Efficacy and safety of Sijunzi Decoction for chronic fatigue syndrome: study protocol for an RCT, Dai et al., 2019

I'm not following why it's completely useless.

It's double blind and placebo controlled. The sample size is good - 212 participants, allocated to either the treatment or placebo. The treatment time of 2 months, with a one month followup, is perhaps a bit short but it's not terrible.

The Chalder fatigue scale is a bad instrument, but some of the secondary outcomes might be better (eg SF36 Physical function, clinical global impression, quality of life). Subjective outcomes are ok with a double blind trial. The spleen deficiency rating scale is a bit random of course, but still, with questions such as 'easy getting cold', 'insomnia', I've seen sillier things.

The selection criteria (CDC? - 6 months of fatigue and 4 of a list that includes but does not require PEM) is not good. The protocol is written up clearly with things that you'd expect from a well run trial. The placebo and treatment will be packaged identically, with only a randomly allocated serial number allowing traceability. Adverse events will be monitored.

Yes, there's probably a fair degree of bias in the researchers. But that only makes the trial completely useless if you are confident that the researchers are going to be fraudulent.

 

I'm afraid the use of the Chalder fatigue scale could muddle the results. It seems so unreliable and ineffective to evaluate anything seriously.

 

There's the vast country of China with TCM practitioners diagnosing spleen deficiency and prescribing Sijunzi decoction to people with CFS-ish illnesses. And plenty of people in other countries spending lots of money on TCM consultations and products.

I think it's very useful to know if it works or not.

The design is pretty robust with respect to blinding - there are third parties preparing the packages. Like I said, fraudulent behaviour could subvert it, but that doesn't mean the protocol is completely useless.

 

The protocol suggests decent efforts are being made. Yes, the food colourants and flavouring agents might have impacts of their own (good or bad).

I just think 'totally useless' goes further than is justified. I'd rather keep that assessment for the likes of the shopping bag studies e.g. studies with no blinding and subjective outcomes.

I'd prefer that these researchers felt able to come on this forum so that we could talk about things like selection criteria and the Chalder scale (and their idea that the BPS theories have some validity) rather than felt completely dismissed.