Therapeutic effect of herbal infusion on abnormal uterine bleeding: interventional non-randomized pilot study

Mejda Selmi; Latifa Lassoued; Badra Bannour; Chahra Chbili; Maha Ben Fredj; Ridha Charfeddin; Hedi Khairi

doi:10.12688/f1000research.122435.1

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Brief Report

Therapeutic effect of herbal infusion on abnormal uterine bleeding: interventional non-randomized pilot study

[version 1; peer review: 2 approved with reservations]

Mejda Selmi ¹, Latifa Lassoued², Badra Bannour², [...] Chahra Chbili¹, Maha Ben Fredj¹, Ridha Charfeddin³, Hedi Khairi²

Mejda Selmi ¹, Latifa Lassoued², [...] Badra Bannour², Chahra Chbili¹, Maha Ben Fredj¹, Ridha Charfeddin³, Hedi Khairi²

PUBLISHED 28 Sep 2022

Author details Author details

¹ Laboratoire de recherche de biophysique métabolique et pharmacologie appliquée (LR12ES02), Université de Sousse, Faculté of Médicine de Sousse,, sousse, sousse, 4000, Tunisia
² Hopital Farhat Hached, Service de Gynécologie Obstétrique,, Université de Sousse, Faculté of Médicine de Sousse, Sousse, Sousse, 4000, Tunisia
³ Laboratories UNIMED, Université de Sousse, Faculté of Médicine de Sousse,4000, Sousse, Tunisie, Sousse, sousse, 4060, Tunisia

Mejda Selmi
Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Resources, Software, Writing – Original Draft Preparation, Writing – Review & Editing

Latifa Lassoued
Roles: Conceptualization, Methodology, Project Administration, Resources, Supervision, Visualization

Badra Bannour
Roles: Conceptualization, Methodology, Project Administration, Resources, Supervision, Validation

Chahra Chbili
Roles: Writing – Original Draft Preparation, Writing – Review & Editing

Maha Ben Fredj
Roles: Project Administration, Resources

Ridha Charfeddin
Roles: Supervision, Visualization

Hedi Khairi
Roles: Data Curation, Project Administration, Resources, Supervision, Validation, Visualization

OPEN PEER REVIEW

REVIEWER STATUS

Abstract

Background: Abnormal uterine bleeding-menometrorrhagia due to uterine myomas is a health problem affecting women’s quality of life and it is considered a frequent cause of emergency visits for women. If first line medication fails to treat symptoms, surgical procedures, such as hysterectomy could be indicated, which could interfere with women's physical, social, emotional, and material quality of life. The purpose of this pilot study was to investigate the effect of a mixture of two medicinal plants, Mentha pulegium L and Artemisia abrotanum L, on 13 women with menometrorrhagia, who were candidates for hysterectomy.
Methods: The herbs were taken as a tea infusion by the oral route. A total of 5 g of the dried aerial parts of the mixture were added to 100 ml of boiling water and the tea infusion was taken three times a day starting from the onset of menstruation for three consecutive days, and it was repeated for three consecutive months.
Results: The study results showed that 10 out of the 13 women involved avoided the surgical procedures. The mean number of bleeding days declined from 11.50 (±3.77) at baseline to 7.60 (±2.11) (p=0.01). Participants confirmed a change in the bleeding intensity, regularization of their menstrual cycle, and improvement in their quality of life.
Conclusions: This preliminary study explores a new approach to treat abnormal uterine bleeding- menometrorrhagia, based on tea infusion consumption of a mixture of two medicinal herbs, and it paves the way for future studies.
Trial registration: This study is registered with ClinicalTrials.gov NCT05406960 (07/06/2022).

Keywords

Abnormal uterine bleeding, Menometrorrhagia, Tisane, Traditional Medicine, North Africa

Corresponding author: Mejda Selmi

Competing interests: No competing interests were disclosed.

Grant information: The author(s) declared that no grants were involved in supporting this work.

Copyright: © 2022 Selmi M 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: Selmi M, Lassoued L, Bannour B et al. Therapeutic effect of herbal infusion on abnormal uterine bleeding: interventional non-randomized pilot study [version 1; peer review: 2 approved with reservations]. F1000Research 2022, 11:1116 (https://doi.org/10.12688/f1000research.122435.1) First published: 28 Sep 2022, 11:1116 (https://doi.org/10.12688/f1000research.122435.1) Latest published: 28 Sep 2022, 11:1116 (https://doi.org/10.12688/f1000research.122435.1)

Introduction

Menometrorrhagia, caused by uterine myomas, is defined as excessive uterine bleeding resulting from a combination of two different conditions, namely menorrhagia or hypermenorrhea, which is blood loss of more than 80 ml per cycle or having a cycle longer than seven days or both,¹ and metrorrhagia, which is uterine bleeding at irregular intervals, particularly between the expected menstrual periods.² It is defined as abnormal uterine bleeding (AUB) and known as prolonged and excessive uterine bleeding in irregular intervals.³ AUB is a worldwide health problem affecting 20% of adolescent girls and more than 50% of women older than 45 years.⁴ Management of AUB includes hormonal and non-hormonal treatments.⁵ If first line medication fails to treat women with AUB, surgical treatment, such as hysterectomy could be indicated. This solution is often used without a clear treatment strategy.⁶^,⁷ The hypoestrogenic state of these therapies can lead to rapid bone demineralization and menopausal symptoms, such as vaginal dryness and hot flushes, having negative effects on women’s quality of life.¹^,⁸ Thus, because of these serious side effects, it seems logical to investigate other available sources. The therapeutic uses of Mentha pulegium L, known as Pennyroyal, and Artemisia abrotanum L, known as Southernwood, as traditional medicinal treatments for painful menstruation, pave the way for the possibility of new health-related uses.⁹^,¹⁰ A mixture of these two herbs is recommended as a strong emmenagogue.¹¹ Only few studies have explored the effect of Pennyroyal on menstruation,¹² however, to the best of the authors’ knowledge, no scientific data highlighting the therapeutic effect of a mixture of Southernwood and Pennyroyal tea infusion on menometrorrhagia in women are available. It is a non-randomized, controlled trial to investigate the effect of a mixture of Pennyroyal and Southernwood tea infusion consumption on women with menometrorrhagia who are candidates for hysterectomy, in avoiding the surgical procedure, reducing the number of days of menstrual bleeding, and improving women’s quality of life.

Methods

Study design

This is an interventional, non-randomized, controlled, single center pilot study. It was conducted in the department of Gynecology and obstetrics at Farhat Hached University Hospital, Sousse, Tunisia.

Ethical approval

Retrospective registration was acquired (Clinicaltrials.gov NCT05406960, 07/06/2022) because the study was taken to be low risk; however, the study was approved by the Human Research Ethics Committee at the Faculty of Medicine of Sousse, Tunisia and it was registered under the number (Ref: CEFMS 27/2019, 29/08/2019).

After being informed about the research protocol, each participant signed a written informed consent form prior to the initiation of the study procedures. All clinical investigation procedures were conducted according to the principles expressed in the declaration of Helsinki guidelines. This study is reported in line with the Consolidated Standards of Reporting Trials (CONSORT) guidelines.²⁶

Recruitment procedures

Participants meeting the inclusion criteria were informed about the research protocol by their gynecologists. They underwent complete physical examination following their acceptance to be enrolled in the study (Figure 1). They were interviewed to complete a quality-of-life questionnaire to determine the impact of the illness on their daily life and to record all details of their gynecological and menstrual histories. All participants were asked to report all details with regard to the effect of the treatment on menstrual cycle, menstruation duration, and bleeding intensity measured using pictorial blood assessment chart (PBAC) during three consecutive menstrual cycles treatments and the three-month follow-up period. They were also asked to report any change in the bleeding pattern and any adverse effects. Participants were recruited between 2019 and 2021. The study was interrupted by the COVID-19 pandemic.

Figure 1. Study design.

Dosage and administration

The herbal tea infusion was taken by the patients at home after providing them with a detailed oral and written explanation. Assistance was provided by phone or via visits if any participant had questions regarding the treatment.

Participants took 5 g of mixed herbs powder added to 100 ml of boiling water and infused for 10 to 15 min, in accordance with the traditional uses. Herbal tea infusion was taken through the oral route before food, three times a day at 4-hour intervals after the first administration for three consecutive days, starting from the first day of the onset of menstruation.

Selection criteria

Inclusion criteria

The study included women with menometrorrhagia who were candidates for hysterectomy, aged between 30 and 55 years, not pregnant and not lactating and having a menstrual period for more than seven days with uterine bleeding at irregular intervals.

Exclusion criteria

The exclusion criteria included women suffering from abnormal uterine bleeding with menometrorrhagia but who were not candidates for hysterectomy, those suffering from gastrointestinal problems or any chronic diseases requiring long-term treatment, participants with increasing menstrual bleeding during the treatment requiring emergency surgical procedures, and those refusing the instructions given or who were participating in other clinical trials.

Therapeutic intervention

Method of herbs powder preparation

Pennyroyal and Southernwood were collected in July 2019 and 2020 from two different areas in the region of Sousse, Tunisia. The aerial parts (leaves and stems) of each plant were dried at room temperature in the shade; then, they were powdered in a rotating knife grinder. The powder was packaged in sachets, each containing 5 g, 2.5 g Pennyroyal and 2.5 g Southernwood, mixed according to the traditional uses of the herbs.¹³

Treatment duration and follow-up

The treatment duration was up to three consecutive menstrual cycles and the total duration of the participants’ involvement in the study ranged between six and nine months.

Participants were followed via phone interview during and after the treatment. They were followed up for six months. Monitoring for efficacy and safety was performed every month starting from the treatment initiation until the treatment completion.

Restriction parameters

During the treatment period, participants were restricted to use just oral iron therapy, opioid analgesics, or acetaminophen. They were strictly asked to stop using any hormonal therapy, other herbal treatments, tranexamic acid, or any other treatment in relation to their disease.

Safety assessments

All participants were asked to record any possible adverse effects occurring during the study period. The effect of mixed herbal tea infusion was evaluated in the first four days. If no improvement in bleeding intensity was noted, participants were asked to stop taking the infusion and to return to their gynecologist to undergo a surgical procedure.

Outcome measurements

Clinical criteria

Participants were evaluated based on the bleeding intensity using PBAC scores, the duration of menstrual bleeding in days, regularization of menstrual cycle, and the improvement in their quality of life.

Biological criteria

Complete blood count (CBC) was performed before the start of the trial and after the third cycle of taking the infusion to control anemia. The safety and hemostatic effects of the treatment were evaluated by the analysis of prothrombin time (PT), prothrombin ratio (INR), and fibrinogen (FIB) to detect bleeding disorders, and the analysis of serum creatinine to detect urinary toxicity. Laboratory tests were conducted in the department of hematology at Farhat Hached University Hospital, Sousse, Tunisia. A 4ml blood sample was collected from each participant during the first visit before the start of the trial and after the last infusion consumption (day 91) in the same laboratory. A heparinized catheter was inserted into the antecubital vein to collect venous blood samples in three different tubes: an EDTA-coated tube, used for the CBC analysis parameters that were assessed following the combining laser diffraction flow cytometry and spectrophotometric technique,¹⁴ a sodium citrate 3.2% tube used to collect blood samples for the hemostasis analysis FIB, PT, and INR that were assessed by the coagulometric method,¹⁵ and finally, a lithium heparin tube used for creatinine analysis that was determined by the Jaffe’s reaction.¹⁶

Sample size and statistical analysis

Sample size

The sample size was assessed according to the following formula Kang et al.¹⁷ N = (Zα/2) 2 s2/d2, where “s” is the standard deviation (SD = 2300.000), and “d” is the accuracy of estimate or how close it is to the true mean (d = 900.40). Given the pioneering nature of this study, the above two data were collected from a previous work including women suffering from abnormal uterine bleeding-menometrorrhagia, conducted by Qaraaty et al.,¹⁸ where the mean number of bleeding days was 10.6 ± 2.7 and 8.2 ± 1.9, respectively, before and after the consumption of myrtle syrup. “Zα/2” is the normal deviate for a two-tailed alternative hypothesis at a level of significance (Zα/2 equal to 1.44 at an error rate of 0.20%). The assessed sample size as N = (1.44)² 2,300.00 / (900.40)² gives a sample of 14 women suffering from abnormal uterine bleeding-menometrorrhagia. Assumption of 40% for non-attendance during the second or the third session gives a revised sample of 24 women suffering from abnormal uterine bleeding-menometrorrhagia (24 = 14/ (1.0−0.40)).

Statistical analysis

Data entry and analysis were performed using SPSS software version 10 to test for normality, distribution of the studied variables was examined in reference to Shaprio-Wilk test. The significance level was fixed at p<0.05. Descriptive statistics were used to examine the characteristics of the studied population (means, standard deviation). Comparison of the biological parameters and scores of PBAC between baseline and the end of treatment was performed using paired t-test when variables were normally distributed and Wilcoxon signed ranks test, as a non-parametric test, when variables were not normally distributed.

Results

Characteristics of the study population

A total of 24 women with abnormal uterine bleeding-menometrorrhagia were involved in this study. During the course of the study, the data of 11 participants were excluded from the final statistical analysis. Indeed, the study was interrupted by the Covid-19 pandemic during which five participants withdrew from the trial because they took other different species of plants in order to prevent or treat Covid-19. Among the 11 excluded participants, three underwent surgeries for other reasons and the remaining three withdrew for personal reasons. Therefore, 13 participants completed the study (Figure 1).

Baseline characteristics, responses, and side effects of herbal tea infusion consumption on 13 Tunisian women with menometrorrhagia that are candidates for hysterectomy are shown in (Table 1). Participants’ ages ranged between 32 and 53 years. Among them, five were single. A total of nine participants were suffering from clot excretion. The infusion of mixed Pennyroyal and Southernwood extracts was effective in 10 participants; normal and less heavy bleeding flow and disappearance of blood clotting were noted. However, positive response means a decrease in bleeding intensity and duration, and recovery of the menstrual cycle regularity. Negative response corresponds to negative feedback reflecting patient unsatisfaction related to the absence of improvement in bleeding intensity and/or duration, and/or persistence of menstrual cycle irregularity. Negative feedback was noted in three participants after being treated for just two menstrual cycles. Persistence and an increase in bleeding was observed during the study, and they underwent hysterectomy. Strong uterine contraction, as a side effect, concomitant with bleeding cessation after three days of tea infusion consumption was reported by four participants. A total of two participants reported having a headache after using the herbal tea infusion in the first day. No other adverse effects or allergic reactions were observed.

Table 1. Data of Baseline Characteristics and response of infusion herbal treatment.

Participants	Age (years)	Marital status	Number of abortions	Using contraceptive	clots	Endometrial finding	Episode of flooding	*Response to treatment	Side effect
1	42	Single	0	no	Yes	Normal	No	Positive	No
2	43	Married	2	yes	No	Fibroma	Yes	Negative	Headache
3	48	Single	0	no	Yes	Fibroma	No	Positive	No
4	50	Married	2	yes	Yes	Fibroma	No	Positive	Strong contraction
5	32	Single	0	no	Yes	Fibroma	No	Positive	Strong contraction
6	53	Married	1	no	Yes	Fibroma	No	Positive	No
7	47	Single	0	no	No	Fibroma	No	Positive	Strong contraction
8	47	Married	1	yes	Yes	Fibroma	No	Positive	Headache
9	43	Single	0	no	Yes	Normal	No	Positive	No
10	51	Married	0	yes	Yes	Fibroma	No	Positive	No
11	51	Married	2	yes	Yes	Fibroma	Yes	Negative	No
12	47	Married	0	no	Yes	Fibroma	No	Positive	Strong contraction
13	49	Married	3	yes	No	Fibroma	Yes	Negative	No

* Responses to the treatment of thirteen Tunisian women with menometrorrhagia candidate for hysterectomies treated with herbal infusion of 5 g mixed southernwood and pennyroyal plants 3 times a day, every 4h after the first administration by oral rout started from the onset of menstruation during 3.

Effect of herbal tea infusion consumption of mixed Pennyroyal and Southernwood extracts on menstrual cycle and the duration and intensity of bleeding

Results of the mean and standard deviation of the number of menstrual bleeding days before and after herbal treatment revealed a significant decline from 11.50 (±3.17) at baseline to 7.60 (±2.11) (p=0.01) to become close to the normal level (Table 2).

Table 2. The effect of herbal tea treatment in clinical and laboratory features at baseline and post treatment.

	Parameter	N	Baseline (±SD)	After herbal treatment (91 days) (±SD)	P value
Laboratory features	RBC	10	4.18 (0.52)	4,25 (0.58)	0.576
	Hbg g/dl	10	9.74 (3,17)	11.59 (1.60)	0.169
	Hct %	10	32.490 (7.09)	35.530 (5.53)	0.415
	MCV fl	10	76.45 (10.73)	83.63 (9.61)	0.07
	MCH pg	10	30.40 (4.00)	32.56 (3.87)	0.515
	PLT *10³/L	10	277.70 (92.35)	242.50 (73.44)	0.139
	Fibrinogen g/L	10	3.64 (1.67)	3.4 (0.41)	0.344
	*Prothrombin (PT) %	10	88.27(10.67)	87 (7.77)	0.593
	**Prothrombin ratio (INR)	10	1.08 (0.11)	1.1 (0.11)	0.715
Clinical features	Menstrual period duration (days)	10	11.50 (3.77)	7.60 (2.11)	*0.01*
Clinical features	PBAC Menstrual scores	10	219.30 (57.03)	79.70 (31.4)	*0.05*

* Data are expressed as median value.

** Wilcoxon Signed Ranks Test, P ≤ 0.05.

Results of the mean PBAC scores of the intensity of bleeding revealed a significant decrease from 219.30 (±57.03) at baseline to 79.60 (±31.09) (P=0.05) (Table 2).

All the participants reported regularization in the menstrual cycle, and improvement in their quality of life.

At the end of the study, herbal tea infusion consumption was found to help 10 participants out of the 13 women avoid the surgical procedure.

Effect of herbal tea infusion of mixed Pennyroyal and Southernwood extracts on blood chemical parameters

Results of the hematologic laboratory evaluation to control anemia before and after herbal treatment are detailed in (Table 2). For each parameter, the mean and the standard deviation were defined. An increase in the mean hemoglobin value (Hgb), from 9.740 (±3.17) g/dl in baseline to 11.59 (±1.6) g/dl after 90 days of treatment was noted. However, the parameters did not achieve a statistically significant level.

No significant differences in PT and INR were observed before and after herbal treatment. They were at the normal level.

Tolerability of mixed Pennyroyal and Southernwood

The serum creatinine levels at baseline and after three months were in the normal range but the difference was not statistically significant (p>0.05) (Table 3). The tea infusion consumed was well-tolerated and participants did not report any serious adverse events.

Table 3. Change in serum creatinine parameter at baseline and post treatment.

Plasma parameter	N	Baseline (±SD) μmol/L	Day 91 (±SD) μmol/L	p-value	Reference values
Creatinine	10	65.56 (11.17)	67.36 (5.45)	0.33	40–120 μmol/L

Discussion

In the present preliminary study, the effect of mixed herbal Pennyroyal and Southernwood tea infusion consumption in a small sample size of women with abnormal uterine bleeding-menometrorrhagia that are candidates for hysterectomy was investigated. Used according to the Tunisian traditional remedies, these two herbs are considered as menstrual regulators and are known to stimulate uterus muscles during painful or strong menstruation.¹¹ Our results revealed that mixed herbal Pennyroyal and Southernwood tea infusion consumption was effective in regulating menstrual problems in 10 women. This result is consistent with that of Firdose et al.¹² showing that Pennyroyal and other species are effective in reducing the number of days of menstrual flow and in normalizing the cycle in patients with infrequent periods of more than 35 days or with scanty flow, both in amount and duration.¹² This positive correlation of the tea infusion of both herbs may be due to their richness in polyphenols and flavonoids, as found in our results.²⁵ Several studies have demonstrated that polyphenols and flavonoids have an effect on hormone regulation in premenopausal women.¹⁹ A study conducted by Taamalli et al.²⁰ revealed that gallocatechin is as a major compound in Pennyroyal from the north-west of Tunisia. Gallocatechin, as a phenolic compound, is a flavan-3-ol.²⁰ According to a study performed by Ko et al.,²¹ this compound has an osteoblastic activity. It is responsible for synthesizing dense cross-linked collagen and proteins.²¹ This activity may be related to the side effect mentioned in the results. This ascertainment is supported by the findings of Alekel et al.,²² showing that bone mineral content increased by 10.1% in 40 postmenopausal women receiving Isoflavone extract.²² In their study, Baiceanu et al.²³ showed that sinapic acid is a major active polyphenols compound in Southernwood.²³ The most interesting effects of sinapic acid are its capacity to influence steroid hormone metabolism and its anti-inflammatory properties.²⁴ The results of this study were similar to the results of Qaraaty et al.¹⁸ in the management of abnormal uterine bleeding-menometrorrhagia by myrtle fruit syrup.

Study limitations

This pilot study presents several limitations. First, it seems that there is a lack of information about the chemical composition of the aqueous extract of these two plants. Therefore, this study needs to be completed to identify the major active components of the two plants. Secondly, our study involved a small sample size of participants due to the inclusion criteria and the limited period of time of the study. Thirdly, investigation of the effect of herbal tea infusion would be strengthened if a placebo group was involved.

Conclusion

Through this pilot study, we tried to explore a new approach to treat menometrorrhagia in women candidates for hysterectomy, based on tea infusion consumption of a mixture of Pennyroyal and Southernwood extracts. The study demonstrated that consumption of this tea infusion during three consecutive menstrual cycles helped 10 out of the 13 participants avoid the surgical procedure and improve their quality of life with no major side effects. However, larger clinical trials involving placebo groups, variable doses, and extended treatment periods are required to investigate the effect of Pennyroyal and Southernwood herbal tea infusion on abnormal uterine bleeding.

Data availability

Underling data

Zenodo: ‘Therapeutic effect of herbal infusion on Abnormal Uterine Bleeding Extended data’, https://doi.org/10.5281/zenodo.6821462.²⁵

This project contains the following underlying data:

• data update version.xlsx (study subjects results (baseline and after three months))
• method of herbs powder preparation.pdf (the method used by subjects to prepare the herbal tea infusion)
• Pictorial Blood Assessment Chart.pdf (method used to assess menstrual blood lose in clinical trials)
• polyphenols and flavnoids content data.xlsx (data of total polyphenols and flavonoids content in the aerial parts (leaves and stems) of Tunisian Pennyroyal and Southernwood extracted by methanol solvent))
• Study protocol.pdf (outlining the study design and describing the objectives and methodology)
• Total polyphenol and flavonoïds compounds contents in the aerial parts of Tunisian Mentha Pulegium.pdf (the total polyphenol and flavonoids compounds contents in the aerial parts of Mentha pulegium (pennyroyal) and artemisia abrotanum (southernwood))
• trendstatement_trend_checklist (1).pdf (Guide standardized reporting non randomized controlled trials)

Reporting guidelines

Zenodo: CONSORT checklist and flow chart for ‘Therapeutic effect of herbal infusion on Abnormal Uterine Bleeding: consort flowchart and checklist’: https://doi.org/10.5281/zenodo.6881765.²⁶

Data are available under the terms of the Creative Commons Zero “No rights reserved” data waiver (CC0 1.0 Public domain dedication).

Acknowledgments

The authors would like to express their sincere gratitude to Mr Samir Boukattaya for proof reading this work.

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VERSION 1 PUBLISHED 28 Sep 2022

Author details Author details

¹ Laboratoire de recherche de biophysique métabolique et pharmacologie appliquée (LR12ES02), Université de Sousse, Faculté of Médicine de Sousse,, sousse, sousse, 4000, Tunisia
² Hopital Farhat Hached, Service de Gynécologie Obstétrique,, Université de Sousse, Faculté of Médicine de Sousse, Sousse, Sousse, 4000, Tunisia
³ Laboratories UNIMED, Université de Sousse, Faculté of Médicine de Sousse,4000, Sousse, Tunisie, Sousse, sousse, 4060, Tunisia

Mejda Selmi
Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Resources, Software, Writing – Original Draft Preparation, Writing – Review & Editing

Latifa Lassoued
Roles: Conceptualization, Methodology, Project Administration, Resources, Supervision, Visualization

Badra Bannour
Roles: Conceptualization, Methodology, Project Administration, Resources, Supervision, Validation

Chahra Chbili
Roles: Writing – Original Draft Preparation, Writing – Review & Editing

Maha Ben Fredj
Roles: Project Administration, Resources

Ridha Charfeddin
Roles: Supervision, Visualization

Hedi Khairi
Roles: Data Curation, Project Administration, Resources, Supervision, Validation, Visualization

Competing interests

No competing interests were disclosed.

Grant information

The author(s) declared that no grants were involved in supporting this work.

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Published: 28 Sep 2022, 11:1116

https://doi.org/10.12688/f1000research.122435.1

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© 2022 Selmi M 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.

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Selmi M, Lassoued L, Bannour B et al. Therapeutic effect of herbal infusion on abnormal uterine bleeding: interventional non-randomized pilot study [version 1; peer review: 2 approved with reservations]. F1000Research 2022, 11:1116 (https://doi.org/10.12688/f1000research.122435.1)

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Open Peer Review

Version 1

VERSION 1

PUBLISHED 28 Sep 2022

Views

6

Reviewer Report 25 Sep 2023

Malarvili Selvaraja, UCSI University, Cheras, Malaysia

Approved with Reservations

https://doi.org/10.5256/f1000research.134421.r198664

The study overall is good. Here are some limitations that authors should take note of:

The problem statement is not well explained. Maybe the statistics for the prevalence or incidence of this condition should be included

The study overall is good. Here are some limitations that authors should take note of:

The problem statement is not well explained. Maybe the statistics for the prevalence or incidence of this condition should be included specifically in Tunisia.
The rationale why this plant has been selected? How widely it has been used? Where is the plant widely available? Are any preliminary studies conducted for the plants in vitro or in vivo models? What is the effect on menometrorrhagia? Is any toxicity information available?
Not much information is available on the Figure 1. More information is required here in terms of patients' conditions if they have any other complications. These will be points to be included in the selection criteria.
How the bleeding days were calculated and differentiated from one to another individual? An individual who is active in physical activities and one who is least active will have different bleeding patterns and times, how this be controlled/assessed?
What kind of improvement was observed in terms of quality of life?
A sample size of 13 is too small to conclude on the effectiveness of the mixed plants.
As mentioned in the conclusion it is important to include a placebo group in non-randomized control trials.
The discussion is very brief.
Most references are more than 5 years old. Try to include more on the latest publications to cite.
Proofreading required.
Grammatical errors to be corrected.

Is the work clearly and accurately presented and does it cite the current literature?

Partly
Is the study design appropriate and is the work technically sound?

Partly
Are sufficient details of methods and analysis provided to allow replication by others?

No
If applicable, is the statistical analysis and its interpretation appropriate?

Partly
Are all the source data underlying the results available to ensure full reproducibility?

Partly
Are the conclusions drawn adequately supported by the results?

Partly

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Immunopharmacology

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

CITE

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Views

12

Reviewer Report 15 Aug 2023

Abhishek Tiwari, IFTM University, Lodhipur-Rajpur, India

Approved with Reservations

https://doi.org/10.5256/f1000research.134421.r193046

The authors have reported the therapeutic effect of herbal infusion on abnormal uterine bleeding: interventional non-randomized pilot study.
The text in Figure 1 is not clear The research is at very preliminary stage.

Provide more comprehensive ... Continue reading

The authors have reported the therapeutic effect of herbal infusion on abnormal uterine bleeding: interventional non-randomized pilot study.
The text in Figure 1 is not clear The research is at very preliminary stage.

Provide more comprehensive details about the selection criteria for participants, including any specific characteristics or conditions they had.

Describe the rationale behind choosing Mentha pulegium L and Artemisia abrotanum L for the herbal mixture, considering their potential benefits and historical use.

Elaborate on any potential safety considerations related to consuming the herbal infusion, including any known contraindications or side effects.

Clearly state how the tea infusion was prepared, ensuring that all steps are well-documented for reproducibility.

Specify the process for measuring bleeding days and how the mean number of bleeding days was calculated.

Provide more context when discussing the results, explaining the clinical significance of the observed reductions in bleeding days and improvements in quality of life. Why are these changes important for the participants' overall well-being?

Discuss potential directions for future research based on these findings. Are there plans for larger trials, mechanisms of action exploration, or investigating long-term effects?

Alongside the ClinicalTrials.gov registration identifier, provide additional information such as the principal investigator.

Proofread the manuscript carefully to correct grammatical mistakes and ensure the text is clear and coherent.

Reference related studies or prior research that support the rationale for using the specific herbal mixture and the potential effects observed.

Sample size chosen is very small. Among 13 women, 6 reported side effects, few of them are serious.

Grammatical mistakes are noticed, kindly check.

No information regarding phytoconstituent as well as characterization of herbal infusion is missing, which is absolutely required. Other iron supplement has been allowed, justify it.

All in all, the manuscript needs extensive modification.

Is the work clearly and accurately presented and does it cite the current literature?

Partly
Is the study design appropriate and is the work technically sound?

Partly
Are sufficient details of methods and analysis provided to allow replication by others?

Yes
If applicable, is the statistical analysis and its interpretation appropriate?

Yes
Are all the source data underlying the results available to ensure full reproducibility?

No
Are the conclusions drawn adequately supported by the results?

Partly

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Cancer

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

CITE

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Version 1

VERSION 1 PUBLISHED 28 Sep 2022

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Version 1 28 Sep 22	read	read

Abhishek Tiwari, IFTM University, Lodhipur-Rajpur, India
Malarvili Selvaraja, UCSI University, Cheras, Malaysia

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Reviewer Report

6 Views

25 Sep 2023 | for Version 1

Malarvili Selvaraja, UCSI University, Cheras, Malaysia

6 Views Cite this report Responses(0)

Approved With Reservations

The study overall is good. Here are some limitations that authors should take note of:

The problem statement is not well explained. Maybe the statistics for the prevalence or incidence of this condition should be included specifically in Tunisia.
The rationale why this plant has been selected? How widely it has been used? Where is the plant widely available? Are any preliminary studies conducted for the plants in vitro or in vivo models? What is the effect on menometrorrhagia? Is any toxicity information available?
Not much information is available on the Figure 1. More information is required here in terms of patients' conditions if they have any other complications. These will be points to be included in the selection criteria.
How the bleeding days were calculated and differentiated from one to another individual? An individual who is active in physical activities and one who is least active will have different bleeding patterns and times, how this be controlled/assessed?
What kind of improvement was observed in terms of quality of life?
A sample size of 13 is too small to conclude on the effectiveness of the mixed plants.
As mentioned in the conclusion it is important to include a placebo group in non-randomized control trials.
The discussion is very brief.
Most references are more than 5 years old. Try to include more on the latest publications to cite.
Proofreading required.
Grammatical errors to be corrected.

Is the work clearly and accurately presented and does it cite the current literature?

Partly
Is the study design appropriate and is the work technically sound?

Partly
Are sufficient details of methods and analysis provided to allow replication by others?

No
If applicable, is the statistical analysis and its interpretation appropriate?

Partly
Are all the source data underlying the results available to ensure full reproducibility?

Partly
Are the conclusions drawn adequately supported by the results?

Partly

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Immunopharmacology

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

Respond to this report

Responses (0)

Back to all reports

Reviewer Report

12 Views

15 Aug 2023 | for Version 1

Abhishek Tiwari, IFTM University, Lodhipur-Rajpur, India

12 Views Cite this report Responses(0)

Approved With Reservations

The authors have reported the therapeutic effect of herbal infusion on abnormal uterine bleeding: interventional non-randomized pilot study.
The text in Figure 1 is not clear The research is at very preliminary stage.

Provide more comprehensive details about the selection criteria for participants, including any specific characteristics or conditions they had.

Describe the rationale behind choosing Mentha pulegium L and Artemisia abrotanum L for the herbal mixture, considering their potential benefits and historical use.

Elaborate on any potential safety considerations related to consuming the herbal infusion, including any known contraindications or side effects.

Clearly state how the tea infusion was prepared, ensuring that all steps are well-documented for reproducibility.

Specify the process for measuring bleeding days and how the mean number of bleeding days was calculated.

Provide more context when discussing the results, explaining the clinical significance of the observed reductions in bleeding days and improvements in quality of life. Why are these changes important for the participants' overall well-being?

Discuss potential directions for future research based on these findings. Are there plans for larger trials, mechanisms of action exploration, or investigating long-term effects?

Alongside the ClinicalTrials.gov registration identifier, provide additional information such as the principal investigator.

Proofread the manuscript carefully to correct grammatical mistakes and ensure the text is clear and coherent.

Reference related studies or prior research that support the rationale for using the specific herbal mixture and the potential effects observed.

Sample size chosen is very small. Among 13 women, 6 reported side effects, few of them are serious.

Grammatical mistakes are noticed, kindly check.

No information regarding phytoconstituent as well as characterization of herbal infusion is missing, which is absolutely required. Other iron supplement has been allowed, justify it.

All in all, the manuscript needs extensive modification.

Is the work clearly and accurately presented and does it cite the current literature?

Partly
Is the study design appropriate and is the work technically sound?

Partly
Are sufficient details of methods and analysis provided to allow replication by others?

Yes
If applicable, is the statistical analysis and its interpretation appropriate?

Yes
Are all the source data underlying the results available to ensure full reproducibility?

No
Are the conclusions drawn adequately supported by the results?

Partly

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Cancer

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

Respond to this report

Responses (0)

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[25] 25. Selmi M, Lassoued L, Bannour B, et al.: Therapeutic effect of herbal infusion on Abnormal Uterine Bleeding Extended data [Data set]. Zenodo. 2022. Publisher Full Text

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Therapeutic effect of herbal infusion on abnormal uterine bleeding: interventional non-randomized pilot study

Abstract

Keywords

Introduction

Methods

Study design

Ethical approval

Recruitment procedures

Figure 1. Study design.

Dosage and administration

Selection criteria

Therapeutic intervention

Outcome measurements

Sample size and statistical analysis

Results

Characteristics of the study population

Table 1. Data of Baseline Characteristics and response of infusion herbal treatment.

Effect of herbal tea infusion consumption of mixed Pennyroyal and Southernwood extracts on menstrual cycle and the duration and intensity of bleeding

Table 2. The effect of herbal tea treatment in clinical and laboratory features at baseline and post treatment.

Effect of herbal tea infusion of mixed Pennyroyal and Southernwood extracts on blood chemical parameters

Tolerability of mixed Pennyroyal and Southernwood

Table 3. Change in serum creatinine parameter at baseline and post treatment.

Discussion

Study limitations

Conclusion

Data availability

Underling data

Reporting guidelines

Acknowledgments

References

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