• Journal of Acupuncture Research
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• v.28 no.5
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• pp.29-38
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• 2011

Objectives : Recent well-designed randomized controlled trials(RCTs) and their meta-analysis have been published on the efficacy of acupuncture in different condition. In most of them, real acupuncture is compared with sham acupuncture including invasive and non-invasive sham methods. But it is not clear how active sham methods are. These results tend to lead the conclusion that acupuncture has no more effective than sham acupuncture. In order to investigate that sham acupuncture is appropriate as a control, we reviewed several acupuncture trials using different sham acupuncture as a control. Methods : We searched Cochrane researches of acupuncture, reviewed and analyzed 25 RCTs in 42 Cochrane reviews. And especially we compared the effect of acupuncture according to the type of sham acupuncture. Results : Invasive sham acupunctures are used in 12 RCTs and non-invasive types are used in the rest. The majority of studies(19 RCTs) fail to show effects beyond a sham acupuncture. Streitberger's sham needle is a validated sham acupuncture of non-invasive type that was used in 8 trials and also no significant group differences are shown except one trial. Conclusions : Acupuncture is a complex intervention. Clinical trials of acupuncture need to be reexamined and redesigned to remove several bias. Especially, sham acupuncture as a control might be investigated for physiological effects as well as validation test including patient-blinding and de qi sensation. Other research need to be investigated and developed for acupuncture trials.

• Journal of Oriental Neuropsychiatry
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• v.28 no.4
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• pp.319-332
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• 2017

Objectives: The present study aimed to provide clinical evidence on the effect of herbal medicine, Hyeolbuchukeo-tang or Xuefu Zhuyu decoction for the treatment of primary insomnia using a systematic review and meta-analysis of randomized controlled trials (RCTs). Methods: This study included RCTs that verified the effects of Hyeolbuchukeo-tang or Xuefu Zhuyu decoction for the treatment of primary insomnia. Literature searches of English, Chinese and Korean databases were performed, and the selected literature was assessed for investigating the risk of bias. Results: The analysis included 10 RCTs. The Chinese Classification of Mental Disorders-3 was most frequently used to define the diagnostic criteria for Hyeolbuchukeo-tang or Xuefu Zhuyu decoction intervention in patients with primary insomnia. The effective rate was the most commonly used outcome measure. A meta-analysis revealed that the effective rate, the Pittsburgh Sleep Quality Index, and the Athens Insomnia Scale in the Modified Xuefu Zhuyu decoction (MXZD) group were higher compared to Western Medicine (WM) group (RR: 1.17, 95% Cl: 1.08 to 1.26, p<0.0001, $I^2$=0/MD: -1.29, 95% Cl: -2.09 to -0.49, p=0.002, $I^2$=0%/MD: -0.99, 95% Cl: -1.81 to -0.18, p=0.02, $I^2$=15%). The effective rate of the MXZD+WM group was significantly different compared to the WM group (RR: 1.28, 95% Cl: 1.11 to 1.47, p=0.0006, $I^2$=2%). The included RCTs were of relatively poor quality and had small sample sizes. Conclusions: Treatment with Hyeolbuchukeo-tang or Xuefu Zhuyu decoction was found to be effective in treating primary insomnia. However, the included RCTs were of relatively poor quality and had small sample sizes. It is hypothesized that this study could serve as a foundation for further clinical studies on the development of diagnosis and treatment methods for primary insomnia based on Korean medicine.

• Journal of Society of Preventive Korean Medicine
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• v.26 no.2
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• pp.11-24
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• 2022

Objectives : This study was designed to investigate the effect of Banhahubak-tang on gastroesophageal reflux disease(GERD) through a systematic review and meta-analysis of randomized controlled trials(RCTs). Methods : RCTs using Banhahubak-tang on GERD was searched in databases such as EMBASE, PubMed, MEDLINE, CENTRAL, CNKI, KISS, RISS, ScienceON, and OASIS. RCTs published up to October 8th, 2021 were included. Meta-analysis was performed by synthesizing outcome data, including Total Effectiveness Rate (TER), Reflux Symptom Index(RSI), Reflux Finding Score(RFS), and Incidence of Adverse Reactions. RevMan 5.4 software was used for data analysis. The Cochrane collaboration bias risk assessment scale was used to evaluate the methodological quality of the included studies. Results : Ten RCTs met the inclusion criteria. The total effective rate was the most commonly used outcome measure. The meta-analysis revealed that the TER in the experimental group was higher than that of the control group(N=2, RR:1.22, 95% CI:1.09 to 1.36, P=0.0004, I²=0%)(N=6, RR:1.22, 95% CI:1.14 to 1.32, P<0.00001, I²=0%)(N=8, RR:1.22, 95% CI: 1.14 to 1.30, P<0.00001, I²=0%). On the other hand, RSI(N=2, MD : -4.29, 95% CI: -4.71 to -3.86, I²=94%), RFS(N=2, MD : -3.28, 95% CI: -3.71 to -2.85, I²=96%), and Incidence of Adverse Reactions(N=5, RR: 0.32, 95% CI: 0.17 to 0.61, I²=0%) in the experimental group were lower than that of the control group. Conclusion : Treatment with Banhahubak-tang was found to be effective on GERD. However the results might be biased because of the poor quality and small sample size of the included RCTs.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.34 no.3
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• pp.27-54
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• 2021

Objectives : This review was conducted to validate the effectiveness and safety of herbal medicine combined with conventional therapy for rosacea. Methods : Randomized controlled trials(RCTs) reporting the effects of herbal medicine treatment on rosacea were searched through eight electronic databases from 2016 to March 17, 2020. This study collection and data extraction were performed by two independent reviews. The Cochrane risk-of-bias tool was used for the evaluation of the risk of bias in all included RCTs. Mean differences(MD) and Risk ratio(RR) of 95% Confidence intervals(Cls) were calculated and data synthesis was conducted using Review Manager(RevMan, ver.5.4) Results : Eighteen RCTs were included and all trials compared the combined therapy of herbal medicine with conventional western therapy to conventional therapy alone. The effective rate of the combination of herbal medicine with western medicine(RR 1.20, 95% CI : 1.13-1.28, p<0.00001, I²=0%), the effective rate of the combination of herbal medicine with laser-based therapy(RR 1.12, 95% CI : 1.04-1.21, p=0.004, I²=18%) and the effective rate of the combination treatment group using herbal medicine, western medicine and external drugs were all statistically higher that of the control group(RR 1.19, 95% CI : 1.11-1.28, p<0.00001, I²=0%). The score of non transient erythema(MD -0.36, 95% CI : -1.01 0.29, p=0.27, I²=93%), flushing(MD -0.69, 95% CI : -0.97, 0.41, p<0.00001, I²=32%), papules or pustules(MD 0.10, 95% CI : -0.15, 0.35 p=0.44, I²=0%) were also seen in the herbal medicine and western medicine combination group. The overall risk of bias of the included studies was some concerns. No serious adverse effects were observed. Conclusions : This review found the safety and effectiveness of the combined therapy of herbal medicine with conventional western therapy for rosacea.

• Journal of Sasang Constitutional Medicine
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• v.29 no.4
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• pp.317-325
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• 2017

Objectives This study is aimed to develop a Clinical Practice Guideline (CPG) on acupuncture treatment for the stroke patients with Post-stroke Urinary Incontinence(PSUI). Methods Experts committee, consisting of stroke or methodology specialists, searched Medline, EMBASE, Cochrane Library, China National Knowledge Infrastructure, and 19 Korean medicine journals. The search terms were selected to screen the randomized controlled trials (RCTs) or systematic reviews for the effectiveness of acupuncture on PSUI, compared with placebo or conventional group. Levels of evidence and grades of recommendations were appraised based on Recommendations for Development of Clinical Practice Guideline in Korean Medicine. Results & Conclusions 8 RCT were included to build the CPG. There was a strong evidence to support the effectiveness of acupuncture treatment for PSUI. The moderate evidence was presented that over 3 times a week of the acupuncture should be performed over 4 weeks on the acupoints, such as BL23, CV3, SP6, CV4, CV6, ST28, BL28, BL32, GV20, BL22, GV4 or ST36, for 15-30 minutes. 1-150 Hz frequency is suggested if electro-acupuncture treatments is performed with. It was also suggested that the procedure should begin at the acute stage just after the vital signs of the patients are stabilized. There was a moderate evidence to support safety of acupuncture treatment for PSUI. We recommend acu-points of constitutional acupuncture for Sasangin on the healthy side.