Acute Pancreatitis
Conditions
Keywords
Tongfu Qinghua Decoction, Ruyi Jinhuang Powder, Traditional Chinese Medicine, Rectal Administration, Traditional Chinese Medicine Enema, External Application, Integrated Chinese and Western Medicine, Gastrointestinal Function
Brief summary
Acute pancreatitis is an inflammatory condition that commonly causes abdominal pain, abdominal distension, impaired gastrointestinal function, and elevated pancreatic and inflammatory biomarkers. Although conventional medical treatment can stabilize most patients, recovery of gastrointestinal function and relief of local inflammation may remain slow. This completed, single-center, randomized controlled study evaluated whether adding Tongfu Qinghua Decoction administered by enema and Ruyi Jinhuang Powder applied externally to conventional medical treatment could improve clinical recovery in adults with acute pancreatitis. A total of 100 participants aged 18 to 75 years were randomly assigned in a 1:1 ratio to receive either conventional medical treatment alone or conventional medical treatment combined with Tongfu Qinghua Decoction enema and external application of Ruyi Jinhuang Powder. Both groups received treatment for 5 days. The study evaluated overall clinical response, length of hospital stay, time to relief of abdominal pain and abdominal distension, recovery of bowel function, time to first food intake, serum and urinary amylase levels, C-reactive protein, procalcitonin, and treatment-related adverse events.
Detailed description
Acute pancreatitis is an acute inflammatory disease caused by abnormal activation of pancreatic enzymes, resulting in injury to the pancreas and surrounding tissues. Patients may experience abdominal pain, abdominal distension, reduced bowel motility, delayed passage of flatus and stool, and systemic inflammatory responses. Conventional management generally includes fasting, gastrointestinal decompression, fluid and nutritional support, inhibition of pancreatic secretion, anti-infective treatment when clinically indicated, and symptomatic treatment. However, gastrointestinal dysfunction and inflammatory responses may persist in some patients. This study was designed to evaluate the efficacy and safety of Tongfu Qinghua Decoction administered by enema combined with external application of Ruyi Jinhuang Powder as an adjunct to conventional medical treatment in patients with acute pancreatitis. This was a single-center, prospective, randomized, parallel-group clinical study conducted at Ruian People's Hospital. A total of 100 eligible participants were randomly assigned in a 1:1 ratio to an experimental group or a control group, with 50 participants in each group. Randomization was performed using a computer-generated random number table. Allocation information was placed in sequentially numbered, sealed, opaque envelopes, which were opened after eligibility confirmation and written informed consent. Participants in the control group received conventional medical treatment, including restriction of oral food and fluids when clinically required, gastrointestinal decompression, fluid resuscitation, nutritional support, inhibition of pancreatic secretion, anti-infective treatment, and analgesic or antispasmodic therapy when necessary. Participants in the experimental group received the same conventional medical treatment together with Tongfu Qinghua Decoction enema and external application of Ruyi Jinhuang Powder. Tongfu Qinghua Decoction was centrally prepared by the hospital's Traditional Chinese Medicine pharmacy. The core formula contained rhubarb, mirabilite, Magnolia officinalis bark, fried immature bitter orange, dandelion, Patrinia herb, Polygonum cuspidatum, honeysuckle, and Salvia miltiorrhiza. Prespecified modifications could be made according to the participant's traditional Chinese medicine syndrome manifestations. The concentrated decoction was prepared to a volume of approximately 200 mL and cooled to 38 to 40 degrees Celsius before administration. With the participant positioned in the left lateral position, a lubricated rectal tube was inserted approximately 15 to 20 cm, and the decoction was administered slowly. Participants were instructed to retain the solution for approximately 30 minutes. The enema was administered once daily for up to 5 consecutive days. Administration could be discontinued earlier if abdominal pain and distension resolved, spontaneous bowel movements recovered, or diarrhea developed. Ruyi Jinhuang Powder was mixed with water or tea to form a paste, applied to gauze, and placed over the Shenque acupoint and the surrounding 3 to 5 cm area. The application was secured with adhesive tape and removed after approximately 4 hours. It was administered twice daily for 5 days. The primary clinical assessment was the overall treatment response after the 5-day treatment period. Clinical response was categorized according to changes in symptoms, signs, and laboratory indicators. Additional assessments included length of hospital stay; time to relief of abdominal pain and abdominal distension; time to first passage of flatus; time to first bowel movement; time to recovery of bowel sounds; and time to first food intake. Serum amylase and urinary amylase were measured before treatment and after completion of the treatment course to assess changes in pancreatic inflammatory activity. Serum C-reactive protein and procalcitonin were also measured before and after treatment to evaluate systemic inflammatory responses. Adverse events of interest included gastrointestinal bleeding, dizziness, headache, gastrointestinal discomfort, skin rash, and perianal redness or swelling. Adverse events were collected through participant reporting, daily clinical observation, and structured assessment on treatment days 1, 3, and 5, at discharge, and 7 days after discharge. Because the enema and external application procedures were readily identifiable, complete blinding of participants, treating clinicians, and outcome assessors was not feasible. To reduce assessment bias, outcome assessors received standardized training, data were recorded using a standardized electronic case report form, assessments were independently cross-checked by two researchers, and disagreements were reviewed by a senior clinician. Treatment-group information was concealed during data entry and statistical analysis where feasible.
Interventions
DRUGTongfu Qinghua Decoction Enema
Tongfu Qinghua Decoction contained rhubarb 10 g, mirabilite 10 g, Magnolia officinalis bark 10 g, fried immature bitter orange 10 g, dandelion 30 g, Patrinia herb 30 g, Polygonum cuspidatum 30 g, honeysuckle 15 g, and Salvia miltiorrhiza 20 g. Prespecified syndrome-based modifications were permitted. The herbs were centrally decocted by the hospital pharmacy and concentrated to approximately 200 mL. The decoction was cooled to 38-40 degrees Celsius and administered slowly through a rectal tube inserted approximately 15-20 cm, with the participant in the left lateral position. Participants retained the solution for approximately 30 minutes. Treatment was administered once daily for up to 5 consecutive days and could be stopped earlier if symptoms resolved, spontaneous bowel movements occurred, or diarrhea developed.
DRUGRuyi Jinhuang Powder External Application
Ruyi Jinhuang Powder, manufactured by Jiangsu 707 Natural Pharmaceutical Co., Ltd., was mixed with water or tea to form a paste and spread onto gauze. The prepared dressing was externally applied over the Shenque acupoint (CV8) and the surrounding area extending approximately 3-5 cm. The dressing was secured with adhesive tape and removed after approximately 4 hours. The intervention was administered twice daily for 5 consecutive days.
Conventional medical treatment for acute pancreatitis was provided according to the participant's clinical condition. Treatment included restriction of oral food and fluids when clinically required, gastrointestinal decompression, fluid resuscitation, nutritional support, inhibition of pancreatic secretion, and anti-infective treatment when indicated. Analgesic and antispasmodic medications were administered for symptomatic relief when necessary. The treatment course was 5 days.
Sponsors
The Third Affiliated Hospital of Wenzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This was an open-label study. Because the Tongfu Qinghua Decoction enema and external application of Ruyi Jinhuang Powder were readily identifiable, participants, care providers, investigators, and outcome assessors were not blinded to treatment assignment. To reduce assessment bias, standardized outcome definitions and electronic case report forms were used, assessments were independently cross-checked, and group information was concealed during data entry and statistical analysis where feasible.
Intervention model description
This was a two-arm, randomized, parallel-group controlled study. Participants were assigned in a 1:1 ratio to receive either conventional medical treatment alone or conventional medical treatment combined with Tongfu Qinghua Decoction enema and external application of Ruyi Jinhuang Powder for 5 days.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of acute pancreatitis according to established clinical diagnostic criteria. * Age 18 to 75 years. * First episode of acute pancreatitis with no treatment received before enrollment. * Voluntary participation and provision of written informed consent.
Exclusion criteria
* Presence of an indication for surgical intervention. * Pre-existing severe gastrointestinal disease. * Significant organ dysfunction or another severe underlying disease. * Pregnancy or breastfeeding. * A mental or psychiatric condition that prevented effective participation in the study. * Any contraindication to traditional Chinese medicine enema treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Clinical Response Rate | At the end of the 5-day treatment period | Percentage of participants who achieved complete cure, marked response, or response after the 5-day treatment period. Complete cure was defined as disappearance of clinical symptoms and signs within 5 days, together with normalization of relevant laboratory indicators. Marked response was defined as disappearance of clinical symptoms and signs within 5 days, together with substantial improvement in laboratory indicators. Response was defined as improvement in clinical symptoms, signs, and laboratory indicators within 5 days. No response was defined as no improvement or worsening of clinical symptoms and signs. Death due to deterioration of acute pancreatitis was not counted as a clinical response. The overall clinical response rate was calculated as: (number of participants with complete cure + marked response + response) / total number of participants assessed × 100%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | From hospital admission through discharge, approximately 1 week | Number of days from hospital admission to hospital discharge. |
| Time to Abdominal Pain Relief | From initiation of treatment through hospital discharge, approximately 1 week | Number of days from initiation of the assigned treatment to the first documented relief of abdominal pain, as assessed and recorded by the study investigators. |
| Time to Abdominal Distension Relief | From initiation of treatment through hospital discharge, approximately 1 week | Number of days from initiation of the assigned treatment to the first documented relief of abdominal distension. |
| Time to First Passage of Flatus | From initiation of treatment through hospital discharge, approximately 1 week | Number of days from initiation of the assigned treatment to the participant's first documented passage of flatus. |
| Time to First Bowel Movement | From initiation of treatment through hospital discharge, approximately 1 week | Number of days from initiation of the assigned treatment to the participant's first documented bowel movement. |
| Time to Recovery of Bowel Sounds | From initiation of treatment through hospital discharge, approximately 1 week | Number of days from initiation of the assigned treatment to the first documented recovery of bowel sounds on clinical examination. |
| Time to First Oral Food Intake | From initiation of treatment through hospital discharge, approximately 1 week | Number of days from initiation of the assigned treatment to the participant's first documented oral food intake permitted according to clinical recovery. |
| Change From Baseline in Serum Amylase | Baseline and immediately after completion of the 5-day treatment period | Serum amylase was measured in fasting venous blood and reported in units per liter (U/L). Change from baseline was calculated as the post-treatment value minus the baseline value. |
| Change From Baseline in Urinary Amylase | Baseline and immediately after completion of the 5-day treatment period | Urinary amylase was measured using a midstream clean urine sample and reported in units per liter (U/L). Change from baseline was calculated as the post-treatment value minus the baseline value. |
| Change From Baseline in C-Reactive Protein | Baseline and immediately after completion of the 5-day treatment period | Serum C-reactive protein was measured in fasting venous blood and reported in milligrams per liter (mg/L). Change from baseline was calculated as the post-treatment value minus the baseline value. |
| Change From Baseline in Procalcitonin | Baseline and immediately after completion of the 5-day treatment period | Serum procalcitonin was measured in fasting venous blood and reported in micrograms per liter (µg/L). Change from baseline was calculated as the post-treatment value minus the baseline value. |
| Incidence of Adverse Events | From signing informed consent through 7 days after hospital discharge | Percentage of participants who experienced at least one adverse event during the observation period. Adverse events of interest included gastrointestinal bleeding, dizziness, headache, gastrointestinal discomfort, skin rash, and perianal redness or swelling. Adverse events were collected through participant reporting, daily clinical observation, and structured follow-up assessments. |
Countries
China
Outcome results
None listed