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Introduction: 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. Method: 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. Results: 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). Conclusion: 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.
RESUMEN
Background: Traditionally, laparoscopic procedures have been performed under general anesthesia. Spinal anesthesia is an effective alternative to general anesthesia. However, one of the intraoperative complications of performing laparoscopic surgery under spinal anesthesia is shoulder pain. This study aimed to compare the effect of transcutaneous electrical nerve stimulation (TENS) with fentanyl on pain relief in patients who underwent gynecologic laparoscopy under spinal anesthesia. Methods: We conducted a prospective randomized clinical trial from May 2016 to March 2017. A sample of patients who underwent gynecological laparoscopy under spinal anesthesia was recruited. If they had shoulder pain, they randomly received either transcutaneous electrical nerve stimulation (TENS) or 50 mg of fentanyl. Pain intensity was measured using the single item visual analogue scale (VAS-10 cm) immediately before and 5, 10, 20, and 30 minutes after treatment. Also, the effect of higher doses of analgesia on pain relief was analyzed. Results: In all, 80 patients (40 patients in each group) were entered into the study. The mean pain intensity score was 9.02 ± 1.32 in the TENS group and 8.95 ± 1.33 in the fentanyl group at baseline (P = 0.80). Repeated measures analysis of variance indicated that there was no significant difference on overall pain scores between the two treatment groups adjusted for age, BMI, total analgesia used, and baseline pain score (F (1, 74) = 1.44, P = 0.23). The use of analgesic drugs in the TENS group was significantly higher than the fentanyl group (P = 0.01). In addition, we found that nine patients (22.5%) complained of nausea/vomiting in the TENS group compared to thirteen patients (32.5%) in the fentanyl group (P = 0.31). Conclusions: The findings indicated that TENS was not superior to fentanyl for pain relief in laparoscopic surgery. It seems that the correct use of TENS parameters might merit further investigation. This trial is registered with: IRCT2016031216765N3.