A 76-week trial

Inspired by Soares-Jr et al 2020.[1]

FSH – follicle stimulating hormone
KMI – Kupperman-Blatt Menopausal Index
VMS – vasomotor symptoms

key to acronyms

This trial (n=123) stood out for me when I watched the video abstract and saw the graph of results. It would have been easy to pass over the paper by scanning the abstract alone, as I tend to do each morning when the notification from PubCrawler arrives (see previous blog for explanation of PubCrawler)

…this trial lasted almost 18 months

It turns out that this trial lasted almost 18 months, and I think that is a record in the acupuncture field. It is also rather unique because it incorporated a six-month period in the middle of the trial when both groups received the verum acupuncture treatment. In the first 6 months one group received verum acupuncture weekly for 10 weeks and then every 2 weeks, whilst the other group received a non-penetrating sham treatment based on an electro-diagnostic device similar to Ryodoraku. The verum acupuncture included 17 bilateral points, 4 midline points and Sishencong (4 points around GV20), which appears to be a total of 42 needle insertions per session. So even if the needling was gentle at each point the total dose would be quite substantial, which is probably what is needed to achieve general effects in the largest number of patients of course. In the last six months of the trial the group that had started with verum acupuncture were switched over to the non-penetrating sham.

The main outcome was the KMI score,[2] and this is very conveniently and succinctly described in the paper.[1]

The KMI is a numerical conversion index and includes the following 11 climacteric symptoms: hot flashes (vasomotor), paresthesia, insomnia, nervousness, melancholia, vertigo, weakness, arthralgia or myalgia, headache, palpitations, and sexual dysfunction. Each symptom was rated on a scale from 0 to 3 for no to severe complaints, respectively. To calculate the KMI score, the symptoms were weighed as follows: hot flashes (x4), paresthesia (x2), insomnia (x2), nervousness (x2), and all other symptoms (x1). The maximum score was 51.

[1]

By putting a key to abbreviations at the top, I guess the you (the readers) have assumed that this is a trial of acupuncture in hot flushes, and you’d be right, but I should clarify that the population was premenopausal, and this trial was focussed on the period of menopausal transition – a period of around 7 years prior to the menopause, characterised by fluctuations in circulating levels of FSH, and prominent VMS. Again, the paper succinctly describes the population included.

The inclusion criteria were the following: (a) age between 45 and 52 years, (b) a desire to receive an alternative nonhormonal treatment and/or a contraindication for a hormone treatment, and (c) moderate to pronounced climacteric symptoms (total score on the KMI was equal to or more than 20) and menstrual irregularity.

[1]

I noted with interest that the data of those patients who were amenorrhoeic for more than 6 months by the end of the trial were excluded. This totalled nearly 20% of the total, which is not insignificant, and it was not quite balanced between the groups.

The other key methodological issue is of course blinding. The paper mentions that the practitioners could not be blind; however, there is no discussion of possible unblinding of the patients. As this was a cross-over trial, all the patients experienced both verum and sham treatments, and the sham was non-penetrating, but it was applied to the same points as the verum acupuncture. There is no discussion of what was said to the patients to explain the changes in treatment, and no data on whether blinding was maintained.

Having said that, even if the patients knew the difference between the treatments, the graphical presentation of KMI scores is rather compelling, and that of average hot flash frequency is rather intriguing. I will present and discuss those in the webinar tonight.

I cannot really present them here, as the paper is not open access, but you could have a look at the video abstract. Skip to 2:18 if you don’t want to follow the entire clip.

Reference list

1         Soares-Jr JM, Branco-de-Luca AC, da Fonseca AM, et al. Acupuncture ameliorated vasomotor symptoms during menopausal transition: single-blind, placebo-controlled, randomized trial to test treatment efficacy. Menopause Published Online First: 7 September 2020. doi:10.1097/GME.0000000000001651

2         Kupperman HS, Blatt MH, Wiesbader H, et al. Comparative clinical evaluation of estrogenic preparations by the menopausal and amenorrheal indices. J Clin Endocrinol Metab 1953;13:688–703. doi:10.1210/jcem-13-6-688

---

Declaration of interests MC