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Research Article
Clinical trial

Efficacy of Curcuma longa in treatment of postprandial distress syndrome: An open-label randomized-controlled trial

[version 1; peer review: 2 approved]
Nicharat Sawangroj
https://orcid.org/0000-0002-3653-3314
1, Jiratha Budkaew1, Bandit Chumworathayi
https://orcid.org/0000-0003-1214-1962
2
Nicharat Sawangroj
https://orcid.org/0000-0002-3653-3314
1, Jiratha Budkaew1, Bandit Chumworathayi
https://orcid.org/0000-0003-1214-1962
2
PUBLISHED 30 Oct 2019
Author details Author details
OPEN PEER REVIEW
REVIEWER STATUS

This article is included in the All trials matter collection.

Abstract

Background: Proton pump inhibitors are effective for functional dyspepsia but ineffective in relieving postprandial distress syndrome. Curcuma longa might be effective for postprandial distress syndrome. The objective of this study was to compare the efficacy of Curcuma longa and simethicone for postprandial distress syndrome in an open-label randomized-controlled trial.
Methods: This trial was conducted between July 2018 and February 2019. In total, 78 patients were randomly assigned to receive 4 weeks of treatment with 750 or 1,500 mg oral Curcuma longa per day or 240 mg simethicone per day. The patients assessed their symptoms using the dyspepsia Global Overall Symptom scale at baseline, week 2, and week 4. After stopping medication for 2 weeks, the patients assessed recurrent symptoms and day of recurrence by themselves at the end of week 6.
Results: In total, 78 patients underwent randomization (27 in 750 mg Curcuma longa, 26 in 1500 mg Curcuma longa, and 25 in simethicone groups). After 2 weeks, there were no significant differences in all mean changes of symptoms scores (95%CI) of postprandial distress syndrome [-4.1 (-4.5, -2.6) vs -4.3 (-5.2, -3.3) vs -4.2 (-4.8, -3.5), P=0.954]. Over a period of 4 weeks, the reduction in mean scores was greater among participants receiving simethicone (although not statistically significant) compared with two intervention groups [-4.6 (-5.7, -3.6) vs -5.4 (-6.6, -4.1) vs -6.2 (-7.2, -5.2), P=0.122]. The rate of recurrence was significantly lower in simethicone than the two Curcuma longa groups (42.9 vs 45.5 vs 13.6%, P=0.047). There was no serious adverse event reported in all three groups.
Conclusions: Curcuma longa had a similar effect on treatment outcomes to simethicone after 2 and 4 weeks, but the recurrence rate of symptoms was significantly higher without serious adverse events.
Registration: Registered with the Thai Clinical Trials Registry on 31 January 2018; TCTR20180131001.

Keywords

Functional dyspepsia, postprandial distress syndrome, global overall symptom scale, Curcuma longa, simethicone

Corresponding author: Bandit Chumworathayi
Competing interests: No competing interests were disclosed.
Grant information: This study was supported by Khon Kaen Hospital (research grant number KE61020), approved on 14th February 2018.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Copyright:  © 2019 Sawangroj N et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
How to cite: Sawangroj N, Budkaew J and Chumworathayi B. Efficacy of Curcuma longa in treatment of postprandial distress syndrome: An open-label randomized-controlled trial [version 1; peer review: 2 approved]. F1000Research 2019, 8:1827 (https://doi.org/10.12688/f1000research.20662.1) First published: 30 Oct 2019, 8:1827 (https://doi.org/10.12688/f1000research.20662.1) Latest published: 30 Oct 2019, 8:1827 (https://doi.org/10.12688/f1000research.20662.1)

Introduction

Dyspepsia is a common functional gastrointestinal disorder which affects 20% of the global population1. Although dyspepsia is not a life-threatening condition, it disrupts the quality of life and also socioeconomic impaction for suffering patients2–4. The United States population spends $18 billion annually on dyspepsia management4. In Thailand, the prevalence of dyspepsia is higher than global prevalence, affecting more than half of the Thai population5.

Rome IV criteria for diagnosis classifies functional dyspepsia (FD) into two groups based on symptoms; (1) postprandial distress syndrome (PDS), consisting of postprandial fullness and early satiety, and (2) epigastric pain syndrome (EPS)6. Currently, proton pump inhibitors (PPI) are regarded as an effective treatment for FD but ineffective in relieving PDS symptoms6. Therefore, physicians frequently consider prescribing other agents for these patients.

Pathogenesis of FD is likely complex and multifactorial. The factors that cause PDS comprise delayed gastric emptying time, impaired gastric accommodation, and gut inflammation6. In addition, psychosocial factors such as anxiety, depression and psychiatric disorders also induce pathogenesis6.

Simethicone is a defoaming agent. Foam, formed by gas in the gastrointestinal tract (GI) and gastric mucous, is a cause of fullness if it accumulates in GI tract7. Therefore, foam reduction can increase gastric emptying time and relieve postprandial fullness8–13. Many studies have found that simethicone has efficacy for treatment of dyspepsia and no serious adverse reaction14–17.

Curcuma longa is a Thai herb that effectively relieves flatulence18. Previous rodent studies19–21 documented that Curcuma longa can decrease gut inflammation via its active ingredient curcumin (R = OCH3, R' = OCH3). Curcumin inhibits many proinflammatory enzymes such as cyclooxygenase-2, 5-lipoxygenase, and inducible nitric oxide synthase enzymes etc. Not only does it have an anti-inflammatory effect, but curcumin also increases gastric emptying time and reduces depressive symptoms via the brain-gut axis22. Thus, Curcuma longa is commonly used for FD treatment.

Many human studies supported the efficacy of Curcuma longa compared with other agents for treatment of dyspepsia19,22,23.A trial in 2007 found that taking a 2-g Curcuma longa capsule daily for four weeks indicated no significant difference with ranitidine for dyspepsia relief23. A later study in 2016 showed that addition of curcumin on top of the standard anti-helicobacter regimen in patients with peptic ulcers was safe and improved symptoms of dyspepsia but did not enhance effect on the eradication of Helicobacter pylori infection24.

However, no current evidence of the efficacy of Curcuma longa as compared with simethicone for PDS symptoms. Thus, the aim of this present study was to assess the efficacy of Curcuma longa compared with simethicone in patients with PDS.

Methods

Patients

Adults (age 20–60 years) with FD, diagnosed during a routine clinical appointment by physicians working at any Social Medicine clinic of Khon Kaen Hospital (Khon Kaen, Thailand), on the basis of Rome IV criteria6, were screened by nurse officers for participation then enrolled in the study by the principal investigator. Inclusion criteria included postprandial distress syndrome, no alarm features, and discontinuation of all GI drugs at least one week before randomization. Patients with a history of either simethicone or Curcuma longa allergy, gastric malignancy, gallstone or biliary obstruction, pregnancy, and on breastfeeding period were excluded. Written informed consent was obtained from all patients.

Study design and oversight

The Khon Kaen Hospital Institute Review Board in human research approved the study protocol. This trial was registered with the Thai Clinical Trials Registry on 31st January 2018; registration number, TCTR20180131001. This randomized, active-comparator, open-label trial was conducted at primary care clusters of Khon Kaen Hospital, and Nam Pong Community Hospital between July 2018 and February 2019. All the authors were involved in the design and performance of the study, which was conducted according to the Declaration of Helsinki. First research assistant (CT) used computer-generated simple randomization and sequentially labeled the number on opaque drug containers for concealment. After the principle investigator (NS) enrolled participants, the second research assistant (MJ) then assigned the concealed interventions in order. There was no deviation from the original trial protocol.

Study treatment and procedures

Patients were randomly assigned to take 750 mg Curcuma longa capsule per day, 1500 mg of Curcuma longa capsule per day or 240 mg of simethicone per day for four weeks. All patients were educated on lifestyle modification, such as stopping drinking and smoking, decreasing spicy foods and the volume eaten per meal, and trying to choose foods with softer consistentcy. Female participants were given a urine pregnancy test, and were excluded if result indicated positive. Baseline characteristics were measured together with BMI and global overall symptom (GOS) scale (described below). Medication was administered orally 30 to 60 minutes after each meal (250 mg (one Curcuma longa capsule per meal), 250 mg (two Curcuma longa capsule per meal), or 80 mg (one simethicone tablet per meal) three times per day). Patient's visits were scheduled at the start of treatment and at the end of 2, 4, and 6 weeks (2 weeks after stopping treatment). All patients discontinued medication after week 4 and reported for recurrence of symptoms at week 6. Patients also completed daily logs of symptoms and adverse events during the week preceding each visit. At each visit, the patient, with the principle investigator (NS), completed the seven-point GOS scale for dyspepsia (which ranges from 1 to 7, with 1 indicating no problem, 2 indicating minimal problem (can be easily ignored without effort), 3 indicating mild problem (can be ignored with effort), 4 indicating moderate problem (cannot be ignored but does not influence my daily activities), 5 moderately severe problem (cannot be ignored and occasionally limits my daily activities), 6 indicating severe problem (cannot be ignored and often limits my concentration on daily activities), and 7 indicating very severe problem (cannot be ignored and markedly limits my daily activities and often requires rest)25.

At the last visit, patients were asked to report their recurrence of symptoms and the date of recurrence after discontinuation of treatment.

Endpoints

We focused on PDS symptoms, measured using the GOS scale, so we combined the early satiety score and postprandial score as the composite outcome. The two primary endpoints were the comparison of mean changes of composite outcome between groups from baseline to week 2 and week 4. Secondary end points were rates and durations of recurrences at week 6, and also adverse effectsas assessed by a daily log of adverse events. Post-hoc analyses included the changes from baseline in each group at week 2 and week 4.

Statistical analysis

We calculated that a sample of 69 patients would provide adequate power for the proposed tests in this three-group study using the formula for sample size calculation to compare k means by one-way ANOVA pairwise, 2-sided equality26. By substitution of mean in treatment group (µtrt) = -1.8624, mean in control group (µcon) = -1.3024, SD in each group = 0.6524, α = 0.05 and β = 0.20, r = 1, n = 22 per group was be derived.

SPSS version 24.0 was used. Mean changes from baseline to week 2 and week 4, in GOS scale, were analyzed with one-way ANOVA. Dichotomous endpoints (recurrent rates) were compared among the groups with the use of Chi-squared and Z-test. The duration of symptoms was compared using Kruskall-Wallis test. Means among the groups were also analyzed using one-way ANOVA. To compare means in each group (before and after), a paired t-test was used. Bonferroni post-hoc test was used for post-hoc analysis.

Results

Study participants

A total of 94 patients with functional dyspepsia were assessed for eligibility. There were 16 patients excluded from study due to not meeting inclusion criteria (n= 14) and declined to participate (n=2). A total of 78 patients underwent randomization. There were 27 in the 750 mg Curcuma longa group, 26 in 1500 mg Curcuma longa group and 25 in the simethicone group; there were 6, 4, and 2 patients lost to follow-up in each group, respectively. Intention-to-treat was used for data analysis, with n=21 in 750 mg Curcuma longa, n=22 in 1500 mg Curcuma longa, and n=23 in simethicone (Figure 1). The characteristics of the patients at baseline were similar across study groups (Table 1). However, in both Curcuma longa groups, patients were slightly overweight (BMI, 23.0-24.9 kg/m2), while in the simethicone group, patients were normal weight (BMI, 18.5-22.9 kg/m2). Participant characteristics, alongside all variables assessed, are available as Underlying data27,28.

38799bb4-59e9-4495-8445-7a28f67403cd_figure1.gif

Figure 1. CONSORT diagram.

Table 1. Baseline characteristics of the patients.

Characteristic750 mg
Curcuma longa
N = 27		1500 mg
Curcuma longa
N = 26		Simethicone
N = 25		P-value
Female sex, n (%)19 (73.1)20 (76.9)18 (69.2)0.856
Age, years*38.0±13.841.4±12.936.2±12.00.348
Weight, kg*60.4±11.763.3±10.357.5±10.40.166
Height, cm*158.0±8.2159.3±7.1160.3±7.60.551
BMI, kg/m2*24.2±4.424.9±3.822.4±3.80.064
Smoking, no (%)0.514
Never25 (92.6)22 (84.6)20 (80.0)
Former2 (7.4)2 (7.7)3 (8.0)
Current02 (7.7)4 (16.0)
Alcohol, n (%)0.169
Never21 (77.8)24 (92.3)18 (72.0)
Former1 (3.7)2 (7.7)2 (12.0)
Current5 (18.5)04 (16.0)
EGD approved FD, n (%)2 (7.4)2 (7.7)4 (16.0)0.517
Duration of symptoms, years**3.0 (5.5)2 (4.0)2 (4.0)0.522
Previous treatment, n (%)23 (85.2)24 (92.3)23 (92.0)0.627
Global overall symptom scale*
     Epigastric pain4.2±1.53.5±1.64.0±1.90.283
     Heartburn2.4±1.52.3±1.52.8±1.90.492
     Upper abdominal bloating3.8±1.73.8±7.83.7±2.00.967
     Excessive belching3.2±1.82.5±1.72.8±1.70.369
     Nausea3.0±1.72.0±1.42.3±1.60.777
     Early satiety4.4±1.74.4±1.74.4±1.70.988
     Posprandial fullness5.6±1.05.5±1.35.5±1.20.906

*Plus minus values are means ± SDs.

**Values are medians (IQRs).

Primary outcomes

After 2 weeks, there was no significant difference in mean change of PDS symptoms among three groups [-4.1 (-4.5, -2.6) vs -4.3 (-5.2, -3.3) vs -4.2 (-4.8, -3.5), P=0.954]. Over a period of 4 weeks, patients who received simethicone, as compared with those who received Curcuma longa, had a greater reduction (improvement) in the composite outcomes of PDS symptoms, but there was no statistically significant difference [-4.6 (-5.7, -3.6) vs -5.4 (-6.6, -4.1) vs -6.2 (-7.2, -5.2), P=0.122] (Table 2).

Table 2. Comparison of before-after treatment GOS scale at the end of 2 and 4 weeks.

Global Overall Symptom (GOS)
scale of dyspepsia		Mean changes of GOS between 2 and 0 weekMean changes of GOS between 4 and 0 week
750 mg
Curcuma
longa
n = 26		1500 mg
Curcuma
longa
n = 23		Simethicone
n=24		750 mg
Curcuma
longa
n = 22		1500 mg
Curcuma
longa
n = 22		Simethicone
n=23
Mean (95%CI)Mean (95%CI)Mean (95%CI)Mean (95%CI)Mean (95%CI)Mean (95%CI)
Epigastric pain-1.7 (-2.2, -1.1)
P<0.001		-1.5 (-2.1, -0.8)
P<0.001		-1.5 (-2.1, -1.0)
P<0.001		-2.0 (-2.7, -1.3)
P<0.001		-2.0 (-2.8, -1.3)
P<0.001		-2.3 (-3.1, -1.5)
P<0.001
Heartburn-0.7 (-0.8, -0.2)
P=0.016		-0.9 (-1.7, -0.2)
P=0.012		-1.0 (-1.6, -0.5)
P=0.001		-0.5 (-1.0, 0.0)
P=0.053		-0.9 (-1.7, -0.8)
P=0.034		-1.5 (-2.3, -0.7)
P=0.001
Upper abdominal bloating-1.5 (-2.1, -0.6)
P<0.001		-1.7 (-2.4, -1.0)
P<0.001		-1.6 (-2.3, -0.8)
P<0.001		-1.9 (-2.9, -0.9)
P=0.001		-1.9 (-2.8, -0.9)
P=0.001		-2.3 (-3.2, -1.4)
P<0.001
Excessive belching-0.7 (-1.2, -0.1)
P=0.042		-0.7 (-1.4, 0.2)
P=0.096		-0.8 (-1.5, -0.2)
P=0.026		-1.2 (-2.1, -0.3)
P=0.010		-0.8 (-1.8, 0.2)
P=0.107		-1.4 (-2.2, -0.6)
P=0.002
Nausea-0.5 (-1.3, 0.2)
P=0.100		-0.3 (-0.3, 0.1)
P=0.162		-0.4 (-1.0, 0.3)
P=0.214		-1.0 (-1.9, -0.1)
P=0.026		-0.2 (-0.8, 0.3)
P=0.381		-0.7 (-1.5, 0.0)
P=0.064
Early satiety-1.7 (-2.1, -0.8)
P<0.001		-1.6 (-2.2, -1.1)
P<0.001		-1.7 (-2.2, -1.1)
P<0.001		-1.6 (-2.4, -0.9)
P<0.001		-2.2 (-2.9, -1.5)
P<0.001		-2.8 (-3.4, -2.1)
P<0.001
Postpandrial fullness-2.4 (-2.6, -1.7)
P<0.001		-2.6 (-3.1, -2.1)
P<0.001		-2.5 (-2.9, -2.0)
P<0.001		-3.0 (-3.6, -2.4)
P<0.001		-3.1 (-3.8, -2.5)
P<0.001		-3.4 (-3.9, -2.8)
P<0.001
Plus score of PDS (Early satiety
and Postpandrial fullness)		-4.1 (-4.5, -2.6)
P<0.001		-4.3 (-5.2, -3.3)
P<0.001		-4.2 (-4.8, -3.5)
P<0.001		-4.6 (-5.7, -3.6)
P<0.001		-5.4 (-6.6, -4.1)
P<0.001		-6.2 (-7.2, -5.2)
P<0.001

Figure 2 shows the mean differences in GOS between three groups at the end of 2 and 4 weeks. When calculating mean differences of treatment effect between Curcuma longa groups and simethicone, there was no significant difference of treatment effect among two pair-wise comparisons (group 3 vs group 1 and group 3 vs group 2) at weeks 2 and 4 (Table 3).

38799bb4-59e9-4495-8445-7a28f67403cd_figure2.gif

Figure 2. Mean differences of Global Overall Symptom score between three groups at the end of 2 and 4 weeks.

Table 3. Comparison of treatment effect by composite outcomes.

Comparison of treatment effect between groups at week 2P-value
Treatment effect: mean differences in change (95% CI)0.954a
Simethicone vs 750 mg Curcuma longa-0.09 (-1.54, 1.36)> 0.999b
Simethicone vs 1500 mg Curcuma longa0.09 (-1.40, 1.58)> 0.999b
Comparison of treatment effect between groups at week 4P-value
Treatment effect: mean differences in change (95% CI)0.122a
Simethicone vs 750 mg Curcuma longa-1.54 (-3.35, 0.28)0.123b
Simethicone vs 1500 mg Curcuma longa-0.81 (-2.62, 1.00)0.828b

aBy one-way ANOVA.

bPairwise comparison of mean differences by Bonferroni post-hoc test.

Secondary outcomes

Comparison of before and after treatment using the GOS scale at the end of 2 weeks. In Table 2, the 750 mg Curcuma longa group showed a significant reduction in all items of GOS scale except nausea which similar in simethicone group. However, in the 1500 mg Curcuma longa group indicated a significant reduction in almost all items of GOS scale except excessive belching and nausea.

Comparison of before and after treatment using the GOS scale at the end of 4 weeks. Over a period of 4 weeks, the participants among three groups showed significant improvement of their symptoms unless heartburn in 750 mg Curcuma longa, excessive belching and nausea in 1500 mg Curcuma longa, and nausea in simethicone (Table 2).

Rate of recurrence. After discontinuing treatment for 2 weeks (washout period), The patients with 1500 mg Curcuma longa reported the highest rate of recurrence, 45.5%, followed by the patients with 750 mg Curcuma longa, 42.9% and the lowest rate was in simethicone group, 13.6% (Table 4). In addition, the rate of symptom recurrence was found statistically significant among three groups (P=0.047).

Table 4. Rate and duration of recurrences.

Rate or duration750 mg Curcuma longa
(N=21)		1500 mg Curcuma longa
(N=22)		240 mg Simethicone
(N=22)		P-value
Recurrence patient -no. (%, 95%CI)9 (29.3%, 95%CI 3.7-54.8%)*10 (31.9%, 95%CI 6.5-7.1%)*30.047a
0.032b
0.020b
Mean duration of recurrence - day,
mean (95%CI)		4.1 (1.0, 7.2)**4.5 (1.0, 8.0)**4.2 (-6.1, 14.6)**0.984a

*Proportion differences when compared to simethicone with its 95%CI (by Z-test)

**The day after day 28th

aOne-way ANOVA

bChi-square

Duration of recurrence. There was no significant difference in the duration of recurrence between groups (Table 4).

Adverse events. There was no any patient who needed to discontinue treatment due to the serious adverse events. Non-serious adverse events were reported in 8 cases (11.9%) from the patients who receive Curcuma longa, including nausea, diarrhea, fever, dizziness and headache (Table 5).

Table 5. Adverse events.

Adverse events750 mg Curcuma longa, n (N=22)1500 mg Curcuma
longa, n (N=22)		240 mg Simethicone,
n (N=23)
Nausea111
Fever200
Diarrhea100
Others101

Discussion

The main limitation of this study is that it is an open-label trial, in which blinding was not performed. There was no co-intervention, but few attrition biases. Although this is an open-label trial, we performed the allocation concealment and a good randomization that the results of similar characteristics among three treatment groups. Due to validity of the outcomes measured with precise 95% CIs in Table 3, our findings are summarizable and generalizable to all similar settings and populations.

The efficacy of Curcuma longa showed non-inferiority to simethicone according to the composite outcome of PDS symptoms among three treatment groups had no significant difference at week 2 and week 4. Our findings were similar to the findings of Sirijarugul and Pongchaidecha23 and Khonche et al24.

The study data also provide evidence of four important aspects of dyspepsia treatment. First, from baseline characteristics, there were more female participants. This is similar to the most recent meta-analysis in 20141. Data from this prior study indicated a greater prevalence of dyspepsia in the women from 312,415 samples (OR 1.24; 95% CI 1.13 to 1.36)1. The other characteristics were also accordant with previous studies23,24.

Second, our findings showed that Curcuma longa groups were also effective in different doses. Suprisingly, the 1500 mg group developed a higher symptom recurrence rate. Therefore, 750 mg Curcuma longa per day should be the recommended dose for FD.

Third, the simethicone group developed significant lower rate of symptom recurrence. To explain this phenomenon, these patients were normal weight from obesity Asian criteria (BMI, 18.5-22.9 kg/m2)29. On the other hand, in both Curcuma longa groups, patients were slightly overweight (BMI 23.0-24.9 kg/m2) that associated with the greater prevalence of GI symptoms30,31.

Finally, the three treatment groups were safe for all participants, similar to previous studies19,22–24, indicating that Curcuma longa can be used generally.

Strengths of this study were; this was a randomized controlled trial that had a high quality of evidence, we studied a washout period, and we are the first who compare the efficacy of Curcuma longa and simethicone. On the other hand, our limitations were; having lower sample size than calculated due to loss to follow up patients that might have less power of study and dyspepsia associated with the multifactorial factor such as environment, various types of food, and participant behaviors. Despite we randomly assigned the treatments, it could not eliminate all confounders. So the outcomes could be imprecise.

Conclusion

In conclusion, Curcuma longa had significant effects on reduction of FD, similar to simethicone after 2 and 4 weeks, but the recurrence rate (i.e. the proportion of reappearance) of dyspeptic symptoms was slightly significantly higher without serious adverse events.

Data availability

Underlying data

Figshare: CurcumaUnderlyingData. https://doi.org/10.6084/m9.figshare.9962723.v127.

This project contains all de-identified variables assessed in this study.

Figshare: CurcumaDataDictionary. https://doi.org/10.6084/m9.figshare.1000062528.

This project contains the data dictionary for the underlying data, described above.

Reporting guidelines

Figshare: CONSORT checklist for ‘Efficacy of Curcuma longa in treatment of postprandial distress syndrome: An open-label randomized-controlled trial’. https://doi.org/10.6084/m9.figshare.9962723.v127.

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).

Acknowledgments

Authors appreciate all supports from Khon Kaen Hospital, patients, volunteers, first research assistant (Chutarat Tanchonnang) second research assistant (Manipa Jamsuwan) and all the staffs of all clinics involving in this study.

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Sawangroj N, Budkaew J and Chumworathayi B. Efficacy of Curcuma longa in treatment of postprandial distress syndrome: An open-label randomized-controlled trial [version 1; peer review: 2 approved]. F1000Research 2019, 8:1827 (https://doi.org/10.12688/f1000research.20662.1)
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ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested
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Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
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Reviewer Report 14 Jan 2021
Somsook Santibenchakul, Department of Obstetrics and Gynaecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand 
Approved
VIEWS 1
https://doi.org/10.5256/f1000research.22724.r74786
Very nice work!

Just one issue: I was curious about the following sentence.

The patients with 1500 mg Curcuma longa reported the highest rate of recurrence, 45.5%, followed by the patients with 750 mg Curcuma longa, 42.9% ... Continue reading
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Santibenchakul S. Reviewer Report For: Efficacy of Curcuma longa in treatment of postprandial distress syndrome: An open-label randomized-controlled trial [version 1; peer review: 2 approved]. F1000Research 2019, 8:1827 (https://doi.org/10.5256/f1000research.22724.r74786)
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https://f1000research.com/articles/8-1827/v1#referee-response-74786
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Reviewer Report 12 May 2020
Jie-ying Bai, Laboratory Animal Center, Academy of Military Medical Sciences, Beijing, China;  Institute of Molecular Medicine, Peking University, Beijing, China 
Approved
VIEWS 12
https://doi.org/10.5256/f1000research.22724.r62820
In this article, the effection of Curcuma Longa vs simeticone to postprandial distress was described. Two dose, 750mg/day and 1500mg/day, of C. longa were employed, the dose of simeticone was 240mg/day. Totally, the study design is appropriate, and enough literature ... Continue reading
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Bai Jy. Reviewer Report For: Efficacy of Curcuma longa in treatment of postprandial distress syndrome: An open-label randomized-controlled trial [version 1; peer review: 2 approved]. F1000Research 2019, 8:1827 (https://doi.org/10.5256/f1000research.22724.r62820)
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https://f1000research.com/articles/8-1827/v1#referee-response-62820
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
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  • Author Response 14 May 2020
    Bandit Chumworathayi, Office of Clinical Epidemiology, Faculty of Medicine, Khon Kaen University, Khon Kaen, 40002, Thailand
    14 May 2020
    Author Response
    Thank you very much for your comments. Further research with larger sample size will be conducted.
    Competing Interests: No competing interests were disclosed.
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  • Author Response 14 May 2020
    Bandit Chumworathayi, Office of Clinical Epidemiology, Faculty of Medicine, Khon Kaen University, Khon Kaen, 40002, Thailand
    14 May 2020
    Author Response
    Thank you very much for your comments. Further research with larger sample size will be conducted.
    Competing Interests: No competing interests were disclosed.
    Report a concern

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Approved
The paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations
A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved
Fundamental flaws in the paper seriously undermine the findings and conclusions

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  1. Jie-ying Bai, Academy of Military Medical Sciences, Beijing, China; Peking University, Beijing, China
  2. Somsook Santibenchakul, Chulalongkorn University, Bangkok, Thailand

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    Alongside their report, reviewers assign a status to the article:
    Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
    Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
    Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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