Efficacy of Malva sylvestris extract (Mallolax™) for the treatment of functional constipation and associated gastrointestinal symptoms in adults: A pilot study

Abstract Background: Functional constipation, a highly prevalent condition worldwide, it is considered the result of a complex interplay between the gastrointestinal tract, the nervous system, the gut microbiome, along with diet and lifestyle factors. Within the dietary-behavioural change, the intake of nutraceutical products has been shown to significantly improve the clinical picture of functional constipation, reducing the risk of side effects of conventional therapies. In this context, the present pilot study aimed to assess the efficacy of a nutraceutical formulation containing a specific Malva sylvestris extract (MALLOLAXTM), titrated on malvidin and malvidin-3-glucosides, in the management of functional constipation and associated gastrointestinal symptoms. Design: A three-arm, randomised controlled study was designed. 75 adults with low fibre intake and meeting the Rome IV criteria for functional constipation were recruited. The effect of the intake of Malva sylvestris extract (500 mg/day or 1000 mg/day of MALLOLAXTM capsules taken in water) during 3 weeks was compared vs placebo in the management of mild constipation. Methods: Primary outcome was the change in frequency of complete spontaneous bowel movements (CSBM). Secondary outcomes were stool consistency, gastrointestinal symptoms, quality of life and mood using the Patient Assessment of Constipation Symptoms (PAC-SYM), Patient Assessment of Constipation Quality of Life (PAC-QoL), and Depression Anxiety and Stress Scale (DASS-21). Safety and tolerability were assessed through. Safety and tolerability were evaluated through the self-reported adverse effect data collected at clinic interviews. The compliance of treatments was monitored using a delivery of diary sheet. Results: At the end of supplementation period CSBM were improved significantly in MALLOLAXTM groups. A notheworthy more significant result were obtained in the higher dose of Mallolax extract group (p<0,0001). In addition, there was a significant improvement in stool consistency (p<0,0001) and bowel movements (p<0,0001) in both active groups compared with placebo. A significant reduction in overall gastrointestinal symptoms (PAC-SYM) and an improvement in quality of life (PAC-QoL) in Mallolax groups has also been shown. Moreover, there was a significant reduction in mean score for depression, anxiety, and stress (DASS-21) for participants who received MALLOLAXTM 1 g/day, indicating a possible dose-related effect on psychological functions. Conclusions: The results showed that MALLOLAXTM formulations assumed for 21 days represents a safe and effective choice for the improvement of functional constipation and associated symptoms in individuals reporting a low fibre intake. Future larger and longer randomised clinical trials are needed to confirm the properties of the extract in functional constipation and to evaluate both efficacy and safety in medium- and long-term treatments.