Pictorial Blood Loss Assessment Chart Research Articles

The association between sonographic features and clinical symptoms of adenomyosis.

To investigate the association of sonographic features and clinical symptoms of adenomyosis. This was a prospective observational study. Only reproductive age women who underwent standardized transvaginal ultrasound examination were included. The diagnosis of adenomyosis was based on sonographic features proposed by Morphological Uterus Sonographic Assessment (MUSA)group. Pictorial blood loss assessment chart (PBAC) and numerical rating scale (NRS) were respectively used for the evaluation of menstrual bleeding and pain. Fifty-three women were recruited. Adenomyosis group consisted of 33 (62.3%) representative cases, whereas control group consisted of 20 (37.7%). Women with adenomyosis experienced significantly heavier menstrual bleeding (p = 0.008) and more painful menstrual periods (p = 0.003). Significant positive correlation between the number of sonographic adenomyosis features and both PBAC (r = 0.613, p < 0.001) and NRS scores (r = 0.402, p = 0.022) was found. PBAC score was significantly higher if either fan-shaped shadowing (r = 0.548, p = 0.001), interrupted junctional zone (JZ) (r = 0.548, p = 0.001) or globular uterus (r = 0.445, p = 0.011) was detected. Interrupted JZ (r = 0.440, p = 0.012) was associated with higher NRS score. Significant positive correlation between PBAC score and adenomyosis spread in uterine layers (r = 0.495, p = 0.004) was established. Certain sonographic features of adenomyosis and assessment of its involvement in uterine layers may predict the severity of adenomyosis symptoms.

Gynecological bleeding in women with congenital bleeding disorders: A comprehensive cohort from Iran

BackgroundGynecological bleeding including menorrhagia and postpartum hemorrhage (PPH) face women's quality of life constantly with difficulties, especially those suffering from inherited bleeding disorders. In this study, we aim to evaluate gynecological bleeding particularly menorrhagia among Iranian women patients with inherited bleeding disorders admitted to the Iranian Comprehensive Hemophilia Care Center (ICHCC). MethodsThis study was conducted on 156 females aged ≥ 12 diagnosed with an inherited bleeding disorder in ICHCC. Demographic and laboratory data were documented for all patients. Bleeding questionnaires (the International Society on Thrombosis and Hemostasis bleeding assessment tool (ISTH-BAT), Molecular and Clinical Markers for the Diagnosis and Management of Type 1 von Willebrand disease (MCMDM-1), and Pictorial blood loss assessment chart (PBAC)) were filled out for all patients. For comparing metric and categorical parameters, Mann-Whitney was performed. Spearman's rho test was used for analyzing correlation. ResultsThe mean age of patients was 33. Von Willebrand disease (VWD), Factor (F) VII deficiency and combined factor deficiency were the most diagnosed disorders. The median of ISTH-BAT, MCMDM-1, and PBAC was 7,7, and 517, respectively. Menorrhagia was the most common reason for diagnosis. Menorrhagia and PPH domain scores ≥ 2 were recorded in 82 and 34 patients, respectively, and PBAC scores > 100 were seen in 118 patients. Significant positive correlations were observed between bleeding scores and menorrhagia and PPH scores. No significant correlations were recorded for VWF: Ag and VWF: RCo with menorrhagia and PPH scores; however, significant correlations were seen for VWF: Ag and VWF: RCo with bleeding score questionnaires. ConclusionMenorrhagia is the most common problem in females affected by different types of inherited bleeding disorders, particularly VWD. Increased awareness among gynecologists and hematologists about bleeding disorders in cases with unexplained menorrhagia is an essential step for optimal management.

Efficacy of etonogestrel subcutaneous implants versus the levonorgestrel-releasing intrauterine system in the conservative treatment of adenomyosis.

To evaluate the clinical efficacy of etonogestrel subcutaneous implant (ENG-SCI) with that of the levonorgestrel-releasing intrauterine system (LNG-IUD) for adenomyosis treatment. A prospective randomized cohort study was conducted including 108 patients (50 patients in ENG-SCI group and 58 in the LNG-IUD group) with adenomyosis from January 2019 to July 2021. After 3 months of treatment, both ENG-SCI group and LNG-IUD group showed significant improvement in patients' visual analog scale, pictorial blood loss assessment chart (PBAC), and uterine volume (P ＜ 0.05). The uterine volume of patients in LNG-IUD group decreased more significantly than that in the ENG-SCI group since 3 months of treatment. The PBAC score in the LNG-IUD group improved better than that in the ENG-SCI group since 6 months of treatment (P ＜ 0.05). No significant difference in the occurrence rate of ideal vaginal bleeding patterns and the hemoglobin levels between the two groups was observed. The ENG-SCI group had a higher probability of weight gain and progesterone-related side effects (P ＜ 0.05). Both ENG-SCI and LNG-IUD were effective in treatment of adenomyosis. However, LNG-IUD had a more significant effect in treating adenomyosis-related dysmenorrhea, excessive menstrual flow, anemia, and uterine enlargement, with relatively fewer side effects.

A Double-blind, Randomized Clinical Trial Study of Plantago major l. Syrup on Menorrhagia

Objective: Menorrhagia is a common and costly complaint of patients in gynecology. Plantago major L. (P.major) is one of the herbal remedies recommended by Persian medicine for menorrhagia. Materials and methods: In this study, women with menorrhagia who did not have abnormal findings in para-clinical evaluation, were divided into two groups: herbal drug (P.major syrup) and placebo (simple syrup). After one cycle, menstrual blood loss based on Pictorial Blood Loss Assessment Chart (PBAC), menstrual duration, hemoglobin and hematocrit were assessed in both groups. Results: 65 patients completed the study. In the herbal drug group, menstrual blood loss and menstrual duration decreased from 205.5 ± 8.38 to 185.03 ± 12.30 (P&lt; 0.001) and from 8.30 ± 0.85 to 7.68 ± 1.62 (P= 0.003), respectively. Although the difference between groups in terms of blood loss in the baseline was not significant, it became significant after intervention (P&lt; 0.001). Also, after intervention hemoglobin and hematocrit were significantly increased from 11.82 ± 0.39 to 11.99 ± 0.20 and from 35.47 ± 1.18 to 35.69 ± 1.32 resp. (P&lt; 0.001) in herbal drug group, however they were decreased significantly in placebo group. No adverse effects were reported after using the herbal drug. Conclusions: P.major may be a good candidate for further study to be considered as a safe and effective remedy for menorrhagia.

Efficacy of a vaginal suppository formulation prepared with Acacia arabica (Lam.) Willd. gum and Cinnamomum camphora (L.) J. Presl. in heavy menstrual bleeding analyzed using a machine learning technique.

Objective: This study aims to determine the efficacy of the Acacia arabica (Lam.) Willd. and Cinnamomum camphora (L.) J. Presl. vaginal suppository in addressing heavy menstrual bleeding (HMB) and their impact on participants' health-related quality of life (HRQoL) analyzed using machine learning algorithms. Method: A total of 62 participants were enrolled in a double-dummy, single-center study. They were randomly assigned to either the suppository group (SG), receiving a formulation prepared with Acacia arabica gum (Gond Babul) and camphor from Cinnamomum camphora (Kafoor) through two vaginal suppositories (each weighing 3,500mg) for 7days at bedtime along with oral placebo capsules, or the tranexamic group (TG), receiving oral tranexamic acid (500mg) twice a day for 5 days and two placebo vaginal suppositories during menstruation at bedtime for three consecutive menstrual cycles. The primary outcome was the pictorial blood loss assessment chart (PBLAC) for HMB, and secondary outcomes included hemoglobin level and SF-36 HRQoL questionnaire scores. Additionally, machine learning algorithms such as k-nearest neighbor (KNN), AdaBoost (AB), naive Bayes (NB), and random forest (RF) classifiers were employed for analysis. Results: In the SG and TG, the mean PBLAC score decreased from 635.322 ± 504.23 to 67.70 ± 22.37 and 512.93 ± 283.57 to 97.96 ± 39.25, respectively, at post-intervention (TF3), demonstrating a statistically significant difference (p < 0.001). A higher percentage of participants in the SG achieved normal menstrual blood loss compared to the TG (93.5% vs 74.2%). The SG showed a considerable improvement in total SF-36 scores (73.56%) compared to the TG (65.65%), with a statistically significant difference (p < 0.001). Additionally, no serious adverse events were reported in either group. Notably, machine learning algorithms, particularly AB and KNN, demonstrated the highest accuracy within cross-validation models for both primary and secondary outcomes. Conclusion: The A. arabica and C. camphora vaginal suppository is effective, cost-effective, and safe in controlling HMB. This botanical vaginal suppository provides a novel and innovative alternative to traditional interventions, demonstrating promise as an effective management approach for HMB.

A 52-mg levonorgestrel-releasing intrauterine system vs bipolar radiofrequency nonresectoscopic endometrial ablation in women with heavy menstrual bleeding: long-term follow-up of a multicenter randomized controlled trial

BACKGROUNDThe symptom of heavy menstrual bleeding has a significant impact on professional, physical and social functioning. In 2021, results from a randomized controlled trial comparing a 52 mg levonorgestrel-releasing intrauterine system and radiofrequency non-resectoscopic endometrial ablation as treatments for women with heavy menstrual bleeding were published. Both treatment strategies were equally effective in treating heavy menstrual bleeding during a two-year follow-up. However, long-term results are also relevant for both patients and health care providers. OBJECTIVEThe aim of this study was to assess long-term differences in reintervention risk and menstrual blood loss in women with the symptom of heavy menstrual bleeding treated according to a strategy starting with a 52 mg levonorgestrel-releasing intrauterine system or radiofrequency non-resectoscopic endometrial ablation. STUDY DESIGNThis study was a long-term follow-up study of a multi-center randomized controlled trial (MIRA trial) in which women were allocated to either a 52 mg levonorgestrel-releasing intrauterine device (n=132) or radiofrequency non-resectoscopic endometrial ablation (n=138). Women from the original trial were contacted to fill out six questionnaires. The primary outcome was reintervention rate after allocated treatment. Secondary outcomes included surgical reintervention rate, menstrual bleeding measured by the Pictorial Blood Loss Assessment Chart, (disease-specific) quality of life, sexual function and patient satisfaction. RESULTSFrom the 270 women that were randomized in the original trial, 196 women (52 mg levonorgestrel-releasing intrauterine system group: n=94; radiofrequency non-resectoscopic endometrial ablation group: n=102) participated in this long-term follow-up study. Mean follow-up duration was 7.4 years (range 6-9 years). The cumulative reintervention rate (including both medical and surgical reinterventions) was 40.0% (34/85) in the 52 mg levonorgestrel-releasing intrauterine system group and 28.7% (27/94) in the radiofrequency non-resectoscopic endometrial ablation group (relative risk: 1.39; 95% confidence interval: 0.92-2.10). The cumulative rate of surgical reinterventions only was significantly higher for patients with a treatment strategy starting with a 52 mg levonorgestrel-releasing intrauterine system compared to radiofrequency non-resectoscopic endometrial ablation (35.3% [30/85] vs. 19.1% [18/94]; relative risk: 1.84; 95% confidence interval: 1.11-3.10). However, hysterectomy rate was similar: 11.8% [10/94] in the 52 mg levonorgestrel-releasing intrauterine system group and 18.1% [17/102] in the radiofrequency non-resectoscopic endometrial ablation group (relative risk: 0.65; 95% confidence interval: 0.32-1.34). Most reinterventions took place during the first 24 months of follow-up. A total of 171 Pictorial Blood Loss Assessment Chart scores showed a median bleeding score of 0.0. No clinically relevant differences were found regarding quality of life, sexual function and patient satisfaction. CONCLUSIONThe overall risk of reintervention after long-term follow-up was not different for women treated according to a treatment strategy starting with a 52 mg levonorgestrel-releasing intrauterine system as compared to a strategy starting with radiofrequency non-resectoscopic endometrial ablation. Yet, women allocated to a treatment strategy starting with a 52 mg levonorgestrel-releasing intrauterine system had a significantly higher risk for surgical reintervention, which was driven by an increase in subsequent endometrial ablation. Both treatment strategies remain effective in lowering menstrual blood loss over the long-term. The results of this long-term follow-up study help physicians to optimize counseling of women suffering from the symptom of heavy menstrual bleeding. Optimized counseling will enable women to make a well-informed choice regarding treatment.

Effect of topical application of a modified dosage form of granulocyte-colony stimulating factor in complex therapy of Ascherman syndrome

The effectiveness of the use of a modified intrauterine gel form of granulocyte colony stimulating factor in the complex treatment of Ascherman syndrome is evaluated. The study involved 31 patients with a history of Ascherman syndrome. For 6 months, the patients underwent weekly intrauterine administration of 1 ml of gel with a concentration of granulocyte colony stimulating factor of 9 million IU/ml using an intrauterine catheter. Monthly M-echo was evaluated on the 19th–22nd day of the menstrual cycle, as well as the volume of menstrual blood loss according to the Pictorial Blood Loss Assessment Chart. After the treatment was completed, a control hysteroscopy was performed. There is a statistically significant increase in M-echo from 2. 61 ± 1. 71 to 6. 52 ± 1. 23 mm (p 0. 001). At the same time, the proportion of patients with M-echo 6 and 7 mm increased from 6. 45 and 0% to 80. 65 and 51. 61, respectively, over the 6 months of the study. There is also a statistically significant increase in menstrual blood loss from 24. 9 ± 2. 6 to 53. 5 ± 3. 4 points on the Pictorial Blood Loss Assessment Chart (p 0. 001). A response to therapy was achieved in 17 patients, among them 12 patients were diagnosed with pregnancy that occurred spontaneously (17. 65%) or as a result of in vitro fertilization protocol (52. 9%). The data obtained indicate that intrauterine administration of a gel with granulocyte colony stimulating factor promotes endometrial regeneration in patients suffering from Ascherman syndrome, which is expressed in an increase in M-echo and the volume of menstrual blood loss. Thus, adjuvant use of a hydrogel with granulocyte colony stimulating factor and hyaluronic acid is an effective treatment option in restoring reproductive function and preventing recurrence of adhesiogenesis after surgical treatment of Ascherman syndrome. In general, the proposed gel form with granulocyte colony stimulating factor allows us to reduce the frequency of administration of the drug, which theoretically can increase both the compliance of patients primarily by reducing the number of invasive procedures, and reduce treatment costs.

Random X-Chromosome Inactivation in Adult Hemophilia B Carriers Does Not Attenuate Bleeding Risk

Introduction: The X-linked bleeding disorder Hemophilia B (HB) results from deficiency in coagulation Factor IX (FIX). In contrast to Hemophilia A, genotype-phenotype correlations in HB males are complex, as some F9 variants in males are associated with low plasma FIX activity (FIX:C) but milder than expected bleeding phenotypes. At least 75% of FIX is extravascular and not adequately measured from plasma. Hemostasis is likely influenced by this extravascular FIX which is bound reversibly to type IV collagen in the subendothelial basement membrane. We predict that genotype-phenotype correlations in female carriers of F9 mutations may have additional complexity as the mutant FIX can competitively interfere with wild type (WT) FIX for extravascular binding sites. F9 expression in female HB carriers is influenced by X-chromosome inactivation (XCI), a process that silences one X in XX females. XCI results in cells that randomly inactivate either the X carrying the mutant or wild type F9, although skewed XCI (&amp;gt;80:20) is found in ~25% of the general population. XCI skewing in HB carriers can lead to preferential expression of the X carrying the F9 mutation, which in turn influences plasma and extravascular levels of FIX and bleeding tendency. How frequently XCI is skewed in HB carriers, and the role of XCI in modulating FIX levels and bleeding phenotypes, remains poorly understood. We sought to determine whether XCI skewing may further differentiate bleeding risk in HB carriers. Methods: Subjects were enrolled in a prospective, observational cross-sectional study with informed consent. Both the Condensed MCMDM-1 bleeding assessment tool (BAT) and Pictorial Blood-loss Assessment Chart (PBAC) were completed at the time of the visit. F9 mutation analysis confirmed carrier status. FIX:C and FIX antigen ELISA assays were performed on all subjects. XCI skewing was assessed using established assays at the Androgen Receptor (AR) and Fragile X Mental Retardation (FMR1) loci. Results: A total of 15 subjects (11 adults) were confirmed F9 mutation carriers; six missense mutations and one frameshift mutation were identified. Abnormal bleeding is frequent in adult HB carriers, with 5/11 (45%) having BAT scores &amp;gt;4. Heavy menstrual bleeding (HMB) is particularly frequent, with all adult HB carriers reporting PBAC &amp;gt; 100, and 8/11 with BAT HMB subcategory score &amp;gt;1. FIX assessment by activity (mean 56% ± 28) and antigen (mean 0.55 IU/mL ± 0.2) assays are highly correlated (r 2= 0.83, p &amp;lt; 0.0001). Notably, only two adult HB carriers with significant bleeding have FIX levels &amp;lt; 50%, while two HB carriers with FIX levels &amp;lt; 50% have BAT scores &amp;lt; 4, indicating that neither FIX:C nor FIX antigen levels adequately predict bleeding risk in all HB carriers. Indeed, for all 11 adult HB carriers, no significant differences in either FIX:C or FIX antigen were observed between those with BAT scores ≥ 4 and &amp;lt; 4. We asked if XCI explained FIX levels or bleeding phenotypes. Nearly half (5/11) of the adult carriers have moderately skewed XCI (&amp;gt; 70:30); only one is extremely XCI skewed (&amp;gt; 80:20), and of the individuals with skewed XCI, 3/5 have BAT scores ≥ 4. Although random XCI is proposed to attenuate HB carrier bleeding phenotype, 2/6 HB carriers with random XCI also have BAT scores ≥ 4. XCI weakly correlated with FIX antigen (n = 15; r 2= 0.27, p &amp;lt; 0.05) but not FIX:C. When assessing this relationship for only the individuals with F9 c.1025C&amp;gt;T (n = 6), there was significant correlation with FIX:C (R 2= 0.73, p &amp;lt; 0.05) but not with FIX antigen or bleeding phenotype. The lack of correlation between XCI and FIX antigen in individuals with an identical F9 mutation argues for additional influences on intravascular, and likely extravascular, FIX levels and will require further investigation. Conclusions: Bleeding tendency in HB carriers is not rare and does not correlate with plasma FIX:C or FIX antigen. Random XCI is not fully protective against abnormal bleeding. Future studies are needed to better understand bleeding phenotypes in HB carriers that consider XCI, F9 mutation type and influences on circulating levels of WT and mutant FIX.

Effect of Ayurvedic Formulations on Abnormal Uterine Bleeding (Asrigdara): A Prospective Uncontrolled Multicenter Clinical Study

IntroductionAsrigdara in Ayurveda simulates the dysfunctional type of abnormal uterine bleeding (AUB) and is a common gynaecological complaint. It negatively affects the quality of life and is associated with the poor health of women. This study aimed to evaluate the effect of Ayurvedic formulations, Pushyanuga churna (PC) and Usheerasava (UA) in managing AUB. MethodsA multicenter, single-arm clinical study was conducted on 80 diagnosed patients of AUB. PC 3 g and UA 20 ml were given twice daily for 90 days. Clinical assessment was done at baseline, every 15th day for the initial 3 months, and on 120th day. Pictorial blood loss assessment chart score, visual analogue scale, and Psychological General Well-being Index were utilised to measure the outcome parameters. The safety of formulations was evaluated by reporting adverse drug reactions and changes in liver function tests and renal function tests at baseline and on 90th day. ResultsSixty-eight participants completed the trial. Data were analysed using SPSS version 28.0. The mean age of the participants was 31.7 ± 6.3 years and majority (73.5%) were multiparous. The most typical presentation was heavy menstrual bleeding in 92.6%, followed by frequent bleeding (52.9%). At baseline, 94.2% participants had a pictorial blood loss assessment chart score >100, which decreased to 30.7% at the end of the study. Highly significant changes (P < 0.001) were observed in frequent, prolonged bleeding and psychological general well-being index score. No adverse drug reactions and significant changes in safety parameters were found. ConclusionsPC and UA are effective, well-tolerable, and safe in managing AUB.

Hysteroscopic diode laser myolysis: from a case series to literature review of incisionless myolysis techniques for managing heavy menstrual bleeding in premenopausal women.

This case series examined the safety and effectiveness of hysteroscopic myolysis using laser-induced interstitial thermo-therapy (LITT) for treating heavy menstrual bleeding (HMB) in premenopausal women with FIGO type 1 or 2 uterine fibroids, not planning for future fertility. Additionally, a comprehensive review of innovative, minimally invasive, incisionless myolysis techniques was conducted. Women with HMB, sonographically diagnosed with a single FIGO type 1 or 2 fibroid, underwent hysteroscopic myolysis using the Leonardo® diode laser. Effectiveness was assessed via transvaginal ultrasound measurement of myoma size, volume and vascularization pre and post-procedure. Moreover, we also evaluated any improvements in symptoms using the Pictorial Blood Loss Assessment Chart (PBAC score) scores. The procedure resulted in significant HMB reductions and noticeable fibroid size, volume, and vascularization decrease in all three patients, with no reported complications. The literature review revealed both advantages and limitations of the minimally invasive, incisionless myolysis techniques. Hysteroscopic laser myolysis is a safe and effective therapeutic intervention for patients experiencing HMB, diagnosed with FIGO type 1 or 2 fibroids, and not planning for future fertility. The procedure resulted in significant reductions in menstrual blood loss and fibroid size. Despite the promising results, it is essential to note the limitations of this report, including its case series design, a small number of patients, and a short follow-up period. Further research is necessary to confirm these results.

Feasibility and Effectiveness of Hysteroscopic Suture Fixation of the Levonorgestrel-Releasing Intrauterine System in the Treatment of Adenomyosis

To evaluate the feasibility and effectiveness of hysteroscopic suture fixation of the levonorgestrel-releasing intrauterine system (LNG-IUS) for the treatment of adenomyosis. A retrospective case series. Two teaching hospitals with the technology of hysteroscopic suture fixation of the LNG-IUS. The study reviewed 79 adenomyosis patients who received the hysteroscopic suture fixation of the LNG-IUS from January 2021 to May 2022. Hysteroscopic suture fixation of the LNG-IUS to the posterior uterine wall with nondissolvable suture. All patients underwent one-year postoperative follow-up to evaluate the LNG-IUS expulsion rate, postoperative efficacy, and side effects. Two patients (2.6%) experienced expulsion of the LNG-IUS at 8 months and 12 months postoperatively, respectively. The visual analog pain scale, pictorial blood loss assessment chart score and carbohydrate antigen 125 markedly decreased after the suture fixation of the LNG-IUS compared with baseline in all patients (p <.001). Hemoglobin increased significantly (p <.001). The most common side effect was irregular bleeding, which accounted for 44.3%. The second common side effect was weight gain, which accounted for 29.2%. The composite effectiveness based on pain and bleeding showed that the effective treatment rates at 1, 3, 6, and 12 months after surgery were 92.4%, 97.4%, 96.2%, and 97.4% respectively. Hysteroscopic suture fixation of the LNG-IUS to the uterine fundus was associated with low expulsion rates and significantly improved dysmenorrhea and bleeding.

PB0704 Clinical Approach and Monitoring Treatment of Menorrhagia with PBAC (Pictorial Blood Loss Assessment Chart) in 20 VWD Patients

PB0704 Clinical Approach and Monitoring Treatment of Menorrhagia with PBAC (Pictorial Blood Loss Assessment Chart) in 20 VWD Patients

The effect of date fruit consumption on early postpartum hemorrhage: a randomized clinical trial

BackgroundPostpartum hemorrhage, anemia, and iron deficiency are important health problems. Using safe, cheap, and available methods to reduce the amount of hemorrhage after childbirth can be effective for the mother's health during this period. Therefore, this study was conducted to determine the effect of date fruit consumption on the amount of hemorrhage after natural childbirth.MethodsThis randomized clinical trial was conducted on 98 women referred to the maternity ward of Al-Zahra Hospital in Rasht using the available sampling method. The primary outcome was postpartum hemorrhage, measured using the Pictorial Blood Loss Assessment Chart (PBLAC). Two hours after delivery, 100 g of date fruits were given to the intervention group, and the amount of hemorrhage was recorded during the first 24 h. Comparison between the two groups was done with the Mann–Whitney test with the Hodges–Lehmann estimator and corresponding exact conditional nonparametric confidence interval (CI) as effect estimate. A P < 0.05 was considered significant.ResultsThe median of postpartum hemorrhage after normal delivery in the date and control groups was 35.0 [interquartile range (IQR): 22.0 to 39.8] and 39.0 [IQR: 27.5 to 64.5], respectively. Using the Hodges–Lehmann estimator, on average, the median postpartum hemorrhage in the date group was 9.0 (95% CI: 2.00–18.0) units lower than the control group (P = 0.009).ConclusionConsumption of dates effectively reduces the amount of hemorrhage after natural childbirth; thus, consuming this fruit during postpartum period is recommended. Also to confirm the findings, it is recommended to conduct similar studies in this field.Trial registrationThis trial was registered with the Iranian Registry of Clinical Trials; https://www.irct.ir/trial/59197 (IRCT20210607051505N2) on 31/10/2021.

Effectiveness of Zhenqi Buxue Oral Liquid Combined with Progesterone for Treatment of Oligomenorrhea and Hypomenorrhea with Qi-Blood and Kidney (Shen) Essence Deficiency: A Randomized Controlled Trial.

To evaluate the effectiveness and safety of Zhenqi Buxue Oral Liquid (ZQ), progesterone capsules, and their combination in treating oligomenorrhea and hypomenorrhea with qi-blood and Kidney (Shen) essence deficiency. This was a prospective, randomized, multi-center controlled trial between June 2022 to December 2022. Ninety-six oligomenorrhea and hypomenorrhea patients with qi-blood and Shen essence deficiency were randomly assigned to receive ZQ (ZQ group, 29 cases), progesterone capsules (PG group, 32 cases), or the combined Chinese and Western medicine (COM group, 31 cases) at a ratio of 1:1:1. Patients in the ZQ or PG group took daily 10 mL twice a day of ZQ or 200 mg once a day of progesterone capsules for 10 consecutive days on day 15 of the menstrual cycle respectively, and patients in the COM group received the same ZQ combined with progesterone capsules. The treatment course lasted for 3 months and follow-up was performed at 1 and 3 months after the end of treatment. Primary endpoint was the menstrual Traditional Chinese Medicine Syndrome Scale (TCMSS) scores. Secondary endpoints included pictorial blood loss assessment chart (PBAC) scores, clinical efficacy rate, 36-item Short Form Health Survey (SF-36) scores, sex hormones and thickness of endometrium. Adverse events (AEs) were recorded. TCMSS scores after 1- and 3-month treatment in all groups were significantly lower than those at baseline (P<0.05). Only TCMSS scores after 3-month treatment in the ZQ and COM groups continuously decreased compared with those after 1-month treatment in the same group (P<0.01). TCMSS scores after 3-month treatment in the ZQ and COM groups were significantly lower than those in the PG group (P<0.05, P<0.01). Compared with baseline, PBAC scores in the ZQ and COM groups after 3 months of treatment were also significantly higher (both P<0.01). The total effective rates of TCM syndrome of 3-month treatment were significantly improved in all groups compared with that after 1 month of treatment (P<0.05). The total effective rate of the COM group was the highest in the 3rd month of treatment and significantly higher than that of PG group alone (P<0.05). Compared with baseline, only the SF-36 scores of COM group were significantly improved after 3 months of treatment (P<0.05). No serious adverse reactions were observed after treatment. The combination of ZQ and PG, or ZQ only had better effects on reducing TCMSS scores compared with PG, and COM showed the higher total effective rate compared with monotherapy. Besides, COM could effectively improve menstrual blood loss and quality of life. ZQ combined with PG may be an effective and safe option for oligomenorrhea and hypomenorrhea patients with qi-blood and Shen essence deficiency.

ULIPRISTAL ACETATE VERSUS PLACEBO FOR FIBROID TREATMENT

Background: The efficacy and safety of oral ulipristal acetate for the treatment of symptomatic uterine fibroids before surgery are uncertain. Methods: We randomly assigned women with symptomatic fibroids, excessive uterine bleeding (a score of &gt;100 on the pictorial blood-loss assessment chart [PBAC, an objective assessment of blood loss, in which monthly scores range from 0 to &gt;500, with higher numbers indicating more bleeding]) and anemia (hemoglobin level of ≤10.2 g per deciliter) to receive treatment for up to 13 weeks with oral ulipristal acetate at a dose of 5 mg per day (96 women) or 10 mg per day (98 women) or to receive placebo (48 women). All patients received iron supplementation. The coprimary efficacy end points were control of uterine bleeding (PBAC score of &lt;75) and reduction of fibroid volume at week 13, after which patients could undergo surgery. Results: At 13 weeks, uterine bleeding was controlled in 91% of the women receiving 5 mg of ulipristal acetate, and 19% of those receiving placebo (P&lt;0.001 for the comparison of each dose of ulipristal acetate with placebo). The rates of amenorrhea were 73%, and 6%, respectively, with amenorrhea occurring within 10 days in the majority of patients receiving ulipristal acetate. The median changes in total fibroid volume were −21%,, and +3% (P = 0.002 for the comparison of 5 mg of ulipristal acetate with placebo. Serious adverse events occurred in one patient during treatment with 5 mg of ulipristal acetate (uterine hemorrhage) and in one patient during receipt of placebo (fibroid protruding through the cervix). Headache and breast tenderness were the most common adverse events associated with ulipristal acetate but did not occur significantly more frequently than with placebo. Conclusions: Treatment with ulipristal acetate for 13 weeks effectively controlled excessive bleeding due to uterine fibroids and reduced the size of the fibroids.

ULIPRISTAL ACETATE VERSUS PLACEBO FOR FIBROID TREATMENT

Background: The efficacy and safety of oral ulipristal acetate for the treatment of symptomatic uterine fibroids before surgery are uncertain. Methods: We randomly assigned women with symptomatic fibroids, excessive uterine bleeding (a score of &gt;100 on the pictorial blood-loss assessment chart [PBAC, an objective assessment of blood loss, in which monthly scores range from 0 to &gt;500, with higher numbers indicating more bleeding]) and anemia (hemoglobin level of ≤10.2 g per deciliter) to receive treatment for up to 13 weeks with oral ulipristal acetate at a dose of 5 mg per day (96 women) or 10 mg per day (98 women) or to receive placebo (48 women). All patients received iron supplementation. The coprimary efficacy end points were control of uterine bleeding (PBAC score of &lt;75) and reduction of fibroid volume at week 13, after which patients could undergo surgery. Results: At 13 weeks, uterine bleeding was controlled in 91% of the women receiving 5 mg of ulipristal acetate, and 19% of those receiving placebo (P&lt;0.001 for the comparison of each dose of ulipristal acetate with placebo). The rates of amenorrhea were 73%, and 6%, respectively, with amenorrhea occurring within 10 days in the majority of patients receiving ulipristal acetate. The median changes in total fibroid volume were −21%,, and +3% (P = 0.002 for the comparison of 5 mg of ulipristal acetate with placebo. Serious adverse events occurred in one patient during treatment with 5 mg of ulipristal acetate (uterine hemorrhage) and in one patient during receipt of placebo (fibroid protruding through the cervix). Headache and breast tenderness were the most common adverse events associated with ulipristal acetate but did not occur significantly more frequently than with placebo. Conclusions: Treatment with ulipristal acetate for 13 weeks effectively controlled excessive bleeding due to uterine fibroids and reduced the size of the fibroids.

COMPARISON OF SAFETY AND EFFICACY OF ORAL PROGESTERONE WITH LEVONORGESTREL INTRAUTERINE SYSTEM IN MANAGEMENT OF DYSFUNCTIONAL UTERINE BLEEDING

The retrospective study was conducted in the Department of Obstetrics and Gynaecology, Nishtar Medical Hospital, Multan, to compare the safety and efficacy of oral progesterone and levonorgestrel-releasing intrauterine system (LNG-IUS) for the management of DUB. The study was conducted on 90 patients who fulfilled the inclusion criteria. Participants were randomly divided into groups A (LNG-IUS) and B (oral progesterone). The primary outcomes were Pictorial blood loss assessment chart (PBAC) scores. Secondary outcomes were the evaluation of adverse effects and Hb levels. A comparison of the mean PBAC score showed that LNG-IUS significantly reduced PBAC scores (P&lt; 0.0001). Comparison of post-treatment HB levels showed that LNG-IUS significantly increased Hb level, and the difference between both groups was statistically significant (P&lt; 0.0001). After 6 months, the incidence of adverse effects in group B was 60%, while in group A was 40%. However, hypomenorrhea was more prevalent in group A. It can be concluded that LNG-IUS is a more effective and safe treatment choice for Dub compared to oral progesterone.

Low-dose letrozole – an effective option for women with symptomatic adenomyosis awaiting IVF: a pilot randomized controlled trial

Research questionCan low-dose letrozole reduce dysmenorrhoea, menorrhagia and sonographic features in symptomatic women with adenomyosis awaiting IVF? DesignThis was a longitudinal randomized prospective pilot study to explore the effectiveness of low-dose letrozole and compare it with a gonadotropin releasing hormone (GnRH) agonist in reducing dysmenorrhoea, menorrhagia and sonographic features in symptomatic women with adenomyosis awaiting IVF. The women were treated for 3 months, either with the GnRH agonist goserelin 3.6 mg/month (n = 77) or the aromatase inhibitor letrozole 2.5 mg three times weekly (n = 79). Dysmenorrhoea and menorrhagia were evaluated at randomization and followed up monthly using a visual analogue score (VAS) and pictorial blood loss assessment chart (PBAC), respectively. A quantitative scoring method was used to assess the improvement of sonographic features after 3 months of treatment. ResultsBoth groups reported a marked improvement in symptoms after 3 months of treatment. In both the letrozole and GnRH agonist groups, VAS and PBAC scores decreased significantly over the 3 months (letrozole: P = 0.0001 and P = 0.0001 for VAS and PBAC, respectively; GnRH agonist: P = 0.0001 and P = 0.0001 for VAS and PBAC, respectively). Participants on letrozole had regular menstruation cycles, while most of the women who received the GnRH agonist were amenorrhoeic, with only four women reporting mild bleeding. Haemoglobin concentrations also improved after both treatments (letrozole P = 0.0001, GnRH agonist P = 0.0001). A quantitative assessment of sonographic features showed significant improvements following both treatments (diffuse adenomyosis of the myometrium: letrozole P = 0.015, GnRH agonist P = 0.039; diffuse adenomyosis of the junctional zone: letrozole P = 0.025, GnRH agonist P = 0.001). Women with adenomyoma also responded well to both therapies (letrozole P = 0.049, GnRH agonist P = 0.024), whereas the letrozole group responded comparatively better in focal adenomyosis when the outer myometrium was involved (letrozole P < 0.001, GnRH agonist P = 0.26). No noticeable side effects were observed in women receiving letrozole therapy. Additionally, letrozole therapy was found to be more cost-effective than GnRH agonist treatment. ConclusionsLow-dose letrozole treatment is a low-cost alternative to a GnRH agonist, with comparable effects in improving the symptoms and sonographic features of adenomyosis in women awaiting IVF.

Effectiveness of Persian Golnar on Excessive Menstrual Bleeding in Women with Abnormal Uterine Bleeding, Compared to Tranexamic Acid: A Triple-Blind, Randomized Equivalence Trial.

Abnormal uterine bleeding (AUB) is a major healthcare problem in females of reproductive age and impacts women's health and quality of life (QoL). This study aimed to test the equivalence of Persian Golnar (PG) and tranexamic acid (TA) for the treatment of excessive menstrual bleeding. A triple-blind randomized equivalence trial with parallel design and block randomization technique was performed. A total of 80 patients with AUB were randomly allocated to receive either PG or TA for three consecutive menstrual cycles. Blood loss was measured by the Pictorial Blood Loss Assessment Chart (PBAC). Hematological evaluations were done before the intervention and after treatment. QoL and premenstrual dysphoric disorder (PMDD) as secondary outcomes were assessed using the menorrhagia questionnaire (MQ) and Premenstrual Symptoms Screening Tool (PSST). Statistical analysis was performed using an independent t-test, paired t-test, χ2 test, Mann-Whitney test, and Wilcoxon signed-rank test. Seventy-six women completed the 12-week follow-up. Both PG and TA groups experienced a significant reduction in blood loss. Furthermore, the serum level of hemoglobin in the PG group enhanced significantly (P < 0.001). QoL and PMDD scores were significantly improved in both groups (P< 0.001). The findings of the current trial supposed that the Golnar product is as effective as tranexamic acid in controlling bleeding and enhancing the quality of life and premenstrual symptoms.

Effect of Saleekha and Majeeth in Polycystic Ovarian Disease: An Open Observational Study

Pharmacognosy Research,2023,15,1,168-175.DOI:10.5530/097484900240Published:December 2022Type:Original ArticleAuthors:Shabnam Bano, Wajeeha Begum, and Syeda Sumaiya Author(s) affiliations:Shabnam Bano*, Wajeeha Begum, Syeda Sumaiya Department of Ilmul Qabalat of Amraze Niswan, National Institute of Unani Medicine, Kottigepalya, Bengaluru, Karnataka, INDIA. Abstract:Introduction: PCOD is a common, complex reproductive endocrinopathy characterized by menstrual irregularities, hyperandrogenism, polycystic ovaries, metabolic and psychological disorders and affects up to 18% of reproductive-aged women. Objectives: To evaluate the effect of Saleekha and Majeeth in PCOD. Materials and Methods: Clinically diagnosed Patients (n=30) with PCOD in age 18-35 years with oligomenorrhea or amenorrhoea were included in the study. Patients with thyroid dysfunction, systemic diseases, endometrial tuberculosis, malignancies on hormonal treatment in the last 3 months, pregnancy, and lactation were excluded. The research drug was administered orally in a dose of 3.5 gm B.D safūf (powder) of Saleekha with Joshānda (decoction) of Majeeth 7 gm BD for 14 days/ cycle for three consecutive cycles. Outcome measures were changes in subjective parameters (nature of bleeding, duration of cycles, duration of flow, amount of flow, weight reduction) and objective parameters, pictorial blood loss assessment chart (PBAC) score, basal metabolic index (BMI), modified Ferriman Gallwey (mFG) score, acanthosis nigricans scale and pelvic ultrasonography. Data were analyzed using the paired Student t-test. Results: Marked improvement was observed in menstrual irregularity and PBAC score with p<0.001 which is highly significant after the intervention. Significant change is seen in BMI, Ovarian volume, and SF-12 with p<0.001 after treatment. Safety parameters were within the normal range. Interpretation and Conclusion: Research drugs (Saleekha and Majeeth) can be used as an alternate remedy in PCOD patients, as it significant effect to regularize menstruation by reduction of BMI and probably by improving insulin resistance in PCOD. No adverse effect of the research drug was noted during the trial. Keywords:BMI, Majeeth, mFG, PBAC score, PCOD, SaleekhaView:PDF (272.5 KB)