Hervik 2009.
Methods | Randomized, single‐blind study of women following a breast cancer surgery. 2 groups: TA and SA | |
Participants | 59 postmenopausal women (no menstruation for at least 3 months) having finished treatment for breast cancer (chemotherapy or radiotherapy), treated with oestrogen antagonist, tamoxifen, for at least 3 months after chemotherapy or radiotherapy, and complaining of hot flushes (no severity limits) Women taking medication for hot flushes either prior to, or during the treatment and follow‐up period; having received previous acupuncture treatment; being treated with other complementary or alternative therapies simultaneously; having serious endocrine or vascular disorders; suffering from psychological problems; and having hypertension (diastolic blood pressure over 95 mm Hg) were excluded Setting: The Breast Centre at Vestfold Central Hospital in Norway |
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Interventions | TA: 30‐minute treatment were given for 10 consecutive weeks (twice per week the 5 first weeks and once per week the remaining 5 weeks) by a physiotherapist (the same for both TA and SA groups) having 3 years' certified training course and 15 years' practice. 8 needles (0.30 mm) were inserted 0.5‐3 cm deep at 8 points along meridians in TCM (LIV3, GB20, LU7, KI3, Sp6, REN4, P7 and LIV8, unilateral) and manually stimulated. The 'De qui' sensation was the elicited response SA: 30‐minute treatment were given for 10 consecutive weeks (twice per week the 5 first weeks and once per week the remaining 5 weeks) by a physiotherapist (the same for both TA and SA group) having 3 years' certified training course and 15 years' practice. 8 needles (identical to TA group) were inserted 2‐3 mm deep at 8 points well away from acupuncture and trigger points (bilateral) |
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Outcomes |
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Source of funding | The Norwegian Acupuncture Association (NAFO), University of Tromso (NAFKAM), and Vestfold Central Hospital | |
Notes | Follow‐up: 12 weeks (after completion of treatment). Additional data obtained from author by personal communication | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Patients were randomized, using a sealed envelope technique, to receive either TA or SA" Comment: does not mention the randomization method |
Allocation concealment (selection bias) | Unclear risk | Quote: "Patients were randomized, using a sealed envelope technique, to receive either TA or SA" Comments: not mentioned whether the envelopes were sequentially numbered and opaque |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "Patients were blinded to the type of acupuncture received" "A neutral attitude towards the patients and potential treatment effects was attempted, and all data was handled by a secretary blinded to the treatment group" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "All patients completed treatment"; "Number of hot flashes was recorded in all but one patient (SA group), the KI was obtained from all patients throughout the study period" No dropout Use of ITT approach or imputation method not mentioned Comments: unclear about what have been done with the missing data |
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 |