Dr. Ron’s Research Review – November 7, 2018

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This week’s research review focuses on Wahls Protocol for multiple sclerosis

Terry Wahls, MD, is a clinical professor of medicine at the University of Iowa. In her 40s she developed disabling multiple sclerosis (MS). Despite the latest medical treatments, her disease progressed. She undertook painstaking research into what nutritional and other lifestyle factors might help her with the disease. By adopting an anti-inflammatory Paleo-styled diet, she was able to reverse her autoimmune disease and return to normal function. Since then she has reached out to help others suffering from MS and other autoimmune conditions in a variety of clinical trials. She conducts a clinic at the University of Iowa, has an interactive website, and lectures widely. She has met with considerable success helping others, and this book is a culmination of her work to date. (Scherger, 2017)

A randomized control trial evaluated  a modified Paleolithic dietary intervention (MPDI) in the treatment of relapsing-remitting multiple sclerosis (RRMS). Of 34 subjects randomly assigned to control (maintain usual diet) and intervention (MPDI) groups, nine subjects (one man) completed the control group and eight subjects (one man) completed the MPDI. Results:  Significant improvements were seen in Fatigue Severity Scale score and also in Multiple Sclerosis Quality of Life-54 and time to complete (dominant hand) 9-Hole Peg Test from baseline in MPDI subjects compared to controls. Increased vitamin K serum levels were also observed in MPDI subjects postprotocol compared to controls.  A Paleolithic diet may be useful in the treatment and management of MS, by reducing perceived fatigue, increasing mental and physical quality of life, increasing exercise capacity, and improving hand and leg function. By increasing vitamin K serum levels, the MPDI may also reduce inflammation. (Irish et al., 2017)
In this one-arm, open-label feasibility trial, participants were prescribed a home-based multimodal intervention, including (1) a modified Paleolithic diet; (2) an exercise program (stretching and strengthening of the trunk and lower limb muscles); (3) neuromuscular electrical stimulation (EStim) of trunk and lower limb muscles; and (4) stress management (meditation and self-massage). Individuals completed measures of mood (Beck Anxiety and Depression Inventories) and cognitive (Cognitive Stability Index, Cognitive Screening Test, Delis-Kaplan Executive Function System) and executive function (Wechsler Adult Intelligence Scale) at baseline and 3, 6, 9, and 12 months after the start of the intervention. Dosage of the multimodal intervention was assessed at 3, 6, 9, and 12 months.  The more individuals participated in the intervention activities, the greater improvements they had from baseline to 12 months on self-report measures of anxiety (Beck Anxiety Inventory [BAI]; ps = 0.001 to 0.02), depression (Beck Depression Inventory [BDI]; ps = <0.0001 to 0.09), cognitive function (Cognitive Stability Index [CSI/T], Delis-Kaplan Executive Function System [DKEFS]; ps = 0.001 to 0.06), and executive function (Wechsler Adult Intelligence Scale [WAIS]; ps = <0.0001 to 0.09). Mood and cognitive improvements were more closely related to a higher intake of the modified Paleolithic diet than to exercise and stress management dosage. Anxiety and depression changes were evident after just a few months, whereas changes in cognitive function were generally not observed until later in the intervention period. Mood and cognitive function changes from baseline to 12 months were significantly associated with fatigue improvements (ps = <0.0001 to 0.03).  A modified Paleolithic diet, exercise, EStim, and stress management intervention like this one has the potential to improve the mood and cognitive symptoms that can lead to considerable suffering in people with MS, potentially improving quality of life and function for people with progressive MS. (Lee et al., 2017)

A study protocol for a randomized controlled trial comparing the modified Paleolithic (Wahls Elimination) and low saturated fat (Swank) diets on perceived fatigue in persons with relapsing-remitting multiple sclerosis has been published. The estimated completion date is January 2020. (Wahls et al., 2018)

 

Dr. Ron

 


 

Articles

A multimodal intervention for patients with secondary progressive multiple sclerosis: feasibility and effect on fatigue.
            (Bisht et al., 2014)  Download
BACKGROUND:  Multiple sclerosis is an autoimmune disease influenced by environmental factors. OBJECTIVES:  The feasibility of a multimodal intervention and its effect on perceived fatigue in patients with secondary progressive multiple sclerosis were assessed. DESIGN/SETTING:  This was a single-arm, open-label intervention study in an outpatient setting. INTERVENTIONS:  A multimodal intervention including a modified paleolithic diet with supplements, stretching, strengthening exercises with electrical stimulation of trunk and lower limb muscles, meditation, and massage was used. OUTCOME MEASURES:  Adherence to each component of the intervention was calculated using daily logs. Side-effects were assessed from a monthly questionnaire and blood analyses. Fatigue was assessed using the Fatigue Severity Scale (FSS). Data were collected at baseline and months 1, 2, 3, 6, 9, and 12. RESULTS:  Ten (10) of 13 subjects who were enrolled in a 2-week run-in phase were eligible to continue in the 12-month main study. Of those 10 subjects, 8 completed the study and 6 subjects fully adhered to the study intervention for 12 months. Over a 12-month period, average adherence to diet exceeded 90% of days, and to exercise/muscle stimulation exceeded 75% of days. Nutritional supplements intake varied among and within subjects. Group daily average duration of meditation was 13.3 minutes and of massage was 7.2 minutes. No adverse side-effects were reported. Group average FSS scores decreased from 5.7 at baseline to 3.32 (p=0.0008) at 12 months. CONCLUSIONS:  In this small, uncontrolled pilot study, there was a significant improvement in fatigue in those who completed the study. Given the small sample size and completer rate, further evaluation of this multimodal therapy is warranted.

Randomized control trial evaluation of a modified Paleolithic dietary intervention in the treatment of relapsing-remitting multiple sclerosis: a pilot study.
            (Irish et al., 2017)  Download
Background/objective:  A Paleolithic diet may improve fatigue and quality of life in progressive multiple sclerosis (MS) patients, but past research has evaluated the effects of this dietary intervention in combination with other treatments such as exercise. Thus, the purpose of this pilot study was to evaluate a modified Paleolithic dietary intervention (MPDI) in the treatment of fatigue and other symptoms in relapsing-remitting MS (RRMS). Methods:  We measured the effects of a MPDI in 17 individuals with RRMS. Of 34 subjects randomly assigned to control (maintain usual diet) and intervention (MPDI) groups, nine subjects (one man) completed the control group and eight subjects (one man) completed the MPDI. Results:  Significant improvements were seen in Fatigue Severity Scale score and also in Multiple Sclerosis Quality of Life-54 and time to complete (dominant hand) 9-Hole Peg Test from baseline in MPDI subjects compared to controls. Increased vitamin K serum levels were also observed in MPDI subjects postprotocol compared to controls. Conclusion:  A Paleolithic diet may be useful in the treatment and management of MS, by reducing perceived fatigue, increasing mental and physical quality of life, increasing exercise capacity, and improving hand and leg function. By increasing vitamin K serum levels, the MPDI may also reduce inflammation.

A Multimodal, Nonpharmacologic Intervention Improves Mood and Cognitive Function in People with Multiple Sclerosis.
            (Lee et al., 2017)  Download
OBJECTIVE:  The objective of this study was to examine whether participation in a 12-month multimodal intervention would improve mood and cognitive function in adults with progressive multiple sclerosis (MS). METHODS:  In this one-arm, open-label feasibility trial, participants were prescribed a home-based multimodal intervention, including (1) a modified Paleolithic diet; (2) an exercise program (stretching and strengthening of the trunk and lower limb muscles); (3) neuromuscular electrical stimulation (EStim) of trunk and lower limb muscles; and (4) stress management (meditation and self-massage). Individuals completed measures of mood (Beck Anxiety and Depression Inventories) and cognitive (Cognitive Stability Index, Cognitive Screening Test, Delis-Kaplan Executive Function System) and executive function (Wechsler Adult Intelligence Scale) at baseline and 3, 6, 9, and 12 months after the start of the intervention. Dosage of the multimodal intervention was assessed at 3, 6, 9, and 12 months. RESULTS:  The more individuals participated in the intervention activities, the greater improvements they had from baseline to 12 months on self-report measures of anxiety (Beck Anxiety Inventory [BAI]; ps = 0.001 to 0.02), depression (Beck Depression Inventory [BDI]; ps = <0.0001 to 0.09), cognitive function (Cognitive Stability Index [CSI/T], Delis-Kaplan Executive Function System [DKEFS]; ps = 0.001 to 0.06), and executive function (Wechsler Adult Intelligence Scale [WAIS]; ps = <0.0001 to 0.09). Mood and cognitive improvements were more closely related to a higher intake of the modified Paleolithic diet than to exercise and stress management dosage. Anxiety and depression changes were evident after just a few months, whereas changes in cognitive function were generally not observed until later in the intervention period. Mood and cognitive function changes from baseline to 12 months were significantly associated with fatigue improvements (ps = <0.0001 to 0.03). CONCLUSIONS:  A modified Paleolithic diet, exercise, EStim, and stress management intervention like this one has the potential to improve the mood and cognitive symptoms that can lead to considerable suffering in people with MS, potentially improving quality of life and function for people with progressive MS.

Neuromuscular electrical stimulation and dietary interventions to reduce oxidative stress in a secondary progressive multiple sclerosis patient leads to marked gains in function: a case report.
            (Reese et al., 2009)  Download
Neuromuscular electrical stimulation has been used to aid musculoskeletal recovery. Excessive oxidative stress and excitoxicity are implicated in secondary progressive multiple sclerosis. A 52-year-old white female with SPMS had been scooter- and cane-dependent for 4 years. She requested and received a trial of neuromuscular electrical stimulation. Two months after initiating NMES the patient adopted several nutritional interventions to lower oxidative stress and excito-toxicity. During the first 2 months of neuromuscular electrical stimulation, the therapist observed modest gait improvements. Following the addition of nutritional interventions, more rapids gains in strength and endurance, including muscle groups not receiving neuromuscular electrical stimulation were observed by both the therapist and the patient. After 8 months of neuromuscular electrical stimulation (6 months of nutritional intervention) the patient's function had improved sufficiently that she no longer used a scooter or cane and rode her bicycle routinely 8 miles, including hills.

The Wahls Protocol.
            (Scherger, 2017)  Download
This is an important book. Terry Wahls, MD, is a clinical professor of medicine at the University of Iowa. In her 40s she developed disabling multiple sclerosis (MS). Despite the latest medical treatments, her disease progressed. She undertook painstaking research into what nutritional and other lifestyle factors might help her with the disease. By adopting an anti-inflammatory Paleo-styled diet, she was able to reverse her autoimmune disease and return to normal function. Since then she has reached out to help others suffering from MS and other autoimmune conditions in a variety of clinical trials. She conducts a clinic at the University of Iowa, has an interactive website,1 and lectures widely. She has met with considerable success helping others, and this book is a culmination of her work to date.

Dietary approaches to treat MS-related fatigue: comparing the modified Paleolithic (Wahls Elimination) and low saturated fat (Swank) diets on perceived fatigue in persons with relapsing-remitting multiple sclerosis: study protocol for a randomized controlled trial.
            (Wahls et al., 2018)  Download
BACKGROUND:  Fatigue is one of the most disabling symptoms of multiple sclerosis (MS) and contributes to diminishing quality of life. Although currently available interventions have had limited success in relieving MS-related fatigue, clinically significant reductions in perceived fatigue severity have been reported in a multimodal intervention pilot study that included a Paleolithic diet in addition to stress reduction, exercise, and electrical muscle stimulation. An optimal dietary approach to reducing MS-related fatigue has not been identified. To establish the specific effects of diet on MS symptoms, this study focuses on diet only instead of the previously tested multimodal intervention by comparing the effectiveness of two dietary patterns for the treatment of MS-related fatigue. The purpose of this study is to determine the impact of a modified Paleolithic and low saturated fat diet on perceived fatigue (primary outcome), cognitive and motor symptoms, and quality of life in persons with relapsing-remitting multiple sclerosis (RRMS). METHODS/DESIGN:  This 36-week randomized clinical trial consists of three 12-week periods during which assessments of perceived fatigue, quality of life, motor and cognitive function, physical activity and sleep, diet quality, and social support for eating will be collected. The three 12-week periods will consist of the following: 1. OBSERVATION:  Participants continue eating their usual diet. 2. INTERVENTION:  Participants will be randomized to a modified Paleolithic or low saturated fat diet for the intervention period. Participants will receive support from a registered dietitian (RD) through in-person coaching, telephone calls, and emails. 3. FOLLOW-UP:  Participants will continue the study diet for an additional 12 weeks with minimal RD support to assess the ability of the participants to sustain the study diet on their own. DISCUSSION:  Because fatigue is one of the most common and disabling symptoms of MS, effective management and reduction of MS-related fatigue has the potential to increase quality of life in this population. The results of this study will add to the evidence base for providing dietary recommendations to treat MS-related fatigue and other symptoms associated with this disease. TRIAL REGISTRATION:  ClinicalTrials.gov, NCT02914964 . Registered on 24 August 2016.

 


 

References

Bisht, B, et al. (2014), ‘A multimodal intervention for patients with secondary progressive multiple sclerosis: feasibility and effect on fatigue.’, J Altern Complement Med, 20 (5), 347-55. PubMed: 24476345
Irish, AK, et al. (2017), ‘Randomized control trial evaluation of a modified Paleolithic dietary intervention in the treatment of relapsing-remitting multiple sclerosis: a pilot study.’, Degener Neurol Neuromuscul Dis, 7 1-18. PubMed: 30050374
Lee, JE, et al. (2017), ‘A Multimodal, Nonpharmacologic Intervention Improves Mood and Cognitive Function in People with Multiple Sclerosis.’, J Am Coll Nutr, 36 (3), 150-68. PubMed: 28394724
Reese, D, et al. (2009), ‘Neuromuscular electrical stimulation and dietary interventions to reduce oxidative stress in a secondary progressive multiple sclerosis patient leads to marked gains in function: a case report.’, Cases J, 2 7601. PubMed: 19918474
Scherger, JE (2017), ‘The Wahls Protocol.’, Fam Med, 49 (2), 149-50. PubMed: 28218946
Wahls, T, et al. (2018), ‘Dietary approaches to treat MS-related fatigue: comparing the modified Paleolithic (Wahls Elimination) and low saturated fat (Swank) diets on perceived fatigue in persons with relapsing-remitting multiple sclerosis: study protocol for a randomized controlled trial.’, Trials, 19 (1), 309. PubMed: 29866196