The Siemandi clinical trial (1997)
A randomized, double-blind, placebo-controlled trial of cetyl myristoleate reported by H. Siemandi, MD, PhD, and colleagues. Summarized below in the study’s own terms.
Objective
Following anecdotal reports that cis-9-cetyl myristoleate might ease various arthritic conditions, the investigators set out to test, under controlled conditions, whether the material produced measurable effects.
Design
As reported, the study was a multicentre, double-blind, randomized, placebo-controlled parallel trial. Patients were allocated to three arms: cis-9-cetyl myristoleate alone; cetyl myristoleate plus a support complex (glucosamine hydrochloride, sea cucumber and hydrolyzed cartilage); or placebo. A target of 431 patients was set, with a reported analysed sample of 382. Eligible patients had inflammatory arthritis of at least one year’s duration and had failed prior NSAID therapy; systemic and intra-articular steroids were not permitted. Participants were asked to abstain from tobacco and caffeine, which the authors noted could blunt results.
Reported results
The investigators defined a “treatment responder” in advance, requiring improvement across multiple assessments. Using that definition, they reported the following response rates (percentage improvement):
| Measure | CM only | CM + support | Placebo |
|---|---|---|---|
| Treatment response | 63.3% | 87.3% | 14.5% |
| Physician overall assessment | 58.1% | 84.2% | 13.9% |
| Patient overall assessment | 59.2% | 88.2% | 16.1% |
| Joint swelling score | 47.5% | 77.2% | 21.1% |
The authors reported that both cetyl-myristoleate arms outperformed placebo, that the support complex appeared to add further benefit, and that most responders did so within the first three weeks. They reported the material was well tolerated, with withdrawals largely attributed to participants’ inability to give up tobacco, caffeine or alcohol.
Conclusion (as stated)
In the authors’ words, cetyl myristoleate — alone and with the support complex — appeared to offer benefits over placebo across a range of arthritic conditions in this trial, and they suggested the findings warranted further study.
See also the San Diego dose-finding study.