Efficacy of digestive enzyme supplementation in functional dyspepsia: A monocentric, randomized, double-blind, placebo-controlled, clinical trial.

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• Digestive enzyme supplementation (400mg BID) may help improve symptoms of functional dyspepsia, including pain, sleep quality, and difficulties associated with eating and drinking normally.

• Quality of life improved after two months of supplementation, suggesting that symptom improvements may also translate into benefits for everyday activities.

• No side effects or adverse reactions were reported during the two-month study, suggesting the digestive enzyme blend was well tolerated by participants.

• Digestive enzymes may offer a potential non-pharmacological option for functional dyspepsia, although further research is needed before conclusions can be made about their longer-term effectiveness.

Introduction -

Treatments for functional dyspepsia involve dietary and lifestyle changes in combination with pharmacological therapies. However, concerns surround serious adverse events, and efficacy means that alternatives to pharmacological treatments are being investigated. Deficiencies or dysfunction in digestive enzymes have been linked to the development of functional dyspepsia and could be a non-pharmacological option for the management of functional dyspepsia. This study aimed to evaluate the effectiveness and tolerability of a multi-enzyme blend in individuals with functional dyspepsia.

Methods -

• This was a two-month randomised, placebo-controlled, double-blind trial of 120 individuals with functional dyspepsia, aged 18-59 years.

• Participants were given either two capsules per day at lunch and dinner with a total of 400mg of broad-spectrum digestive enzyme blend containing protease, amylase, lipase and cellulase, or placebo.

• The primary outcome was improvements in quality of life (QoL) as evaluated by the Nepean Dyspepsia Index-SF (NDI-SF).

• The secondary outcomes were the severity of pain and quality of sleep as assessed by the Visual Analogue Scale (VAS) and Pittsburgh Sleep Quality Index (PSQI) questionnaire.

Results -

• The results showed that the NDI-SF score measuring QoL was statistically  significantly improved after two months of digestive enzyme treatment (β = 7.1 ± 3.3, t₃₄₇ =2.100, P = 0.036).

• Older age was associated with statistically significantly lower NDI-SF scores, indicating an age associated change (β = −0.20 ± 0.09, t₃₃₈ =2.062, P = 0.037).

• Statistically significant improvements in the four domains captured in the NDI-SF- interference in daily activities, disease control, ability to eat and drink normally and sleep quality - were also seen with digestive enzyme supplementation (β = 35.7 ± 5.2, t₃₄₉ =6.907, P < 0.001, and β = 77.3 ± 5.2, t₃₄₉ =14.951, P < 0.001, respectively).

• VAS score of pain was also statistically significantly improved with digestive enzyme supplementation (β = −1.5 ± 0.4, t₃₃₃ =4.211, P < 0.001).

• Older age was also associated with a statistically significantly improved VAS score (β = −0.05 ± 0.01, t₃₄₆ =4.699, P < 0.001).

• Women had a statistically significantly higher VAS than men following digestive enzyme supplementation (β = 1.0 ± 0.3, t₃₃₇ =3.261, P = 0.0012). It is not clear from the data provided if women’s VAS was higher at baseline.

• The PSQI measuring sleep quality was statistically significantly improved with digestive enzyme supplementation (β = 6.6 ± 0.4, t₃₁₁ =14.55, P < 0.001).

• Older age was associated with statistically significantly improved PSQI (0.03 ± 0.01, t320 = 2.178, P = 0.030).

• No individual reported side effects or adverse reactions with digestive enzyme supplementation.

Conclusion -

It was concluded that digestive enzyme supplementation may be an effective therapy to decrease functional dyspepsia symptoms.

• Digestive enzyme supplementation may be considered as a non-pharmacological adjunct for individuals with functional dyspepsia, alongside established dietary and lifestyle management strategies.

• A broad-spectrum digestive enzyme blend may help improve quality of life, including the ability to eat and drink normally, pain-associated daily activities, and sleep-related outcomes.

• Digestive enzymes may help reduce dyspepsia-related pain, providing another potential management option for practitioners.

• Supplementation particularly benefitted dyspepsia, sleep quality, and pain in older adults and this cohort may  warrant particular consideration.

• Short-term supplementation appeared well tolerated, with no adverse effects or reactions reported over the two-month intervention.

• Determine whether improvements in the ability to eat and drink translate into better nutritional intake, particularly in older adults or individuals whose dyspepsia restricts food intake.

• Compare digestive enzymes with established dietary, lifestyle and pharmacological approaches, both alone and in combination, to establish where enzyme supplementation could fit within functional dyspepsia management.