Streitberger 2004.
Methods | Parallel‐group randomized trial, conducted in Germany. Study was conducted between January and August 2002. | |
Participants | 212 women undergoing gynaecological or breast surgery under general anaesthesia. Exclusion: acupuncture treatment during the last 6 months, pregnancy, nausea or vomiting during the past 24 h, lymphoedema of the upper limbs, eczematous skin changes at the P6 acupoint, and coagulopathy. 1 woman in the acupuncture group withdrew consent and was treated as a failure in the analysis. | |
Interventions | Acupuncture group: 52 participants had acupuncture to P6 acupoint on both wrists, 20 min before induction of anaesthesia; another 54 participants had acupuncture to P6 acupoint on both wrists immediately after induction of anaesthesia. Sham acupuncture: 51 participants had placebo acupuncture to P6 acupoint on both wrists, 20 min before induction of anaesthesia; another 55 participants had placebo acupuncture to P6 acupoint on both wrists immediately after induction of anaesthesia. |
|
Outcomes | Nausea (0 ‐ 24 h), vomiting (0 ‐ 24 h), risk of rescue antiemetic drugs, adverse events related to acupuncture. | |
Notes | Dimenhydinate and dolasetron rescue antiemetics used. Haematomas reported by 1 participant in the acupuncture group and by 2 participants in the placebo acupuncture group. Allergy to sticky plaster reported by 5 participants in each group. No severe adverse reaction reported. Funding source from University of Heidelberg (grant number F.203583). No details about any declarations of interest among authors. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "The patients were randomly distributed by type of surgery (gynaecological or breast) to ensure balance between groups". Comment: no further details provided in the paper. |
Allocation concealment (selection bias) | Low risk | "The acupuncturist obtained randomisation allocation by phone from a member of the Coordination Centre for Clinical Trials, University of Heidelberg, who had no contact with study patients. An adequate concealment was thereby assured". |
Blinding of patients (performance bias) All outcomes | Low risk | Authors took adequate steps to make interventions appear similar. To assess blinding, patients were asked what kind of needle they believe they had received". |
Blinding of healthcare providers (performance bias) All outcomes | Low risk | "The patients, the observer of the endpoints, the nurses, the anaesthetists and all other staff members were not informed about the allocation". |
Blinding of outcome assessor (detection bias) All outcomes | Low risk | "The patients, the observer of the endpoints, the nurses, the anaesthetists and all other staff members were not informed about the allocation". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Reasons for withdrawals given. Intention‐to‐treat analysis used. |
Selective reporting (reporting bias) | Low risk | All expected outcomes reported. |
Other bias | Low risk | Baseline characteristics were comparable. "Baseline characteristics revealed no relevant differences between the two groups (table 1)". |