Inspired by Lu et al 2024.[1]
ET – endocrine therapy
AI – aromatase inhibitor(s)
FACT-ES – Functional Assessment of Cancer Therapy – Endocrine Symptoms
ESS – endocrine symptom subscale (of FACT-ES)
MA – manual acupuncture
EA – electroacupuncture
RIX – radiation-induced xerostomia– key to acronyms
Hot flushes was the subject of my first blog back in 2016 – Acupuncture for menopausal hot flushes. This will be the 11th post in the category Hot Flushes, although the first that focusses on women with breast cancer undergoing endocrine therapy (ET). The latter fact surprised me because we seem to have been talking about acupuncture for the treatment of hot flushes related to use of tamoxifen and then aromatase inhibitors (AI) for years.[2]
On checking my records, it seems that we may not yet have definitive evidence of efficacy for acupuncture in hot flushes, although the data on AI-related joint pain has reached the threshold to enter guidelines – see category: AI-related joint pain.
Despite the absence of data on efficacy beyond sham for the symptom of hot flushes, there seems to be rather more pragmatic data suggesting effectiveness.
This paper adds to the depth and quality of the pragmatic data by utilising one of my favourite methodologies for clinical trials of acupuncture – acupuncture versus waiting list with the latter group receiving acupuncture after a certain delay. This method avoids the problems of sham acupuncture and the theoretical problem of demoralisation in the group that are not randomised to acupuncture immediately.
The trial is described as multinational, and it appears to be a coordinated set of trials in 3 different countries (Korea, US, and China) using the same population and the same primary outcome. FACT-ES has a 19-item subscale (ESS) with scores ranging from 0 to 76. Lower scores are associated with worse symptoms.
The patients recruited to the trials were all women with hormone receptor positive breast cancers who were receiving adjuvant endocrine therapy (tamoxifen, AIs, goserelin, leuprolide).
Acupuncture was performed twice a week for 10 weeks followed by a further 10-week follow-up. During the follow up period the waiting list group received the same acupuncture package. The acupuncture protocol was standardised to 5 core points plus 6 optional points. The core points were: SP6, LI11, Yintang, GV20, Shenmen (ear point). The optional points were: LR3, ST36, KI3, PC7, CV6, Heart (ear point). MA was used for the first session, and in subsequent sessions EA was used between GV20 and Yintang.
With the methodology of this trial (A plus B vs B, or A plus UC vs UC, where UC is usual care and A is acupuncture) it is not a surprise to find that adding a therapy is associated with an improvement in symptoms, especially when those symptoms are rated subjectively, and the rating is not masked in any way. In this case there was a very highly significant difference between groups and the change in the acupuncture group reached clinical significance (half of an SD of the change from baseline).[3]
The unexpected result was that there was a significant difference between centres in terms of the size of the effect. The effect was biggest in Korea, followed by the US, and then China. The last time I commented on differential effects between countries it was between US (Texas) and China (Shanghai) and the topic was xerostomia (RIX), see: RIX sham and cultural differences and RIX sham and cultural difference 2022.
This is the first time I have seen better effects from acupuncture in the US compared with China, and there are a number of different possibilities; however, the most likely is the rather unexciting prospect that it was due to chance and small numbers of patients from China and Korea. But there is the more exciting prospect that there may be differential effects based on symptom severity, prescription of different ET drugs, and possibly even protocol differences ;-).
References
1 Lu W, Giobbie-Hurder A, Tanasijevic A, et al. Acupuncture for hot flashes in hormone receptor-positive breast cancer: A pooled analysis of individual patient data from parallel randomized trials. Cancer. Published Online First: 24 June 2024. doi: 10.1002/cncr.35374
2 Filshie J, Bolton T, Browne D, et al. Acupuncture and self acupuncture for long term treatment of vasomotor symptoms in Cancer patients – audit and treatment algorithm. Acupunct Med. 2005;23:171–80. doi: 10.1136/aim.23.4.171
3 Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care. 2003;41:582–92. doi: 10.1097/01.MLR.0000062554.74615.4C
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