Randomized Multicenter Placebo-Controlled Trial of Omega-3 Fatty Acids for the Control of Aromatase Inhibitor-Induced Musculoskeletal Pain: SWOG S0927

Hershman DL, Unger JM, Crew KD, Awad D, Dakhil SR, Gralow J, Greenlee H, Lew DL, Minasian LM, Till C, Wade JL 3rd, Meyskens FL, Moinpour CM · Journal of Clinical Oncology

Pain fell substantially — more than half — in both arms, and identically: adjusted 12-week Brief Pain Inventory scores did not differ (p = 0.58). Triglycerides fell on omega-3 and not on placebo (p = 0.01), confirming the dose was taken and absorbed, while CRP, HDL and LDL did not move. A well-powered demonstration of how large the placebo response is in a joint-pain endpoint.

Population

Women with early-stage breast cancer on an aromatase inhibitor, with joint pain/stiffness scored at least 5 of 10

Intervention

3.3 g/day omega-3 fatty acids for 24 weeks

Comparator

Soybean/corn oil placebo

Limitations

Aromatase-inhibitor arthralgia is a drug side effect, not osteoarthritis, and the comparator oil is not inert. Recorded for the size of the shared improvement rather than for the null.