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Competing interests
The authors declare that they have no competing interests.
PMC10082980
References
PMC10082980
Purpose
PPH, hemorrhoids, prolapse, anal pain
HEMORRHOIDS, PROLAPSE, COMPLICATIONS, HAND SWELLING
The purpose of this study was to explore the effect of electroacupuncture (EA) at Baliao point on short-term complications, such as anal pain and swelling, after procedure for prolapse and hemorrhoids (PPH) in patients with mixed hemorrhoids.
PMC10115677
Methods
A total of 124 eligible patients undergoing PPH surgery were included in this study and randomly divided into a control group (
PMC10115677
Results
tenesmus, urinary retention
The visual analogue scale (VAS) scores of EA group at 8, 24, 48, and 72 h after operation were significantly lower than those of control group. The anal distension scores at 8, 48, and 72 h after operation were also significantly lower than those of control group. The number of postoperative analgesic drug administrati...
PMC10115677
Conclusion
swelling, hemorrhoids, prolapse, anal pain, urinary retention
HEMORRHOIDS, PROLAPSE
EA treatment at the Baliao point can alleviate short-term anal pain and anal swelling after the procedure for prolapse and hemorrhoids, reduce the incidence of urinary retention, and decrease the use of postoperative analgesic drugs.
PMC10115677
Trial registration
This study was approved and registered by the Chinese Clinical Trial Center, Registration number: ChiCTR2100043519, Registration time: February 21, 2021 (
PMC10115677
Keywords
PMC10115677
Introduction
PPH, hemorrhoids, defecation disorders
MIXED HEMORRHOIDS, DISEASE, DISEASES, HEMORRHOIDS
Mixed hemorrhoids are a common disease that afflicts people all over the world, and PPH is a common operation for the treatment of mixed hemorrhoids [The Baliao point (BL31–BL34) is a traditional Chinese acupuncture point with a long history. They are divided into four pairs, namely Shang liao (BL31), Ci liao (BL32), Z...
PMC10115677
Patients and methods
PPH
This study was an investigator blinded randomized pilot study. Since the lack of objective, prospective studies on the effects of EA at Baliao point on patients after PPH, the actual sample size calculations could not be performed. And this study was conducted in accordance with the ethical, moral, and scientific princ...
PMC10115677
Participants
hemorrhoids
HEMORRHOIDS
A total of 261 patients with mixed hemorrhoids who underwent PPH surgery in Shanghai Fifth People’s Hospital from March 2021 to March 2022 were identified with 128 patients were excluded. The most common reason for exclusion was meeting our exclusion criteria. Those who met the exclusion criteria were 121 (Table Reason...
PMC10115677
Inclusion criteria
hemorrhoids
INTERNAL HEMORRHOIDS, HEMORRHOIDS
(1) patients with severe internal hemorrhoids or mixed hemorrhoids with surgical indications; (2) age between 18 and 70 years old; (3) no history of anorectal surgery; (4) patients gave informed consent to participate in this study.
PMC10115677
Exclusion criteria
mental disorders, perianal infection, hernia, diabetes
PROSTATIC HYPERPLASIA, PERIANAL INFECTION, DISEASES, DIABETES
(1) patients with mental disorders; (2) those who have poor compliance and do not accept this clinical trial; (3) pregnant women, menstrual, and lactating women; (4) combined with perianal infection and other benign anorectal diseases; (5) patients with prostatic hyperplasia, diabetes, and other underlying diseases tha...
PMC10115677
Randomization
Patients were randomized to receive either the control group or the EA group using the sealed envelope method by means of a one-to-one treatment allocation. The randomization was carried out by a clinician not involved in this study. Treatment assignments were generated using a randomized numerical table method. Envelo...
PMC10115677
Procedure
PPH, hemorrhoids, bleeding, pain
STERILE, BLEEDING, HEMORRHOIDS
Preoperative preparation: All patients were given glycerol enema 2 h before surgery to empty the stool.Surgical procedure of PPH: Spinal anesthesia was used for anesthesia. After successful anesthesia, the patient took the jackknife position. The surgical field was routinely disinfected with iodophor, and sterile towel...
PMC10115677
Outcomes
bleeding, seizures, Postoperative defecation, tenesmus, Postoperative pain, diarrhea, postoperative anal distension, pain, constipation, infection, impaired urination, anal pain, Urination, Postoperative anal distension
ADVERSE REACTIONS, BLEEDING, ADVERSE EVENT, INFECTION, URINATION DISORDER
Main outcome measures: The primary endpoint was the VAS scores and the anal distension scores at 8, 24, 48, and 72 h after operation. Secondary endpoints were urination, time to first defecation after surgery, feeling of tenesmus, use of postoperative analgesic drugs, and other related indexes which were observed after...
PMC10115677
Statistical analysis
Data were analyzed using GraphPad 9.0 software. Measurement data were expressed as mean ± standard deviation (
PMC10115677
Results
PMC10115677
Subject demographics
hemorrhoids
HEMORRHOIDS
From March 2021 to March 2022, a total of 124 patients with hemorrhoids who met the inclusion criteria and underwent PPH surgery were collected in Shanghai Fifth People’s Hospital. The patients were randomly assigned to the control group (Characteristics of the patients
PMC10115677
Primary outcomes
urinary retention, Defecation, urination disorder, pain
URINATION DISORDER
The VAS scores of the patients in the EA group at 8, 24, 48, and 72 h after the operation was significantly lower than that of the control group (Fig. VAS pain score within 72 h after operation. Note: *Score of anal distension within 72 h after operation. Note: *Analgesic drug use after operationThe urination score 24 ...
PMC10115677
Postoperative adverse events
bleeding, diarrhea, Postoperative adverse, tenesmus, hematochezia, postoperative bleeding, constipation, infection, anal pain
BLEEDING, HEMATOCHEZIA, POSTOPERATIVE BLEEDING, INFECTION, POSTOPERATIVE WOUND INFECTION
One case of postoperative bleeding, one case of postoperative surgical incision infection and one case of reoperation due to bleeding occurred in the control group, and one case of surgical incision infection occurred in the EA group. There was no statistically significant difference between the two groups in postopera...
PMC10115677
Discussion
bleeding, diarrhea, tenesmus, hemorrhoids, postoperative urinary retention, Acupuncture, postoperative urination disorder, ’ anal pain, pain, postoperative infection, postoperative bleeding, chronic anal pain, constipation, PPH, urinary retention
BLEEDING, HEMORRHOIDS, POSTOPERATIVE COMPLICATION, POSTOPERATIVE BLEEDING, POSTOPERATIVE INFECTION, SURGICAL COMPLICATIONS, SECONDARY, COMPLICATIONS
PPH surgery is a good choice for the treatment of hemorrhoids, which has the advantages of short operation time, low incidence of surgical complications, rapid postoperative recovery, and reliable surgical effect [Acupuncture and moxibustion is a kind of treatment in traditional Chinese medicine, which has been increas...
PMC10115677
Author contribution
Yuankun Cai and Lifeng Gong designed the study. Jiamen Shen and Xiecheng Zhou shared in the data analysis, interpretation, and writing and drafting of the manuscript. Huipeng Wang and Tao Ye contributed to data collation. Xin Wang and Wenjie Chen analyzed and interpreted the data. Jiaying Zhao contributed to the interp...
PMC10115677
Funding
This study was supported by grants from the Special Project of integrated traditional Chinese and Western medicine of Shanghai (No. ZHYY-ZXYJHZX-202007).
PMC10115677
Data availability
The data used to support the findings of this study are available from the corresponding author upon request. The data are not publicly available due to privacy or ethical restrictions.
PMC10115677
Declarations
PMC10115677
Conflict of interest
The authors declare no competing interests.
PMC10115677
References
PMC10115677
Background
Innovative mobile health (mHealth) interventions can improve maternal knowledge, thereby supporting national efforts to reduce preventable maternal and child mortality in South Africa. Studies have documented a potential role for mobile video content to support perinatal health messaging, enhance maternal satisfaction,...
PMC10612008
Objective
We aimed to measure the effect of SAS videos on maternal knowledge and user satisfaction for mothers enrolled in antenatal care programs at 2 public health facilities in the Tshwane District of South Africa.
PMC10612008
Methods
We used a randomized controlled trial with a nested evaluation of user satisfaction. Participants were randomized 1:1 into Standard-of-Care (SOC) Control, and SAS Intervention groups. The intervention videos were delivered through WhatsApp, and 1 month later, participants responded to telephone surveys assessing their ...
PMC10612008
Results
SECONDARY
We surveyed 204 participants. Of them, 49.5% (101/204) were aged between 25 and 34 years. Almost all participants self-identified as Black, with the majority (190/204, 93.2%) having completed secondary school. The mean overall knowledge score was 21.92/28. We observed a slight increase of 0.28 (95% uncertainty interval...
PMC10612008
Conclusions
While the SAS videos resulted in high user satisfaction, measured knowledge gains were small within a participant population that was already receiving perinatal health messages through antenatal clinics. The higher knowledge scores observed in older participants with higher education levels suggest that boosting mater...
PMC10612008
Trial Registration
Pan African Clinical Trials Registry PACTR202203673222680; https://tinyurl.com/362cpuny
PMC10612008
Introduction
Despite documented reductions in maternal and child mortality during the era of the Millennium Development Goals [SMS text message–based dissemination was originally chosen to make MomConnect universally accessible to mothers with basic (nonsmart) cell phones [Short, animated storytelling (SAS) videos constitute a prom...
PMC10612008
Methods
PMC10612008
Intervention
With input from local mothers and community health workers in South Africa, we developed the Amandla Mama intervention, a collection of 10 short, animated storytelling videos focused on critical perinatal health topics. During the content creation process, research partners at the Clinton Health Access Initiative in So...
PMC10612008
Trial Design
We used a randomized controlled trial with a nested user satisfaction evaluation to measure the effect of the Amandla Mama videos on maternal knowledge and to assess maternal satisfaction. Participants were randomly assigned to either the SAS Intervention group or the Standard-of-Care (SOC) Control group. SOC in South ...
PMC10612008
Study Setting
This study took place in the City of Tshwane Metropolitan District of Gauteng, South Africa. The Tshwane Health District is situated in the northern region of Gauteng Province. In 2019, the Tshwane District had a population of more than 3 million people, with a population density of 515/km
PMC10612008
Recruitment and Informed Consent
RECRUITMENT
Participants were recruited at the clinics while they waited for their antenatal appointments. As such, this was a convenience sample, recruited consecutively by research team members affiliated with the Clinton Health Access Initiative in South Africa. Members of the research team described the trial to mothers and ga...
PMC10612008
Participants and Eligibility Criteria
Eligible participants were expectant mothers accessing routine antenatal health care services at the 2 facilities [Flow diagram for the Amandla Mama Study.
PMC10612008
Measures
Sociodemographic data were collected verbally from enrolled participants and immediately entered into a shared spreadsheet by our local research team. Since the trial involved testing and implementing a new intervention and we found no appropriate perinatal knowledge assessments that had been validated within this stud...
PMC10612008
Maternal satisfaction items. For each question, participants indicated how satisfied they were with the videos they saw on a scale of score 1-5, with 1=not at all satisfied and 5=extremely satisfied.
Were the videos easy to understand? (1=not easy at all, 5=very easy)Do you think the videos were useful? (1=not useful at all, 5=very useful)How easy was it for you to download the videos? (1=not easy at all, 5=very easy)How fast was it to download the videos? (1=very slow, 5=very fast)How easy was it for you to watch...
PMC10612008
Outcomes
SECONDARY
The primary outcome in this study was maternal knowledge. The secondary outcome was maternal satisfaction, defined as the mean response of all participants in the SAS Intervention group for each of the 8 satisfaction items.
PMC10612008
Assignment of Interventions, Allocation, and Blinding
Participants were randomly assigned 1:1 to either the SAS Intervention group or the SOC Control group. A computer-generated randomization sequence was used to assign participants to their respective groups. To implement the randomization, a table with the randomized sequence was created, and participants were added seq...
PMC10612008
Participant Time Line
Upon enrolling in the study, participants in the intervention group received the video intervention through WhatsApp, delivered to their cellphones. One month later, all of the participants were contacted telephonically by the research team to respond to the surveys. Following the unblinding of the interviewers, partic...
PMC10612008
Sample Size
We determined the sample size for this trial based on our primary outcome, maternal knowledge. We used a significance level of .05 (We hypothesized that, at the 2-week data collection time point, the mean score of participants in the control group on the knowledge questionnaire would be 43% (12 points out of 28 points ...
PMC10612008
Statistical Analysis
REGRESSION
We compared the distribution of demographic variables between the trial arms with the chi-square test or the exact Fisher test, as appropriate. Regarding the primary outcome, the sum of the scores is a discrete count, but with a bounded value at the total number of questions (28 knowledge questions). Thus, we modeled t...
PMC10612008
Access to the Full Protocol, Participant-Level Data, and Statistical Code
The protocol for this trial was published as open access in June 2022 [
PMC10612008
Ethical Considerations
Ethical approval for the study was granted by the Pharma-Ethics Independent Research Ethics Committee, the Tshwane Health Research and Ethics Committee, and the Scientific Research Ethics Committee of the Clinton Health Access Initiative. We also registered this study on the National Health Research Database (GP2021110...
PMC10612008
Results
PMC10612008
Knowledge Outcomes
Our participants achieved a mean overall score of 21.92 (78.3%) on the knowledge questionnaire (Table S1 in Changes in overall knowledge scores by baseline variable and intervention exposure.
PMC10612008
Maternal Satisfaction Outcomes
Finally, we present the results of our nested maternal satisfaction evaluation in Maternal satisfaction items describing the experience of using short, animated storytelling (SAS) videos.
PMC10612008
Discussion
PMC10612008
Principal Results
SECONDARY
In this study, we observed slight gains in maternal knowledge with large uncertainty after a single exposure to a series of 10 short, animated storytelling videos delivered through WhatsApp to expectant mothers in the Tshwane District of Gauteng Province, South Africa. Mothers with secondary level education or higher d...
PMC10612008
Limitations
Our initial expectation of a larger effect size (5 points increase) led to an underpowered sample size to detect smaller gains in knowledge. Our participants were all receiving routine antenatal care, where they were likely hearing similar perinatal health messages to the ones included in the SAS videos. Other signific...
PMC10612008
Comparisons With Previous Work
In a recent meta-analytic review, Feeley et al [
PMC10612008
Conclusions
The high maternal satisfaction related to the use of SAS videos suggests that there may be a role for SAS videos in augmenting widely adopted interventions like MomConnect. Especially as internet access and smartphone penetration increase across South Africa, there may be a growing role for innovative approaches that e...
PMC10612008
Abbreviations
mobile healthshort, animated storytellingstandard-of-careuncertainty interval
PMC10612008
Data Availability
The data collected as part of this study are available upon request from the corresponding author MA. The data are not publicly available, as we wish to protect the privacy of the expectant mothers who agreed to participate. The entire video series is available in
PMC10612008
Background
INTRAUTERINE GROWTH RETARDATION
The authors have declared that no competing interests exist.Micronutrient-fortified balanced energy-protein (BEP) supplements are promising interventions to prevent intrauterine growth retardation in low- and middle-income countries. On the other hand, one concern with blanket prenatal supplementation programs using en...
PMC10406330
Methods and findings
The MISAME-III study is an open label individually randomized controlled trial where pregnant women (
PMC10406330
Conclusions
Micronutrient-fortified BEP supplementation during pregnancy can increase maternal and newborn FFMI, without significant effects on FMI.
PMC10406330
Trial registration
ClinicalTrials.gov with identifier In a sub-study nested under the MISAME-III trial, an individually randomised controlled efficacy trial in rural Burkina Faso, Carl Lachat and colleagues investigate the effect of prenatal micronutrient-fortified balanced energy-protein supplementation on body composition of mothers an...
PMC10406330
Author summary
PMC10406330
Why was this study done?
overweight
INTRAUTERINE GROWTH RETARDATION
Prenatal multimicronutrient-fortified balanced energy-protein (BEP) supplementation is a promising nutritional intervention to alleviate the high burden of intrauterine growth retardation, including low birth weight and small-for-gestational age, in low- and middle-income countries.On the other hand, one concern with b...
PMC10406330
What did the researchers do and find?
In a sub-study nested under the MISAME-III trial, an individually randomized controlled efficacy trial in rural Burkina Faso, we evaluated the effects of prenatal micronutrient-fortified BEP supplementation on body composition of mothers and their newborns.Our trial indicates that micronutrient-fortified BEP supplement...
PMC10406330
What do these findings mean?
adiposity
ADIPOSITY
Our findings that prenatal BEP improved FFMI without increases in FMI address the possible concern that prenatal BEP could lead to excess adiposity and associated long-term health risks.Future research is required to investigate the long-term effects of prenatal BEP on body composition of older infants and children.
PMC10406330
Data Availability
The informed consent form does not allow sharing of personal data outside the research team. Request to access data need to be directed to the ethics committee of Ghent University Hospital through ethisch.
PMC10406330
Introduction
overweight, LBW
PRETERM DELIVERY, FETAL GROWTH RESTRICTION
Low birth weight (LBW; i.e., born <2,500 g) is a marker of suboptimal fetal growth and development caused by preterm delivery (i.e., gestational duration <37 weeks) and/or fetal growth restriction, which results in a small-for-gestational age (SGA) newborn (i.e., birth weight below the tenth percentile of a reference g...
PMC10406330
Methods
PMC10406330
Ethics statement
The MISAME-III study protocol was approved by the ethics committee of Centre Muraz in Burkina Faso (N°2018–22/MS/SG/CM/CEI) and Ghent University Hospital in Belgium (B670201734334). Participant mothers provided their written consent for participation after an information session detailing the study, voluntary participa...
PMC10406330
Study design and intervention
The MISAME-III study is an individually randomized 2 × 2 factorial trial evaluating the efficacy of a combination of micronutrient-fortified BEP and iron-folic acid (IFA) supplementation, as compared to IFA supplementation alone, during pregnancy and during lactation on various maternal, newborn and infant outcomes. In...
PMC10406330
Study participants
The prenatal phase of the main MISAME-III study was conducted between the first enrollment on 30 October 2019 and the last delivery on 7 August 2021. Pregnant women (
PMC10406330
Stable isotope administration and saliva sample collection
EVENT
The body composition of mothers and infants was assessed using the stable isotope dilution technique with deuterium oxide (DIn the event that both the mother and her newborn were selected (The D
PMC10406330
Study outcomes and measurement
The primary outcomes of interest of the study are fat-mass index (FMI) and fat-free mass index (FFMI) (i.e., mass divided by squared height) in mothers and newborns. Secondary study outcomes are %FFM and %FM of total body weight in mothers and newborns; maternal BMI; and newborn length-for-age, weight-for-age, and weig...
PMC10406330
Statistical analysis
REGRESSION
Data analyses were conducted using Stata 17.1 (Statacorp, Texas, USA) and a two-sided statistical significance was considered at alpha <0.05. Descriptive statistics are presented as means ± SD for the continuous variables and as frequencies (%) for the categorical variables. Study outcomes were checked for normality of...
PMC10406330
Results
From the 880 newborns considered for the body composition sub-study, we analyzed data from 720 (81.8%) newborns (
PMC10406330
Trial flow diagram of the MISAME-III body composition sub-study.
BC, body composition; MISAME, MIcronutriments pour la SAnté de la Mère et de l’Enfant.
PMC10406330
Discussion
lean mass accretion, adiposity, FM
ADIPOSITY
Our study found that prenatal BEP led to a higher maternal and newborn FFMI without significant effects on FMI. The positive effect of prenatal BEP on maternal FFMI was found to be larger among mothers with a better nutritional status at baseline (i.e., BMI ≥21.0 kg/mOur results are in contrast to those from the MISAME...
PMC10406330
Supporting information
PMC10406330
Nutritional values of the ready-to-use supplementary food for pregnant women.
(DOCX)Click here for additional data file.
PMC10406330
Comparison of participants between the MISAME-III study and the body composition sub-studies.
(DOCX)Click here for additional data file.
PMC10406330
Effect of prenatal micronutrient-fortified BEP supplementation on maternal and newborn body composition using CACE estimates.
(DOCX)Click here for additional data file.
PMC10406330
Relationship between newborn and maternal FFMI and FMI and birth anthropometry.
(DOCX)Click here for additional data file.
PMC10406330
Treatment effect on maternal and newborn FFMI across the distribution of maternal BMI at baseline.
The estimated difference in FFMI between the intervention and control groups is plotted as a function of the percentiles of maternal BMI. The zero line indicates no efficacy of BEP. The positive y values indicate a higher FFMI in the intervention group, and the negative y values indicate a lower FFMI, with upper and lo...
PMC10406330
Treatment effect on maternal and newborn FMI across the distribution of maternal BMI at baseline.
The estimated difference in FMI between the intervention and control groups is plotted as a function of the percentiles of maternal BMI. The zero line indicates no efficacy of BEP. The positive y values indicate a higher FMI in the intervention group, and the negative y values indicate a lower FMI, with upper and lower...
PMC10406330
Locally weighted scatterplot smoothing plotting the relationship between newborn and maternal FFMI.
REGRESSION
Linear regression model was fitted to estimate the beta and 95% CIs for the relationship between newborn and maternal FFMI.(TIF)Click here for additional data file.
PMC10406330
CONSORT checklist of the manuscript.
(PDF)Click here for additional data file.
PMC10406330
Impact of a prenatal and postnatal balanced energy protein supplement on birth size and postnatal child growth in Burkina Faso.
Dougoumato II
(PDF)Click here for additional data file.The authors thank all the women from Boni, Dohoun, Karaba, Dougoumato II, Koumbia, and Kari who participated in the study, the data collection team and Henri Somé from AFRICSanté. We thank Nutriset (France) for donating the BEP supplements.
PMC10406330
Abbreviations
balanced energy-proteinbody mass indexconfidence intervalcomplier average causal effectdeuterium oxideestimated average requirementfat-free mass indexfat-free mass as percentage of total body weightfat-mass indexfat-mass as percentage of total body weightFourier-transformed infrarediron-folic acidlow birth weightlipid-...
PMC10406330
References
PMC10406330
Objectives
osteopenia
AGE-RELATED MACULAR DEGENERATION, OSTEOPENIA
This study aimed to analyze the relationship between age-related macular degeneration and osteopenia, defined as decreased bone mineral density, in the Polish population.
PMC10586687
Methods
osteopenia, AMD-1
AGE-RELATED MACULAR DEGENERATION, OSTEOPENIA, DECREASED BONE MINERAL DENSITY
Participants were derived from the population-based Bialystok PLUS Study. Randomized individuals were stratified into two groups, those with age-related macular degeneration (AMD-1 group) or without age-related macular degeneration (AMD-0 group). Using a cutoff value of −1.0 to identify low bone mass, participants with...
PMC10586687
Conclusion
AGE-RELATED MACULAR DEGENERATION
Decreased femoral bone mineral density may be associated with a higher risk of age-related macular degeneration in men, but a causal link remains unclear.
PMC10586687
Data Availability
All relevant data are available on Harvard Dataverse:
PMC10586687
Introduction
AMD, blindness, vision loss, osteoporosis, trauma
AGE-RELATED MACULAR DEGENERATION, OSTEOPOROSIS, BLINDNESS
Age-related macular degeneration (AMD) is the primary cause of irreversible blindness in developed countries [AMD primarily affects the macula, leading to vision loss in the central 15 to 20 degrees of the visual field, often in both eyes. Not surprisingly, patients with AMD frequently sustain injuries, including skele...
PMC10586687
Materials and methods
PMC10586687
Study design and participants
endocrine diseases
ENDOCRINE DISEASES, POLAND
The study included participants of the Bialystok PLUS Study, who were 50–80 years of age. The Bialystok PLUS Study was a prospective, population-based, cohort study in which the determinants and occurrence of cardiovascular, neurological, ophthalmic, psychiatric, musculoskeletal, and endocrine diseases were analyzed am...
PMC10586687
Bone mineral density measurement
osteoporosis
OSTEOPOROSIS
The analyzed parameters included the areal BMD of the total hip, femoral neck, lumbar spine, and total body/whole skeleton. The BMD was measured using dual-energy X-ray absorptiometry (Lunar iDXA; GE Healthcare, Madison, WI, USA). Standard densitometric procedures and quality assurance were performed, and standard scan...
PMC10586687