Objective

2

To observe the clinical efficacy of the novel plum-blossom needling with a mild moxibustion device in treating post-stroke constipation （PSC）.

Methods

2

From October 2023 to April 2024， a total of 88 PSC patients were recruited from the Acupuncture Clinics and inpatient departments of three medical institutions， i.e.， Beijing Huguosi Traditional Chinese Medicine Hospital affiliated to Beijing University of Chinese Medicine， Beijing Xiaotangshan Hospital， and Beijing Furongli Community Health Care Centre in Haidian District， Beijing. The patients were randomized in a 1：1 ratio into the acupuncture-moxibustion group and the control group using stratified block randomization. The acupuncture-moxibustion group was treated with the novel plum-blossom needling with mild moxibustion device， while the control group received the sham device treatment. The outcomes assessed included the weekly complete spontaneous bowel movements （CSBMs）， PAC-SYM score， Bristol stool form score， modified Barthel index score， and Hamilton Anxiety Scale （HAMA） score before and after treatment， and at a 1-month follow-up. Safety measures （adverse reactions， skin temperature at acupuncture-moxibustion points， and PM10 concentration in the clinic room） were also monitored. The overall blinding success rate was evaluated using the James Blinding Index （JBI）， and the blinding success of both groups was assessed using the Bang Blinding Index （BBI）.

Results

2

The clinical total effective rate in the acupuncture-moxibustion group was higher than in the control group （

P

<

0.05）. After treatment and during follow-up， the a

cupuncture-moxibustion group showed significant improvements in CSBMs， Bristol stool form score， and modified Barthel index score compared to those before treatment （

P

<

0.05）， while the PAC-SYM score and HAMA score significantly decreased （

P

<

0.05）. In the control group， there were no statistically significant differences in CSBMs， PAC-SYM score， or Bristol stool form score after treatment and during follow-up compared to those before treatment （

P

>

0.05）， but the modified Barthel index score increased （

P

<

0.05） and the HAMA score decreased （

P

<

0.05）. After treatment and during follow-up， the acupuncture-moxibustion group had higher CSBMs， Bristol stool form scores， and modified Barthel index scores， and lower PAC-SYM and HAMA scores than the control group （

P

<

0.05）. No adverse reactions such as burns or allergies were observed in either group. The acupuncture-moxibustion group had higher skin temperature and PM10 concentration in the clinic room compared to the control group （

P

<

0.05）. In the acupuncture-moxibustion group （41 patients）， 40 patients believed they received treatment with the novel plum-blossom needling with mild moxibustion device， and 1 patient believed they received the sham device. In the control group （42 patients）， 28 patients believed they received treatment with the novel device， and 14 patients believed they received the sham device. The JBI value was 0.36 （95%

CI

： 0.30-0.43）. The BBI value for the acupuncture-moxibustion group was 0.95 （95%

CI

： 0.87-1.00）， while the BBI value for the control group was -0.40 （95%

CI

： -0.64 to -0.16）.

Conclusion

2

The novel plum-blossom needling with a mild moxibustion device significantly improves the frequency of CSBMs， alleviates the degree of constipation， improves stool form， reduces anxiety， and enhances the quality of life in PSC patients， with good safety. The blinding effect of the study was successful.