ABSTRACT
Background and Aims: Many women reported experiencing abnormalities in their cycle after being vaccinated with Covid-19 vaccination. To understand this issue further, our study aimed to evaluate the menstrual cycle patterns among women of childbearing age after receiving COVID-19 vaccinations. Methods: A cross-sectional study was conducted to investigate the impact of COVID-19 vaccine on women aged 18 years and above in Saudi Arabia. A self-administered online questionnaire was distributed among participants who had received at least one dose of COVID-19 vaccine. The questionnaire included questions about the participants' demographic characteristics, medical history, and vaccine-related adverse events. Results: The study included 383 female participants with an average age of 30.8 ± 8.1 years. The majority of participants, 92.7%, were Saudi, and more than half, 51.4%, were single. Of the participants, 78.9% were disease-free, and a majority of 67.9% had no history of Coronavirus Disease 2019 infection. A significant proportion of participants reported postvaccination changes in the menstrual cycle. Specifically, 43.1% reported changes after the first dose, and 38.4% reported changes after the second dose (p = 0.044). The severity of premenstrual symptoms increased from 44 (11.5%) to 113 (29.5%) after the first dose. Reported pain on the (WONG-BAKER) scale was also significantly elevated from 34 (8.9%) to 87 (22.7%) (p < 0.001) after the first dose. Conclusion: A relatively high prevalence of menstrual cycle irregularities was reported by Saudi vaccinated women, particularly young adults. These findings suggest the need to further research and explore the underlying causes of these irregularities and develop interventions that may help mitigate their impact on women's health. It is also recommended that women who observe long-term changes in their menstrual cycles seek follow-up and consultation with healthcare providers to ensure that any potential health concerns are addressed promptly.
ABSTRACT
Background: The coronavirus 2019 (COVID-19) disease, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus led to a global pandemic. HCQ and FPV were used early in the pandemic as a treatment modality for COVID-19. Various studies evaluated the HCQ and FPV effectiveness, based on the mortality endpoint and showed conflicting results. We hypothesize that analyzing the difference in the LOS as a significant endpoint would be of a major interest, especially for healthcare providers, to prevent a lengthy hospitalization and disease progression. Methods: This is a retrospective observational study, conducted via a medical chart review of COVD-19 patients who were admitted between April 2020 and March 2021 with a moderate to severe illness. The LOS endpoint was tested using the paired Wilcoxon signed-rank (WSR) model. Prior to using the WSR model, the balance between the HCQ and FPV groups, the propensity score matching, the LOS distribution, and the normality assumptions were tested. Two sensitivity statistical analyses were conducted to confirm the results (stratified log-rank test and U Welch test after transforming the LOS by the squared root values). Results: A total of 200 patients were included for the analysis: 83 patients in the HCQ group and 117 patients in the FPV group. Thirty-seven patients were matched in each group. The LOS data was positively skewed and violated the normality (Shapiro−Wilk p < 0.001) and had an unequal variance (Levene's test, p = 0.019). The WSR test showed no statistical significance in the LOS endpoint, with a median of −0.75 days (95% confidence interval: −4.0 to 2.5, p = 0.629), in favor of the HCQ group (four days), in comparison to seven days of the FPV group. The WSR findings were further confirmed with the stratified log rank test (p = 740) and the U Welch test (p = 391). Conclusions: The study concluded that the HCQ and FPV treatments have a comparable effectiveness in terms of the LOS in the moderate to severe COVID-19 patients. This study highlights the importance of analyzing the LOS as a relevant endpoint, in order to prevent the costs of a lengthy hospitalization and disease progression. The current study also emphasizes the importance of applying the appropriate statistical testing when dealing with two-sample paired data and analyzing non-parametric data such as the LOS.
