Complementary and Alternative

Therapies (CAM)

Deborah Rothman, Ph.D. , M.D.Shriners Hospital for Children

Springfield, MAJA 2011 National Conference

Arlington, VA

Why is there so much interest in CAM?

Dissatisfaction with current therapies :

• Side effects

• Possible long term adverse effects • The appeal of a “natural” remedy

How does this apply to children with arthritis?

• Is there a way to feed my child that will make her arthritis better?

• Is there a special supplement that will help?

• Do certain foods make arthritis worse?

Goals

Give you tools to help you make decisionsabout CAM with your child’s physician:

1. Is there evidence that this is effective?

2. Is there evidence that this is harmful?

3. Where I am getting this information?

How do we know something helps?

There is a great deal of information on the

Internet about alternative therapies for JIA.

The volume of information isoverwhelming.

How can you possibly evaluate all of thesuggested alternative therapies?

Reliable Sources:Tufts University Health and NutritionLetter (tuftshnltr@aol.co)

International Bibliographic Information on Dietary Supplements

(IBIDS) (http://ods.od.nih.gov/databases/ibids.html

NIH Clinical Nutrition Service(http://www.cc.gov/ccc/supplements/intro.html)

PDR for Herbal MedicinesPDR for Nonprescription Drugs and DietarySupplements

www.foodnews.org (organic vs nonorganic )

Not so Reliable Sources

• Random sites on the internet• Jenny McCarthy• Sites that end in .com• Wikipedia• Friends, relatives, total strangers• Infomercials

Warning

The information that is readilyavailable on the internet may havebeen put there by people whose motivation is primarily financial. It

iscompletely unregulated.

Suggestions

• Download anything from the internet that you want to try and send to your doctor so you can discuss it at your child’s next appointment.

• If you are using alternative therapies let your doctor know.

What is the evidence that this is effective?

Has it been studied in children and the

results published in a peer-reviewed

journal?

How do we know a therapy is effective ?

Randomized placebo-controlled trials

(RCTs) are the gold standard for evaluating

medications and therapies.

What is a RCT?

The intervention is compared to a placebo( fake drug or inactive supplement ) withneither the patient, the parent or theinvestigator knowing who is receiving theactive drug or the placebo (blinded). Thedata is then analyzed to see if there is asignificant difference between the twogroups.

Diet I• Vegetarian diet

• Fasting

• Fish oil

• Borage oil

Vegetarian Diet

• No controlled trials in children.

• Poorly controlled study in adults with RA showing slight improvement

• Vegetarian diets can be healthful for children but may be limited in iron, protein, calcium and certain vitamins.

Types of Vegetarian Diets

• Vegan : Exclude meat, poultry, fish, eggs, dairy

• Lacto-vegetarian : Exclude meat, poultry, fish, eggs, allows dairy

• Lacto-ova vegetarian : Excludes meat, poultry, fish, allows dairy and eggs

• Pesco -vegetarian: Allows fish• Pollo-vegetarian: Allows chicken• Snickers-Vegetarian

Vegetarian Diet

If you are considering a vegetarian diet for

your child ask for a referral to a Registered

Dietician who can review a safe and nutritious vegetarian diet. She can also review drug/nutrient

interactions.Example: calcium and steroids,methotrexate and folic acid.

FASTING

Short-term modified fasting in adults for7-10 days showed improvement in RAactivity. Clin Exp Rheumatol 2000:18,

357.

No studies done in children

Children with S-JIA have profound anorexia with no improvement

Fish Oil

Adult studies: Multiple RCT’s showing

improvement in RA

Pediatric studies: Several RCT’s showing modest improvement: decreased CRP, able to decrease NSAID dose

Fish Oil Caveats

Fish oil thins the blood so could increasethe risk of bleeding if also taking

NSAIDs

Challenging to get children to swallow the

supplements

Mercury

Fish Recommendations

• Good fat: mackerel, herring, sardines, anchovies, albacore tuna, salmon

• BUT for young children NO mackerel

• Up to 12 oz/week of seafood that’s low in mercury: shrimp, salmon (wild), canned light tuna (albacore has 3x more mercury)

Botanical (Plant) Oils

Borage Oil: GLA (gammalinolenic acid) → DGLA→ Prostaglandin E1 which hasantiinflammatory and

immunoregulatoryproperties. It has been shown to

reducesynovitis in adults with RA.

Borage Oil

One RCT in children with JRA showed modest but statistically significantimprovement in children treated

withborage oil compared to a placebo.

A&R 42 (Suppl): S229, 1999.

GLA suppresses acute and chronic inflammation in animal models of arthritis. It has also been shown in placebo-controlled double-blind trials to reduce synovitis in adults with rheumatoid arthritis

These promising results were the basis for this clinical trial to study borage oil for the treatment of JIA.

What does this mean?

There appears to be an effect of this oil in

animal studies. Does that translate tochildren?

There appears to be an effect in adults with

RA. Does that translate to children?

Study Design I

The study was multi-center, randomized,

double-blind, and placebo-controlled. The study duration was 12 months

withthe first 6 months on borage oil orplacebo and then cross over for the

last 6 months.

What does this mean?

The groups had to be comparable

There had to be a placebo

Study Design II

Patient selection:

All patients included in the analysisfulfilled the ACR criteria for JRA.

Study drugs:

GLA in borage oil (23%) at 40 mg/kg/day BID

Safflower oil placebo given in equal volume

Results

Outcome Variable Borage Oil

Placebo P value

Physician’s global assessment (0-4)

0.38 (1.02)

0.92 ( 1.20)

0.002

Parent’s global assessment (0-100)

10.82 (13.78)

17.46 (22.40)

0.069

Functional ability scale (0-3)

0.34 (.40 )

0.42 (.47)

0.113

Number of joints with active arthritis

4.39 ( 9.75)

5.68 ( 9.85)

0.045

Number of joints with limited range of motion

2.75 (5.37)

3.54 (4.80)

0.117

Number of swollen joints 4.25 ( 9.72)

5.46 (9.91)

0.371

Number of tender joints 0.57 (2.10)

0.25 (.84)

0.825

Changing Gears

Diet II

Nutritional Elimination Diets

1.Nightshade vegetables2.Wheat3.Milk/dairy products

Elimination: Nightshade Vegetables

Potatoes, tomatoes, peppers, eggplant

All reports from same author and from anon-scientific review article

Many hits on the internet about thisCourtesy Barbara Ostrov, M.D.

Elimination: Wheat

If your child has celiac disease then wheat

and gluten need to be eliminated fromher/his diet.1.5 -10% of JIA co-exists with celiacdisease. (Rheum 2005: 44, 517)Resolve/improve on gluten-free diet

Celiac disease is a medicaldiagnosis.

Elimination: Milk

• Fewer than 10% of those who believed they were sensitive showed consistent effect of manipulation of milk in diet in PCRCT (Ann Rheum Dis 1992:51, 298)

• True cow’s milk allergy needs to be diagnosed by an allergist

Recommendations

Restrictive diets can deprive children ofvaluable nutrients.

They can isolate children and limit their ability to socialize with their peers.

For those rare children who requirerestrictive diets, work with your physician and a registered dietician.

Safe Nutrition Interventions

• Cook with olive oil

• Eat fish 2x/week

• Vegetarian diets can be safe

• Borage oil supplements