Table 1.
Characteristics of Included Studies.
| Author | Region, setting | Participants | Intervention | Control | Outcomes and main results | ||
|---|---|---|---|---|---|---|---|
| Age (y) | Diagnosis | Sample size | |||||
| Birling et al 25 | Australia, Trial center | E 52 (13) C 50 (16) |
Insomnia | E: 38 C: 47 |
ZRAS, 3 capsules, 2.28 g/capsule; oral, q.d. 4 weeks | Placebo 3 capsules of placebo oral q.d. 4 weeks | • ISI: E 11.6 (0.9), C 12.3 (0.9) • DASS: E 5.8 (0.8), C 5.9 (1.0) • FSS: E 33.1 (2.0), C 28.9 (1.8) • AQoL: E 16.3 (0.4), C 16.7 (0.5) • CSD and Actigraphy |
| Chan et al 34 | Taiwan, Hospital | E 40.6 (7.2) C 38.6 (6.9) |
General sleep disturbance | E: 45 C: 45 |
SZRT 4 g granules oral t.i.d 4 weeks | Placebo 4 g, granules oral t.i.d. 4 weeks | • PSQI: E 7.8 (3.7), C 9.6 (3.1) • BAI: E 12.8 (13.2), C 8.8 (13.0) • BDI-II: E 13.0 (13.9), C 11.5 (13.3) • Heroin craving by VAS and Sleep dairy |
| Dai et al 35 | China, Hospital | E 59.9 (8.3) C1 59.1 (8.8) C2 60.5 (9.2) |
Insomnia | E: 36 C1: 36 C2: 36 |
NXAS 1 bag of herbal granules oral b.i.d. 4 weeks | C1 placebo 1 bag, oral b.i.d. 4 weeks C2 Zopiclone 3.75 mg oral q.d. 4 weeks |
• ISI: E 11.0 (4.4), C1 16.0 (4.4), C2 9.5 (3.7) • PSQI: E 7.0 (3.7), C1 13.5 (3.7), C2 8.0 (1.7) • TCM Syndrome |
| Hu et al 36 | China, Hospital | E NA C NA |
Insomnia | E: 60 C: 59 |
SZR-ZZC 150 ml herbal decoction, oral b.i.d. 4 weeks | Lorazepam 2 tablets, 0.5 mg/tablet, oral b.i.d. 4 weeks | • ISI: E 7.2 (3.6), C 9.4 (4.1) • PSQI: E 7.6 (3.8), C 12.0 (3.4) • SAS: E 35.3 (12.9), C 40.3 (10.5) • Polysomnography |
| Lee et al 37 | Korea, Hospital | E 55.7 (23-70) C 52.6 (38-73) |
General sleep disturbance | E: 60 C: 59 |
GGBT 3.75 g dried spray of herbal extractions oral t.i.d. 2 weeks | waitlist (no treatment) | • ISI: E −5.5 (4.4), C 0.1 (1.1) • BDI: E −1.3 (7.0), C -0.4 (0.7) • BFI: E −0.8 (0.8), C 0.0 (0.3) • MoCA: E −0.1 (1.6), C 0.3 (1.3) |
| Moon et al 42 | Korea, Hospital | E 63 (53-71) C 63 (54-67) |
Insomnia | E: 11 C: 11 |
Cheonwangbosimdan 20 ml herbal decoction oral q.d. 4 weeks | CBT-I once per week for 4 weeks | • ISI: E −8.5 (−12.0, −5.0), C −6.5 (−10.0, −3.0) • PSQI: E −7.5 (−9.0, −5.0), C −3.5 (−5.0, −2.0) • SAS: E −7.5 (−9.0, −4.0), C 2.0 (−2.0, 5.0) • BFI: E −1.5 (−2.3, −1.2), C −0.8 (−1.3, −0.1) • EQ-5D-5L: E 0 (−0.03, 0.05), C 0 (−0.13, 0.01) • ECOG-PS and ESS (All data were presented as mean with 95% CI for this study) |
| Mun et al 43 | Korea, Hospital | E 37.7 (4.8) C 37.3 (6.0) |
Insomnia | E: 20 C: 20 |
HT002 hot tea 3 g herb infusion, oral b.i.d. 4 weeks | Waitlist (no treatment) | • ISI: E −4.0 (0.8), C −0.4 (0.8) (4 weeks); E −4.8 (0.7), C 0.9 (0.7) (8 weeks) • PSQI: results not reported • SF-12: E 2.2 (0.9), C −2.5 (0.9) (physical component score); E 3.6 (2.1), C −3.5 (2.1) (mental component score) |
| Scholey et al 44 | Australia, Hospital | E 31.0 (10.5) C 29.6 (9.1) |
Insomnia | E: 86 C: 85 |
LZComplex3 two tablets, 5.2 g/tablet, oral q.d. 2 weeks | Placebo two tablets oral q.d. 2 weeks | • ISI: results not reported • PSQI: E −1.8 (2.1), C −1.3 (2.4) (2 weeks); E −1.5 (2.3), C −1.7 (2.8) (3 weeks) • STAI-S: results not reported • QoLs: E 2.7 (2.0, 3.4), C 3.0 (2.3, 3.7) (data were presented as mean with 95% CI) • CFS: E −0.9 (−1.4, −0.5), C −1.0 (−0.5, −1.5) (data were presented as mean with 95% CI) • MTF: E −0.5 (−1.4, 0.1), C −0.7 (−1.5, 0.5) (data were presented as mean with 95% CI) • LESE, ESS, and CSD |
| Song et al 45 | China, Hospital | E 44.0 (10.5) C 39.3 (9.4) |
Insomnia | E: 120 C: 120 |
JWSZRD 150 ml decoction oral b.i.d.; lorazepam 0.5 mg oral q.d. 12 weeks | Lorazepam 0.5 mg oral q.d. 12 weeks | • ISI: specific data not reported • SAS: specific data not reported • SDS: specific data not reported • SSS: specific data not reported • SF-36: specific data not reported • Sleep diary |
Abbreviations: E, experimental group; C, control group; ZRAS, Zhao Ren An Shen; ISI, Insomnia Severity Index, DASS, Depression Anxiety Stress Scale 21-item; FSS, FSS, Fatigue Severity Scale; AQoL, Assessment of Quality of Life; CSD, Consensus Sleep diary; SZRT, Suan Zao Ren Tang; PSQI, Pittsburgh Sleep Quality Index; BAI, Beck anxiety inventory; DBI, Beck Depression Inventory; VAS, visual analog scale; NXAS, NXAS, Nin Xing An Sheng; TCM, traditional Chinese medicine; SZR-ZZC, Suan Zao Ren Tang-Zhi Zhi Chi Tang; SAS, Self Rating Anxiety Scale; GGBT, Gamguibi-tang; BFI, brief fatigue inventory; MoCA, Montreal Cognitive Assessment scores; CBT-I, Cognitive-behavioral therapy for insomnia; ESS, Epworth Sleepiness Scale; EQ-5D-5L, Euroqol-5 Dimensions 5 Levals; ECOG-PS, Eastern Corporative Oncology Group Performance Status; HT002, a herbal tea composed of 4 herbs; SF-12, 12-item Short Form Health Survey; LZComples3, a complex composed of lactium™; LESE, Leeds Sleep Evaluation Questionnaire, QoLs, Burckhardt Quality of Life Scale; CFS, Chalder Fatigue Scale; STAI-S, State-Trait Anxiety Inventory; MTF, multi-tasking framework; JW-SZRDz, Jiawei Suan Zao Ren Decoction; SDS, Slef Rating Depression Scale; SSS, Somatic Self Rating Scale; SF-36, 36 item Short Form Health Survey.