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Randomized Trial Of Acupuncture
Compared With Prokinetic Drugs And Sham Acupuncture
For Chronic Idiopathic Dyspepsia
Mauro Cittadini, MD
Federico Marmori, BTCM
Daniele Diacinti, MD
Jane I. Walker, MD
ABSTRACT
Context Chronic idiopathic dyspepsia (CID) involves the proximal digestive tract. Studies have shown that acupuncture may affect gastric motility through parasympathetic nerve stimulation.
Objective To compare the efficacy of acupuncture treatment with a prokinetic drug in patients with CID.
Design, Setting, and Participants A randomized controlled trial in 152 patients (aged 28-62 years), diagnosed as having CID at 3 outpatient clinics in Italy, from 1996-2001. Patients were randomized to 1 of 3 groups: 50 patients were treated with pharmacotherapy, 50 patients were treated with twelve 30-minute acupuncture sessions 3 times weekly; and 52 patients were treated with sham acupuncture.
Intervention Domperidone (10 mg capsule before each meal); acupuncture at ST 36 Zu San Li, PC 6 Nei Guan, and Ren 12 Zhong Wan; and sham acupuncture at points outside the meridians.
Main Outcome Measures Decrease in signs/symptoms, change in antral volume, and gastric emptying measured on ultrasound. Adverse effects were also monitored.
Results The domperidone and active acupuncture groups obtained clinical improvement, with a decrease in their signs/symptoms of 72% and 70%, respectively, compared with 23.5% for the sham acupuncture group. The active treatment groups both experienced a significant decrease in antral volume (P<.01); gastric empyting was also significant for the active groups (P<.01). Among the domperidone group, 8/50 reported mild adverse effects of nausea and/or diarrhea, which did not lead to treatment interruption. In the active acupuncture group, 2/50 patients had to discontinue therapy due to acupuncture pain intolerance. In the sham acupuncture group, 3/52 patients experienced an adverse effect of paradoxical vagal response, but only 1 patient ceased the treatment.
Conclusions These findings demonstrate that acupuncture can be considered effective as short- and medium-term treatment for CID, with fewer adverse effects and longer effectiveness than treatment with a prokinetic agent. Future research should investigate the effect of acupuncture used with medications acting on gastric motility for patients with severe, recalcitrant motor dyspeptic symptoms.
KEY WORDS
Chronic Idiopathic Dyspepsia, Acupuncture, Domperidone, Randomized Controlled Trial
INTRODUCTION
arious clinical and research studies show that acupuncture acts on gastric motility through parasympathetic nerve stimulation, and thus affects peristalsis.1 Altered peristalsis is typically present in chronic idiopathic dyspepsia (CID). A joint study involving Marburg University and University of California Los Angeles demonstrated that acupuncture stimulates release of pancreatic polypeptide, a marker used to study vagal activity.2-4 The plasma level of pancreatic polypeptide increases when there is gastric distention.5-7
CID involves the proximal digestive tract and signs/symptoms are often related temporally to meal intake. Typical recurrent symptoms include epigastric pain and discomfort, postprandial heaviness, early satiety, nausea and vomiting, and a sensation of abdominal distension. CID is considered chronic if symptoms have been present for longer than 6 weeks.
CID is considered only after ruling out all other possible causes of secondary digestive dyspepsia (organic alterations of digestive tract and biliary or pancreatic dysfunction), extradigestive causes (thyroid pathology, cardiac disease, menstrual disorders, electrolytic imbalance, etc.), or psychological causes.
Pathophysiologically, CID is divided into 2 groups. In the 1st group, symptoms are linked to a sensation of postprandial fullness and heaviness from a selective delay of gastric emptying of solid food secondary to antral hypomotility (dysmotility-like dyspepsia). The 2nd group manifests as epigastric burning and pain (ulcer-like dyspepsia). Our study considered patients belonging to the 1st group.
The purpose of this study was to compare the efficacy of acupuncture treatment with a prokinetic drug treatment in patients with CID.
METHODS
This study was a randomized, placebo- and alternative treatment-controlled clinical trial performed at 3 outpatient clinics in Italy, from 1996 to 2001.8 We studied 152 patients between the ages of 28 and 62 years diagnosed with CID, 80 men and 72 women. Patient consent was obtained. An independent examiner assessed eligible patients willing to participate in the study. Study selection criteria required that patients have symptoms for more than 6 weeks, such as epigastric fullness/distension, anorexia, excessive burping, and nausea.
Patients with dyspepsia secondary to organic, metabolic, or psychological causes were excluded. These cases were determined by abdominal ultrasound, blood work, esophagogastroduodenoscopy, and interview with a psychologist.
All study patients had to undergo gastric emptying ultrasound to demonstrate delayed gastric emptying.9 Ultrasound was used to study gastric motility because it is non-invasive, accurate, and costeffective. Basal antral volume and antral volumetric variations (% of basal) were determined through antral longitudinal and transverse scanning techniques. Ultrasound was performed hourly for 6 hours following a standard meal, which consisted of 140 g of bread, 80 g of cooked ham, 70 g of cheese, 3.5 g of bran, and water. Results showed that for a non-CID patient, all antral stomach volume values return to baseline within 5 hours of eating. In subjects with CID, there is a significant increase in antral volume at the 2nd hour and again at the 3rd hour, generated by retrograde food movement that coincides with symptom peak.
Each symptom was assigned a score, 0 for absence of a symptom, up to 3 for severe symptoms. Each patient's score was then totaled and they were given a "symptom score." Participants were randomly assigned to 1 of 3 groups to receive acupuncture, therapy with domperidone, or sham acupuncture.
The 1st group consisted of 50 patients treated with domperidone, 10 mg capsules, 1 capsule 20 minutes prior to the 2 main daily meals, for 2 months. The 2nd group consisted of 50 patients treated with 12 acupuncture sessions, 3 times weekly, 30 minutes each, using the following acupuncture points: ST 36 Zu San Li, PC 6 Nei Guan, and Ren 12 Zhong Wan.10-13 The 3rd group consisted of 52 patients treated with acupuncture, but with points outside the meridians, i.e., sham acupuncture. The frequency of the sham acupuncture treatment was also 3 weekly for 4 weeks.
Ultrasound assessments to measure gastric emptying were performed by a blinded observer before the intervention, during treatment, and 6 months after treatment was completed. Statistical analysis of the data was performed using the Fisher exact test. Informed, written consent was obtained from all patients.
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Table 1. Antral Volumetric Variation Comparison (% of Basal) By Group*
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Domperidone
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Acupuncture
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Sham Acupuncture
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(n=50)
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(n=50)
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(n=52)
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Before therapy
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35
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32
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34
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After 3 hours
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12
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13
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27
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P value
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<.01
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<.01
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>.05
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*Evaluation was performed through gastric empyting ultrasound.
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Table 2. Symptom Score Before and 6 Months After Therapy, Mean (SD)
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Domperidone
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Acupuncture
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Sham Acupuncture
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(n=50)
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(n=50)
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(n=52)
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Before therapy
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6.24 (1.2)
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6.94 (1.1)
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6.83 (1.6)
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After therapy
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1.8 (0.61)
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1.6 (0.62)
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5.7 (0.45)
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P value
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<.01
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<.01
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>.05
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RESULTS
Study results demonstrated that the domperidone and active acupuncture groups obtained definite clinical improvement, with a decrease in their signs/symptoms of 72% and 70%, respectively; the sham acupuncture group showed a 23.5% decrease. Associated with
these findings was a statistically significant decrease of antral volume (as noted in Table 1), indicating enhanced stomach emptying.
Among the domperidone group, 8 of 50 reported mild adverse effects of nausea and/or diarrhea, which did not lead to treatment interruption. In the active acupuncture group, 2 of the 50 patients had to discontinue the therapy due to acupuncture pain intolerance. In the sham acupuncture group, 3 of the 52 patients experienced an adverse effect of paradoxical vagal response, but only 1 patient ended the treatment.
Results from both the prokinetic drug group and the group treated with active acupuncture demonstrated improvement of symptoms (Table 2), as well as enhanced gastric emptying as seen on ultrasound. However, 6 weeks after the domperidone treatment group stopped taking the medication, the symptom score and ultrasound findings reverted to pretreatment baseline. Six weeks after termination of acupuncture treatment, only a minor increase in gastric symptoms was noted without any corresponding ultrasound abnormalities.
CONCLUSION
These findings demonstrate that acupuncture treatment may be effective as short- and medium-term treatment for CID, with fewer adverse effects and longer effectiveness than treatment with a prokinetic agent. Future research should investigate the effect of acupuncture used with medications acting on gastric motility for patients with severe, recalcitrant motor dyspeptic symptoms.
REFERENCES
- Wing W, Li Q. Effects of different manipulations of acupuncture on electrical activity of stomach in humans. J Tradit Chin Med. 1998;18:39-42.
- Monnikes H, Sun P, et al. Acupuncture affects perception of gastric distension by naloxone-sensitive pathways in healthy volunteers. Presented at: 3rd European Union Gastroenterology Week; June 25-29, 1994; Oslo, Norway.
- Schwartz TW. Pancreatic polypeptide: a hormone under vagal control. Gastroenterology. 1983;85:1411-1425.
- Tougas G, Yuan LY, Radamaker JW, Chiverton SG, Hunt RH. Effect of acupuncture on gastric acid secretion in healthy male volunteers. Dig Dis Sci. 1992;37:1576-1582.
- Chen R, Kang M. Observation on frequency spectrum of electrogastrogram (EGG) in acupuncture treatment of functional dyspepsia. J TraditChin Med. 1998;18:184-187.
- Li Y, Tougas G, Chiverton G, Hunt RH. The effect of acupuncture on gastrointestinal function and disorders. Am J Gastroenterol. 1992;87:1372-1381.
- Jin HO, Zhou L, Lee KY, et al. Inhibition of acid secretion by electrical acupuncture is mediated via beta-endorphin and somatostatin. Am JPhysiol. 1992;271:G524-G530.
- NIH Consensus Conference. Acupuncture. JAMA. 1998;280:1518-1524.
- Ricci R, Bontempo I, La Bella A, De Tschudy A, Corazziari E. Ultrasonography as a valuable method to assess the volume of gastric antrum. Gastroenterology. 1987;92:1594.
- Chang FY, Chey WY, Ouyang A. Effect of transcutaneous nerve stimulation on esophageal function in normal subjects: evidence for a somatovisceral reflex. Am J Chin Med. 1996;24:185-192.
- Anscombere S, Lepage P. Approche acupuncturale et treatment des troubles digestifs dé l'opéré récent. Mer. 1992;97:135-144.
- AAVV. Jianming Zhongyi Cidian. Beijing, China: People's Health Press; 1980.
- Zhang RF, Wu XF. I Punti di Agopuntura e i Loro Meccanismi di Azione. Milan, Italy: Masson; 1994.
AUTHORS' INFORMATION
Dr Mauro Cittadini is a Gastroenterologist, Licensed Acupuncturist, and Academic Dean of Villa Giada TCM Superior Institute in Rome, Italy.
Mauro Cittadini, MD
Appia Nuova. 206
Rome, Italy
Phone: 39+ 06.70.45.05.54 • E-mail: mcittadini@jadecampus.com
Federico Marmori has a Bachelor of Traditional Chinese Medicine (TCM) degree; is Founder and Director of the Continuing Medical Education in Chinese Medicine (www.jadecampus.com); is a member of PEFOTS (Pan American Federation of TCM Societies) Science and Education Teaching Commission; and is an Acupuncture Lecturer at the Health Dept Unit (ASL) ROMA C Italy.
Federico Marmori, BTCM
194 rue du Chateau des Rentiers
75013 Paris, FRANCE
Phone: 33 1 53 79 91 49 • E-mail: marmori@jadecampus.com • www.jadecampus.com
Dr Daniele Diacinti is a Radiologist, Internist, and Associate Professor at Universita La Sapienza in Rome, Italy.
Daniele Diacinti, MD
E-mail: centrogiado@tin.it
Dr Jane I. Walker is a Board-certified Family Practice physician in Windsor, Connecticut.
Jane I. Walker, MD*
151 Palisado Ave
Windsor, CT 06095
Phone: 860-285-8730 • E-mail: jsperry@attbi.com
*Send all correspondence and reprint requests to Dr Walker at the above address.
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