Clinical Characteristics Of Functional Dyspepsia Patients With Weight Loss And Intervention Of Mirtazapine

Functional dyspepsia (FD) is one of the most prevalent functionalgastrointestinal disorders (FGIDs) and biopsychosocial diseases. It has a highincidence, which markedly reduces the patients,quality of life and the impact of thiscondition on health care systems has been shown to be considerable. Therefore,clinicians and scholars pay more attention to FD patients. Weight loss is a classic andalarming symptom of digestive diseases, and may indicate organic diseases. However,patients with FD often have a weight loss in clinical practice. At present, FD patientswith weight loss has been poorly studied. Reports about the symptom patterns,psychological disorders, care-seeking behaviors, and quality of life (QOL) thataccompany this condition are not known. Moreover, reports about the treatment of FDpatients with weight loss are rare.This study was divided into two parts: the first part was the research of clinicalfeatures in FD patients with weight loss, and our aims were to investigate symptomspatterns, behavioral factors, psychological disorders, quality of life (QOL) thataccompany this condition, also, we hoped this study was for physicians to payattention to FD with weight loss; the second part was the clinical study about FDpatients with weight loss treated with mirtazapine, and our aims were to explore thesafe and efficient treatment.Part One: Clinical characteristics of functional dyspepsia patients with weight lossThis was a multi-center, prospective study which was registered in ChineseClinical Trial Registry center (Registration number: ChiCTR-TRC-12001968). Patients presented to the gastrointestinal (GI) clinics in Guangzhou First People,sHospital Affiliated to Guangzhou Medical University, Nansha Hospital, the SecondPeople,s Hospital of Guangdong Province, and Meizhou People,s Hospital inGuangdong were consecutively recruited between June and September in2012. Thequestionnaire surveys in the three hospitals were respectively performed by twotrained clinicians of the departments of Gastroenterology and PsychosomaticMedicine in a quiet environment, including basic informations, appetite, the NepeanDyspepsia Index (NDI)-symptom checklist, the Hamilton Rating Scale of Anxiety/Depression (HAMA/HAMD), the NDI quality-of-life (QOL) index, the PittsburghSleep Quality Index (PSQI), healthy care-seeking behaviors.1057outpatients whohad completed informations were divided into two groups according to the percentageabout weight loss of the initial body weight: FD with weight loss group (WTLgroup:≥5%) and FD patients without (NWTL group:<5%), and to compare thedifferences between them.Two hundred and seven of1057outpatients with FD was reported a weight lossof≥5%, and the proportion of FD patients with weight loss is about19.58%. None of1057FD patients had the rating of appetite as very good. The proportion of the ratingof appetite as poor or very poor in WTL group had significantly higher than NWTLgroup. The incidence of anxiety and depression and the total score of the PSQI forWTL group were all significantly higher than those for the other group (56.04%vs30.59%;59.90%vs28.24%;8.08±4.99vs6.22±4.43; respectively, all P<0.05).Compared to the other group, interference with daily activities work, knowledge andcontrol, eating/drinking and sleep disturbance measured by the NDI-QOL index weresignificantly worse in WTL group (72.62±15.37vs78.78±14.74;61.69±17.86vs67.93±33.77;56.24±22.18vs66.08±20.41;69.32±28.02vs79.22±23.19; respectively,all P<0.05). The frequency of care-seeking and direct medical costs in WTL groupwere sharply greater than those in NWTL group (8.05±6.51vs6.14±5.06;583.86±384.10vs500.27±222.42; respectively, all P<0.05).Part Two: Clinical study of the intervention of mirtazapine in FD patients with weightloss This was a prospective, randomized and controlled trial which was registered inChinese Clinical Trial Registry center (Registration number: ChiCTR-TRC-13003161). All subjects presented to the gastrointestinal (GI) clinics inGuangzhou First People,s Hospital Affiliated to Guangzhou Medical University,Nansha Hospital between June2012and February2014. Sixty depressive FD patientswith weight loss were randomly divided into mirtazapine group, paroxetine group orconventional group for8weeks, respectively. The conventional therapy includedhistamine-type2receptor antagonists or proton pump inhabitor or prokinetic agents;the mirtazapine group treated by conventional therapy in combination withmirtazapine (15~30mg/d); the paroxetine group treated by conventional therapy incombination with paroxetine (10~20mg/d). Assessments including body weight,appetite, the Nepean Dyspepsia Index (NDI)-symptom checklist, the Hamilton RatingScale of Depression (HAMD) were performed before the treatment for baseline and2week,4week,6week,8week during treatment period. And then the adverse effectswere recorded when patients saw the doctors.After the2nd week of the treatment, the score of Nepean Dyspepsia Index(NDI)-symptom checklist in the mirtazapine group was significantly lower than thatin the other two groups (all P<0.05), but there was no significant difference betweenparoxetine group and conventional therapy group (P>0.05). From the4th week, thescore of NDI-symptom checklist in the mirtazapine group was samely lower than thatin the other two groups, moreover, the score of Nepean Dyspepsia Index(NDI)-symptom checklist in the paroxetine group was significantly lower than that inconventional therapy group (all P<0.05). From the2nd week, the proportion of therating of appetite as poor or very poor in the mirtazapine group were significantlydecreased compared with the other two groups (all P<0.05), but there was nostatistically significantly differences between paroxetine group and conventionaltherapy group (P>0.05). From the2nd week, the scores of HAMD in the mirtazapinegroup and paroxetine group were significant lower than that in conventional therapygroup (all P<0.05), moreover, the score of HAMD in the mirtazapine group wassharply lower than that in paroxetine group (P<0.05). From the4th week, the scores of HAMD in the mirtazapine group and paroxetine group were samely significantlylower than that in conventional therapy group (all P<0.05), but there was nostatistically significantly differences between mirtazapine group and paroxetine group(P>0.05). After6th week of the treatment, the body weight in the mirtazapine groupwas significantly higher compared with the other two groups (all P<0.05), but therewas no statistically significant difference between the paroxetine group and theconventional therapy (P>0.05). The adverse effects associated with the mirtazapinegroup were dizziness (10%), lethargy (15%), fatigue (15%). These adverse effectswere mild and there were no need to treatment.Conclusions1.FD with weight loss is not rare in clinical practice, and often associate with poorerappetite, higher psychological difficulties and sleep disturbance, moreover, patientsaccompany with this condition have poorer quality-of-life, more frequent care-seeking,greater direct medical costs.2.Mirtazapine significantly improved dyspepsia symptoms, depressive scoring,appetite, and better recovery of weight loss for depressive FD patients with weightloss and it had few adverse effects.