Frey 2009a.
Methods | Parallel 4‐arm randomized trial, conducted at a single German centre. Study dates not reported. | |
Participants | 214 adult women undergoing vaginal hysterectomy requiring general anaesthesia. Exclusion: women with cardiac pacemaker or implanted defibrillator, at risk of malignant hyperthermia, had allergy to nickel/chrome, or change in surgical technique. | |
Interventions | Group 1: Acu‐stimulation (ReliefBand) before induction of anaesthesia at P6 acupoint on dominant forearm for 24 h after surgery (n = 48). Group 2: Acu‐stimulation (ReliefBand) after induction of anaesthesia at P6 acupoint on dominant forearm for 24 h after surgery (n = 53). Group 3: Sham acustimulation (inactivated ReliefBand electrodes with a silicone cover) before induction of anaesthesia at P6 acupoint on dominant forearm for 24 h after surgery (n = 49). Group 4: Sham acustimulation (inactivated ReliefBand electrodes with a silicone cover) after induction of anaesthesia at P6 acupoint on dominant forearm for 24 h after surgery (n = 50). |
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Outcomes | Nausea (0 ‐ 6 h), vomiting (0 ‐ 6 h), rescue antiemetic (tropisetron 2 mg). | |
Notes | Combined Groups 1 and 2 as acustimulation group, and Groups 3 and 4 as sham group for analysis. No cumulative incidence of 0 ‐ 24 h outcomes reported. No details about funding source or any declarations of interest among authors. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient details. |
Allocation concealment (selection bias) | Unclear risk | Participants randomized by "drawing a sealed envelope indicating treatment assignment." No details about envelopes being opaque. |
Blinding of patients (performance bias) All outcomes | Low risk | Authors made efforts to inactivate electrodes and place a silicone cover over the device which "was invisible for both patients and investigators." |
Blinding of healthcare providers (performance bias) All outcomes | Low risk | Authors made efforts to inactivate electrodes and place a silicone cover over the device which "was invisible for both patients and investigators." |
Blinding of outcome assessor (detection bias) All outcomes | Low risk | "The investigators responsible for collecting data were blind to the treatments administered to the study patients." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 14 participants excluded after randomization due to change in surgical technique, resulting in final sample size of 200. |
Selective reporting (reporting bias) | High risk | Side effects of active and sham ReliefBand not assessed or reported. |
Other bias | Low risk | Groups were comparable for participant characteristics, duration of surgery and anaesthesia and risk score for PONV. |