Research Briefs for Practitioners – May 2022 - Dr. Michael Ruscio, DNM, DC
Future of Functional Medicine Review Clinical Newsletter

Research Briefs for Practitioners – May 2022

by Dr. Ruscio, DNM, DC, Gavin Guard, PA-C, MPAS, CISSN, Pn1, and the Ruscio Institute for Functional Medicine Clinical Team

Medically reviewed & fact checked by a
board-certified doctor
Medically reviewed & fact checked by a
board-certified doctor
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Episode 52

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Featured Studies

  • Effects of a gluten challenge in patients with irritable bowel syndrome: a randomized single-blind controlled clinical trial
    • 50 IBS patients 
    • All patients were treated w/ low FODMAP + gluten free diet (GFD) x 6 weeks, then randomized to either:
      • Gradual gluten reintroduction x 6 weeks (with dose-escalation each 2 weeks)
      • Unrestricted gluten-containing diet
      • Continued low FODMAP + GFD x 6 weeks
    • The low FODMAP + GF diet led to improvements in all symptoms
    • After 3 months, all groups had similar:
      • Abdominal pain
      • Bloating
      • IBS symptom score
      • Quality of life
    • Low FODMAP + GFD led to the greatest reduction in anxiety 
    • Commentary: While a low FODMAP and GFD was effective for improving IBS symptoms, the introduction of gluten did NOT worsen IBS symptoms.
  • The effect of low FODMAP diet with and without gluten on irritable bowel syndrome: A double blind, placebo controlled randomized clinical trial
    • 49 IBS patients treated w/ low FODMAP diet (LFD), randomized to:
      • Placebo (gluten free rice flour)
      • Gluten powder
    • After 6 weeks, both groups experienced statistically significant improvements in:
      • IBS symptom score (-32% gluten group, -49% placebo group)
      • Abdominal pain intensity (-45% vs -52%)
      • Abdominal pain frequency (-26% vs -46%)
      • Abdominal distension (-29% vs -63%) 
      • Quality of life (+23% vs +32%) 
    • Commentary: LFD was helpful for IBS patients with or without the restriction of gluten. However, there was a trend towards greater improvement in the LFD + gluten free group.

Final Commentary: These two studies show similar results; gluten avoidance may lead to additional improvements in GI and non-GI symptoms compared to low FODMAP diet alone. However, it’s important to not be dogmatic with gluten-free recommendations and help your patients determine their individual response to a gluten-free trial, and eventually get them to the broadest diet possible.


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Gastrointestinal Studies

  • Gastric intestinal metaplasia: Long-term follow-up results
    • 156 patients w/ intestinal metaplasia, 150 healthy controls
    • Average followup of 4 years
    • Of those w/ intestinal metaplasia:
      • Gastric cancer found in 3 participants (0 in healthy controls)
      • Gastric dysplasia found in 9 (2 in healthy controls)
    • Of those who were followed up in 5-10 years, NO difference in dysplasia and cancer development between two groups (metaplasia vs healthy controls)
    • Commentary: Gastric adenoma rates are very low. A longer followup interval may be appropriate for those w/ intestinal metaplasia.

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Autoimmunity Study

  • Prevalence of autoimmune thyroid disease in patients with psoriasis: a meta-analysis
    • 11 studies, 253,313 psoriasis patients, 1.3 million controls
    • Compared to healthy controls, patients with psoriasis had higher rates of:
      • Autoimmune thyroid disease (OR 1.7)
      • Positive TPO antibodies (OR 2.1)
      • Positive thyroglobulin antibodies (OR 1.9)
    • Commentary: Psoriasis patients have a higher risk of also being diagnosed with autoimmune thyroid disease.

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Thyroid & Hormones Studies


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Diet & Lifestyle Studies

  • Association between the severity of chronic spontaneous urticaria and sleep-disordered breathing
    • 37 patients w/ chronic spontaneous urticaria (CSU)
      • 19 had mild CSU, 18 had moderate-severe CSU
    • All had sleep study
    • The sleep apnea severity was higher in the severe CSU group (18 vs 4 AHI)
    • Moderate-severe sleep apnea was associated with moderate-to-severe CSU even after adjusting for the BMI (OR 22)
    • Commentary: This small study sheds light on a possible connection between urticaria and sleep disordered breathing.

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Episode 51

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Featured Study


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Gastrointestinal Studies

  • Pepsinogen II in gastritis and Helicobacter pylori infection
    • 39 studies
    • Pepsinogen II (PgII) levels were associated with:
      • Non-atrophic gastric inflammatory lesions
      • H pylori positivity
    • PgII levels decreased after H pylori eradication
    • Commentary: PgII levels may be related to gastritis and H pylori.
  • Green tea extract to prevent colorectal adenomas, results of a randomized, placebo-controlled clinical trial
    • 879 participants w/ prior colon adenomas in past 6 months
    • Randomized to: 
      • Green tea extract (EGCG 150 mg BID)
      • Or placebo
    • After 3 years of supplementation, the green tea group had a non-statistically significant lower rate of adenomas (54.3% vs 48.3%)
    • There was a significant lower rate of adenomas in men (-7.5% absolute risk reduction)
    • Commentary: This study had a smaller sample size for a short amount of time to show possible statistically significant improvement of colon cancer rates.

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Diet & Lifestyle Studies


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Episode 50

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Featured Study


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Gastrointestinal Studies

  • Meta-analysis of randomized controlled trials of the effects of probiotics on type 2 diabetes in adults
    • 33 studies, 1,927 type-2 diabetics
    • Compared to placebo, probiotics led to greater improvements in: 
      • HbA1c (-0.2%)
      • Fasting glucose (-18 mg/dl)
      • Fasting insulin (-0.8 uIU/ml)
      • Insulin resistance (HOMA IR -1)
    • Multi-dose strain and high-dose probiotics had the greatest effect on glycemic control compared to single-strain and low-dose probiotics 
    • Commentary: High-dose and multi-strain Probiotics have a beneficial effect on glucose control.

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Thyroid & Hormones Studies

  • Untreated thyroid autoantibody-negative SCH increases the risk of spontaneous abortions
    • Retrospective study, 1,344 pregnant women divided into 2 groups:
      • Subclinical hypothyroidism (SCH) w/o antibodies, n=94
        • 40% treated w/ levothyroxine 
        • 60% not treated
      • Euthyroid, n= 1,250
    • The SCH women who were not treated w/ levothyroxine had a higher risk of spontaneous abortion (OR 3.1)
    • Commentary: Pregnant women who have SCH without antibodies who are NOT treated have a higher risk of spontaneous abortions. However, according to the previous study, euthyroid pregnant women with antibodies do NOT benefit from replacement therapy.
  • Fracture recurrence in hip fracture with menopausal hormone therapy versus risedronate: a clinical trial
    • 281 post-menopausal women with recent hip fracture, randomized to: 
      • Oral risedronate
      • Hormone therapy (topical estradiol + oral progesterone)
    • After 4 years, NO significant difference in new fracture rates observed between groups (8.6 vs 12.8 per 100 person-years)
    • Hip bone-mineral density increased in the hormone therapy group, not the risedronate group (+2.8% vs 0%)
    • Commentary: Hormone therapy improved hip bone-mineral density more than risedronate, but no difference was observed in incidence of new fractures.

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Diet & Lifestyle Studies

  • Mouth Closing to Improve the Efficacy of Mandibular Advancement Devices in Sleep Apnea
    • Cross-over study, 21 participants w/ sleep apnea randomized to:
      • No treatment
      • Mandibular advancement device (MAD)
      • Mouth tape
      • MAD + mouth tape
    • Sleep apnea improved in 76% of participants in the MAD + mouth tape group compared to 43% in the MAD alone group 
    • Mouth taping alone did NOT significantly improve sleep apnea
    • Commentary: MAD + mouth taping led to greater improvements in sleep apnea compared to MAD or mouth taping alone.

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Episode 49

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Featured Study

  • Clinical effect of methimazole combined with selenium in the treatment of toxic diffuse goiter in children
    • 103 kids w/ Graves’ disease (GD), randomized to:
      • Methimazole alone
      • Combined methimazole + selenium (50 mcg/d)
    • The combined methimazole + selenium group had:
      • Lower thyroid volume
      • Lower IL-6 and IL-8 
      • Lower TRAb (-411 vs -105 μ/mL)
      • Lower TPO Ab levels (-191 vs -97 μ/mL)
      • Took less time for fT4 to return to normal level (90 vs 120 days)
    • Commentary: Combined methimazole and selenium (even at a lower dose) is more effective than methimazole alone in managing GD, even in a pediatric population.

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Gastrointestinal Studies

  • Hydrogen-producing small intestinal bacterial overgrowth is associated with hepatic encephalopathy and liver function
    • Prospective study of 107 hospitalized patients w/ liver dysfunction encephalopathy
    • SIBO detected in 29% of participants
    • NO difference in liver function between SIBO + and SIBO – participants
    • But, H2 SIBO was associated w/ hepatic encephalopathy (50% H2 vs 24% CH4)
    • 8 hepatic encephalopathy patients treated w/ Rifaximin
      • H2 SIBO patients had higher response rate of breath test improvement (response rate 67% H2 vs 20% CH4)
    • Commentary: H2 SIBO may be more closely associated with hepatic encephalopathy and liver function than CH4 SIBO.
  • Evaluation of Intestinal Parasites and Some Clinical Symptoms in Children with Diarrhea
    • 300 kids w/ diarrhea, 100 healthy control kids
    • All had stool samples
    • Intestinal parasites were found at a higher rate in the diarrhea group (35% vs 17%)
      • Blastocystis hominis (13%)
      • Cryptosporidium spp
      • (3%)
      • Giardia intestinalis (2%)
    • The presence of parasites were also associated w/ abdominal pain and nausea
    • Commentary: This study found an association of intestinal parasites and diarrhea.

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Thyroid & Hormones Studies

  • Association Between Generic-to-Generic Levothyroxine Switching and Thyrotropin Levels Among US Adults
    • Observational study, 15,829 hypothyroid patients w/ normal TSH, taking generic levothyroxine for at least 3 months
    • After 3 months:
      • 82.4% continued taking the same generic levothyroxine (non-switchers)
      • 17.6% switched to a different generic levothyroxine (switchers)
    • Patients had follow up thyroid labs between 6 weeks and 1 year AFTER switching to a different generic levothyroxine
    • Comparing switchers to non-switchers, NO significant difference was observed in the number of patients with:
      • Normal TSH (84.5% vs 82.7%) 
      • Significantly abnormal TSH (<0.1 or >10.0 mIU/L) (2.5% vs 3.1%)
    • Commentary: Switching between different generic levothyroxine medications is not associated with clinically meaningful changes in TSH.
  • Excess use of thyroid hormone treatment among patients with fibromyalgia: a cross-sectional study in primary health care
    • 16 fibromyalgia patients taking levothyroxine 
    • Initial TSH and T4 values were assessed prior to beginning levothyroxine
    • 74% of patients taking levothyroxine initially had either:
      • Normal thyroid function
      • Subclinical hypothyroidism
    • Only 25% had overt or central hypothyroidism 
    • Commentary: A significant number of fibromyalgia patients are inappropriately prescribed levothyroxine despite NO true hypothyroid diagnosis. Dr. Ruscio describes this as well-intended but inappropriate care.

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Diet & Lifestyle Studies


Discussion

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