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The purpose of this pilot study is to investigate the effects of GB34 acupuncture, performed as adjuvant to standard medical treatment, on clinical response and laboratory parameters of patients with a diagnosis of acute cholecystitis.
Acute cholecystitis is a frequent complication of gallbladder stones. The prevalence of gallbladder stone is 10-15% and in 35% of patients complications and recurrent symptoms develop in their lifetime. Acute cholecystitis is one of the most frequently encountered acute surgical conditions. It is manifested in 3-10% of patients referred to emergency departments with complaints of abdominal pain.
Although the gold standard of therapy is laparoscopic cholecystectomy in symptomatic cholecystitis and related complications, more than 70% of patients respond well to medical treatment at first place. Actually, timing of cholecystectomy was studied extensively, yet is still debatable. Early cholecystectomy is the operation performed within 72 hours of the beginning of the symptoms. Delayed cholecystectomy is the operation performed 6 weeks after the suppression of the inflammation. Investigators perform early cholecystectomy is in cases with perforation and complication like gangrenous or emphysematous acute cholecystitis whereas delayed cholecystectomy is preferred in the remaining patients.
In fact it is known for some time that ear and body acupuncture have modulatory effects on motor functions of gallbladder and even provide some improvement in acute cholecystitis. Previously, studies demonstrating that GB34 has specific effects on the motility of bile ducts were published. More recently, researchers were able to demonstrate that GB34 electro acupuncture have positive effects on gall bladder wall thickness and on WBC levels, by using an experimental rabbit model of acute cholecystitis. Additional functional MR studies were used to distinguish the neural specificity of the acupuncture points. GB34 were found to induce a specific response pattern which is more significant in motor functions in brain. Furthermore it is known for decades that acupuncture other than point specific effects, triggers self-healing mechanisms of the body via endogen pathways.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Experimental | GB34 acupuncture will be applied every day. Patients will receive standard medical treatment |
|
| Controls | No Intervention | Patients will only receive standard medical treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Procedure | Acupuncture will be performed bilateral on fibular aspect of the leg, in the depression anterior and distal to the head of the fibula by using 0,25x50mm needles. |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived pain | Measured by Visual Analog Scale scored between 0 and 10. Zero refers to no pain whereas 10 refers to the worst pain perceived by the patient. | From hospital admission (baseline) until hospital discharge, with VAS assessments performed every 12 hours, assessed up to a maximum of 168 hours. |
| Analgesic dosage | Total dosage of analgesic administered in mg | From hospital admission (baseline) until hospital discharge, assessed up to a maximum of 168 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Guarding | presence or absence of abdominal guarding assessed by investigators. Guarding is defined as a spasm of muscles that minimizes the motion or agitation of sites that are affected by injury or disease. | At hospital admission (baseline) and every 24 hours until hospital discharge, assessed up to a maximum of 168 hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alirıza Erdoğan, MD | Niğde Ömer Halisdemir University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Niğde Ömer Halisdemir University Training and Research Hospital | Niğde | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31768828 | Background | Bouassida M, Zribi S, Krimi B, Laamiri G, Mroua B, Slama H, Mighri MM, M'saddak Azzouz M, Hamzaoui L, Touinsi H. C-reactive Protein Is the Best Biomarker to Predict Advanced Acute Cholecystitis and Conversion to Open Surgery. A Prospective Cohort Study of 556 Cases. J Gastrointest Surg. 2020 Dec;24(12):2766-2772. doi: 10.1007/s11605-019-04459-8. Epub 2019 Nov 25. | |
| 28740954 |
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| ID | Term |
|---|---|
| D041881 | Cholecystitis, Acute |
| ID | Term |
|---|---|
| D002764 | Cholecystitis |
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Abdominal tenderness |
presence or absence of abdominal tenderness assessed by investigators. Rebound tenderness refers to pain or discomfort after pressing on the patient's abdomen . |
| At hospital admission (baseline) and every 24 hours until hospital discharge, assessed up to a maximum of 168 hours. |
| Oral intake | if patients tolerate oral intake or not | From hospital admission (baseline) until first tolerated oral intake, assessed up to hospital discharge (maximum 168 hours). |
| Antibiotic dosage | Total antibiotic dose administered during hospitalization (mg) | From hospital admission (baseline) through hospital discharge, assessed up to a maximum of 168 hours |
| Direct bilirubin | Direct bilirubin levels expressed in mg/dL | At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours |
| Total bilirubin | Total bilirubin levels expressed in mg/dL | At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours |
| Amylase | Amylase levels expressed in U/L | At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours |
| GGT | Gamma glutamyl transferase levels expressed in U/L | At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours |
| ALP | Alkaline phosphatase levels expressed in U/L | At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours |
| ALT | Alanine aminotransferase levels expressed in U/L | At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours |
| AST | Aspartate aminotransferase levels expressed in IU/L | At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours |
| CRP | C-reactive protein levels expressed in mg/L | At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours |
| PLT | platelet count in microliter | At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours |
| LYM% | percent of lymphocytes | At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours |
| NEU% | percent of neutrophils | At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours |
| WBC | White blood cell count in microliter | At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours |
| Hb | Hemoglobin values expressed as g/dL | At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours |
| Arer IM, Yabanoglu H, Caliskan K. Can red cell distribution width be used as a predictor of acute cholecystitis? Turk J Surg. 2017 Jun 1;33(2):76-79. doi: 10.5152/turkjsurg.2017.3392. eCollection 2017. |
| 26237977 | Background | Zhou ML, Jia WR, Wang JT, Wang P, Guo LH, Sui MH. [Effect of Electroacupuncture at "Yanglingquan" (GB 34) Acupoint on White Blood Cell Count and Gallbladder Wall Thickness in Rabbits with Acute Cholecystitis]. Zhen Ci Yan Jiu. 2015 Jun;40(3):233-7. Chinese. |
| 25220656 | Background | Yeo S, Choe IH, van den Noort M, Bosch P, Jahng GH, Rosen B, Kim SH, Lim S. Acupuncture on GB34 activates the precentral gyrus and prefrontal cortex in Parkinson's disease. BMC Complement Altern Med. 2014 Sep 15;14:336. doi: 10.1186/1472-6882-14-336. |
| 19666085 | Background | Na BJ, Jahng GH, Park SU, Jung WS, Moon SK, Park JM, Bae HS. An fMRI study of neuronal specificity of an acupoint: electroacupuncture stimulation of Yanglingquan (GB34) and its sham point. Neurosci Lett. 2009 Oct 16;464(1):1-5. doi: 10.1016/j.neulet.2009.08.009. Epub 2009 Aug 8. |
| 8569551 | Background | Andersson S, Lundeberg T. Acupuncture--from empiricism to science: functional background to acupuncture effects in pain and disease. Med Hypotheses. 1995 Sep;45(3):271-81. doi: 10.1016/0306-9877(95)90117-5. |