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JKM > Volume 41(1); 2020 > Article
Nam: The Effectiveness of Bojungikgi-tang and its modifications on Chronic Fatigue Syndrome: A Systematic Review And Meta-analysis

Abstract

Objectives

The aim of this review is to ascertain whether Bojungikgi-tang and its modifications is more effective than non-specific management in chronic fatigue syndrome (CFS).

Methods

We collected clinical trials to investigate the effects of Bojungikgi-tang and non-specific management on general symptoms, fatigue, and sleep quality in CFS patients. The databases used for data retrieval were Pubmed, Central Cochrane, CNKI, VIP, CiNii, OASIS, RISS, and Koreamed. We performed selection/exclusion process from the found records according to prespecified criteria, and assessed the final included trials according to the Cochrane risk of bias tool. The included studies were classified on the basis of interventions in experimental group.

Results

Seven randomized controlled trials (476 participants) were eligible and their results were synthesized in the meta-analysis. The synthesis showed a substantial effect of Bojungikgi-tang (relative risk 0.20 [95% CI 0.13 to 0.31], Z=7.44, P<0.00001; I2=0%) and combination of Bojungikgi-tang and Sosiho-tang (relative risk 0.15 [95% CI 0.08 to 0.28], Z=5.85, P<0.00001; I2=0%) compared with non-specific management on improvement of general symptoms. However, we could not find sufficient clinical research records to determine their effects of improvement on fatigue and sleep quality.

Conclusions

Bojungikgi-tang and its modifications are more effective than non-specific management for improvement of general symptoms in CFS post-treatment.

Fig. 1
PRISMA chart. It presents the process for study selection
jkm-41-1-93f1.gif
Fig. 2
Risk of bias summary (A) and its graph (B). Each risk of bias item for all included studies was shown.
jkm-41-1-93f2.gif
Fig. 3
Forest plot for improvement of general symptoms.
jkm-41-1-93f3.gif
Table 1
Summary Table of the Included Studies.
Author Year Diagnostic criteria Pattern No. of case (male : female) [experimental : control] Intervention Outcomes Adverse event
Experimental control Duration
Shu YQ 1997 CDC 1988 - 58 (16:42) [30:28] BIT a,b Usual care 2 months Effectiveness N.A.E.
Yang SH 2004 CDC 1994 Liver depression and spleen deficiency 72 (35:37) [38:34] BIT+SST c Supplement 1 month Effectiveness N.R.
Jiang Q 2012 CDC 1994 Insufficiency of middle qi, Dual deficiency of the heart and spleen 70 (35:35) [35:35] BIT+GBT a Supplement + education 8 weeks Effectiveness, IgA, IgG, IgM N.A.E.
Tian H 2012 CDC 1994 - 64 (36:28) [32:32] BIT a Usual care 8 weeks Effectiveness N.R.
Wang H 2012 CDC 1988 Liver depression and spleen deficiency 84 (32:52) [42:42] BIT+SST a Supplement 4 weeks Effectiveness, Symptom severity N.R.
Teng FY 2014 CDC 1994 Insufficiency of middle qi 60 (23:37) [30:30] BHT a,b Supplement 8 weeks Effectiveness N.R.
Li YM 2015 CDC 1994 Liver depression and spleen deficiency 68 (37:31) [34:34] BIT+SST a Supplement 4 weeks Effectiveness, Fatigue severity N.R.

BIT means Bojungikgi-tang (補中益氣湯); SST, Sosiho-tang (小柴胡湯); GBT, Gwibi-tang (歸脾湯); BHT, Bojunghaepi-tang (補中解疲汤); N.A.E., no adverse event; N.R., not reported.

a liquid extracted by boiling the raw material;

b modification according to symptoms;

c extract granules.

Table 2
The Quality of Evidence.
Outcome Certainty assessment Summary of findings

Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations Effect (95% CI) Certainty
General status Bojungikgi-tang (補中益氣湯) versus control: 7 studies

RCT Very seriousa Not seriousb Not seriousc Not seriousd Nonee RR 0.20 (0.13 ~ 0.31) ⊕⊕○○LOW

Bojungikgi-tang (補中益氣湯) versus control: 3 studies

RCT Very seriousa Not seriousb Not seriousc Seriousf Nonee RR 0.27 (0.15 ~ 0.49) ⊕○○○
VERY LOW

Bojungikgi-tang (補中益氣湯) + Sosiho-tang (小柴胡湯) versus control: 3 studies

RCT Very seriousa Not seriousb Not seriousc Not seriousd Nonee RR 0.15 (0.08 ~ 0.28) ⊕⊕○○
LOW

Bojungikgi-tang (補中益氣湯) + Gwibi-tang (歸脾湯) versus control: 1 study

RCT Very seriousa Not seriousb Not seriousc Seriousf Nonee RR 0.13 (0.02 ~ 0.95) ⊕○○○
VERY LOW

Fatigue Bojungikgi-tang (補中益氣湯) + Sosiho-tang (小柴胡湯) versus control: 1 study

RCT Very seriousa Not seriousb Not seriousc Seriousg Nonee MD 2.24 (3.02 ~ 1.46) ⊕○○○
VERY LOW

RCT means randomized controlled trial; CI, confidence interval; RR, relative risk; MD, mean difference.

a the proportion of studies assessed as low risk of bias was less than 30%;

b I2 was less than 50%;

c directness was undoubted;

d total sample size was more than 200, and 95% CI of RR did not cross 1;

e publication bias was not assessed;

f total sample size was less than 200, but 95% CI of RR did not cross 1;

g total sample size was less than 200, but 95% of MD did not cross zero.

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