Acupuncture for Irritable Bowel Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether acupuncture can help children with gut-brain disorders, such as irritable bowel syndrome, feel better. It compares real acupuncture to a placebo version to determine any differences in pain reduction and quality of life improvement. Children aged 8-17 with specific stomach issues who have not tried acupuncture before may qualify. Participants will receive either real or placebo acupuncture alongside their usual care, and researchers will monitor changes in their symptoms. The goal is to discover a new way to help children manage these challenging conditions. As an unphased trial, this study provides a unique opportunity for children to explore an alternative treatment option that could enhance their quality of life.
Will I have to stop taking my current medications?
The trial requires that participants have been on stable doses of antidepressant and/or ADHD medications for at least 8 weeks before joining. However, you must stop using ketamine, opioids, antibiotics, or probiotics at least 2 weeks before starting the trial.
What prior data suggests that acupuncture is safe for pediatric patients with DGBIs?
Research has shown that acupuncture is generally safe for treating irritable bowel syndrome (IBS). One study found acupuncture to be a practical and safe treatment for IBS, with no serious side effects. Another study demonstrated that acupuncture reduced symptoms like stomach pain, with benefits lasting for weeks, and participants found it easy to tolerate. These findings suggest that acupuncture is a safe option for managing IBS symptoms, with a low risk of negative effects.12345
Why are researchers excited about this trial?
Unlike the standard treatments for Irritable Bowel Syndrome (IBS), which often include dietary changes, medications like antispasmodics, and probiotics, acupuncture offers a unique approach by using precise needle insertion to potentially relieve symptoms. This ancient practice targets specific points on the body, believed to influence energy flow and alleviate pain, which is quite different from the pharmacological methods commonly used. Researchers are excited about acupuncture because it may provide a natural, non-drug alternative that could reduce IBS symptoms without the side effects often associated with medication. Additionally, the control group using sham acupuncture helps to ensure that any positive effects are truly due to the acupuncture itself, rather than a placebo effect.
What evidence suggests that acupuncture might be an effective treatment for irritable bowel syndrome?
Research has shown that acupuncture can help treat irritable bowel syndrome (IBS). One study found that acupuncture reduced stomach pain and improved stool consistency in IBS patients, with benefits lasting up to 18 weeks. Another study found acupuncture more effective than some medications for IBS, with effects lasting up to 12 weeks. Additionally, acupuncture has improved symptoms and quality of life for IBS patients. In this trial, participants will be divided into two groups: one receiving active acupuncture treatment and the other receiving a sham acupuncture treatment. These findings suggest that acupuncture might help reduce symptoms and enhance well-being for those with IBS.24678
Are You a Good Fit for This Trial?
This trial is for children aged 8-17 with irritable bowel syndrome, abdominal migraines, or functional abdominal pain. They must be medically stable, English-speaking, able to attend visits in Aliso Viejo, and not have had prior acupuncture or certain medications recently.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either acupuncture or sham acupuncture once weekly for eight weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Acupuncture
Trial Overview
The study compares real acupuncture to a sham (placebo) version in kids with gut-brain disorders like IBS. Participants are randomly assigned to either group and receive treatments alongside standard care over a set period.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
The active treatment group will receive standardized acupuncture based on a protocol for functional abdominal pain, using seven acupuncture points: ST36 (Zusanli), LV3 (Taichong), REN12 (Zhongwan), PC6 (Neiguan), SP4 (Gongsun), EX-HN (Sishencong), and DU24 (Shenting) using sterile, single-use Seirin needles. Sessions will occur once weekly for eight weeks, each lasting 40 minutes.
The control group will receive Park Sham Acupuncture Devices at the same scalp points, designed to mimic the sensation of acupuncture without actual needle insertion. Both groups will continue receiving standard care throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Hospital of Orange County
Lead Sponsor
Citations
Efficacy of ACupuncTure in Irritable bOwel syNdrome ...
Acupuncture improved abdominal pain and stool consistency in patients with IBS-D, with sustained efficacy over 18 weeks. The results of this trial suggest that ...
Efficacy of ACupuncTure in Irritable bOwel syNdrome ...
Conclusions: Acupuncture improved abdominal pain and stool consistency in patients with IBS-D, with sustained efficacy over 18 weeks. The results of this trial ...
Effect of Acupuncture in Patients With Irritable Bowel ...
Conclusion. Acupuncture may be more effective than PEG 4000 or pinaverium bromide for the treatment of IBS, with effects lasting up to 12 weeks.
Effectiveness comparisons of acupoint stimulation ...
Our NMA results showed that the three acupoint stimulation intervention therapies were effective in reducing symptom severity and improving the quality of life ...
Acupuncture for the Treatment of Diarrhea-Predominant ...
In this pilot randomized clinical trial, acupuncture in both the SA and NSA groups showed clinically meaningful improvement in IBS-D symptoms.
The effect of acupuncture on quality of life in patients ... - PMC
The pooled result showed acupuncture can significantly improve the QoL of patients with IBS compared to the conventional treatment.
Effect of Acupuncture in Patients With Irritable Bowel ...
From baseline to 6 weeks, the total IBS-Symptom Severity Score decreased by 123.51 (95% CI, 116.61 to 130.42) in the acupuncture group and 94.73 (95% CI, 85.03 ...
Efficacy of acupuncture in refractory irritable bowel ...
From baseline to 4 weeks, the IBS-SSS total score decreased by 140.0 (95% CI: 126.0 to 153.9) in the acupuncture group and 64.4 (95% CI: 50.4 to ...
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