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Adverse events in a chiropractic spinal manipulative therapy single-blinded, placebo, randomized controlled trial for
Aleksander Chaibi1, Jūratė Šaltytė Benth2, Peter J Tuchin3
1Head and Neck Research Group, Research Centre, Akershus University Hospital, 1478, Lørenskog, Oslo, Norway; Institute of Clinical Medicine, Campus Akershus University Hospital, University of Oslo, 1474, Nordbyhagen, Oslo, Norway.
Background:
Unlike pharmacological randomized controlled trials (RCTs), manual-therapy RCTs do not always report adverse events (AEs). The few manual-therapy RCTs that provide information on AEs are frequently without details, such as the type and-, severity of the AE and reason for withdrawal.
Objective:
To prospectively report all AEs in a chiropractic spinal manipulative therapy (CSMT) RCT.
Design:
A prospective 3-armed, single-blinded, placebo, RCT.
Methods:
Seventy migraineurs were randomized to the CSMT or a placebo, with 12 intervention sessions over three months. The recommendations by CONSORT and the International Headache Society's Task Force on AEs in migraine RCTs were followed. A standardized reporting scheme designed for pharmacological RCTs was used, and the AEs were described as frequencies and percentages within each group. The 95% confidence intervals (CIs) for the percentages (absolute risk) of AEs in each group were calculated when possible. Attributable risk (%) and relative risk were calculated with the corresponding 95% CIs.
Results:
AEs were assessed in 703 sessions, with 355 in the CSMT group and 348 in the placebo group. Local tenderness was the most common AE, reported by 11.3% and 6.9% of the CSMT group and the placebo group, respectively, and tiredness on the intervention day was reported by 8.5% and 1.4% of CSMT group and the placebo group, respectively. The highest attributable risk was for tiredness on the treatment day, 7.0% (CI 3.9-10.2%) which presented a relative risk of 5.9 (CI 2.3-15.0).
Conclusions:
AEs were mild and transient, and severe or serious AEs were not observed.
