ACTION Trial

The **ACTION trial** was a significant clinical study designed to evaluate the efficacy and safety of acupuncture in treating diarrhea-predominant irritable bowel syndrome (IBS-D). Below is a detailed summary of the trial:

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### **Background**

• **Global burden of IBS-D**: IBS affects approximately 4.1% of adults worldwide, with IBS-D accounting for about one-third of all cases. It is associated with frequent loose stools, abdominal pain, reduced quality of life, and considerable psychological and socioeconomic burden.
• **Limitations of standard therapies**: Common treatments, including dietary modifications, medications, and cognitive behavioral therapy, often provide incomplete relief, come with side effects, or lead to symptom recurrence.
• **Rationale for acupuncture**: Acupuncture has long been used for gastrointestinal disorders, but high-quality evidence supporting its efficacy for IBS-D has been limited.

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### **Objective**

The **ACTION trial** aimed to determine whether acupuncture could improve abdominal pain and stool consistency in IBS-D patients compared to sham acupuncture.

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### **Study Design**

• **Type of trial**: Multicenter, randomized, sham-controlled clinical trial.
• **Location**: Conducted across six hospitals in China.
• **Timeline**: May 2021 to August 2022.
• **Participants**:
• A total of 584 adults were screened.
• 280 adults aged 18–75 who met the Rome IV criteria for IBS-D were randomized equally into two groups: acupuncture and sham acupuncture.

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### **Treatment Protocol**

• **Duration**: Participants received 15 sessions over six weeks:
• Three sessions per week during weeks 1–3.
• Two sessions per week during weeks 4–6.
• **Administration**: All sessions were conducted by licensed acupuncturists.

#### **Acupuncture Group**

• **Acupoints**: Needles were placed at eight fixed points (CV12, CV4, ST25, ST36, ST37) and one optional bilateral pair (LR3, SP6, or ST44).
• **Technique**: Manual stimulation was applied to elicit the "deqi" sensation, which is a characteristic feeling of needle insertion in acupuncture.

#### **Sham Control Group**

• **Procedure**: Participants received identical adhesive pads, but no needles were inserted or stimulated.
• **Rescue medication**: Loperamide was allowed for both groups as needed.

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### **Primary Endpoint**

• **Composite response at week 6**: Defined as:
• A ≥30% reduction in the worst abdominal pain.
• A ≥50% reduction in diarrhea days from baseline.

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### **Key Results**

#### **Primary Outcome**

• At week 6, **57.9%** of acupuncture patients achieved the primary endpoint compared to **41.4%** in the sham group.
• **Relative Risk (RR)**: 1.40
• **Statistical significance**: P = 0.008.

#### **Sustained Efficacy**

• Improvements were observed as early as week 3 and remained significant through week 18.
• Per-protocol analysis confirmed the findings:
• **58.7%** of acupuncture patients vs. **41.0%** of sham patients achieved the primary endpoint (P = 0.011).

#### **Stool Consistency**

• **Acupuncture group**: Mean days with loose stools decreased from 5.1 to 2.1.
• **Sham group**: Mean days decreased from 5.2 to 3.0.
• Significant between-group differences were evident from week 5 onward.

#### **Abdominal Pain Relief**

• Both groups showed improvement, but the acupuncture group achieved greater long-term reductions:
• By week 18: **−2.54** (acupuncture) vs. **−1.99** (sham); P = 0.012.

#### **IBS Symptom Severity**

• The **IBS Symptom Severity Scale (IBS-SSS)** improved more in the acupuncture group:
• Acupuncture: **−127.3**.
• Sham: **−89.3**.
• **P < 0.001**.
• Benefits were sustained at the 12-week follow-up.

#### **Adequate Relief Perception**

• **61.4%** of acupuncture patients reported adequate relief compared to **35.0%** in the sham group (P < 0.001).
• Differences were noticeable from week 2 onward.

#### **Responder Rates**

• **83%** of acupuncture patients achieved a ≥50-point reduction in IBS-SSS compared to **68.4%** in the sham group (P = 0.004).

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### **Secondary Outcomes**

• **Quality of Life (IBS-QOL)**: No significant differences between groups.
• **Psychological outcomes** (e.g., PHQ-9 for depression): No significant differences.
• **Bloating and stool frequency**: No significant differences between groups.

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### **Safety and Tolerability**

• **Adverse events**: Mild and transient, primarily:
• Minor bleeding (11.3%).
• Post-needling pain (5.7%).
• No serious adverse events were reported.

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### **Conclusion**

The **ACTION trial** demonstrated that acupuncture significantly improved:

• **Abdominal pain**.
• **Stool consistency**.
• **Global symptom relief**.
• **IBS severity**.

These benefits were durable, lasting up to 18 weeks, and acupuncture was well-tolerated with a favorable safety profile. This study provides robust evidence supporting the use of acupuncture as an effective treatment option for IBS-D.