Three hundred and twenty-seven patients who attended the gastroenterology units of GATA Haydarpaşa and Gümüşsuyu Millitary Hospital with dyspeptic complaints were included in the study. Institutional Review Board approval for the study and written informed consent from the patients were obtained prior to the study. Before study procedures, information on previous history of predisposition to nausea and vomiting, smoking, gastric complaints, alcohol usage, use of medications, motion sickness and previous experience with nausea and vomiting was obtained. Patients with a history of gastroscopy and gastric, intestinal or gall bladder surgery; pregnant women; diabetic, hypertensive, uremic patients; patients with renal insufficiency; patients who received chemotherapy; and patients with gastrointestinal obstruction; infection in upper extremities; and neurological or vascular disorders were excluded. Before the procedures, the patients were informed about differences between the terms "nausea", "retching" and "vomiting", and they were instructed not to use these terms interchangeably. Vomiting was not used as an index because the patient’s stomach was empty. Nausea was defined as a subjective unobservable phenomenon of an unpleasant sensation experienced in the back of the throat and the epigastrium, which may or may not result in vomiting (also referred to as "feeling sick in the stomach". Retching is the attempt to vomit without expelling any material, also called "dry heaves" (17-19).
The choice of acupoint and Sham-point
A point on the dorsal side of the right forearm, four fingerbreadths’ proximal to the proximal flexor palmar crease was used for Sham stimulation.
Two physicians were trained about the P6 point and Sham point by an anesthesiologist experienced in the field of acupuncture, and following the training session, these two physicians (fellows of Internal Medicine) were asked to find the location of acupoint and Sham point on 63 patients. A concordance rate of 97% was achieved between the two physicians, who were informed whether the device was applied or turned on. Endoscopists were blinded as to the application or the state of the device in accordance with Kaptchuk’s suggestions (20). To provide complete blinding, the patient’s right wrist was totally covered with a band.
Acustimulation was applied on the right hand unilaterally with a portable, watch-like, battery-powered acustimulation device (Reliefband; Maven Lab, Yuba City, CA), which provides a low-frequency, low-intensity, burst-train type of stimulation to the specific acupoint. The operating voltage is 4-4.5 volt, and the stimulation pulse intensity level is 0-28 mA. In this study, the reliefband was operated selectively at mode B, which provides a moderate frequency (4 Hz) of stimulation. The skin contact surface has two metal electrodes. Before the device is attached, a conductive gel is applied.
Patients
The patients were randomly assigned without stratification and classified into four groups. Acustimulation device was attached and turned on 15 minutes prior to the procedure in Group 1 (n: 78). In Group 2, the device was attached but not turned on (n: 79). In Group 3, the device was attached to the Sham point (n: 79). And in Group 4 the procedure was performed with no attachments (n: 77). Patients in Groups 1, 2 and 3 were informed about the device before the procedure, but they were not aware of whether or not the device was turned on.
Local anesthesia with xylocaine was applied to the pharynx, but no sedation was used. At the end of the procedure, the patients were asked about the degree of difficulty in swallowing the endoscope (easy, moderately easy, difficult, very difficult). The patient’s opinion about the severity of nausea and retching was measured on a visual analogue scale (VAS), which was divided into four main parts. The endpoints were assigned ‘‘no nausea’’ to the left and ‘‘worst possible nausea’’ to the right (10). The endoscopists were also asked to rate the procedure considering the following: 1. no nausea and retching; 2. a duration of nausea and retching of less than 25% of the total procedure; 3. a duration of nausea and retching of between 25% and 50% of the total procedure; and 4. a duration of nausea and retching of between 50% and 100% of the procedure. A concordance rate of 94% between the two endoscopists was observed when they were queried about the degree of difficulty experienced during the first 50 procedures.
Patients were asked if they could undergo re-endoscopy if required. The data were compared using the chi-square test.
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