PMID- 35255832
OWN - NLM
STAT- MEDLINE
DCOM- 20220309
LR  - 20231105
IS  - 1471-230X (Electronic)
IS  - 1471-230X (Linking)
VI  - 22
IP  - 1
DP  - 2022 Mar 7
TI  - A novel duodenal-release formulation of caraway oil and L-menthol is a safe, 
      effective and well tolerated therapy for functional dyspepsia.
PG  - 105
LID - 10.1186/s12876-022-02181-5 [doi]
LID - 105
AB  - BACKGROUND: A randomized, placebo-controlled clinical trial (FDREST) of a novel 
      formulation of caraway oil and L-menthol (COLM-SST) demonstrated symptom relief 
      in patients with functional dyspepsia (FD). Two follow-up studies were conducted 
      to evaluate patient satisfaction, self-regulated dosing, and long-term safety 
      data: FDACT, Functional Dyspepsia Adherence and Compliance Trial, and FDSU36, 
      Functional Dyspepsia Safety Update at 36 months. METHODS: A patient reported 
      outcomes (PRO) questionnaire was designed and distributed online to assess 
      real-world satisfaction and dosing frequency of open-label COLM-SST in patients 
      with FD. A separate study analyzing voluntary safety surveillance data evaluated 
      the frequency and severity of reported adverse events (AEs). RESULTS: A total of 
      600 FD patients were enrolled in the PRO study. Ninety five percent of 
      respondents reported a major or moderate improvement in their FD symptoms and 
      91.7% indicated a major or moderate improvement in quality of life (QOL) using 
      COLM-SST. Between 1 and 4 capsules were consumed daily by 91.2% of respondents, 
      with 56.2% taking them before meals. Symptom relief was rapid, with 86.4% of 
      respondents indicating relief within 2 h of taking COLM-SST. Few adverse events 
      (AEs) were reported (0.0187%) by patients using COLM-SST. No serious AEs were 
      identified. CONCLUSION: COLM-SST is safe, well tolerated, and provides rapid 
      relief of FD symptoms. These findings, demonstrated in the FDREST trial, were 
      further supported by a large prospective PRO study evaluating self-regulated 
      dosing frequency, symptom improvement, and QOL. COLM-SST was well-tolerated based 
      on review of AE data at 36 months.
CI  - (c) 2022. The Author(s).
FAU - Lacy, Brian E
AU  - Lacy BE
AD  - Gastroenterology and Hepatology, Mayo Clinic, 4500 San Pablo Road South, 
      Jacksonville, FL, 32224, USA.
FAU - Chey, William D
AU  - Chey WD
AD  - Division of Gastroenterology, Department of Internal Medicine, Michigan Medicine, 
      University of Michigan, Ann Arbor, MI, 48109, USA.
FAU - Epstein, Michael S
AU  - Epstein MS
AD  - Digestive Disorders Associates, 621 Ridgely Ave, #201, Annapolis, MD, 21401, USA.
FAU - Shah, Syed M
AU  - Shah SM
AD  - Nestle Health Science, 1007 US Highway 202/206, Building JR2, Bridgewater, NJ, 
      08807, USA.
FAU - Corsino, Patrick
AU  - Corsino P
AD  - IM Health Science, 1100 Holland Drive, Boca Raton, FL, 33487, USA.
FAU - Zeitzoff, Linda R
AU  - Zeitzoff LR
AUID- ORCID: 0000-0003-2868-2018
AD  - Medical Affairs, Nestle Health Science, 1007 US Highway 202/206, Building JR2, 
      Bridgewater, NJ, 08807, USA. Linda.Zeitzoff@us.nestle.com.
FAU - Cash, Brooks D
AU  - Cash BD
AD  - Division Gastroenterology, Hepatology and Nutrition, McGovern Medical School, 
      University of Texas Health Science Center at Houston, Houston, TX, 77031, USA.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20220307
PL  - England
TA  - BMC Gastroenterol
JT  - BMC gastroenterology
JID - 100968547
RN  - 0 (Plant Oils)
RN  - 1490-04-6 (Menthol)
RN  - C2J9B08Q3I (caraway oil)
SB  - IM
MH  - *Dyspepsia/diagnosis/drug therapy
MH  - Humans
MH  - *Menthol/therapeutic use
MH  - Plant Oils
MH  - Prospective Studies
MH  - Quality of Life
MH  - Treatment Outcome
PMC - PMC8900420
OTO - NOTNLM
OT  - Abdominal pain
OT  - Caraway oil
OT  - Dyspepsia
OT  - Functional dyspepsia
OT  - L-menthol
COIS- BEL: Scientific advisory boards for Allergan, Salix, IM Health Science, Ironwood, 
      Arena and is a consultant for Viver, Nestle Health Science; WDC: Board 
      member-American College of Gastroenterology, GI on Demand, International 
      Foundation of Functional GI Disorders, Rome Foundation; Consultant-AbbVie, 
      Alfasigma, Allakos, Alnylam, Arena, Bayer, Biomerica, Cosmo, IM Health Science, 
      Ironwood, QOL Medical, Nestle Health Science, Phathom, Redhill, Ritter, 
      Salix/Valeant, Takeda, Urovant, Vibrant; Grant/Research Support: Bioamerica, 
      Commonwealth Diagnostics International, QOL Medical, Salix; Stock/Stock options: 
      GI on Demand, Modify Health; MSE: Consultant to Nestle Health Science; Speaker 
      for BMS, Redhill, Gilead, Salix. Pfizer. SMS: Consultant to Nestle Health 
      Science; PC: none; LRZ: employee Nestle Health Science; BDC: Consultant to Nestle 
      Health Science.
EDAT- 2022/03/09 06:00
MHDA- 2022/03/11 06:00
PMCR- 2022/03/07
CRDT- 2022/03/08 05:33
PHST- 2021/11/09 00:00 [received]
PHST- 2022/02/22 00:00 [accepted]
PHST- 2022/03/08 05:33 [entrez]
PHST- 2022/03/09 06:00 [pubmed]
PHST- 2022/03/11 06:00 [medline]
PHST- 2022/03/07 00:00 [pmc-release]
AID - 10.1186/s12876-022-02181-5 [pii]
AID - 2181 [pii]
AID - 10.1186/s12876-022-02181-5 [doi]
PST - epublish
SO  - BMC Gastroenterol. 2022 Mar 7;22(1):105. doi: 10.1186/s12876-022-02181-5.