Efficacy and Safety of the Traditional Herbal Medicine, Gamiguibi-tang, in Patients With Cancer-Related Sleep Disturbance: A Prospective, Randomized, Wait-List-Controlled, Pilot Study
Changes in the ISI (A) and BFI (B) scores in the GGBT and wait-list groups. The ends of whiskers represent the upper and lower limit of the values and columns represent 25th and 75th percentile with the median value. The connecting lines represent changes of mean values. *Represents change that was statistically significant (P < .05). White columns represent GGBT group, whereas gray columns represent wait-list group. ISI, Insomnia Severity Index; BFI, Brief Fatigue Inventory; GGBT, Gamiguibi-tang.
This study showed that GGBT significantly improved sleep quality and fatigue level but not depression and cognitive impairment in patients with cancer after 2 weeks of intervention without serious adverse events.
Patients with cancer have difficulty maintaining good sleep quality because of their psychosocial and physical stresses. However, standard nonpharmacological and pharmacological approaches to alleviate sleep disturbance in patients with cancer are still lacking. The duration and depth of sleep in these patients is affected by physical problems such as respiratory failure or pain, stressful decisions about cancer therapies and therapy-induced adverse events, as well as circadian disturbance caused by the cancer itself.7,24 In addition, sleep insufficiency arouses immunosuppression and increases the incidence of cardiac, metabolic, and inflammatory diseases.25,26 However, cognitive behavior therapy—one of the nonpharmacological approaches and the current standard recommendation—requires sufficient amount of time and workforce to administer. The possibilities of impaired liver or renal function due to chemotherapies or cancer-related issues call for safer pharmacological approaches for patients with cancer and survivors of cancer.