“Zhibian (BL54) to Shuidao (ST28)” Acupuncture Manipulation Combined with Analgesics in Postoperative Pain Management for Patients with Mixed Hemorrhoids: A Randomized Controlled Trial Protocol

Te Wang,1 Jun Qiang Gao,2 Min Chang,1 Ming Chen Ma,1 Yu Tong Wang,1 Tu Ning Guo,1 Yan Lin Zhang,3 Zhen Gao,1 Hai Jun Wang,1,* Yu Xia Cao4,* 1The Second Clinical College, Shanxi University of Chinese Medicine, Jinzhong, Shanxi, People’s Republic of China; 2 7th Ward of Colorectal and Anal Surgery Department, Shanxi Provincial People’s Hospital, Taiyuan, Shanxi, People’s Republic of China; 3College of Acupuncture and Massage, Tianjin University of Traditional Chinese Medicine, Tianjin, People’s Republic of China; 4 3rd Ward of Acupuncture Department, The Affiliated Acupuncture and Tuina Hospital of Shanxi University of Chinese Medicine, Taiyuan, Shanxi, People’s Republic of China*These authors contributed equally to this workCorrespondence: Hai Jun Wang, Professor, Shanxi University of Chinese Medicine, Jinzhong, Shanxi, People’s Republic of China, Email [email protected] Yu Xia Cao, Chief Physician, the Affiliated Acupuncture and Tuina Hospital of Shanxi University of Chinese Medicine, Taiyuan, Shanxi, People’s Republic of China, Email [email protected]: Mixed hemorrhoids patients often face severe postoperative pain, typically treated with Non-steroidal anti-inflammatory drugs (NSAIDs) or opioids, which may lead to gastrointestinal and Central Nervous System (CNS) side effects. The “Zhibian (BL54) to Shuidao (ST28)” manipulation acupuncture combined with analgesics shows promise as a safe and effective alternative. Thorough randomized controlled trials (RCTs) are crucial for determining the effectiveness and safety when used in conjunction with pain relievers.Patients and Methods: This double-blind randomized controlled trial aims to assess the effectiveness and safety of the acupuncture method connecting the “Zhibian (BL54)” and “Shuidao (ST28)” points combined with analgesics in alleviating pain following surgery for mixed hemorrhoids. A total of 104 patients who meet diagnostic criteria and undergo Milligan-Morgan open hemorrhoidectomy (MMH) will be randomized into control (n = 52) or acupuncture (n = 52) groups. The control group will receive diclofenac sodium, while the acupuncture group will additionally undergo the “Zhibian (BL54) to Shuidao (ST28)” manipulation acupuncture. The intervention will span a duration of five days, with data collection occurring both prior to and following the intervention. Primary outcomes include Visual analogue scale (VAS) scores for pain, with secondary outcomes assessing analgesic efficiency, increased pain medication use, and pain interference in daily activities. Statistical analysis will be conducted utilizing SPSS software, version 26.0.Discussion: This forward-looking, randomized study aims to assess the effectiveness of combining acupuncture with medication in alleviating postoperative pain for individuals suffering from mixed hemorrhoids, wih the goal of establishing a safe and potent therapeutic strategy and broadening the clinical applications of this intervention.Conclusion: This randomized study evaluates the effectiveness of combining acupuncture with medication to relieve postoperative pain in patients with mixed hemorrhoids, aiming to establish a safe and effective treatment strategy and expand its clinical use.Keywords: mixed hemorrhoid, pain, acupuncture, Zhibian (BL54) to Shuidao (ST28), protocol