Effects of a Herbal Medicine, Yukgunja-Tang, on Functional Dyspepsia Patients Classified by 3-Dimensional Facial Measurement: A Study Protocol for Placebo-Controlled, Double-Blind, Randomized Trial

Kim, Ju‐Yeon; Park, Jae-Woo; Ko, Seok‐Jae; Jeon, Soo-Hyung; Kim, Jong-Won; Yeo, In‐Kwon; Kim, Jin-Sung

doi:10.1155/2017/2894507

Cited by 6 publications

(8 citation statements)

References 30 publications

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“…NDI is yet another most commonly used analysis tool for FD specifically to measure the symptoms and health-related quality of life [ 38 ]. NDI index was validated by Nkurunziza et al and has been widely used in many recent studies [ 45 , 49 , 50 ]. In the present study, NDI scores were significantly reduced (47%) in Asafin treated group in comparison with the baseline values, whereas no significant change was observed in placebo.…”

Section: Discussionmentioning

confidence: 99%

Safety and Efficacy of Ferula asafoetida in Functional Dyspepsia: A Randomized, Double-Blinded, Placebo-Controlled Study

Malá

Thomas²,

Syam

et al. 2018

Evidence-Based Complementary and Alternative Medicine

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Despite the availability of various synthetic drugs for the treatment of functional dyspepsia (FD), the side effects and their cost have always created a great interest in the search for novel natural alternatives for the management of gut disorders. The present contribution reports the safety and efficacy of the kitchen spice asafoetida (Ferula asafoetida) in FD for the first time. In the double-blinded, placebo-controlled study, 43 subjects diagnosed to have moderate to severe discomforts of nonulcer FD were randomized to receive hard-shell capsules (250 mg × 2/day) of either placebo (n=22) or a food-grade formulation of asafoetida (Asafin) (n=21) for 30 days. When evaluated by a set of validated indexing tools (GSRS, GDSS, and NDI), almost 81% in the Asafin group showed significant (p < 0.01) improvement in the overall score and quality of life as compared to the placebo. At the end of the study, 66% of subjects in the Asafin group remained symptoms-free. Although the symptoms score improved significantly in both the groups (from -5.67 to -25.29 in Asafin group versus -1.55 to -6.0 in the placebo; p ≤ 0.001), the relative percentage of subjects in the Asafin group with more than 80% reduction in various symptoms were: bloating (58%), appetite (69%), postprandial fullness (74%) motion sickness (75%), and digestion (77%) as compared to less than 10% nonspecific improvement in the placebo group. All the subjects remained safe with no adverse events or variations in haematological and biochemical parameters. The study was registered at http://ctri.nic.in/ (CTRI/2018/ 01/011149).

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Section: Discussionmentioning

confidence: 99%

Safety and Efficacy of Ferula asafoetida in Functional Dyspepsia: A Randomized, Double-Blinded, Placebo-Controlled Study

Malá

Thomas²,

Syam

et al. 2018

Evidence-Based Complementary and Alternative Medicine

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“…Thirty-four of the 49 RCTs were performed at a single center [ 14 , 15 , 17 , 19 – 21 , 23 – 27 , 29 , 31 , 32 , 34 , 35 , 37 , 39 , 40 , 42 – 45 , 47 – 53 , 57 – 60 ], and 15 were multicenter [ 12 , 13 , 16 , 18 , 22 , 28 , 30 , 33 , 36 , 38 , 41 , 46 , 54 – 56 ]. 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 ...…”

Section: Resultsmentioning

confidence: 99%

“…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 ].…”

Section: Resultsmentioning

confidence: 99%

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

Jeon

Nam

Kim

2021

Trials

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Background The dropout rate is an important determinant of outcomes in randomized controlled trials (RCTs) and should be carefully controlled. This study explored the current dropout rate in studies of Korean medicine (KM) interventions by systematic evaluation of RCTs conducted in the past 10 years. Methods Three clinical trial registries (Clinical Research Information Service, ClinicalTrials.gov, and World Health Organization International Clinical Trials Registry Platform) were searched to identify RCT protocols for KM interventions, such as acupuncture, herbal medicine, moxibustion, or cupping, and studies of mixed interventions, registered in Korea from 2009 to 2019. The PubMed, Embase, and OASIS databases were searched for the full reports of these RCTs, including published journal articles and theses. Dropout rates and the reasons for dropping out were analyzed in each report. The risk of bias in each of the included studies was assessed using the Cochrane risk of bias tool. The risk difference for dropping out between the treatment and control groups was calculated with the 95% confidence interval in a random effects model. Results Forty-nine published studies were included in the review. The median dropout rate was 10% in the treatment group (interquartile range 6.7%, 17.0%) and 14% in the control group (interquartile range 5.4%, 16.3%) and was highest in acupuncture studies (12%), followed by herbal medicine (10%), moxibustion (8%), and cupping (7%). Loss to follow-up was the most common reason for dropping out. The risk difference for dropping out between the intervention and control groups was estimated to be 0.01 (95% confidence interval − 0.02, 0.03) in KM intervention studies. Conclusions This review found no significant difference in the dropout rate between studies according to the type of KM intervention. We recommend allowance for a minimum dropout rate of 15% in future RCTs of KM interventions. Review protocol registration PROSPERO CRD42020141011

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“…The trial protocol was approved by the Institutional Review Board of the Kyung Hee University Korean Medicine Hospital (IRB number KOMCIRB-160115-HR-001) and the Dong-Eui University Korean Medicine Hospital (IRB number 2016-01). The protocol for this study was previously published [ 31 ] and there were no major changes to the design after initiation of the study.…”

Section: Methodsmentioning

confidence: 99%

“…In the GB subtype, the area of the side face is smaller than that of the front face. A detailed explanation of the 3-FSDS was described in a previously published paper [ 31 ].…”

Section: Methodsmentioning

confidence: 99%

An Herbal Medicine, Yukgunja-Tang is more Effective in a Type of Functional Dyspepsia Categorized by Facial Shape Diagnosis: A Placebo-Controlled, Double-Blind, Randomized Trial

Park

Lee

et al. 2018

Evidence-Based Complementary and Alternative Medicine

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Introduction Functional dyspepsia (FD) is a functional gastrointestinal disorder characterized by persistent upper dyspeptic symptoms without organic lesions. There is no standard therapy for FD. Yukgunja-tang (YGJT) is an herbal medicine used for treating upper gastrointestinal symptoms in Asia. Studies on the effect of YGJT on FD have been conducted. However, the results were inconsistent. In Hyungsang medicine, traditional Korean medicine, FD patients are classified into bladder body (BB) or gallbladder body (GB) subtypes by the shape and angle of their faces. Each subtype may have different characteristics, physiology, and pathology of the same disease. YGJT is more effective for patients with BB subtype. The three-dimensional facial shape diagnostic system (3-FSDS) was shown to be effective in diagnosing BB or GB subtypes. This study aimed to investigate the effect of YGJT on FD patients classified using the 3-FSDS. Materials and Methods The current study was a placebo-controlled, double-blinded, randomized, two-center trial. Eligible patients were diagnosed with either BB or GB FD subtype using the 3-FSDS. Ninety-six participants (48 BB and 48 GB subtypes) were randomly allocated to treatment or control groups in a 2:1 ratio. YGJT or placebo was administered for eight weeks. The primary outcome was assessed using the total dyspepsia symptom scale (TDS), while the secondary outcomes were assessed using the single dyspepsia symptom scale (SDS), proportion of responders, visual analog scale, Nepean dyspepsia index, functional dyspepsia-related quality of life, and spleen qi deficiency questionnaire. Results and Discussion The result of TDS showed the superior effect of YGJT on BB over GB subtype. The subgroup analysis of TDS and SDS scores showed the superior effect of YGJT over placebo. Other outcome variables did not show any significant differences between groups. Conclusion YGJT may be considered for FD patients diagnosed with BB subtype using 3-FSDS.

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Effects of a Herbal Medicine, Yukgunja-Tang, on Functional Dyspepsia Patients Classified by 3-Dimensional Facial Measurement: A Study Protocol for Placebo-Controlled, Double-Blind, Randomized Trial

Cited by 6 publications

References 30 publications

Safety and Efficacy of Ferula asafoetida in Functional Dyspepsia: A Randomized, Double-Blinded, Placebo-Controlled Study

Safety and Efficacy of Ferula asafoetida in Functional Dyspepsia: A Randomized, Double-Blinded, Placebo-Controlled Study

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

An Herbal Medicine, Yukgunja-Tang is more Effective in a Type of Functional Dyspepsia Categorized by Facial Shape Diagnosis: A Placebo-Controlled, Double-Blind, Randomized Trial

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