Deng 2007.
Methods | Randomized, controlled, subject‐blinded trial. 2 groups: true acupuncture and SA | |
Participants | 71 women undergoing treatment for breast cancer at Memorial Sloan‐Kettering Cancer Center having a Karnofsky's performance score > 60 and experiencing an average of 3 or more hot flushes per day for 1‐week period with baseline diary Women planning surgery, chemotherapy, radiotherapy, immunotherapy; having initiated or ceased HT during the trial or within 3 weeks before the trial; using pharmacological treatment of hot flushes or SSRIs (unless dose remained stable for 4 weeks prior to study); having skin infection; having received acupuncture treatment in the 6 weeks prior to study or acupuncture given specifically for the treatment of hot flushes in the previous 6 months were excluded Setting: Memorial Sloan‐Kettering Cancer Center, New York, USA |
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Interventions | True acupuncture: Treatment given 2 times per week for 4 weeks by several licensed acupuncturists having 3 years of normal postgraduate training and 3 to 25 years of continuous practice Needles (stainless‐steel filiform 0.20 x 30 mm manufactured by Seiring Corp, Shizuoka, Japan) were inserted 0.25 to 0.5 inches into the skin at 19 acupuncture points (DU14, GB20, BL13, PC7, H6, K7, ST36, SP6, ear shen men, ear sympathetic point) for 20 minutes, and were manually stimulated. The 'De Qui' sensation was the elicited response SA: Treatment given 2 times per week for 4 weeks by several licensed acupuncturists having 3 years of normal postgraduate training and 3 to 25 years of continuous practice Needles (Streitberger sham needles 0.30 x 30 mm manufactured by Asjamed, Pullach, Germany) were applied a few centimetres away from the true acupuncture points for 20 minutes. Rather than penetrating the skin, the needle retracted inside its handle after insertion through an adhesive tape placed on a plastic supporting ring |
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Outcomes | Frequency of hot flushes per day using a diary | |
Source of funding | National Cancer Institute | |
Notes | Follow‐up: 6 months after initiation of treatment | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Random assignment of participants was accomplished using a secure, password‐protected, institutional computer system that stratified by using permuted blocks of random length" |
Allocation concealment (selection bias) | Low risk | Quote: "The system is designed to ensure that allocation cannot be guessed before a patient is registered and cannot be changed afterwards, thus ensuring full allocation concealment.” "After participant registration and random assignment, a research assistant who was otherwise unconnected with the trial accessed allocation and telephoned the acupuncturist with the details of allocation" |
Blinding (performance bias and detection bias) All outcomes | Low risk | "Patients, researchers, and others involved in patient care were blind to study group; only acupuncturists and the designated research assistant were aware of which patients received true and which received placebo treatment" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Few dropouts and lost of follow‐up (true acupuncture, 2%; SA, 7%). Reason for missing outcome data unlikely to be related to true outcome. 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 |