Content of review 1, reviewed on October 18, 2018

The aim of the study is clearly stated and title clearly reflects aim of the study. Abstract concisely presents background, design, and results in great detail. References appear relevant to the study. Some references >10 years of the study publication, but could be due to recent limited studies regarding this topic. If possible, I’d recommend referencing more recent articles of study to help support the article.

Introduction is well-designed. The structure and design of the introduction adds to emphasize the drastic differences between the two treatment therapies. It’s clearly defined why this particular study differs from others that did not consider Ayruvedic diagnosis and multidimensional approach. The research aim is clearly stated and justified based on the background information and lack of studies on complex Ayurvedic OA treatment.

Selection process is clear with definitive and measurable requirements and clearly defined exclusion criteria. Study utilizes researched and measurable outcome measure and included secondary outcome measures, which is beneficial to examine other aspects of improvement in both intervention groups. This information can also be used in other studies as needed. Clearly defined requirements for Ayurvedic and conventional medicine practitioners. Sample size recommendation considered drop outs.

Results of the actual study not provided as this was a study protocol article. But Figure 4 is especially helpful in visualizing efficacy/effectiveness of study. All figures were relevant, clearly displayed without excessive information, and visually aid study design.

Study attempts to limit bias. Although a limitation, consultation time differences reflects real-life care settings. Conclusions are supported by reference articles. Other limitations to the study design to consider include: cost, monitoring use and frequency of emergency medications, monitoring application of nutrition/lifestyle advice in Ayurvedic group, being a longitudinal study. I might recommend participant interviews to track use of emergency medications and nutrition/lifestyle compliance. But hopefully if this study is to represent real-world situations, the Ayurvedic group would have higher compliance rate due to complex and individually tailored interventions. This study did address bias towards Ayurvedic groups, but was not able to resolve bias. For longitudinal study, I might recommend increasing sample size for >150 and perhaps recommend looking at other longitudinal studies similar to this and compare sample sizes and significance to ensure adequate sample size is used.

The study design was well-thought out and is innovative in examining whole medical systems. It’s a good representation of a comparative- effective research study. There are many real-life limitations that may occur during this actual study and effect the overall results.

Source

    © 2018 the Reviewer.

References

    M., W. C., Andreas, M., Stephanie, R., Antonio, M., Shivnarain, G., Mark, R., Ludwig, K., Elmar, S., Syed, H., Matthias, M., Christian, K. 2013. Comparative effectiveness of a complex Ayurvedic treatment and conventional standard care in osteoarthritis of the knee - study protocol for a randomized controlled trial. Trials.