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Protocol for Randomized Clinical Trial of Acupuncture Versus Sham Acupuncture in Irritable Bowel SyndromeAcupuncture Helps IBS When Anxiety Strikes

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Key Takeaway
Note that this is a study protocol; efficacy and safety results for acupuncture in IBS are not yet available.

This document describes a study protocol for a randomized clinical trial with placebo run-in. The target population consists of 80 eligible IBS patients without strong placebo responses. The study aims to evaluate efficacy in patients with Irritable bowel syndrome, Anxiety, and Depression.

Participants will receive either true acupuncture or sham acupuncture. The primary outcome is the response rate, defined as a proportion of patients with a decrease of greater than or equal to 50 points in the IBS Symptom Severity Scale score from baseline at week 4. Secondary outcomes include response rates at other time points, original IBS-SSS scores, Hospital Anxiety and Depression Scale scores, Visual Analog Scale for abdominal pain, satisfaction with bowel habits, blinding assessment, and Credibility Expectancy Questionnaire scores.

No main results are reported in this document. Safety will be monitored and recorded during the trial, but serious adverse events, discontinuations, and tolerability data are not reported. The follow-up duration is 8-week follow-up. Limitations are not reported in the protocol.

As this is a study protocol, results are not yet published. Clinicians should note that efficacy and safety data are pending. Practice relevance is not reported at this stage. Consequently, this evidence cannot support immediate clinical decision-making regarding acupuncture for IBS. Further data collection is required before any conclusions can be drawn.

The Gut-Brain Tangle

Imagine you have a stomach ache. You go to the doctor. They give you medicine for your tummy. But the pain stays. Why? Because you are also feeling sad or worried.

This is the problem for many people with irritable bowel syndrome, or IBS. Their gut and their brain are connected. Stress makes the gut worse. Anxiety makes the pain feel stronger.

Doctors have tried many things. Some medicines help the tummy. Some help the mood. But few fix both at the same time. Patients often feel stuck. They try one thing, then another. Nothing seems to work well enough.

Millions of people live with IBS. It changes their daily lives. They might skip work or school because of pain. They worry about every meal.

Current treatments often miss the mark. They treat the body but ignore the mind. Or they treat the mind but ignore the body. We need a way to help both.

The Surprising Shift

Acupuncture is an old Chinese practice. It uses thin needles to balance energy. Some studies say it helps IBS. But most studies include everyone. They mix people who are calm with people who are very anxious.

This mix hides the truth. If acupuncture works for calm people, does it work for anxious ones? We do not know for sure.

What Scientists Didn't Expect

This study changes the plan. It will only look at patients with anxiety or depression. It will separate them from those who are calm.

Think of it like a key and a lock. Some keys fit all locks. Others only fit specific ones. We suspect acupuncture is a special key for the anxious mind. But we need to test it carefully.

Acupuncture works like a switch. It sends signals to the brain and the gut. It can calm the nervous system.

For an anxious person, the body is like a car in high gear. The engine revs high. The brakes are tight. Acupuncture might help shift the gears down. It tells the body to relax. It tells the gut to slow down.

The needles are very thin. They feel like a tiny pinch. Most people feel relaxed after a session. The goal is to quiet the noise in the head and the tummy.

The Study Snapshot

Researchers will start with a one-week test. Everyone gets fake needles first. This checks if the patient believes in the treatment.

If a patient feels better just because they think it works, they will leave the study. We want to see if the real needles do something extra.

Then, 80 patients will join the main test. They will get real needles or fake ones. They will visit three times a week for four weeks. Then, they will be checked again for eight weeks.

The main goal is simple. Did the patient feel much better? Scientists will look for a big drop in pain scores.

They will also check mood. Did the anxiety go down? Did the depression lift? They will ask patients how happy they are with their bowel habits.

If the real needles work better than the fake ones, it proves the treatment is special. It is not just a trick of the mind.

This doesn't mean this treatment is available yet.

The Catch

There is a big catch. This study has not finished yet. It is planned for the future. We are writing about a plan, not a finished result.

The study will start soon. It will take time to get the data. We must wait for the results to be published.

If you have IBS and anxiety, talk to your doctor. Do not stop your current medicine. Ask if acupuncture is right for you.

Some clinics offer acupuncture now. It can be a helpful addition to your care. But be careful. Not all treatments work for everyone.

This plan has limits. It is a proposal, not a report of finished work. The results could change. Small studies sometimes show big effects that do not last.

We must wait for the full report. Only then will we know if this is a real solution.

The next step is waiting. Researchers will run the trial. They will collect the data. Then, they will write a paper.

That paper will go to a medical journal. Doctors will read it. They will decide if they can use this method.

Until then, the best advice is patience. Science takes time. We want to make sure the new method is safe and effective. Then, we can share it with everyone who needs it.

Study Details

Study typeRct
EvidenceLevel 2
PublishedApr 2026
View Original Abstract ↓
BackgroundGastrointestinal and psychological symptoms jointly motivate patients with irritable bowel syndrome (IBS) to seek medical care, with the latter often exacerbating the difficulty of achieving overall improvement. Although acupuncture has been shown to improve gastrointestinal symptoms in the general IBS population, the evidence in individuals with psychological disturbances remains insufficient.MethodsThis will be a placebo run-in, randomized controlled trial. After the 1-week sham acupuncture intervention run-in period, the 80 eligible IBS patients without strong placebo responses will be randomly assigned to the true acupuncture (TA) group and sham acupuncture (SA) group. During the 4-week intervention period, all patients will receive the assigned intervention three times per week, followed by an 8-week follow-up. The primary endpoint is the response rate, defined as the proportion of patients with a decrease of greater than or equal to 50 points in the IBS Symptom Severity Scale (IBS-SSS) score from baseline at week 4. Secondary outcomes include the response rates at other time points, original IBS-SSS scores, Hospital Anxiety and Depression Scale (HADS), Visual Analog Scale (VAS) for abdominal pain, satisfaction with bowel habits, blinding assessment, and Credibility/Expectancy Questionnaire. Safety will be monitored and recorded during the trial.DiscussionThis trial will provide individualized evidence for addressing IBS with key comorbidities while excluding placebo response. The results of this trial will be published in a peer-reviewed journal.Clinical Trial Registrationhttps://itmctr.ccebtcm.org.cn/mgt/project/view/1985616257155727360, identifier ITMCTR2025002100.
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