Able to improve the spasms of SO; literature showed that it treated biliary disorders effectively.

Contains the active pharmaceutical ingredient (API) and has the effects of fighting infection, alleviating pain, promoting bile secretion and lifting muscle spasms; literature showed that Danshu Capsules effectively improved the symptoms of biliary disorders, such as pain, nausea and abdominal distension.

Sphincter of Oddi Dysfunction

Danshu Capsules (0.9g potid/day) for three months by oral

Danshu Capsules

Pinaverium Bromide (100mg potid/day) for three months by oral

Pinaverium Bromide

Zhang Yong

Pinaverium Bromide in Post-cholecystectomy Sphincter of Oddi Dysfunction

Application of Pinaverium Bromide in the Treatment of Patients With Post-cholecystectomy Sphincter of Oddi Dysfunction (SOD): A Randomized, Controlled and Multicenter Clinical Study

abdominal pain scores (baseline vs. 3 months after treatment)
Abdominal pain score based on main symptom: Degree of pain in point（0 - no pain [0 point]；1~3 - mild pain [1 point]；4~6 moderate pain [2 point]]；7~10 - severe pain [3 point]）、Frequency in times/week (No episodes[0 point]；1 time/week[1 point]；2 times/week[2 point]; 3 times/week[3 point])、Duration in days/week(No episodes[0 point]；< 1 day/week[1 point]；1-2days/week[2 points]；≥ 3days/week[3 points])
The sum of the scores for the above three items is the total score for abdominal pain.
Efficacy evaluation: reduction in abdominal pain score, as compared with the baseline
= 100%: complete remission (CR)；60%~99%: significant remission (SR)；30% ~ 59%: partial remission (PR)；0% ~ 29%: no response (NR)
Treatment response = CR + SR
Treatment response rate = (CR + SR) / the total number of patients

Changes in the CBD diameter measured by ultrasound B
Each patient is required to abstain from eating for 12 hours and then takes a measurement of the CBD diameter by ultrasound B the next morning
The measurement takes places once a month, four times totally (baseline / 4w after treatment / 8w after treatment / 12w after treatment)

Changes in hepatic enzyme levels (ALT, AST and ALP)
The measurement takes place once a month, four times totally (baseline / 4w after treatment / 8w after treatment / 12w after treatment)

The number of patients presenting the symptoms of diarrhea will be calculated at the time of enrollment (baseline) and 3 months after treatment respectively.

Incidence of adverse events (throughout the treatment)
The type and number of adverse events will be calculated at the baseline and each visit
Inquire about symptoms: rashes, pruritus, acid regurgitation, abdominal distention, diarrhea, etc.
Perform the following examinations at the last visit: blood / urine / stool test, liver / kidney function test, ECG

sphincter of oddi dysfunction/diarreya

Pinaverium Bromide in Post-cholecystectomy Sphincter of Oddi Dysfunction

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