Table 7.
Review of randomized controlled trials.
| First author (year) | Country | Sample size (T/C) | Sex (M:F) | Average age (T/C) | The average duration of disease (T/C) (m) | Diagnosed by | Intervention | Duration of treatment | Outcomes | Significant findings | Side effects (n) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Chin et al. (2012) [52] | China | 37 (23/14) | (T) 18:5 (C) 10:4 |
74.5 | No mention | El Escorial criteria | (T) Liqitongbianxieding decoction, general treatment, acupuncture, massage (C) Placebo, general treatment |
14d | TER Number of evacuation Stool characteristics Symptoms of difficulty in evacuation Companion symptoms during the evacuation Pulmonary function test |
TER T 100%, C 83.3% Improving number of evacuation, stool characteristics, symptoms of difficulty in evacuation, and companion symptoms during evacuation Improving peak airway pressure, respiratory frequency, and airway resistance |
Diarrhea(2) |
| Jin (2013) [53] | China | 28 (15/13) | (T) 11:4 (C) 9:4 |
54.45 (57.83/50.54) | (18.62/18.25) | ALS diagnosis criteria | (T) Guiluerxianjiaojiajian, riluzole, acupuncture (C) Riluzole |
6 m | ALSFRS-R TCM syndrome score |
Compared with the control group, the treatment group showed a lower decrease in the ALSFRS-R score | None |
| Pan et al. (2013) [54] | China | 42 (23/19) | (T) 14:9 (C) 11:8 |
50.4 (51.6/50.1) | (25.9/26.1) | El Escorial criteria | (T) Jiaweisijunzitang (C) Riluzole |
6 m | ALSFRS SF-36 physical function |
Limbs first attacked in patients in the treated group had a smaller rate of change of ALSFRS scores | Constipation(2) Nausea(2) |
| Fang (2016) [55] | China | 37 (18/19) | (T) 13:5 (C) 11:8 |
51.31 (49.1/53.4) | (17.6/12.9) | Guidelines for the diagnosis and treatment of ALS in China | (T) Jianpiyifei decoction (C) Riluzole |
12w | Frenchay Dysphagia score kubota drinking water test speech-ALSSS swallowing-ALSSS ALSFRS-R bulbar symptoms self-score |
No statistical significant difference | No mention |
| Bao et al. (2016) [56] | China | 45 (24/21) | (T) 15:9 (C) 14:7 |
No mention | No mention | El Escorial criteria | (T) Jiaweisijunzitang, general treatment (C) General treatment |
6 m | TCM spleen deficiency symptoms score Shortness of breath Mental fatigue score |
Delayed TCM deterioration Spleen deficiency symptoms, Shortness of breath, and mental fatigue |
No mention |
| Zhu et al. (2017) [57] | China | 45 (24/21) | (T) 15:9 (C) 14:7 |
No mention | No mention | El Escorial criteria | (T) Jiaweisijunzitang, general treatment (C) Placebo, general treatment |
9 m | ALSFRS-R TCM syndrome score |
Delaying the deterioration of related symptoms and ALSFRS-R | None |
| Gao et al. (2017) [58] | China | 42 (22/20) | (T) 14:8 (C) 13:7 |
50.4 (50.2/50.7) | (23.9/24.3) | El Escorial criteria | (T) Jian Pi Lian Se Tang (C) Placebo, general treatment |
6 w | QS FNU ESS ALSFRS |
Improving the scores of the QS, FNU, and ESS | None |
| Yang (2019) [59] | Korea | 30 (19/11) | (T-1) 5:5 (T-2) 7:3 (C) 7:3 |
56.47 (54.50/58.30/56.60) | No mention | El Escorial criteria | (T-1) Mecasin∗ 1.6 g, riluzole (T-2) Mecasin∗ 2.4 g, riluzole (C) Placebo, riluzole |
12 w | ALSFRS-R SF-8 MRC scale for muscle strength VAS pain HRSD FSS PGIC Pulmonary function test Creatinine kinase Body weight |
K-ALSFRS-R were significantly decreased in the (C) compared to (T-1), (T-2) | (T) Anxiety (2), Cough (2), Sputum (2), Insomnia (1), Hyperlipidemia (1), Shoulder pain (1), Low back pain (1), Tingling sense (1), Arm pain (1), Frequent voiding (1), Upper respiratory infection (1) (C) Insomnia (2), Constipation (1), |
∗ Curcuma longa, Salvia miltiorrhiza, Gastrodia elata, Chaenomeles sinensis, Polygala tenuifolia, Paeonia lactiflora, Glycyrrhiza uralensis, Atractylodes lancea, and Aconitum carmichaeli. It is a 30% ethanol extraction. T, treatment group; C, control group; M, male; F, female; w, week(s); m, month(s); TER, total effective rate; ALSFRS, amyotrophic lateral sclerosis functional rating scale; ALSFRS-R, ALSFRS-Revised; SF, short from; TCM, traditional Chinese medicine; ALSSS, amyotrophic lateral sclerosis severity scale; ESS, Epworth sleepiness scale; QS, quantity of salivation/sialorrhea; FNU, frequent nighttime urination; MRC, Medical Research Council; VAS, visual analogue scale; HRSD, Hamilton rating scale for depression; FSS, fatigue severity scale; and PGIC, patient global impression of change.