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Background: Fasting headaches frequently occur during the first few days of Ramadan, and treatment is challenging because of fasting. Objective: This study aimed to evaluate the effect of extended‐release paracetamol on preventing fasting headaches. Methods: A randomized, open‐label clinical trial investigated the efficacy of extended‐release paracetamol at a daily dose of 1330 mg in preventing fasting headache. Adults aged 18 years and older were recruited through the Clinical Trial Unit at the King Saud University Medical City. The eligible participants in the study fasted 13.5 h daily during the first week of Ramadan. Participants in the treatment and control arms were followed up to investigate the occurrence, severity, and timing of headache symptoms via self‐reporting using a standardized headache diary scale with a daily online link or phone call. The primary outcome was the frequency of headache episodes while fasting during the first week of Ramadan. Results: A total of 238 participants were enrolled and randomized. Of these, 173 followed the protocol (80 treated, 93 control) for at least the first day and were included in the analysis. Most participants were young and healthy, with a mean age of 32.2 ± 10.2 years. More men were included in the study (102/173; 59.0%), a small proportion of participants were smokers (31/173; 17.9%), and almost all participants reported being coffee drinkers (165/173; 95.4%); nonetheless, these characteristics were evenly distributed between the two groups in the study. The overall incidence of headache episodes was 33.0% (57/173) on day 1 and decreased to 11.3% (18/159) on day 7. On average over the 7 days, no significant effect was observed for the treatment on the incidence of headache, as the findings from the generalized estimating equation model indicated (β = −0.398, p = 0.084; odds ratio = 0.67, 95% confidence interval [CI] 0.42–1.06). Moreover, there was initially no significant difference in the incidence of headache episodes between the treatment and control groups. However, the treatment group had significantly fewer headache episodes during fasting than the control group on day 3 (4/72 [5.6%] vs. 15/91 [16.5%], p = 0.031; relative risk [RR] = 0.34, 95% CI 0.12–0.97) and day 6 (5/69 [7.2%] vs. 20/90 [22.2%], p = 0.010; RR = 0.33, 95% CI 0.13–0.82). No adverse effects were observed during the study period. Conclusion: No significant differences were observed in the occurrence of fasting headaches between the two groups on most days during the study period. Additional studies are required to address fasting headaches during the first week of Ramadan. Plain Language Summary: Ramadan is a month in which millions of Muslims fast from dawn to dusk; however, fasting during the day (e.g., for 13 hours) may cause headache and discourage individuals from this spiritual practice and can impact normal productivity, especially during the first week as the body adapts. We tested whether taking extended‐release paracetamol before fasting in the morning could avert fasting‐induced headache. Extended‐release paracetamol can be partially beneficial in delaying, but not necessarily preventing, fasting‐induced headache. [Correction added on 12th September 2024, after the first online publication: The Plain Language Summary has been updated.] [ABSTRACT FROM AUTHOR]

The article explores the effects of preemptive extended-release paracetamol on fasting-induced headaches during Ramadan, finding that it reduced headache occurrence on certain days and delayed the onset of headaches. Topics include fasting-induced headaches, the use of paracetamol during Ramadan, and strategies to prevent fasting-related discomfort.