Evaluating the use of paracetamol to prevent fasting headache during the first week of Ramadan: A randomized, open-label, clinical trial

Background Fasting headaches frequently occur during the first few days of Ramadan, and treatment is challenging because of fasting.ObjectiveThis study aimed to evaluate the effect of extended-release paracetamol on preventing fasting headaches.MethodsA 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.ResultsA 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 (beta = -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.ConclusionNo 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. Preemptive use of extended-release paracetamol (acetaminophen) during the first week of fasting Ramadan did not overall affect whether participants experience of fasting-induced headache. However, it did reduce headache occurrence on Days 3 and 6, and delayed the average onset of headache on Day 6. Overall, the incidence of headache episodes was 33.0% on Day 1 and declined to 11.3% on Day 7. Ramadan is a blessed month in which millions of Muslims fast from dawn to dusk. However, fasting during the daytime (e.g., 13 h) may cause headache, which can dissuade individuals from this spiritual practice and normal productivity, especially during the first week as the body adapts. Identifying an effective preventative approach will support fasting communities in their spiritual objectives and/or quality-of-life improvement. We tested whether taking extended-release paracetamol before fasting could avert fasting-induced headache. Participants consisted of 173 healthy adult volunteers who fasted during Ramadan, randomly split into two groups. Those in the treatment group were provided with 1330 mg extended-release paracetamol to be taken once-daily just before fasting for the first seven days of Ramadan. The control group did not receive any treatment. All participants kept a diary in which they answered a daily questionnaire about their development of any headache, and its time and severity. This made it possible to assess differences between the medicated and nonmedicated groups. Use of paracetamol did not affect headache occurrence on most days of the first week. However, headache occurrence was significantly reduced in the group receiving paracetamol on Days 3 and 6. In addition, paracetamol delayed average headache onset time by more than 4 h on Day 6 as compared to the nonmedicated group. The extended-release paracetamol can be partially beneficial in delaying but not necessarily preventing fasting-induced headache. It may be suggested that the paracetamol dose or formulation can be optimized to improve its preventative effect. Additional studies are required and encouraged to prevent fasting-induced headache.