Evaluating the Effects of <i>Crocus sativus</i> L. Herbal Product on Chronic Fatigue Syndrome in Patients with Chronic Obstructive Pulmonary Disease: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Abstract

Background: Chronic fatigue syndrome (CFS) is a complex and debilitating disorder characterized by extreme fatigue that cannot be explained by any underlying medical condition. Chronic fatigue syndrome significantly impacts the daily lives of patients with chronic obstructive pulmonary disease (COPD). Currently, there is no definitive treatment for CFS. Objectives: This study aimed to determine the effects of Crocus sativus L. herbal product on improving CFS and quality of life (QOL) in patients with COPD. Methods: This study was conducted as a randomized, double-blind, placebo-controlled clinical trial. Chronic obstructive pulmonary disease patients with CFS were randomly assigned to either the intervention or control group using block randomization generated by the Sealed Envelope online tool. Data were coded to ensure that both researchers and analysts were blinded to group assignments. Participants in the intervention group (n = 37) received 30 mg of dry saffron extract capsules twice daily for eight weeks, while those in the control group (n = 34) received a placebo. The primary outcome was the effect of C. sativus on CFS, assessed using the Chronic Respiratory Questionnaire (CRQ) and the Manchester COPD Fatigue Scale (MCFS). The secondary outcome was the effect on QOL, measured using the St. George’s Respiratory Questionnaire (SGRQ). Patients were evaluated at baseline, after one month, and after two months. Results: Based on mixed repeated measures ANOVA models, the effect of C. sativus on CRQ total scores was significant (P < 0.001), while the effect on the Dyspnea subscale was not significant (P = 0.38). The effect on chronic fatigue status based on MCFS was significant (P < 0.001). The effect on total QOL score based on SGRQ was also significant (P = 0.012), while the effect on the Symptoms subscale was not significant (P = 0.158). Conclusions: The findings indicate that C. sativus herbal product is effective in reducing CFS and improving QOL in COPD patients. However, it may not be effective in reducing COPD symptoms, including dyspnea.