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Publicly Available Published by De Gruyter October 1, 2016

A low fermentable oligo-di-mono saccharides and polyols(FODMAP) diet reduced pain and improve ddaily life in fibromyalgia patients

  • Ana Paula Marum EMAIL logo , Cátia Moreira , Fernando Saraiva , Pablo Tomas-Carus and Catarina Sousa-Guerreiro

Abstract

Background and aims

Fibromyalgia (FM) is a chronic, rheumatic disease characterized by widespread myofascial pain, of unknown aetiology, having a major impact on quality of life (QOL). Available pharmacotherapy for FM is marginally effective. FM is associated with co-morbidities of gastrointestinal (GI) disorders and Irritable Bowel Syndrome (IBS). There is growing evidence that diets low in FODMAPs, “fermentable oligo-, di- or mono-saccharides and polyols” [Low FODMAP Diet (LFD)], are effective in treating IBS. The aim of this pilot study was to examine the effects of LFDs on symptoms of FM, especially with regard to pain, QOL and GI disorders.

Methods

A longitudinal study using LFD intervention was performed on 38, 51±10 year-old, female patients diagnosed with FM for an average of 10 years, based on ACR (American College of Rheumatology) 2010 criteria. The study was conducted from January through May, 2015, using a four-week, repeated-assessment model, as follows: Moment 0 – introduction of the protocol to participants; Moment 1 – first assessment and delivery of individual LFD dietary plans; Moment 2 – second assessment and reintroduction of FODMAPs; Moment 3 – last assessment and final nutritional counselling. Assessment tools used were the following: RFIQ (Revised Fibromyalgia Impact Questionnaire), FSQ (Fibromyalgia Survey Questionnaire), IBS-SSS (Severity Score System), EQ-5D (Euro-QOL quality of life instrument), and VAS (Visual Analogue Scale). Daily consumption of FODMAPs was quantified based on published food content analyses. Statistical analyses included ANOVA, non-parametric Friedman, t-student and Chi-square tests, using SPSS 22 software.

Results

The mean scores of the 38 participants at the beginning of the study were: FSQ (severity of FM, 0–31) – 22±4.4; RFIQ (0–100) – 65±17; IBS-SSS (0–500) – 275± 101; and EQ-5D (0–100) – 48± 19. Mean adherence to dietary regimens was 86%, confirmed by significant difference in FODMAP intakes (25 g/day vs. 2.5 g/day; p < 0.01). Comparisons between the three moments of assessment showed significant (p < 0.01) declines in scores in VAS, FSQ, and RFIQ scores, in all domains measured. An important improvement was observed with a reduction in the severity of GI symptoms, with 50% reduction in IBS scores to 138±117, following LFD therapy. A significant correlation (r = 0.36; p < 0.05) was found between improvements in FM impact (declined scores) and gastrointestinal scores. There was also a significant correlation (r = 0.65; p < 0.01) between “satisfaction with improvement” after introduction of LFDs and “diet adherence”, with satisfaction of the diet achieving 77% among participants. A significant difference was observed between patients who improved as compared to those that did not improve (Chi-square χ2 = 6.16; p < .05), showing that the probability of improvement, depends on the severity of the RFIQ score.

Conclusions

Implementation of diet therapy involving FODMAP restrictions, in this cohort of FM patients, resulted in a significant reduction in GI disorders and FM symptoms, including pain scores. These results need to be extended in future larger studies on dietary therapy for treatment of FM.

Implications

According to current scientific knowledge, these are the first relevant results found in an intervention with LFD therapy in FM and must be reproduced looking for a future dietetic approach in FM.

1 Introduction

Fibromyalgia (FM) is a functional, diffuse pain-syndrome classified and recognized by World Health Organization as rheumatic pathology with unknown aetiology and without effective therapy [1, 2]. FM is the third most frequent rheumatic disease in the Portuguese population with an estimated prevalence of 3.7% (2–5.4%), being 5.1% in females and 2.3% in males [3]. Within the age-range of 50–65 years, prevalence rates reaches 8%. Internationally, prevalence of FM is observed in 2–5.3% of population with 90% of diagnoses occurring in women (female:male ratio 7–10:1) with an average age of 59 years old [1, 4]. Current guidelines [5, 6] for FM diagnosis and treatment are consistent in recommending a multidisciplinary treatment. Moreover, nutrition can have a significant impact on well-being in cases of chronic diseases [7]. Hence, a balance nutrition could potentially play a role in improving the sense of well-being and quality of life among FM suffers [8]. This pilot study examines an innovative dietary approach for treatment of FM. A new dietary therapy was tested involving restriction of FODMAPs (“Fermentable Oligo-Di-Mono-saccharides And Polyols”), which has shown to be potentially effective in treating diseases having similar syndromice profiles as FM [9]. FODMAPs are poorly absorbed, short-chain carbohydrates including lactose, free fructose, polyols, fructans, and galacto-oligosaccharides [10]. Reduction of FODMAPS has shown significant benefits in the treatment of Irritable Bowel Syndrome (IBS). Since there is evidence that Low FODMAP Diets (LFDs) reduce IBS symptoms, and 70% of FM patients suffer from IBS [11, 12] we hypothesize that LFD could serve as an effective treatment of FM, not only for gastrointestinal (GI) symptoms, but also, with possible benefit on somatic pain and impact on daily life.

There are known food sensitivities in the course of FM with possible association with central sensitization [14, 15]. A food awareness survey showed that FM patients reported exacerbation of symptoms with certain foods, and 30% of patients attempted to control symptoms by restricting certain foods [15]. Dietary interventions suggested for treating FM have included restriction of gluten, lactose or FODMAPs [16]. A pilot study has recently been proposed to examine if a gluten-free diet could alleviate FM symptoms [17], although, gluten had shown no effect on patients with non-celiac gluten sensitivity (NCGS) [18]. Based on these observation, the authors suggested that NCGS symptoms could be triggered by “wheat FODMAPs” [19]. To date, no clinical trial have been performed to examine effects of LFDs on symptoms of FM. The aim of this study was to perform a pilot, preliminary clinical trial to evaluate LFDs effects, if any, on somatic pain, GI symptoms and impact on daily life in addition to QOL in patients with FM.

2 Materials and methods

2.1 Participants

A longitudinal clinical trial was performed in order to evaluate the efficacy of LFDs in a populational sample of 38 participants suffering from FM. Participants were referred to our consultation after rheumatology evaluation for FM diagnosis assertion, according to ACR (American College of Rheumatology) 2011 criteria [20]. Inclusion criteria for participants enrolment was adult age (18–70 years old) diagnosed with FM for at least one year, and having not received any changes in therapy in a period at least 3 months, prior to the beginning of the study. Referrals already on diets reducing FODMAP foods, who presented co-morbidities requiring specific nutritional needs or presented clinical intercurrences, were excluded.

The trial was conducted betweenJanuary and May, 2015, using a four-week, repeated-assessment programme. All participants signed informed consent agreements according to the Helsinki Declaration, AMM 2013 version. The project was approved by the Ethics Commission of the Medical Academic Centre of Lisbon.

2.2 Study protocol

The study cohort was assessed at three moments, at repeated intervals, over a four-week period and a total of eight weeks for each participant. Thirty-one participants (82%) completed the entire programme. An initial evaluation (Moment 0) was performed prior to LFD introduction (Moment 1), followed by a second evaluation performed 4 weeks after LFD introduction, at the time when FODMAPS were reintroduced (Moment 2), and then a third, evaluation four weeks later (Moment 3). A medical doctor and a qualified dietician were present during all evaluations.

At Moment 0, an LFD instruction booklet was distributed to each participant. The booklet included detailed recipes, food tables and a record-keeping section for cataloguing foods consumed over a 72 h. At Moment 1, a clinical/dietary anamnesis was performed to record biographical, demographic aspects, co-morbidities, medication, food intolerance and allergy information. Additionally, several assessment tools, were applied to assess FM and IBS. Participants answered the same assessment questionnaires in Moment 1, Moment 2 and Moment 3 where clinical and nutritional data were collected. Participants were also evaluated for satisfaction and adherence to the diets, including a questionnaire with several questions about overall satisfaction with the study, specific satisfaction with the clinical improvement, the quality of the counselling, the cost of the diet and with the difficulties encountered to follow it. Instructions were given for gradual reintroduction of different groups of FODMAPs in accordance with individual diet plans. At Moment 3, final clinical assessments were performed and participants fulfilled the questionnaires. At the end of the trial, dietary advice was provided on an individual basis.

Applied assessment tools are here described: (1) Fibromyalgia Survey Questionnaire (FSQ) [20] – fibromyalgia severity score, according to new ACR criteria, using a “widespread pain index” (19 points) and a “severity score index” (12 points), wherein combined scores ≥ 13 (0–31) indicate positive criteria of FM diagnosis [20]; (2) Revised Fibromyalgia Impact Questionnaire (FIQR) [21, 22] – assesses impact of FM symptoms on daily life, includes 21 questions under three domains denoted as “function”, “overall impact” and “symptoms”, quantified by a score-range of 0–100, and ranked as “low impact” (15–50), “moderate impact” (50–65) and “severe or extreme impact” (>65). A average score, globally, is 56.5 ± 19.9 [21]; (3) Irritable Bowel Syndrome-Symptom Severity Survey (IBS-SSS) [23] – uses a five visual analogue scale to quantify abdominal pain, abdominal distension, intestinal transit and interference of IBS in daily life (0–500), and the score is ranked as “mild disease” (75–175), “moderate disease” (175–300) and “serious illness” (>300) [23]; and (4) The Portuguese version of the Euro-Qol (EQ-5D-5L) [24] assesses 5 dimensions of QOL: mobility, self-care, daily activities, pain and discomfort, and anxiety or depression. The scale for the dimensions ranges varies from 1 to 5 (no problems, light/moderate/extreme problems or unable to do).

Individual dietary plans were designed for participants in order to restrict foods rich in FODMAPs. The dietary plans were given to the participants, with requests to follow diets rigorously, and to fully cooperate with the study-plan. Researchers were able to consistently monitor and contact participants, by phone or email whenever needed. Table 1 describes examples of high FODMAPs foods sources that were restricted in prescribed dietary plans and their substitutes.

Table 1

Examples of high FODMAPS food sources and their suitable alternatives.

Excess fructose Lactose Olisaccharides Polyols

Fructans Galactans
High FODMAP High FODMAP High FODMAP High FODMAP High FODMAP
Apple, mango, peaches, pear, watermelon Honey Sweeteners as fructose, HFCS Milk and derivatives Wheat Rye Onion Garlic Leeks… Cabbage Legumes: chickpeas, beans, lentils… Apricots, cherries, nectarine, plums, cauliflower, Sweeteners: sorbitol xilitol…
Low FODMAP Low FODMAP Low FODMAP Low FODMAP Low FODMAP
Banana, blueberry, grape, melon, orange, strawberry… Lactose free products Rice milk… Gluten free products, corn, spelt, rice, oat Garlic-infused oil Vegetables: carrot, celery, green beans, lettuce, pumpkin, potato, tomato… Banana, blueberry, grapefruit, melon, kiwifruit, lemon, lime, orange, passionfruit…

In addition to assessment questionnaires, changes in total quantity of FODMAPs (g/day), energy (kcal/day), and fibre (g/day) consumed, for each monitoring period (moment), were calculated. The quantification was based upon participant records of foods consumed (72 h each) and published amounts of FODMAPs [25, 26], calories, and fibre in those respective foods.

2.3 Statistical analysis

Initially, the Kolmogorov–Smirnov normality test with Lilliefors correction was used to assess data normality. Changes in values between moments were tested using analyses of variance for repeated measures ANOVA or Friedman test. For the correlations analyses Pearson test or Spearman test were used. All analyses were performed using SPSS (version 22.0; SPSS, Inc., Chicago, IL, USA), and the significance level was set at p≤ 0.01 for all tests. The Chi-square statistical test was applied to valuate sub-group comparisons.

3 Results

3.1 Participants

All 38 participants eligible for the study were female, aged 51±10 years, with a mean duration of 10 years of FM diagnosis. The main co-morbidity within this FM cohort was GI disorders (88%), with a majority of participants (60%) reporting some form of food intolerance. The average scores measured at Moment 1 were, as follows: (1) FSQ – 21.8±4.4 (0–31) for severity of FM; (2) RFIQ (total) – 64.8 ± 16.7 (0–100) for impact of FM on daily life, mainly defined as “extreme impact”, with scores distributed among FIQR categories as Function 18.9±4.9 (0–30), Overall impact 12.2±5.9 (0–20) and Symptoms 32.7±8.0 (0–50); (3) IBS-SSS – 275.3±101 (0–500) for severity of IBS; and (4) EQ-5D – 47.6±18.9 (0–100) for effect on quality of life (Table 2).

Table 2

Characterization of FM among participants (n = 38)evaluated by assessment test scores (M1 = pre-LFD phase).

Assessment test[a] (Mean ± 1SD) Range
FSQ 21.8 ± 4.4 0–31
RFIQ total 64.8 ± 16.7 0–100
 Function 18.9 ± 4.9 0–30
 Overall impact 12.2 ± 5.9 0–20
 Symptoms 32.7 ± 8.0 0–50
IBS-SSS 275.3 ± 101 0–500
EQ-5D 47.6 ± 18.9 0–100
 Mobility 2.7 ± 0.9 1–5
 Personal care 2.2 ± 1.1 1–5
 Daily activities 3.1 ± 0.8 1–5
 Pain/discomfort 3.5 ± 0.9 1–5
 Anxiety/depression 2.8 ± 1 1–5
  1. FSQ = Fibromyalgia Survey Questionnaire; RFIQ = Revised Fibromyalgia Impact Questionnaire; IBS-SSS = Irritable Bowel Syndrome-Severity Score System, EQ-5D = Euro-QOL-Quality of life.

3.2 Symptoms scores

Comparisons of scores (Table 3) through the three Moments of assessment during LFD intervention, showed significant relief from FM severity (declined scores) (FSQ) (M1 =21.8, M2 = 16.9, M3 = 17; p < 0.01) and fibromyalgia Impact (FIQR) (M1 = 61.6, M2 = 47.9; M3 = 48.1), in all domains of the test (p < 0.01). The mean impact score improvement (declined score FIQR) was –13±15, in the majority of studied population (83% participants improved, 30/36).

Table 3

Comparison of repeated assessments of disease scores and dietetic intake of women with FM in three moments of the trial (N = 31).

Parameter M1 M2 M3 p Value (M1–M2) (M2–M3)
FSQ 21.8 16.9 17.0 <0.01 [**],[b] ns
IBS-SSS 275.3 137.4 158.1 <0.01 [**],[a] ns
RFIQtotal 61.6 47.9 48.1 <0.01 [**],[b] ns
 Function 18.4 14.7 14.3 <0.01 [**],[b] ns
 Overall impact 11.5 9.5 8.7 <0.04 [*],[b] ns
 Symptoms 31.8 25.7 25.1 <0.01 [**],[b] ns
Pain score 6.6 4.9 5.4 0.00 [**],[b] ns
EQ-5D 49.7 58 56 0.13 ns[a] ns
 Mobility 2.67 2.31 2.29 0.02 [*],[a] ns
 Personal care 2.19 1.94 2.06 0.83 ns[a] ns
 Daily activities 3.08 2.64 2.65 0.03 ns[a] ns
 Pain/discomfort 3.47 2.83 2.97 <0.01 [**],[a] ns
 Anxiety/Depression 2.75 2.53 2.55 0.32 ns[a] ns
FODMAPs, g/day 24.4 2.6 6.1 <0.01 [**],[a] ns
Energy, kcal/day 1973 1615 1566 <0.01 [**],[b] ns
Fibre, g/day 22.7 21.1 20.7 0.29 ns[b] ns
  1. FSQ = Fibromyalgia Survey Questionnaire; IBS-SSS = Irritable Bowel Syndrome-Severity Score System, RFIQ = Revised Fibromyalgia Impact Questionnaire; EQ-5D = Euro-QOL-Quality of life.

The average VAS score for somatic pain (M1=6.6, M2 = 4.9, M3 = 5.4) also showed a significant decline (p < 0.01). The severity of gastrointestinal symptoms (IBS-SSS) showed a significant reduction of 50% after 4 weeks of a LFD (M1 =275.3, M2 = 137.4, M3 = 158.1), a mean improvement reflected in a decline in score of –138±117.

Overall quality of life (EQ-5D) in our LFD cohort showed a trend towards improvement, not statistically significant, (M1 = 49.7, M2 = 58, M3 = 56). However, the domains within the EQ-5D survey showed a significant improvement in criteria like “Mobility” (p < 0.05) and reduction of “Pain” (p < 0.01).

Of special note is the significant correlation (rs = 0.36, p < 0.05) between declining FM impact (FIQR) and declining in GI disorders (IBS-SSS). Significant correlations were also observed between declines of RFIQ with reducing of abdominal pain and distension VAS scores (r =0.448 and r = 0. 476 respectively; p < 0.01). In addition, significant correlations (p < 0.01) were observed between declines in abdominal pain and somatic pain, within the VAS assessment (r = 0.443), and between somatic pain measured by VAS and the IBS-SSS score (rs = 0.406), following introduction of LFD. Lastly, a strong correlation was detected (r = 0.650; P < 0.01) between “rate of satisfaction with the improvement in symptoms” and “rate of adherence to the diet”. This correlation especially supports that LFD introduction impacted the reduction of FM symptoms. In general 77% of patients were satisfied with the diet and was found 85% of adherence.

3.3 Diets

A significant difference (p < 0.01) of FODMAPs intake was observed between M1 and M2 (p < 0.01), but not after reintroduction of FODMAPs; M1 = 24.4±12 FODMAP g/day in the pre-LFDs phase compared with M2 = 2.63±5.4 FODMAP g/day after introduction of LFD and M3 = 6.06 ± 5.5 FODMAP g/day after reintroduction of FODMAPs. In addition, a significant reduction (p < 0.01) in caloric intake was observed after introduction of LFD but no significant difference was observed in fibre intake (Table 3). The majority of patients were compliant (85%) to LFD dietary plans by the participants. This adherence is represented by no significant difference (p = 0.84) between FODMAPs calculated for foods recorded in participant ledgers (2.63 g/day) and mean levels in assigned diet plans (0.96±1.14 g/day).

3.4 Individual analysis on FM daily impact

The variation of RFIQ score varied between 28.5–91.3 in Ml and 5.6–94.8 in M2.

Table 3 shows the distribution of participants according to the severity of RFIQ score in two moments of the study; before (Ml) and after LFD (M2): level 0 (<15; without impact), level 1 (15–50; low impact), level 2 (50–65; moderate impact), level 3 (>65, extreme impact) (Table 4).

Table 4

Participants distribution according to the level of severity of RFIQ score in two moments.

RFIQ M1 No. participants (%) M2 No. participants (%)
Level 0 (<15) 0/36 (0%) 2/36 (1%)
Level 1 (15–49) 7/36 (19%) 17/36 (48%)
Level 2 (50–64) 12/36 (33%) 5/36 (18%)
Level 3 (>65) 17/36 (48%) 12/36 (33%)

The group of participants classed in with moderate impact (level 2) category presented the best response to LFD (67% improvement). The group of participants classed as low and extreme impact of FM, responded modestly to LFD (only 14% and 40% improve, respectively). A significant difference was observed between patients who improved as compared to those that did not improve (Chi-square χ = 6.16; p<.05), showing that the probability of improvement, depends on the severity of the RFIQ score (Fig. 1).

Fig. 1 
							Response to LFD by levels of severity of impact of FM.
Fig. 1

Response to LFD by levels of severity of impact of FM.

4 Discussion

LFD therapy prescribed in this pilot study proved to have a highly positive effect throughout the spectrum of symptoms associated with FM, including improvements in somatic pain and GI disturbances, with general impact on daily life in addition to improved well-being. LFD was especially effective in reducing the visceral and somatic painful hypersensitivity, a common mechanism in mediating symptoms of FM and IBS.

As far as we know, this is the first published study reporting the effects of LFD intervention on the FM symptoms, and its potential use as a therapeutic regimen. We underline the peculiarity of the hypothesis: if the LFD can improve functional GI symptoms which are highly prevalent in FM, could the LFD also help improving other fibromyalgia symptoms? This relationship has not been described before, or even more, has no linear explanation or biological plausibility, but it is here to be entitled.

4.1 Biological plausibility

To discuss a possible mechanism that links the action of FODMAPs with the FM benefits, we need to resume the complex pathophysiology of FM whose central dysfunction is in the nociceptive system with changes in pain processing. Authors [1, 4, 17] describes disturbs in nervous systems (central, peripheral and vegetative), in immune and redox systems including imbalances between excitatory and inhibitory neurotransmissors, neuroendocrine imbalances, neuroplastic changes. Finally dysbiotics disturbances are described as bacterial overgrowth in small intestine (SIBO) associated with intestinal hyperpermeability and food sensitivities [28]. We suggest Gut-Brain-Axis could be the mediator of these changes.

The effect of FODMAPs over the intestines are known [27], but up to now no biological plausibility has been found to clarify a hypothetical relationship between these sugars and the systemic symptoms of FM. De Giorgio et al. [19], related FODMAPs, enteric nervous system and central nervous system through the Gut-Brain Axis and referred to the interaction between dietary factors and the microbiota. Hence the passage of noxious macromolecules may trigger the release of mast cell mediators and the activation of the immune system. These mechanisms, at the base of mechanoreceptor and sensory nerve pathway activation, are ultimately responsible for commonly reported symptoms especially in genetically predisposed patients. Moreover, stress (evoked anxiety/depression), can directly impair intestinal barrier function, thus favouring passage of previously mentioned noxious macromolecules.

There’s a growing evidence of the role of the microbiota in neural development, plasticity, modulation of pain perception and somatic or visceral. Animal studies demonstrate that the interaction of microbes is required to nociception [29].

4.2 The response of IBS symptoms in FM

This study evaluated a number of FM symptoms in a cohort of 38 women and found a significant reduction in IBS symptoms, as co-morbidity of FM. The research team outlined study with expectation of obtaining these results according to the findings published to date [9, 28], however our results have the originality to be the first study referring to FM. Alternatively, our study is the first to show that LDF reduces somatic pain associated with FM. This improvement from suffering from IBS in our cohort is in agreement with the results obtained in other studies [9, 28] which showed a 75% improvement in reducing symptoms of IBS patients as compared to 81% of improvement on IBS symptoms beyond the 83% of improvement on FM impact, in our results.

The high prevalence of functional GI symptoms found in our cohort (36/38) is in accordance with the recorded high prevalence (70%) of IBS in FM patients [12, 13]. Our study showed a mean IBS-SSS score similar to that described by Marsh et al. [9] (275 vs. 232, respectively) with similar reductions in IBS scores following LFD intervention (138 vs. 123, respectively).

We point out that, despite the similarity between the two diseases and this study showed similar benefits in FM, there is no guideline with dietary recommendations for FM.

4.3 General symptoms of FM

Additionally, regarding the impact of FM in daily life (RFIQ score) on outset of the study, is similar to those presented in FM studies, as follows (cited study vs. our study): RFIQ total – 68.2±17.5 vs. 64.8±16.7; RFIQ function score – 19.2±6.8 vs. 18.9±4.9; RFIQ overall impact score – 11.8±5.4 vs. 12.2±5.9; and RFIQ symptoms – 37, 5±8.7 vs. 32.7±8.0 [22]. This mean impact of FM in daily life ranks our sample in the limit of the extreme impact (>65). Analysing the sample according the individual values of the score RFIQ, the distribution observed in present study population, ranged from the minimum limit of the slight impact to an extreme impact limit.

Our study showed significant reductions (improved participant comfort) in a variety of FM scores (RFIQ, FSQ VAS pain; p < 0.01) following 4 weeks on a LFD regimen. The variation of the parameters related to FM was according to the variation of FODMAPs intake, with a significant difference after the LFD period and with no significant difference after the reintroduce of FODMAPs. It was demonstrated, also, that the improvement of impact of FM depends on the case severity. The subgroup of participants classified with moderate impact of FM (RFIQ – 50–65) showed the most significant response to LFD. Therefore, the data suggested that a diet therapy with FODMAPs restriction should be implemented especially in patients presenting with a moderate impact score of the FM.

While FM morbidity-scores remained somewhat stable after reintroduction of FODMAPs, IBS-SSS tended to worsen. This difference in response between systemic and GI symptoms suggests that the GI tract is more quickly exposed and, perhaps, more sensitive to FODMAPs activation of FM symptoms.

The overall EQ-5D score showed a nonsignificant trend towards improvement, but it is interesting that the significant improvements in the “pain/discomfort” and “mobility “domains which reinforce the main scores seems to be related with FM (FIQR, FSQ).

The satisfaction and adherence to the LFD noted in our study, were similar to those observed studies with LFD in IBS. Our cohort showed an 85% adherence to diet with 77% of the patients reporting an overall satisfaction with the study, including 76% of patients referring satisfaction with symptomatic improvement and 75% expressing the diet was easy to follow. Staudacher et al. found 76% of satisfaction with symptomatic improvement, 64% of adherence to diet with 70% expressing that diet was straight forward and easy to follow [28]. Other recent study of LDF therapy for IBS, involving 31 participants, reported 70.9% of participants were satisfied with the LFD [30].

The interesting positive correlations found, between the “improvements of impact of FM in the daily life of this participants” with the “improvement in symptoms of IBS” needs reflexion. It was further shown that “rate of satisfaction with improvement in symptoms” correlating with “diet compliance rate”, suggested that patients were conscious that the compliance to the LFD had lowered the severity of symptoms.

These surprising findings, without similar description in the literature, requires reflection for its originality. These results are encouraging but limited, has an open-label design and a small number of participants; requiring additional or more comprehensive studies, including a larger cohort, in order to verify our findings. Controlled studies are proposed to be conducted introducing a previous control Moment with a high FODMAP content in order to limit other interfering factors.

FM is a disease that requires upon a multifaceted approach to its therapeutic approach. The recommendations for FM treatment may include nutrition as a potential top therapy. But, this requires further verification and an understanding of its mode of action. This pilot study is the first clinical trial referring of LFD intervention for FM treatment. The results here obtained are encouraging and should stimulate further, broader studies on LFD therapy for treating FM.

5 Conclusion

This pilot study showed that a LFD may have potential as a major therapeutic tool for treatment of FM. The introduction of a LFD to FM patients resulted in significant reductions of disease severity scores, individual FM symptoms, including generalized somatic pain, and impact on daily life. The effect of LFD was noted, in special, in the participants with moderate severity of FM. Future efforts should be made to rigorously verify the specifics of LFD for treatment of FM. Our study suggests that future studies should be performed on safety of LFDs on a short- and long-term basis, and understanding the mode of action of FODMAPs on the GI tract and their role in central sensitization.

6 Implications

As far as we know, this pilot study was the first intervention with a LFD in FM and the unexpected results can open up new lines of research. The surprising results found in this experimental intervention according to current scientific knowledge, must be reproduced looking for a future dietetic approach in FM. The challenges for researchers who are working with this innovative diet therapy include the need to ensure its effectiveness and safety, not only in IBS but also in FM. The dietary advice should be a recommendation for FM, by the evident relationship between diet/well-being and chronic disease. It’s needed to develop research to have a diet therapy integrated in future guidelines of FM.

Highlights

  • This was the first pilot study on FM with a Low FODMAP Diet(LFD).

  • LFD has growing evidence in the treatment of IBS symptoms(70% of prevalence).

  • LFD promoted symptomatic improvement in FM, with an important significance.

  • Not only in the expected gastrointestinal symptoms, but also in somatic pain and in impact of the Fibromyalgia on daily life.


DOI of refers to article: http://dx.doi.org/10.1016/j.sjpain.2016.06.001.



Universidade de Lisboa, Alameda da Universidade 1649-004 Lisboa.

  1. Statement of authorship: Ana Paula Marum contributed to concept/design, data collection/analysis/interpretation, and drafting article; Cátia Moreira contributed to dietary plans and nutritional quantifications, Pablo Tomas-Carus contributed to recruitment, critical revision of article, Fernando Saraiva contributed to recruitment and critical revision of article, Catarina Sousa Guerreiro contributed to concept/design, revising it critically for important intellectual content and final approval of the version to be submitted.

  2. Funding: Not applicable.

  3. Ethical issues: All participants signed informed consent agreements according to the Helsinki Declaration of the AMM 2013 version. The project was approved by the Ethics Commission of the Medical Academic Centre of Lisbon.

  4. Conflict of interest: Author Ana Paula Marum, Author Cátia Moreira, Author Fernando Saraiva, Author Pablo Tomas-Carus and Author Catarina Sousa Guerreiro, declare that they have no conflict of interest.

Acknowledgments

We thank to Santa Maria Hospital, Department of Rheumatology, and Myos Association the consent and logistic support for the field research. We also thank Prof. Elisabete Carolino and Prof. Alice Gonçalves for statistical assistance and Dr. Bruce Campbell for the English revision.

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Received: 2016-04-01
Revised: 2016-07-20
Accepted: 2016-07-21
Published Online: 2016-10-01
Published in Print: 2016-10-01

© 2016 Scandinavian Association for the Study of Pain

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