EXCELLENT PREDICTIVE VALUE OF HYALURONIC ACID INJECTIONS BEING NO BETTER THAN INJECTIONS OF BUPIVICAINE, CORTISONE, POLYNUCLEOTIDES, PLACEBO OR EXERCISE.

> 25% OF STUDIES WERE LEVEL 1 AND PREDICTIVE OF NO DIFFERENCE. STUDIES BEING FAVOR-ABLE WERE OF LIMITED FOLLOW UP OF 6 MONTHS OR LESS, OR UNDERPOWERED TO ACHIEVE STATISTICAL SIGNIFICANCE. Of note is the limited number of level 1 and 2 studies over the past 20 years.

The preponderance of studies are high levels of evidence and are unfavorable for the prediction of success of surgery for lumbar disc degeneration without instability, fracture, or scoliosis. This means that the predictive value for success in non-operative care is excellent (greater than 25% level I studies). This also means that the success of operative care is very poor. Since the question is usually asked whether an operation will be successful in this case, we have chosen to answer that as above.

HYALURONIC ACID INJECTIONS FOR OSTEOARTHRITIC JOINTS
Studies Favorable: Total 4

Level II: 4 Studies

1. Intra-articular hyaluronic acid compared with corticoid injections for the treatment of rhizarthrosis
Fuchs S, Mönikes R, Wohlmeiner A, Heyse T.
Osteoarthritis Cartilage. 2006 Jan;14(1):82-8. Epub 2005 Oct 19.
CONCLUSION: A single course of three SH injections is effective in relieving pain and improving joint function in patients with OA of the CMC joint of the thumb. Although in comparison with triamcinolone its effects are achieved more slowly, the results indicate a superior long-lasting effect of hyaluronan at 6 months after end of treatment period.
Level 1 – Favorable for CMC joint of thumb

2. Efficacy of intraarticular hyaluronic acid in patients with osteoarthritis–a prospective clinical trial.
Miltner O, Schneider U, Siebert CH, Niedhart C, Niethard FU.
Osteoarthritis Cartilage. 2002 Sep;10(9):680-6.
CONCLUSIONS: This controlled prospective clinical trial confirmed that 5 weekly intraarticular injections of HA (Hyalart) in patients with OA of the knee provide pain relief and functional improvements.
Level 2 – Favorable.

3. Treatment of painful osteoarthritis of the knee with hyaluronic acid. Results of a multicenter Asian study.
Bunyaratavej N, Chan KM, Subramanian N
J Med Assoc Thai. 2001 Oct;84 Suppl 2:S576-81.
Injection of hyaluronic acid into OA of the knee (Hyalgan 2 ml/wk for 4 doses) in international multicentres gave dramatic responses: decreased pain, increased mobility of the joint after 49 days of injections compared to a placebo (2 ml of normal saline) p<0.01.
Level 2 – Favorable

4. The double-blind test of sodium hyaluronate (ARTZ) on osteoarthritis knee.
Wu JJ, Shih LY, Hsu HC, Chen TH.
Zhonghua Yi Xue Za Zhi (Taipei). 1997 Feb;59(2):99-106.
CONCLUSIONS: The effective period could last up to three months without additional treatment. The efficacy of ARTZ on osteoarthritis knees was more prominent for relief of motion pain and improvement of knee movement. No side effects developed during a six month period.Based on clinical results here, SPH is a safe drug for administration as an alternative approach to treat the osteoarthritis knee.
Level 2 Favorable

HYALURONIC ACID INJECTIONS FOR OSTEOARTHRITIC JOINTS
Studies Unfavorable: Total 4

Level I: Total 3

1. Clinical and biochemical characteristics after intra-articular injection for the treatment of osteoarthritis of the knee: prospective randomized study of sodium hyaluronate and corticosteroid
Shimizu M, Higuchi H, Takagishi K, Shinozaki T, Kobayashi T.
J Orthop Sci. 2010 Jan;15(1):51-6. Epub 2010 Feb 12.
CONCLUSIONS: The results of this prospective randomized study suggest that the clinical effects of Na-HA and CS as local therapies for OA are comparable and that both drugs are useful.
Level I – Unfavorable ie no better

2. Efficacy of intra-articular polynucleotides in the treatment of knee osteoarthritis: a randomized, double-blind clinical trial
Vanelli R, Costa P, Rossi SM, Benazzo F.
Knee Surg Sports Traumatol Arthrosc. 2010 Jul;18(7):901-7. Epub 2010 Jan 29.
These findings suggest that intra-articular polynucleotides can be a valid alternative to traditional hyaluronan supplementation for the treatment of knee osteoarthritis
Level 1 – Unfavorable ie no better

3. Intra-articular hyaluranic acid compared with progressive knee exercises in osteoarthritis of the knee: a prospective randomized trial with long-term follow-up.
Rheumatol Int. 2006 Feb;26(4):277-84. Epub 2005 Mar 18.
Karatosun V, Unver B, Gocen Z, Sen A, Gunal I.
There were no statistically significant differences between the groups.
Level 1 – Unfavorable ie no better

Level II: Total 1

1. Intra-articular hyaluronan injections for the treatment of osteoarthritis of the knee: a randomized, double blind, placebo controlled study
Tamir E, Robinson D, Koren R, Agar G, Halperin N
Clin Exp Rheumatol. 2001 May-Jun;19(3):265-70.
RESULTS AND CONCLUSION: The results through week 20 indicate that BioHy provides relief for osteoarthritic patients without causing adverse effects, although the study was not sufficiently powered to obtain statistically significant differences between the treatment groups.
Level 2 – Unfavorable

HYALURONIC ACID INJECTIONS FOR OSTEOARTHRITIC JOINTS
Studies Neutral: Total 1

Level I: Total 1

1. Intra-articular hyaluronic acid compared to exercise therapy in osteoarthritis of the ankle. A prospective randomized trial with long-term follow-up.
Karatosun V, Unver B, Ozden A, Ozay Z, Gunal I.
Clin Exp Rheumatol. 2008 Mar-Apr;26(2):288-94.
CONCLUSION: This prospective randomized trial confirmed that, both HA injections and exercise therapy pro-vide functional improvement. owever, larger trials with longer follow-up are necessary for more definite conclusions.
Level 1 – Neutral – no conclusion

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.

For More Information On Evidence Based Medicine Rating System Click Here.