Journal article review of "Comparing Verum and Sham Acupuncture in Fibromyalgia Syndrome: A Systematic Review and Meta-Analysis"

In today's article we will critically review the following research paper:

Comparing Verum and Sham Acupuncture in Fibromyalgia Syndrome: A Systematic Review and Meta-Analysis

J Kim, SR Kim, H Lee, DH Nam

J Evidence-Based Complementary and Alternative Medicine 2019 (2019).

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6732586/

So what type of evidence is this article?
The below image shows where this article ranks in the hierarchy of evidence:

So this article comes under the second from the top: Other SR & Meta-Analyses

What conclusion is made?

The author concluded that "verum acupuncture is more effective than sham acupuncture for pain relief, improving sleep quality, and reforming general status in FMS post treatment. However, evidence that it reduces fatigue was not found."

Are the conclusion’s justified by the data?

It would appear that the they are justified due to the meta-analysis analysing 10 randomised controlled trials (RCTs) with a total of 690 participants, after this they included 8 RCTs in the meta-analysis. This is certainly good data to pool from as the RCTs are reasonably high on the hierarchy of research.

What is the article briefly saying?

For Fibromyalgia sufferers they found that real acupuncture is more effective than essentially a placebo version (either non acupuncture point real needling or simulation of needling.) The effects were positive for pain, sleep and general status



Is the purpose of the study clear and what is it?

Yes it is clear.  To establish real acupuncture had better effects than it's placebo version so working out if acupuncture is simply a placebo or not.


Were the search methods used to locate relevant studies comprehensive?

They pooled from 1990 to August 2018 and they used 9 databases, which were: PubMed; Cochrane Central Register of Controlled Trials; EMBASE; PsycINFO; CNKI (China National Knowledge Infrastructure) and Chongqing VIP; and three Korean databases, namely, OASIS (Oriental medicine Advanced Searching Integrated System), KoreaMed, and RISS (Research Information Sharing Service). They used the following keywords for the search: (“fibromyalgia” [MESH] OR fibromyositis OR “fibromyalgia-fibromyositis syndrome” OR “myofascial pain syndrome”) and (acupuncture OR auriculotherapy OR electroacupuncture OR acupoint OR needling). They used inclusion and exclusion criteria with two reviewers and if they disagreed then they used a further review to make the decision. 
So it is good that they used studies that we current but they did go back to some quite old studies too. but overall they were pretty comprehensive in their search methods.

Is it clear what was measured, how & what the outcomes were?

They detail what was measured for each area although they block the non pain measures together, which is less clear.

Are the measurements valid, reliable & reproducible?

They used the following to assess pain intensity:
Visual analog scale (VAS)
Pain scale in the fibromyalgia impact questionnaire (FIQ)
McGill pain questionnaire (MPQ), 
Regional pain score (RPS)
Numerical rating scale (NRS)
Multidimensional pain inventory (MPI)). 

They used the following for fatigue, sleep quality and general status:
Pain scale in the fibromyalgia impact questionnaire (FIQ)
Visual analog scale (VAS)
Multidimensional fatigue inventory (MFI)
Pittsburgh sleep quality index (PSQI)

The pain ones are the most comprehensively valid, reliable and reproducible. Fatigue used one measure and this is valid and is used in chronic fatigue syndrome. For sleep quality this measurement has been shown to be valid and reliable and reproducible in multiple studies. 

Is the data suitable for analysis?

Yes, the data were synthesized using the Review Manager software program (version 5.3, Nordic Cochrane Centre, The Cochrane Collaboration, Copenhagen, Denmark). They grouped the studies according to the types of sham used, which gave them 3 categories. for continuous data they used the mean difference (MD) and 95% CI was calculated. Due to different measures being used in the different studies, they used a calculation to find the standardised mean difference (SMD) and  used a random-effects model with an inverse variance method.



Are results presented clearly & in sufficient detail to enable readers to make their own judgement?

Yes, they discuss each measure separately and included tables showing the results. The only issues are the difficultly in recognising the clinical significance of the reductions with the measures used.

Are results discussed in relation to existing knowledge? 

They discuss previous meta-analysis results, which found differing negative results. They don't discuss the Cochrane reviews on this either and these show no difference between sham and real acupuncture. 




Is the discussion biased?

In terms of bias, the journal for publication is the Journal of Evidence-Based Complementary and Alternative Medicine and so they might be considered having some bias. One of the backing organisations was potentially biased as they were the Traditional Korean Medicine R&D Program. In regards to the authors, they say that they have no conflict of interests but it is difficult to find information on them to ratify this.

Implications of the review for practice & research:

On the face of it, it seems that acupuncture is more than a placebo for pain, sleep and general status in Fibromyalgia. However there are issues, firstly the inability to blind the practitioners makes bias possible and the fact that blinding the participants accurately is also difficult because they certainly could tell that it was sham acupuncture in the simulated groups. Overall though it gives some clout to it's use in practice.


Conclusion:

In conclusion this meta-analysis shows that acupuncture is possibly worth trying with Fibromyalgia sufferers and at worst it works but is quite placebo driven. However this is put into doubt because the non acupuncture point needling is easier to blind the participants even if it still doesn't blind the therapists. As always there are issues that are hard if not impossible to solve to correct these limitations but overall it works and may be legitimately better than placebo.



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