared with standard oral iron therapy in pregnant women with moderate-to-severe anaemia. FUNDING WHO, India.