Sator‐K 2006.
Methods | Randomised controlled trial in fertility clinic in Austria | |
Participants | Patients were randomised in proportions of 1:1:1 to treatment with electro‐acupuncture (n = 32), auricular acupuncture without electrical stimulation (n = 32) or a control group without needles or electrical stimulation (n = 30). The mean ages (± SD) of the women undergoing IVF treatment in the group receiving electro‐acupuncture with remifentanil (EA), acupuncture with remifentanil (A), and remifentanil with placebo (CO) were 33.3 years (± 1.7), 34.2 years (± 1.1) and 33.9 years (± 1.9), respectively. There were no differences in the number of failed cycles or causes of subfertility. |
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Interventions | EA, or EA with electrical stimulation or control of conventional analgesia (remifentanil) at the time of oocyte retrieval | |
Outcomes | Pain intensity and subjective well being were assessed using a visual analogue scale Nausea and tiredness were also assessed using a visual rating scale Analgesic drug requirements during the entire study period | |
Assisted conception protocols | Protocol breakdown not provided | |
Notes | Study designed to assess effectiveness of acupuncture as an analgesic Each P‐Stim™ was programmed by an independent technician for electrical stimulation or no stimulation before the study. To ensure blinding of the investigator, each P‐Stim™ was packed in a non‐transparent case in which the respective permanent needles or adhesive tapes were also included. The packages were numbered consecutively, according to the randomisation list. Patients and investigators were blinded to the randomisation |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | computer generated sequence randomisaton |
Allocation concealment (selection bias) | Unclear risk | ‘Randomisation was concealed until at least 30 patients were randomized.’ ‘Patients and investigators were blinded to the randomisation’. Method of allocation concealment not clearly reported |
Blinding (performance bias and detection bias) All outcomes | High risk | Control group had traditional I.V. pain relief. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 94 were randomized. 1 drop out. |
Selective reporting (reporting bias) | Unclear risk | LBR outcome not reported. |
Other bias | Low risk | None known |