Acupuncture versus Sham Acupuncture for Chronic Sciatica – another finding that is too good to be true?

Although acupuncture is widely used by patients with chronic sciatica, the evidence of its efficacy is scarce. The objective of this multicenter 2-arm randomized clinical trial, conducted in 6 tertiary-level hospitals in China, was to investigate the efficacy and safety of acupuncture compared with sham acupuncture in patients with chronic sciatica from herniated disk. Participants were recruited from March 25, 2021, to September 23, 2021, with a final follow-up through September 22, 2022. Data analyses were performed from December 2022 to March 2023.

Participants were randomly assigned to receive:

• 10 sessions of acupuncture (n = 110) or
• 10 sessions of sham acupuncture (n = 110) over 4 weeks.

Participants, outcome assessors, and statisticians were blinded.

The 2 primary outcomes were changes in visual analog scale (VAS) for leg pain and Oswestry Disability Index (ODI) from baseline to week 4. Secondary outcomes were adverse events.

A total of 216 patients (mean [SD] age, 51.3 [15.2] years; 147 females [68.1%] and 69 males [31.9%]) were included in the analyses. The VAS for leg pain decreased:

• 30.8 mm in the acupuncture group,
• 14.9 mm in the sham acupuncture group at week 4 (mean difference,
  −16.0; 95% CI, −21.3 to −10.6; P < .001).

The ODI decreased:

• 13.0 points in the acupuncture group,
• 4.9 points in the sham acupuncture group at week 4 (mean difference, −8.1; 95%
  CI, −11.1 to −5.1; P < .001).

For both VAS and ODI, the between-group difference became apparent starting in week 2 (mean difference, −7.8; 95% CI, −13.0 to −2.5; P = .004 and −5.3; 95% CI, −8.4 to −2.3; P = .001, respectively) and persisted through week 52 (mean difference, −10.8; [95% CI, −16.3 to −5.2; P < .001; and −4.8; 95% CI, −7.8 to −1.7; P = .003, respectively). No serious adverse events occurred.

The authors concluded that this randomized clinical trial found that in patients with chronic sciatica from herniated disk, acupuncture resulted in less pain and better function compared with sham acupuncture at week 4, and these benefits persisted through week 52.
Acupuncture should be considered as a potential treatment option for patients with chronic sciatica from a herniated disk.

At first glance, this certainly looks like a rigorous and well-reported study. Yet, at a second glance, multiple concerns emerge about its reliability. Here are some of my reasons:

1. The study was started 3 years ago and concluded in 2022; I am wondering why it took 2 years to get it published.
2. A clinical trial with ~200 patients cannot reasonably assume to “investigate the safety” of a therapy.
3. I am amazed that the trialists found >200 patients with severe chronic sciatica who did not take any medication (In my experience, 100% of these patients take something against their pain). Those who did were told to stop them and renter the trial after a washout phase; I am wondering whether this would pass an ethics committee in a Western country.
4. The authors state that all verum patients experienced de qi. It is not my experience that 100% of patients excerience this sensation during acupuncture.
5. The therapists were told to follow a standardised protocol. Yet I doubt that they were not able to influece patients by their verbal or non-verbal communication – after all, they had a poweful vested interest to generate a positive result.
6. The authors state that blinding the therapist is not possible in trials of acupuncture. I disagree.
7. The authors report that they tested the degree to which patients were unblinded and state “patients were unaware of assigned treatments”. I find this utterly implausible. There are several reasons for my disbelief: 1) sham patients did not experience de qi, according to the authors., while the verum patients are said to have experienced this sensation with each of the 5 needles inserted at each of the 10 session. 2) While in the verum group the needles were manipulated and left in place for 30 minutes, this did not happen in the sham group. I cannot believe that these differences did not prompt a large degree of de-blinding.

We have often reported that acupuncture trials from China invariably report positive results. We have also repeatedly mentioned that >80% of Chinese clinical trials are said to be fabricated. If I consider all of this and look at the results of this study critically, I have to say that I find them far too good to be true.