The aim of this study is to evaluate the effects and safety of acupuncture on anxiety and/or depression among patients with breast cancer.
Female, aged 18 to 70 years old;
Meeting the diagnostic criteria for breast cancer and at TMN I-III;
Having completed specialized active treatment for at least one month;
With an ECOG score of 0-2;
Starting to take or change the regimen of anti-anxiety and/or -depression disorder medication within one month before enrolment;
Received psychological intervention or physical therapy one month before enrolment or planning to use in the next 5 months;
With diagnosis of anxiety and/or depression disorder prior to the diagnosis of breast cancer;
Patients with suicidal tendencies, bipolar disorder and psychotic symptoms;
Parallel
Electroacupuncture group
DeviceThe needles will be inserted to 15-40mm in acupoints through adhesive pads. Needles will be lifted, thrusted and twirled gently for 3 times to achieve deqi sensation and manipulated every ten minutes during 30-minute maintenance. The electronic acupuncture apparatus will be connected to the bileteral Taiyang, Anmian and Baihui, with a continuous wave of 2 Hertz (Hz) and an electric current of 1-3 milliampere (mA). Participants receive acupuncture treatment three times a week in the first two weeks and twice a week in the last six weeks.
Sham electroacupuncture
DeviceThe needle will be inserted to 2-3mm in Bai Hui acupoint. For the remaining acupoints, needles will be inserted into the pad till reaching but without penetrating the skin. Needles will be lifted, thrusted and twirled gently for 3 times to simulate the effects of the needle tip penetrating the skin. The electronic acupuncture apparatus will be connected to the Baihui acupoint, Shang Yin Tang acupoint, and bilateral An Mian acupoints, with a continuous wave of 2 Hertz (Hz) and an electric current of 0.1-0.3 mA. In about 3-5 seconds, the electric current will be turned down. Participants receive acupuncture treatment three times a week in the first two weeks and twice a week in the last six weeks.
The change from baseline in the total score of Hospital Anxiety and Depression Scale (HADS).
The total score of HADS ranges from 0 to 42, with higher scores indicating greater anxiety and depression.
The change from baseline in the total score of HADS.
The total score of HADS ranges from 0 to 42, with higher scores indicating greater anxiety and depression.
The change from baseline in the score of HADS-A and HADS-D
The HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression.
Proportion of participants with a total HADS score less than 15, an HADS-A score of less than or equal to 7, and an HADS-D score of less than or equal to 7
The HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression.
Change from baseline in Hamilton Depression Scale-14
The Hamilton Depression Scale (HAMD) was developed by Hamilton in 1959 and is a clinical tool used to assess anxiety symptoms. All items use a 5-point rating scale from 0 to 4, with a total score ranging from 0 to 56. The cut-off value is 14 points. Generally, a score of \>14 points indicates anxiety, \>29 points indicates severe anxiety, and the higher the score, the more severe the anxiety symptoms.
Expectance assessment
Participants will be asked: How do you expect your anxiety and depression will be in 8 weeks?
Assessment of belief in acupuncture
Participants will be asked the question: Do you think your anxiety and depression may be helped by acupuncture?
Blinding assessment
Participants will be asked the question: Do you think you have received traditional electroacupuncture in the past 8 weeks?
Adherence assessment
Adherence will be assessed via counting treatment sessions. Those who complete over 80% treatment sessions will be defined as of good adherence.
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