Wyon 2004.
| Methods | Randomized controlled trial. 3 groups: EA, SNI, and ET | |
| Participants | 28 postmenopausal women aged 48‐63 years with vasomotor symptoms and a spontaneous menopause at least 6 months previously. Women were excluded if they had a severe metabolic, thromboembolic, or endocrine disease; they had uncontrolled hypertension (> 95 mmHg diastolic); they were using sedative, anxiolytic, or antidepressant medication; if they were using narcotics; they were doing regular exercise more than once per week Setting: gynaecological outpatient clinic of the Linköping University Hospital in Sweden |
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| Interventions | EA: 30‐minute treatment given by an experienced physiotherapist skilled in acupuncture for 12 weeks (twice per week for the first 2 weeks and once a week for the next 10 weeks). 12 needles (stainless‐steel, Hwato 0.25 mm diameter, 15 mm long, and 0.30 mm diameter and 30 mm long) were inserted 5‐20 mm into the skin at different point locations (bilaterally, B15‐23‐32; unilaterally, HT7, SP6‐9, LR3, PC6, GV20). 4 needles in lower back were attached to an electrical stimulator (IC‐1107, Ito Co., Ltd, Japan) with a burst frequency of 2 Hz alternating current stimulation. The 'De qui' and a non‐painful local muscle contractions were the elicited responses Follow‐up: once a week for the next 6 month after treatment SNI: 30‐minute treatment given by an experienced physiotherapist skilled in acupuncture for 12 weeks (twice per week for the first 2 weeks and once a week for the next 10 weeks). Small‐dimension needles (Hwato, 0.25 mm diameter, 15 mm long) were inserted parallel to the skin 1‐5 cm away from EA points. 3 needles (BL15‐23‐32) were moved laterally on the back about 10‐15 cm. No additional stimulation after insertion was elicited Follow‐up: once a week for the next 6 months after treatment ET: Women were given oral 2 mg 17β‐oestradiol for 12 weeks. They were suggested to continue their ET with additional sequential progestogens given monthly Follow‐up: once a week for the next 6 month after treatment |
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| Outcomes | Primary:
Timing of assessment of the main outcome: before treatment; after 4, 8, and 12 weeks of treatment; and 12 and 24 weeks after the end of therapy Secondary:
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| Source of funding | The Swedish Medical Research Council grant to K2001‐72x‐12651‐O4B, The Swedish Foundation for Health Care Sciences and Allergy Research and Cancer and Trafikskadades Förbund, The Lions Foundation | |
| Notes | No significant difference of groups at baseline except that women in the oestrogen group were slightly younger Follow‐up: 6 month (after completion of treatment) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Method not reported |
| Allocation concealment (selection bias) | Unclear risk | Quote: "Randomization was performed by the use of identical, opaque, sealed envelopes, containing label to determine the treatment." Not reported whether envelopes sequentially numbered |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "The gynaecologists and nurses evaluating the patients were blind to treatments, i.e. at evaluation, the physician and research nurse did not know which acupuncture treatment each women had and not until after analysis of the results did we unveil the treatment modalities. Furthermore, the patients were only informed that two different modalities were used but not that we expected one to be more efficient" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "All women randomized to electro‐acupuncture and estradiol therapy completed the 12 weeks of treatment" At 6 months, few dropouts and exclusions (EA :4, SNI :1, ET:6) Reasons for withdrawals reported No ITT analysis |
| Selective reporting (reporting bias) | Low risk | The published report included all expected outcomes |
| Other bias | Low risk | The study appeared free of other sources of bias |