INHE 3003 Week 5 Methods Summary Example

How the Tasmanian Turmeric Trial Was Run, Restated Plainly and Without a Verdict: A Methods Summary From the Published Abstract and the Trial Registration

Student Name

Walden University

INHE 3003: Research Literacy for Integrative Health Professionals

Instructor Name

Month Day, Year

How the Tasmanian Turmeric Trial Was Run, Restated Plainly and Without a Verdict: A Methods Summary From the Published Abstract and the Trial Registration

Sources Used

This summary restates the methods of one randomized trial of turmeric root extract for knee osteoarthritis, the trial identified by the Week 4 search (Wang et al., 2020). It draws on the published abstract and on the trial's entry in the Australian New Zealand Clinical Trials Registry, which records design details registered before the trial began (Australian New Zealand Clinical Trials Registry [ANZCTR], 2018). Where the two sources describe the same feature, the published article is followed; where only the registry gives a detail, the summary says so.

Design and Setting

The study was a randomized, double-blind, placebo-controlled trial with two parallel groups, run at a single center in southern Tasmania, Australia. Enrollment ran from June to December 2018, and data collection ended in March 2019, according to the registry.

Participants

Seventy adults took part. To enter, a person had to be over 40, have knee pain on most days that scored above 40 of a possible 100 mm on a visual analog pain scale, meet the American College of Rheumatology clinical criteria for knee osteoarthritis confirmed by a clinician, and show fluid and lining thickening in the knee, called effusion-synovitis, of at least 4 mm on ultrasound. People were excluded if they could not have an MRI, had severe joint space narrowing on X-ray, had another inflammatory arthritis such as rheumatoid arthritis or gout, had a recent knee injury or surgery, had recent steroid or hyaluronic acid injections into the knee, or were pregnant or breastfeeding, among other criteria in the registry.

Intervention and Comparison

Thirty-six participants took two capsules of Curcuma longa extract a day, which the registry describes as two 500-mg capsules, for 12 weeks. Thirty-four took two identical-looking placebo capsules of microcrystalline cellulose. Adherence was checked by counting returned capsules at the 12-week visit.

Allocation and Blinding

According to the registry, participants were assigned by computer-generated block randomization, with allocation handled centrally, and participants, staff giving the capsules, outcome assessors and data analysts were all blinded to group.

Outcomes

There were two primary outcomes: change in knee pain on the visual analog scale, and change in effusion-synovitis volume measured on MRI. Key secondary outcomes were change on the pain subscale of the WOMAC, a standard osteoarthritis questionnaire, and a measure of cartilage composition on MRI. Outcomes were assessed over the 12 weeks; the registry schedules pain ratings at entry and every fourth week through week 12. Adverse events were recorded in both groups.

Analysis

The registry describes pain and function comparisons using a repeated-measures mixed model that adjusts for baseline values, age, sex and body mass index, and linear regression for changes in effusion-synovitis size.

Funding

The trial was funded by the University of Tasmania and Natural Remedies Private Limited, a company in India that makes herbal extracts (Wang et al., 2020).

What This Summary Leaves Out

No judgment is made here about whether the methods were adequate, whether the sample was large enough or what the funding source might mean. Those questions belong to the Week 8 appraisal. Reporting guidance for trials lists the elements a methods section should contain (Schulz et al., 2010), and this summary follows that list without grading the trial against it.

References

Australian New Zealand Clinical Trials Registry. (2018). A randomised trial of Curcuma longa for treating symptoms and effusion-synovitis of knee osteoarthritis (ACTRN12618000080224). https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618000080224

Schulz, K. F., Altman, D. G., & Moher, D. (2010). CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. BMJ, 340, Article c332. https://doi.org/10.1136/bmj.c332

Wang, Z., Jones, G., Winzenberg, T., Cai, G., Laslett, L. L., Aitken, D., Hopper, I., Singh, A., Jones, R., Fripp, J., Ding, C., & Antony, B. (2020). Effectiveness of Curcuma longa extract for the treatment of symptoms and effusion-synovitis of knee osteoarthritis: A randomized trial. Annals of Internal Medicine, 173(11), 861-869. https://doi.org/10.7326/M20-0990