MAVERICK LUMBAR DISC REPLACEMENT

7 Studies

3 Studies

0 Studies

6 Level IV
1Level V

1 Level II
2 Level IV

LEVEL I

Randomized, controlled clinical trials. Researchers would use a computer program to randomly assign patients with back pain into two groups of 20. The first group (placebo group known as the control) would drink water (that only tasted like pomegranate juice but was not) for 10 days. The second group would drink real pomegranate juice for 10 days. None of the patients would know if they were drinking the real pomegranate juice or not. (This is called a blinded study). Then a researcher who does not know which person drank what (which now makes this a what’s called a “double blinded” study) would interview the patients to determine if their back pain was reduced, worsened or stayed the same. After this was all done, the information about which patients drank what would then be revealed. One could then see if those who drank the real pomegranate juice were better or not than the water drinking group.

LEVEL II

Non-randomized, prospective comparative study. A researcher looks at 40 patients medical records to select 20 patients for the pomegranate drinking group and 20 patients for the control group who will drink water. This is called a “cohort,” namely a control and experimental patient make a cohort. Here the researcher may introduce his own bias whether he intends to or not. If he believes pomegranate is a safe, effective treatment for back pain then whether he means to or not he may put the healthier patients with less back pain in the pomegranate group and patients complaining of more back pain in the water-drinking group. (This particular bias is called “selection bias.” See section on types of research bias.)

LEVEL III

Retrospective (already occurred) comparative study or case controlled study (each “experimental“ patient is matched to a patient that never had the experimental). This is not a reliable standard for determining one treatment over another, though it can be helpful to, say, see how many complications a certain treatment has. Researchers do a retrospective study for example reviewing 20 patient records of patients who reported they have been drinking pomegranate juice in the past and then 20 patients who have not reported drinking pomegranate juice. Then the researchers review the patients’ medical records determine if the back pain was reported better, worse or stayed the same. Here again, the selection process may introduce bias intentionally or not. In this case it may not only be selection bias, but could involve “recall” bias, or “expectation bias” or “attention bias.” (See Bias in Research section).

LEVEL IV

Case series do not determine success or failure of a treatment compared to other treatments or no treatment at all. Researchers or a physician does a case study on 20 patients who drink pomegranate juice for 10 days and then report the results. In this case there is no control group or comparison to patients who are not drinking pomegranate juice. It does not take into consideration that back pain could get better in 10 days if the patient takes nothing at all for the pain. These studies are easier and cheaper. They can be of value to determine better methods of doing a particular treatment, or what the complications of a certain treatment are, but NOT for determining if one treatment is better than another.

LEVEL V

Expert opinion. One physician expert’s opinion on if pomegranate juice helps reduce back pain. No original research is conducted. Instead, just a written opinion or editorial that may talk about other research and give opinions, but no clinical study is conducted. AME considers this to be one step above hearsay for determining one treatment over another, though it may be valuable for stimulating discussion and ideas on a particular topic.