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

Abstract

Background: Sleep disturbance is the second most bothersome symptom in patients with cancer, and it can significantly impair their quality of life. The aim of this study was to investigate the efficacy and safety of the traditional herbal medicine Gamiguibi-tang (GGBT) in patients with cancer-related sleep disturbance. Methods: We conducted a prospective, randomized, wait-list-controlled, open-label pilot clinical trial on cancer-related sleep disturbance. Patients with cancer experiencing poor sleep quality with a Pittsburgh Sleep Quality Index of at least 6 were randomly assigned to the GGBT and wait-list groups to receive GGBT and conventional care, respectively, for 2 weeks. The primary endpoint was the Insomnia Severity Index (ISI) score. Fatigue, depression, and cognitive impairment were assessed as the secondary endpoints by using the Brief Fatigue Inventory (BFI), Beck Depression Inventory (BDI), and Montreal Cognitive Assessment (MoCA). Results: Thirty participants who met the eligibility criteria were enrolled. Sleep disturbance assessed using the ISI improved significantly more in the GGBT group than in the wait-list group (−5.5 ± 4.4 vs 0.1 ± 1.1, P < .001). Fatigue level determined using the BFI also improved significantly more in the GGBT group than in the wait-list group (−0.8 ± 0.8 vs 0.0 ± 0.3, P = .002). The BDI and MoCA scores showed no significant changes. Adverse events were reported in two patients in the GGBT group and consisted of mild dyspepsia and mild edema. Conclusion: GGBT may be a potential treatment option for cancer-related sleep disturbance. Further research is needed to investigate the efficacy and safety of GGBT.

Sipjeondaebo-tang in patients with breast cancer with fatigue: a protocol for a pilot, randomised, double-blind, placebo-controlled, cross-over trial

“…So far, most studies on patients with cancer using traditional Korean medicine conducted in Korea are small-scale studies. Similar to other small pilot studies on sleep disturbance, 47 fatigue, 48 pain 49 and anorexia 50 in patients with cancer conducted in Korea, which have provided evidence for further study, we hope that the present study will also promote further studies and the use of herbal medicines in patients with cancer. The present study may be regarded as a study that investigates preventive effect of SJDBT in fatigue during chemotherapy.…”

Dropouts in randomized clinical trials of Korean medicine interventions: a systematic review and meta-analysis

“…Twenty RCTs were performed in a double-blind manner [ 20 , 21 , 25 , 30 , 32 – 42 , 52 , 54 – 56 , 58 ], and 14 were single-blind [ 12 , 14 , 15 , 17 – 19 , 23 , 24 , 27 , 29 , 45 , 47 , 51 , 53 ]. Fifteen studies were performed without any blinding of participants or researchers [ 13 , 16 , 22 , 26 , 28 , 31 , 43 , 44 , 46 , 48 – 50 , 57 , 59 , 60 ]. Thirty-nine studies had a parallel design with a single control group [ 12 – 22 , 25 – 27 , 29 – 41 , 43 – 51 , 53 , 55 , 56 ], six included three or more parallel intervention groups [ 23 , 24 , 42 , 52 , 54 , 58 ], and two had a crossover design [ 57 , 59 ].…”

“…Acupuncture was the most frequently investigated KM and was assessed in 21 studies ( n = 195) [ 12 – 32 ]. Herbal medicines were investigated in 17 studies ( n = 132) [ 33 – 44 , 54 – 58 ], moxibustion in four ( n = 25) [ 45 – 47 , 59 ], cupping therapies in two ( n = 5) [ 48 , 49 ], and mixed interventions in five ( n = 12) [ 50 – 53 , 60 ] (Supplementary File 2 ). Forty-four studies received funding support from the government, research institutions, or schools [ 12 – 25 , 27 – 32 , 34 – 56 , 58 ].…”

“…Sequence generation was conducted appropriately using a random number table or by coin tossing, and allocation concealment was achieved adequately in the studies using sealed opaque envelopes. However, in the open trials, the risk of bias was evaluated as high or unclear in the domains concerning blinding of research personnel and participants [ 12 , 13 , 16 , 22 , 26 , 28 , 29 , 31 , 43 , 44 , 46 , 48 – 50 , 57 ]. Selective outcome reporting and other domains showed a low risk of bias in most studies (Supplementary Files 4 and 5 ).…”

Comparative Effectiveness of Cheonwangbosimdan (Tian Wang Bu Xin Dan) Versus Cognitive-Behavioral Therapy for Insomnia in Cancer Patients: A Randomized, Controlled, Open-Label, Parallel-Group, Pilot Trial

“…94 , 95 Gamiguibi-tang, a traditional KM, also has been used to mitigate sleep disturbance represented efficacy and safety for cancer patients with insomnia. 96 …”