Safety Of Oral Tranexamic Acid Research Articles

A Randomized Study to Evaluate the Efficacy of Oral Tranexamic Acid, Modified Kligman's Formula, and Placebo Cream in Melasma.

Despite the availability of various treatment modalities, the treatment of melasma is often incomplete, with a high recurrence rate. The present study was undertaken to assess the efficacy and safety of oral tranexamic acid (TXA), modified Kligman's formula (MKF), and a placebo cream in melasma. Ninety cases of melasma of both sexes were enrolled, and divided into three groups of 30 patients each. The baseline severity of melasma was graded by Melasma Area Severity Index (MASI) score. Group A, B, and C patients were treated with oral TXA 250 mg twice daily, daily MKF cream at night, and daily placebo cream at night, respectively, for 12 weeks. Improvement in MASI score was calculated after 4, 8, and 12 weeks. At each visit, adverse effects, if any, were noted. Statistical analysis was done using Chi-square test. Based on intention to treat analysis, at the end of 12 weeks, the reduction in MASI score in oral TXA, MKF, and placebo groups was 9.94(65.91%), 6.12(54.78%), and 2.07(17.22%), respectively (P = 0.00). The difference in reduction of mean MASI scores after 12 weeks between oral TXA group and MKF group was not significant (P = 0.29). The efficacy of oral TXA and MKB was significantly higher than that of the placebo group (P = 0.01 and P = 0.03, respectively). Adverse effects in all groups were mild and self-limiting. A limited sample size, non-blinded design, and absence of dermoscopic evaluation were the study limitations. In view of its excellent safety profile, oral TXA may be considered as a better option for moderate to severe melasma.

Assessing the efficacy of oral tranexamic acid as an adjuvant to triple combination topical treatment in melasma: a meta-analysis of randomized controlled trials

Abstract Melasma is a skin pigmentation disorder that lacks consistent treatment success, despite various methods used. Tranexamic acid (TXA) has shown hypopigmentation properties, but whether its administration should be combined with standard treatment has yet to be clarified. We aimed to perform an investigation of the effectiveness and safety of oral TXA as an adjuvant to triple combination cream (TCC) treatment in melasma. We searched PubMed, Embase and Cochrane (CENTRAL) for studies that compared TCC + adjuvant TXA to TCC treatment alone in patients with melasma. Outcomes of interest included change from the baseline Melasma Area and Severity Index (MASI) score, recurrence of melasma and adverse events. Statistical analysis was performed using R Studio 4.3.2. Four trials involving 490 patients were included. In the pooled analysis, the decrease from baseline in MASI score [mean difference –3.10, 95% confidence interval (CI) –5.85 to –0.35] was significantly higher in patients treated with oral TXA as an adjuvant to TCC compared with TCC alone. Melasma recurrence [risk ratio (RR) 0.28; 95% CI 0.16–0.49] was significantly lower in the group treated with TCC and TXA. Regarding erythema (RR 0.63, 95% CI 0.34–1.17) and burning (RR 0.59, 95% CI 0.30–1.17), no statistically significant difference was found. This meta-analysis demonstrated statistically significant benefits of TCC + TXA combination treatment compared with TCC alone. Furthermore, the results suggest that the addition of TXA to TCC treatment may reduce melasma recurrence.

Efficacy and safety of the combination of oral tranexamic acid and intense pulsed light versus oral tranexamic acid alone in the treatment of refractory Riehl's melanosis: A prospective, comparative study.

There is no standardized and effective treatment modality for Riehl's melanosis. To compare the efficacy and safety of oral tranexamic acid (TXA) combined with intense pulsed light (IPL) versus TXA alone in the treatment of refractory Riehl's melanosis. A prospective study of 28 subjects with refractory Riehl's melanosis and Fitzpatrick Skin Types III or IV was conducted. All subjects received oral TXA 500 mg daily and 11 of them were treated in combination with monthly IPL therapy for 6 months. The primary outcome measure was mean melanin index (MI), erythema index (EI) and acquired dermal macular hyperpigmentation area and severity index (DPASI). The Physician Global Assessment (PGA) and patient satisfaction scale were documented. After treatment, DPASI, mean MI, and EI were significantly reduced in both groups. The group treated with combination therapy showed better improvement according to MI (p = 0.0032) and DPASI (p = 0.00468). PGA and patient satisfaction scale showed superior efficacy in the combination group. No significant difference was observed in treatment-related side effects. The combination of oral TXA and IPL proves to be a safe and satisfactory treatment strategy for refractory Riehl's melanosis.

Oral tranexamic acid with a triple combination cream versus oral tranexamic acid monotherapy in the treatment of severe melasma.

Melasma is an acquired pigmentation disorder with a complex multifactorial etiopathogenesis. Oral tranexamic acid (TA) is a promising drug for its treatment and may enhance outcomes when used in combination. To provide evidence of the efficacy and safety of oral TA as a monotherapy, and in combination with a triple combination cream, for treating melasma in the Hispanic population. Forty-four female Hispanic patients with melasma were randomly assigned to receive 325mg of oral TA every 12h plus f-TCC (fluocinolone-based triple combination cream) every 24h (group A) or 325mg of oral TA every 12h (group B) for 8weeks, after which both groups were crossed-over, and treated for an additional 8weeks. Evaluations of the mMASI score, the melanin index, and the MelasQoL were made at baseline and Weeks 4, 8, 12, and 16. There was a 50.04% and 65.45% improvement in mMASI at Weeks 4 and 8, respectively, in group A, compared to baseline, while for Week 16, an improvement of 76.85% was achieved in group B compared to baseline. Highest scores were consistent with the use of the combined treatment modality in both groups, and were evidenced by the values of the melanin index obtained. There was no significant difference in MelasQoL scores between the 2groups. No serious side effects were observed. The combination of oral TA and f-TCC is more effective than oral TA alone in the treatment of severe melasma in Hispanic patients.

Role of Oral Tranexamic Acid in Treating Patients of Melasma in A Charity Hospital of Lahore

Objective: To evaluate the efficacy and safety of oral tranexamic acid (TA) in the treatment of melasma Method: This was a descriptive, cross sectional study which was performed in department of dermatology in Akhtar Saeed Trust Hospital, Lahore from April till December 2019. 70 patients of moderate to severe melasma were enrolled regardless of gender, > 18 years of age. 250 mg oral TA was given BD for 3 months along with broad spectrum topical sunscreen. Follow up done on monthly basis, 2 months after stopping the treatment. Photographs were taken at first visit & MASI (melasma area severity index) scoring done at start & after 3 months of treatment. Side effects were noted down if present. Results were recorded & analysed using SPSS. Results: A total of 70 patients were enrolled, 44 females and 26 males. Mean age of patients was 30.7. There was a significant decrease mean 3.4 in MASI scoring at 12 wks of treatment. 25 patients had good, 22 had fair, 7 had fair response to TA. No serious side effects were noted at end of treatment. No reversal of melasma was recorded at 2 months after stopping treatment. Conclusion: Oral tranexamic acid is a quick & effective treatment of patients of melasma. Key words: Melasma, tranexamic acid, treatment.

Comparing the Effectiveness of Oral Formulation of Tranexamic Acid in Treating Melasma versus Topical Treatmentlike Kojic Acid

Aim: To compare the efficacy and safety of oral tranexamic acid with topical kojic acid in treatment of melasma. Method: This study was an interventional, randomized control trial done in Department of Dermatology Akhtar Saeed Trust Hospital Lahore from January 2020 till June 2020. 40 patients with moderate to severe melasma were enrolled for this study. These were divided into two groups A and B. In group A 20 patients were given oral tranexamic acid along with topical treatment and in group B, 20 patients were treated only with topical treatment. Oral tranexamic acid was given in dosage of 250 mg twice a day for 3 months and then follow-up was done at 8th and 12th wks. The evaluation of effectiveness of treatment was done with MASI(Melasma Area Severity Index). Comparison was done in the mean of the MASI scores obtained in both groups. Result: In both groups female patients were more in number. The mean age of patients in group A was 29.75 years & in group B it was 32.55 years. MASI scoring was done in both groups at baseline and at 8th& 12th wks. There was a significant decrease in this score in group A patients with oral tranexamic acid (12.08±2.8 vs 9.1±2.2 at 8th wk. andvs 8.2±2.0 at 12thwk.; P <0.05for both). Whereas in group B patients the decrease in mean MASI score was significant at 8thwk.& insignificant at 12th wk. (12.6±2.9 vs 10.9±2.4at 8th wk. and vs 10.3±2.4at 12th wk.; p<0.05 for former but p>0.05 for later). Conclusion: Oral tranexamic acid is a safe and effective treatment modality for treating moderate to severe melasma. Keywords: Melasma, oral tranexamic acid

Oral tranexamic acid, hydroquinone 4% and low-fluence 1064 nm Q-switched Nd:YAG laser for mixed melasma: Clinical and dermoscopic evaluation.

Tranexamic acid (TA) can prevent melanocyte activation by various stimuli. Combining TA with either hydroquinone 4% or Q-switched Nd:YAG laser may be associated with greater improvement of melasma. We aimed to evaluate the efficacy and safety of oral TA alone and combined with either topical hydroquinone 4% or low-fluence 1064nm Q-switched Nd:YAG laser in treatment of mixed melasma. Patients were randomly divided into three groups of 20 patients each. Group A were treated with oral TA 250mg twice daily for three months; group B were treated with TA similarly combined with topical hydroquinone 4% cream; group C were treated with TA combined with two sessions of 1064nm low-fluence Q-switched ND:YAG laser (850-1200mJ/cm2 , 4-5Hz,spot size 4mm) spaced 4weeks apart. Patients were followed monthly for 9months. After cessation of therapy, the mean mMASI score was lowest in group B (2.34±2.37) followed by groups A (6.38±4.04) and C (7.24±4.95).Mean percentage of mMASI score improvement was 35.91±24.13, 77.47±19.07, and 24.94±27.79 in groups A, B, and C (p<0.001). There was a significant reduction of telangiectasia in the three groups. Reported side effects were itching & irritation, post-inflammatory hyperpigmentation, and gastritis. Oral TA is a tolerable effective treatment modality for melasma. Combining hydroquinone 4% with oral TA is associated with a relatively earlier and better cosmetic outcome.

Efficacy and safety of oral tranexamic acid as an adjuvant in Indian patients with melasma: a prospective, interventional, single-centre, triple-blind, randomized, placebo-control, parallel group study.

Melasma is a chronic recalcitrant pigmentary disorder whose treatment frustrates physician and patient alike. Tranexamic acid, a plasmin inhibitor, has demonstrated hypopigmenting properties. To compare safety and efficacy of combination of oral tranexamic acid (TXA) and topical fluocinolone-based combination cream (FbTC) with that of topical FbTC alone in melasma. One hundred and eighty patients patients of facial melasma of either sex attending dermatology OPD were screened. Consenting 130 participants were randomized into two blinded groups with 65 patients in each group. Group A patients received oral tranexamic acid 250mg and oral ranitidine 150mg twice daily and applied a triple combination cream containing fluocinolone acetonide 0.01%, tretinoin 0.05% and hydroquinone 2% once daily, and Group B was asked to take placebo tablets (calcium lactate and multivitamin) and apply the cream only for 12weeks. Response was evaluated using modified melasma area severity index (mMASI) and graded mMASI improvement at 4th, 8th and 12th weeks, and at 24th week for recurrence. Data were analysed using SPSS software. Results were analysed in 120 patients who completed the study with 61 and 59 patients in group A and B, respectively. Demographic profile was equally distributed in both the groups. In group A, 13.1% patients showed marked improvement (>75%) in mMASI as compared to group B (1.7%) at 4th week. By 12th week, 65.6% patients had marked improvement in group A in contrast to only 27.1% in group B. At 24th week, group A (65.6%) had sustained improvement as compared to group B (11.9%) despite stopping treatment; all of which were statistically significant. Recurrence observed was 18.03% in group A vs. 64.4% in group B at 24th week. Oral tranexamic acid is definitely a boon to the armamentarium of melasma management and should be used as an adjuvant to fluocinolone-based triple combination cream for a faster, sustained improvement and to prevent recurrence.

Comparison of oral and intravenous tranexamic acid in total hip arthroplasty: a systematic review and meta-analysis

BackgroundTotal hip arthroplasty is associated with substantial blood loss which can lead to postoperative anemia. The purpose of this systematic review and meta-analysis was to compare efficacy and safety of oral tranexamic acid (TXA) and intravenous TXA.MethodsPubMed, EMBASE, and Cochrane Library were searched from inception until December 2019. A combined searching strategy of subject words and random words was adopted. Only clinical randomized controlled trials were included. The comparisons were made with regard to total blood loss, hemoglobin drop, transfusion rate, and postoperative thromboembolic complications including deep vein thrombolism (DVT) and pulmonary embolism (PE). The meta-analysis was conducted by using the Review Manager 5.3, and bias evaluation was performed based on the Cochrane Handbook 5.1.0.ResultsIn this meta-analysis, five randomized controlled trials were included. The results showed that there were no significant differences between the oral TXA group and intravenous TXA group concerning total blood loss [mean difference (MD) =3.01, 95% confidence interval (95% CI): − 43.90 to 49.92, p = 0.90], hemoglobin drop (MD = 0.05, 95% CI: − 0.10 to 0.20, p = 0.50) and transfusion rate of allogeneic blood [risk ratio (RR) =1.09, 95% CI: 0.46 to 2.62, p = 0.84]. No significant difference was found in the incidence of thromboembolic events (RR = 1.71, 95% CI: 0.71 to 4.16, p = 0.97).ConclusionsCompared with intravenous TXA, oral TXA is equally able to reduce total blood loss, hemoglobin drop, and transfusion requirement for total hip arthroplasty. It is a lower-cost method that does not increase the incidence of thromboembolic events.

Comparing Efficacy and Safety of Oral Tranexamic Acid and 4% Topical Hydroquinone Cream in Melasma Treatment: A Randomized Controlled Clinical Trial and Review of Literature

Abstract Introduction. Melasma is a common skin pigmentation disorder affecting a patient’s life psychologically and socially. Topical medications or lasers can have temporary and limited therapeutic effects on melasma. Material and Methods. This study is a prospective clinical trial comparing therapeutic effects of oral Tranexamic acid (TXA) and topical Hydroquinone (HQ) cream. A total number of 69 patients were examined. During the study, 10 patients failed to appear for the follow-up and 59 of them completed the trial. The patients were also divided randomly into two groups. Group A received TXA capsule 250 mg every 12 hours and group B received 4% topical HQ cream day and night. The patients from both groups were treated for 3 months. Melasma Area and Severity Index (MASI) scores were then calculated at the baseline, 4 weeks, and 12 weeks into the treatment and 3 months after the end of intervention. Results. MASI baseline, 4 weeks,12 weeks, and 24 weeks in TXA group were 21.66, 13.69, 9.10, 9.24; respectively. Reduction of MASI between baseline and 4 weeks was statistically significant. Such a decreasing trend in MASI scores between baseline and 12 weeks was also reported as statistically significant (p=0.001). In the HQ group, MASI baseline,4 weeks, 12 weeks, and 24 weeks were 21.46, 13.57, 10.93, 11.20; respectively. Reduction of MASI scores between baseline and 4 weeks was statistically significant. Moreover, a decline in MASI scores was observed between baseline and 12 weeks that was statistically significant (p=0.001). Considering both groups MASI scores were reduced but the difference between two study groups was not statistically significant (p=0.98). Conclusion. The efficacy of TXA and HQ was the same and both could significantly reduce MASI scores.

The efficiency and safety of oral tranexamic acid in total hip arthroplasty: A meta-analysis.

Background:Intravenous (IV), topical and combination of both application of tranexamic acid (TXA) can reduce blood loss, hemoglobin drop, and transfusion rate in patients following total hip arthroplasty (THA). Lately, published articles reported that oral TXA had as similar blood-saving as IV and topical TXA in THA. The purpose of this meta-analysis is to investigate the efficiency and safety of oral TXA in THA.Methods:We systematically searched articles about oral administration of TXA in THA from PubMed, Embase, Scopus, Web of Science, the Cochrane Library, and the Chinese Wanfang database. Study eligibility criteria:1.Patients underwent primary THA;2.The intervention was oral application of TXA in THA;3.Outcomes included hemoglobin drop, total blood loss, transfusion rate, length of stay, and complications;4.The studies were designed as randomized controlled trials (RCTs) or clinical comparative trial (CCT).The outcomes were collected and analyzed by the Review Manager 5.3.Results:Nine RCTs and 1 CCT, containing 1305 patients, were ultimately included according to the inclusion criteria and exclusion criteria in the meta-analysis. The effectiveness of oral TXA was as similar as the IV or topical TXA in regard to hemoglobin drop (SMD = −0.14; 95% CI, [−0.28, 0.01]; P = .06), total blood loss (SMD = 0.01; 95% CI, [−0.13, 0.16]; P = .84), transfusion rate (OR = 0.76; 95% CI, [0.38, 1.55]; P = .37). Compared with single oral TXA or blank group, multiple oral TXA effectively reduced hemoglobin drop (SMD = −1.06; 95% CI, [−1.36, −0.77]; P < .05), total blood loss (SMD = −1.30; 95% CI, [−1.66, −0.94]; P < .05), transfusion rate (OR = 0.53; 95% CI, [0.29, 0.95]; P = .03). There were no significant difference in terms of length of stay and complication among all of enrolled studies.Conclusion:Oral TXA has favorable effect of blood-saving and do not increase risk of complication in patients following THA. Oral TXA may have no effect in the length of stay. More high quality RCTs are necessary.

A randomized, open-label, comparative study of oral tranexamic acid and tranexamic acid microinjections in patients with melasma

Melasma poses a great challenge as its treatment modalities are unsatisfactory. Treatment using tranexamic acid is a novel concept. This study aimed to compare the therapeutic efficacy and safety of oral tranexamic acid and tranexamic acid microinjections in patients with melasma. This is a prospective, randomized, open-label study with a sample size of 64, 32 in each treatment arm. Thirty-two patients were administered localized microinjections (4 mg/ml) of tranexamic acid monthly in 1 arm, while in the other arm, 32 were given oral tranexamic acid 250 mg twice a day. Patients were followed up for 3 consecutive months. Clinical photographs were taken at each visit, and a modified melasma area and severity index scoring was performed at the beginning and end of treatment. Improvement in melasma area and severity index score in the oral group was 57.5% as compared to 43.5% in the intralesional group. All 32 patients in the oral group (100%) showed >50% improvement, out of which 8 showed >75% improvement. In the intralesional group, 17 (53%) patients had >50% improvement, of which 3 had >75% improvement. The remaining 15 patients in this group had <50% improvement. Thus, the oral group showed a more significant response as compared to the intralesional group. No major adverse effects were observed in both the groups. At 6-month follow-up, two patients (6.2%) in the oral group had recurrence as compared to three patients (9.4%) in the intralesional group. A small sample size was one of the limitations in this study. The dose of tranexamic acid in microinjections and the frequency of injections could have been increased. Tranexamic acid provides rapid and sustained improvement in the treatment of melasma. It is easily available and affordable. Oral route is undoubtedly efficacious, but the results of microinjections, while encouraging, can probably be enhanced by either increasing the frequency of injections or increasing the concentration of the preparation.

Efficacy and safety of oral tranexamic acid in total knee arthroplasty: A systematic review and meta-analysis.

Background:Tranexamic acid (TXA) is an antifibrinolytic drug widely used as a blood-sparing technique in total knee arthroplasty (TKA), and it is usually administrated by intravenous or intraarticular injection. Recently, the oral form of TXA has been applied in TKA patients. However, there is no final consensus regarding the effectiveness and safety of oral TXA. The purpose of this systematic review and meta-analysis of randomized controlled trials (RCTs) was to evaluate the efficacy and safety of oral TXA versus control for blood loss after TKA.Methods:We searched PubMed, Embase, Medline, Web of Science, and Cochrane Library databases for relevant studies through August 2017. The mean difference (MD) of total blood loss, hemoglobin (Hb) drop, hematocrit (Hct), drain output, and risk difference (RD) of transfusion rate and thromboembolic complications in the TXA and control groups were pooled throughout the study. The outcomes were pooled by Stata 12.0.Results:A total of 5 RCTs (608 patients) were included in this study. All the included studies were randomized and the quality of included studies was relatively high. The pooled results indicated that the oral TXA group had significantly less Hb drop (standardized mean difference [SMD], −0.936; 95% confidence intervals [CI], −1.118,−0.754), Hct drop (SMD, −0.693; 95% CI, −1.113, −0.274), and drain output (SMD, −0.793; 95% CI, −0.959, −0.628) than the control group. No statistically significant differences were found in transfusion rate and the incidence of thromboembolic complications between the 2 groups. Total blood loss could not be evaluated for the insufficient date.Conclusions:Our meta-analysis suggested that the administration of oral TXA provided significantly better results with respect to Hb drop, Hct drop, and drain output without increasing the transfusion rate and the risk of thromboembolic complications after TKA. Nevertheless, our current study with some limitations such as the small sample size only provided limited quality of evidence, confirmation from further meta-analysis with large-scale, well-designed RCTs is required.

Efficacy and Safety of Oral Tranexamic Acid in Women with Heavy Menstrual Bleeding and Fibroids

To evaluate the efficacy and safety of oral, modified-release tranexamic acid in women with heavy menstrual bleeding and fibroids. This was a pooled analysis of two pivotal Phase III studies. Fibroids were evaluated by transvaginal ultrasonography. Menstrual blood loss (MBL) was measured via a validated alkaline hematin method. In women with and without fibroids, mean MBL was reduced compared with placebo across all treatment cycles (p < 0.001). Within the tranexamic acid group, more statistically significant (p < 0.001) reductions in MBL compared with placebo occurred in women with fibroids than in those without fibroids. Adverse events were similar between treatment groups. Tranexamic acid was well tolerated and reduced MBL in women with and without fibroids.

Tranexamic acid without prophylactic factor replacement for prevention of bleeding in hereditary bleeding disorder patients undergoing endoscopy: a pilot study

The risk of bleeding in patients with hereditary bleeding disorders (HBD) undergoing gastro-intestinal (GI) endoscopic procedures is unknown but guidelines generally recommend correction of factor deficiency. Investigate the safety of oral tranexamic acid (TA) without prophylactic factor replacement to prevent bleeding complications in patients with HBD undergoing elective GI endoscopic procedures. A prospective single-arm pilot study testing the feasibility of using TA, without prophylactic factor replacement or desmopressin preprocedure, for prevention of bleeding complications following elective standard risk (<1% risk of bleeding) endoscopic procedures in patients with HBD. Baseline factor levels, haemoglobin and iron studies (IS) were measured preprocedure. Primary outcome of bleeding (NCI CTCAE v3.0 Bleeding Scale) was undertaken by patient review and repeat Hb, IS on day 21. Twenty-eight patients underwent 32 GI endoscopic procedures from September 2010 until June 2012. The median age was 53 years (range 24-75 years) and disease types included mild haemophilia A/B (n = 12), severe haemophilia A/B (n = 9), von Willebrand disease (n = 5), FXI deficiency (n = 1) and FVII deficiency (n = 1). Procedures performed included 11 gastroscopies, 12 colonoscopies, 8 gastroscopies and colonoscopies and 1 flexible sigmoidoscopy. Fourteen standard risk procedures and two high risk procedures were performed. Two patients experienced Grade 1 bleeding and one patient experienced Grade 2 bleeding. This study suggests that TA without prophylactic factor replacement may be a safe approach for mild and moderate HBD patients undergoing standard risk endoscopic procedures, particularly where no biopsy is performed. These findings should be confirmed in a larger study.

Role of oral tranexamic acid in melasma patients treated with IPL and low fluence QS Nd:YAG laser

Background: Recently, tranexamic acid (TNA) containing oral medication has gained public attention, claiming for whitening effects. Objective: This study was performed to evaluate the clinical efficacy and safety of oral TNA as an adjuvant to intense pulsed light (IPL) and laser treatment in melasma. Methods: A total of 51 patients were included in the study. Patients who have been on oral TNA during IPL and laser treatments (group A) and those who were treated with only IPL and laser (group B) were analyzed (from winter to summer). Modified melasma area and severity index (mMASI) scores were blindly evaluated by two investigators using digital photographs taken at each visit. Results: The mean modified MASI score decreased from 11.33 ± 7.07 to 6.21 ± 5.04 in group A and from 11.70 ± 6.72 to 8.93 ± 5.89 in group B (baseline vs. 2 weeks after the last treatment, p = 0.005). Modified MASI score right before and after IPL were more reduced in group A. No serious adverse effects were reported up to 8 months of oral TNA medication. Conclusion: Oral TNA may improve clinical efficacy in light- or laser-based melasma treatment especially during the period of relative high sun exposure without serious adverse effects.