A Randomized, Double-blind, and Placebo-controlled Study on the Treatments of Irritable Bowel Syndrome

Conditions

Irritable Bowel Syndrome

Keywords

Irritable bowel syndrome,, Pinaverium, Herbal medication for IBS,, Tong Xie Yao Fang (Formula for pain and diarrhea)

Brief summary

The purpose of this study is to test the efficacy and safety of pinaverium and an herbal medication for irritable bowel syndrome (IBS). Pinaverium has been in many countries, but there is no randomized, double-blind, large sample size, and placebo-controlled study on this medication yet. Tong Xie Yao Fang (Formula for pain and diarrhea) is a historically and contemporarily used traditional Chinese medicine that can be used for IBS. The hypothesis is that the two remedies are effective and safe for IBS treatment when tested by modern clinical standards and criteria.

Detailed description

Pinaverium bromide (pinaverium), an antispasmodics, is one of the most commonly used IBS medication worldwide. However, original clinical studies on pinaverium are scarce. Only five original clinical studies from Europe, one from Latin America, and one from Asian were found. These studies were single-centered and small sample sized (19 - 53 IBS patients) studies. Tong Xie Yao Fang has long been used in China. Its efficacy and safety has not been evaluated by modern scientific method. This study is designed to evaluate the efficacy and safety of pinaverium and Tong Xie Yao Fang for IBS treatment in a double-blind, randomized, and large sample size clinical trial using placebo as a control.

Wang Y, Fan H, Qi X, Lai Y, Yan Z, Li B, Tang M, Huang D, Li Z, Chen H, Zhu Q, Luo C, Chen X, Fen J, Jiang Z, Zheng L, Liu X, Tang Q, Zuo D, Ye J, Yang Y, Huang H, Tang Z, Lu W, Xiao J, Pharm D for the China Irritable Bowel Syndrome Consortium.

2018-08-086 citations

10.1016/j.ctim.2018.07.002

Tongxie Formula Reduces Symptoms of Irritable Bowel Syndrome.

Fan H, Zheng L, Lai Y, Lu W, Yan Z, Xiao Q, Li B, Tang M, Huang D, Wang Y, Li Z, Mei Y, Jiang Z, Liu X, Tang Q, Zuo D, Ye J, Yang Y, Huang H, Tang Z, Xiao J, China Irritable Bowel Syndrome Consortium.

2017-06-1721 citations

10.1016/j.cgh.2017.06.026

Pinaverium Reduces Symptoms of Irritable Bowel Syndrome in a Multicenter, Randomized, Controlled Trial.

Zheng L, Lai Y, Lu W, Li B, Fan H, Yan Z, Gong C, Wan X, Wu J, Huang D, Wang Y, Mei Y, Li Z, Jiang Z, Liu X, Ye J, Yang Y, Huang H, Xiao J.

2015-01-2646 citations

10.1016/j.cgh.2015.01.015

Interventions

DRUGPinaverium

To test the effectiveness and safety of the formula for pain and diarrhea, we will randomly assign patients into one 3 groups: Pinaverium, TCM (Formula for pain and diarrhea) group, and placebo group, and treat them accordingly.

DEVICEAtractylodes

Atractylodes (\ 10-15g)

DEVICEPaeonia Lactiflora

Paeonia Lactiflora (\ 15-30g)

DEVICETangerine Peel

Tangerine Peel (\ 10g)

DRUGLedebouriella Root

Ledebouriella Root (\ 10g)

DRUGRadix codonopsitis

Radix codonopsitis (\ 10-15g)

DRUGRadix curcumae

Radix curcumae (\ 10g)

DRUGFingered citron

Fingered citron (\ 10g)

DRUGTuckahoe

Tuckahoe (15g)

DRUGPlacebo

Placebo is blindly given to patients.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

No

Inclusion criteria

* 18 to 70 years old age group, male and female * In accordance with the above Western medicine Rome III standards. * In accordance with the above description of Deficient Spleen Qi and Liver Qi Stagnation * Informed consent for treatment * No change in appetite during treatments periods

Exclusion criteria

* Pregnant or lactation female patients, and Fertility male patients * Present digestive system disease within current three months * Take IBS medicines within ten days prior to treatment or during treatment * Take depression medicine within ten days prior to treatment or during treatment * Take pain reliever medicine within ten days prior to treatment or during treatment * Have serious primary heart, liver, kidney, lung and blood system diseases, asthma, and Lung and liver dysfunction patients * If an emergency occurs; a physician terminates the treatment * Cannot comply with the rules and cannot cooperate

Design outcomes

Primary

Measure	Time frame	Description
The relief of irritable bowel syndrome symptoms was used to measure the effectiveness of the drugs	TCM group: 4 weeks. Pinaverium: 4 weeks. Placebo: 4 weeks.	The parameters used to evaluate the effectiveness of the drugs included i) Abdominal pain (0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain); ii) Frequency of the pain (# of pains per day); iii) Abdominal discomfort (0 = No discomfort,1 = mild,2 = moderate,3 = severe); iv) Frequency of discomfort (# of discomfort per day); v) # of stools per day; vi) Form (appearance) of stool (0 = Normal,1 = soft pieces with clear-cut edges,2 = mushy,3 = watery)

Secondary

Measure	Time frame	Description
The side effect associated with the treatments	TCM group: 4 weeks. Pinaverium: 4 weeks. Placebo: 4 weeks.	The following will be documented: constipation, headache, dizzy, hypertension, chest pain, abdominal pain, flatus, anxiety, insomnia, nausea, fever, fatigue, muscle pain, urinary infection, respiratory tract infection, Others.

Countries

China

Outcome results

None listed