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The Cochrane Database of Systematic... Mar 2017Tongue-tie, or ankyloglossia, is a condition whereby the lingual frenulum attaches near the tip of the tongue and may be short, tight and thick. Tongue-tie is present in... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Tongue-tie, or ankyloglossia, is a condition whereby the lingual frenulum attaches near the tip of the tongue and may be short, tight and thick. Tongue-tie is present in 4% to 11% of newborns. Tongue-tie has been cited as a cause of poor breastfeeding and maternal nipple pain. Frenotomy, which is commonly performed, may correct the restriction to tongue movement and allow more effective breastfeeding with less maternal nipple pain.
OBJECTIVES
To determine whether frenotomy is safe and effective in improving ability to feed orally among infants younger than three months of age with tongue-tie (and problems feeding).Also, to perform subgroup analysis to determine the following.• Severity of tongue-tie before frenotomy as measured by a validated tool (e.g. Hazelbaker Assessment Tool for Lingual Frenulum Function (ATLFF) scores < 11; scores ≥ 11) (Hazelbaker 1993).• Gestational age at birth (< 37 weeks' gestation; 37 weeks' gestation and above).• Method of feeding (breast or bottle).• Age at frenotomy (≤ 10 days of age; > 10 days to three months of age).• Severity of feeding difficulty (infants with feeding difficulty affecting weight gain (as assessed by infant's not regaining birth weight by day 14 or falling off centiles); infants with symptomatic feeding difficulty but thriving (greater than birth weight by day 14 and tracking centiles).
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and CINAHL up to January 2017, as well as previous reviews including cross-references, expert informants and journal handsearching. We searched clinical trials databases for ongoing and recently completed trials. We applied no language restrictions.
SELECTION CRITERIA
Randomised, quasi-randomised controlled trials or cluster-randomised trials that compared frenotomy versus no frenotomy or frenotomy versus sham procedure in newborn infants.
DATA COLLECTION AND ANALYSIS
Review authors extracted from the reports of clinical trials data regarding clinical outcomes including infant feeding, maternal nipple pain, duration of breastfeeding, cessation of breastfeeding, infant pain, excessive bleeding, infection at the site of frenotomy, ulceration at the site of frenotomy, damage to the tongue and/or submandibular ducts and recurrence of tongue-tie. We used the GRADE approach to assess the quality of evidence.
MAIN RESULTS
Five randomised trials met our inclusion criteria (n = 302). Three studies objectively measured infant breastfeeding using standardised assessment tools. Pooled analysis of two studies (n = 155) showed no change on a 10-point feeding scale following frenotomy (mean difference (MD) -0.1, 95% confidence interval (CI) -0.6 to 0.5 units on a 10-point feeding scale). A third study (n = 58) showed objective improvement on a 12-point feeding scale (MD 3.5, 95% CI 3.1 to 4.0 units of a 12-point feeding scale). Four studies objectively assessed maternal pain. Pooled analysis of three studies (n = 212) based on a 10-point pain scale showed a reduction in maternal pain scores following frenotomy (MD -0.7, 95% CI -1.4 to -0.1 units on a 10-point pain scale). A fourth study (n = 58) also showed a reduction in pain scores on a 50-point pain scale (MD -8.6, 95% CI -9.4 to -7.8 units on a 50-point pain scale). All studies reported no adverse effects following frenotomy. These studies had serious methodological shortcomings. They included small sample sizes, and only two studies blinded both mothers and assessors; one did not attempt blinding for mothers nor for assessors. All studies offered frenotomy to controls, and most controls underwent the procedure, suggesting lack of equipoise. No study was able to report whether frenotomy led to long-term successful breastfeeding.
AUTHORS' CONCLUSIONS
Frenotomy reduced breastfeeding mothers' nipple pain in the short term. Investigators did not find a consistent positive effect on infant breastfeeding. Researchers reported no serious complications, but the total number of infants studied was small. The small number of trials along with methodological shortcomings limits the certainty of these findings. Further randomised controlled trials of high methodological quality are necessary to determine the effects of frenotomy.
Topics: Ankyloglossia; Breast Feeding; Female; Gestational Age; Humans; Infant, Newborn; Lingual Frenum; Mastodynia; Nipples; Pain Measurement; Randomized Controlled Trials as Topic
PubMed: 28284020
DOI: 10.1002/14651858.CD011065.pub2 -
The Cochrane Database of Systematic... Sep 2020Engorgement is the overfilling of breasts with milk, often occurring in the early days postpartum. It results in swollen, hard, painful breasts and may lead to premature...
BACKGROUND
Engorgement is the overfilling of breasts with milk, often occurring in the early days postpartum. It results in swollen, hard, painful breasts and may lead to premature cessation of breastfeeding, decreased milk production, cracked nipples and mastitis. Various treatments have been studied but little consistent evidence has been found on effective interventions.
OBJECTIVES
To determine the effectiveness and safety of different treatments for engorgement in breastfeeding women.
SEARCH METHODS
On 2 October 2019, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP), and reference lists of retrieved studies.
SELECTION CRITERIA
All types of randomised controlled trials and all forms of treatment for breast engorgement were eligible.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for eligibility, extracted data, conducted 'Risk of bias' assessment and assessed the certainty of evidence using GRADE.
MAIN RESULTS
For this udpate, we included 21 studies (2170 women randomised) conducted in a variety of settings. Six studies used individual breasts as the unit of analysis. Trials examined a range of interventions: cabbage leaves, various herbal compresses (ginger, cactus and aloe, hollyhock), massage (manual, electromechanical, Oketani), acupuncture, ultrasound, acupressure, scraping therapy, cold packs, and medical treatments (serrapeptase, protease, oxytocin). Due to heterogeneity, meta-analysis was not possible and data were reported from single trials. Certainty of evidence was downgraded for limitations in study design, imprecision and for inconsistency of effects. We report here findings from key comparisons. Cabbage leaf treatments compared to control For breast pain, cold cabbage leaves may be more effective than routine care (mean difference (MD) -1.03 points on 0-10 visual analogue scale (VAS), 95% confidence intervals (CI) -1.53 to -0.53; 152 women; very low-certainty evidence) or cold gel packs (-0.63 VAS points, 95% CI -1.09 to -0.17; 152 women; very low-certainty evidence), although the evidence is very uncertain. We are uncertain about cold cabbage leaves compared to room temperature cabbage leaves, room temperature cabbage leaves compared to hot water bag, and cabbage leaf extract cream compared to placebo cream because the CIs were wide and included no effect. For breast hardness, cold cabbage leaves may be more effective than routine care (MD -0.58 VAS points, 95% CI -0.82 to -0.34; 152 women; low-certainty evidence). We are uncertain about cold cabbage leaves compared to cold gel packs because the CIs were wide and included no effect. For breast engorgement, room temperature cabbage leaves may be more effective than a hot water bag (MD -1.16 points on 1-6 scale, 95% CI -1.36 to -0.96; 63 women; very low-certainty evidence). We are uncertain about cabbage leaf extract cream compared to placebo cream because the CIs were wide and included no effect. More women were satisfied with cold cabbage leaves than with routine care (risk ratio (RR) 1.42, 95% CI 1.22 to 1.64; 152 women; low certainty), or with cold gel packs (RR 1.23, 95% CI 1.10 to 1.38; 152 women; low-certainty evidence). We are uncertain if women breastfeed longer following treatment with cold cabbage leaves than routine care because CIs were wide and included no effect. Breast swelling and adverse events were not reported. Compress treatments compared to control For breast pain, herbal compress may be more effective than hot compress (MD -1.80 VAS points, 95% CI -2.07 to -1.53; 500 women; low-certainty evidence). Massage therapy plus cactus and aloe compress may be more effective than massage therapy alone (MD -1.27 VAS points, 95% CI -1.75 to -0.79; 100 women; low-certainty evidence). In a comparison of cactus and aloe compress to massage therapy, the CIs were wide and included no effect. For breast hardness, cactus and aloe cold compress may be more effective than massage (RR 0.66, 95% CI 0.51 to 0.87; 102 women; low-certainty evidence). Massage plus cactus and aloe cold compress may reduce the risk of breast hardness compared to massage alone (RR 0.38, 95% CI 0.25 to 0.58; 100 women; low-certainty evidence). We are uncertain about the effects of compress treatments on breast engorgement and cessation of breastfeeding because the certainty of evidence was very low. Among women receiving herbal compress treatment, 2/250 experienced skin irritation compared to 0/250 in the hot compress group (moderate-certainty evidence). Breast swelling and women's opinion of treatment were not reported. Medical treatments compared to placebo Protease may reduce breast pain (RR 0.17, 95% CI 0.04, 0.74; low-certainty evidence; 59 women) and breast swelling (RR 0.34, 95% CI 0.15 to 0.79; 59 women; low-certainty evidence), whereas serrapeptase may reduce the risk of engorgement compared to placebo (RR 0.36, 95% CI 0.14 to 0.88; 59 women; low-certainty evidence). We are uncertain if serrapeptase reduces breast pain or swelling, or if oxytocin reduces breast engorgement compared to placebo, because the CIs were wide and included no effect. No women experienced adverse events in any of the groups receiving serrapeptase, protease or placebo (low-certainty evidence). Breast induration/hardness, women's opinion of treatment and breastfeeding cessation were not reported. Cold gel packs compared to control For breast pain, we are uncertain about the effectiveness of cold gel packs compared to control treatments because the certainty of evidence was very low. For breast hardness, cold gel packs may be more effective than routine care (MD -0.34 points on 1-6 scale, 95% CI -0.60 to -0.08; 151 women; low-certainty evidence). It is uncertain if women breastfeed longer following cold gel pack treatment compared to routine care because the CIs were wide and included no effect. There may be little difference in women's satisfaction with cold gel packs compared to routine care (RR 1.17, 95% CI 0.97 to 1.40; 151 women; low-certainty evidence). Breast swelling, engorgement and adverse events were not reported.
AUTHORS' CONCLUSIONS
Although some interventions may be promising for the treatment of breast engorgement, such as cabbage leaves, cold gel packs, herbal compresses, and massage, the certainty of evidence is low and we cannot draw robust conclusions about their true effects. Future trials should aim to include larger sample sizes, using women - not individual breasts - as units of analysis.
Topics: Acupuncture Therapy; Brassica; Breast Diseases; Cryotherapy; Female; Humans; Lactation Disorders; Massage; Mastodynia; Oxytocin; Peptide Hydrolases; Phytotherapy; Plant Leaves; Pregnancy; Randomized Controlled Trials as Topic; Ultrasonic Therapy
PubMed: 32944940
DOI: 10.1002/14651858.CD006946.pub4 -
PloS One 2015Gynecomastia and/or mastodynia is a common medical problem in patients receiving antiandrogen (bicalutamide or flutamide) treatment for prostate cancer; up to 70% of... (Review)
Review
INTRODUCTION
Gynecomastia and/or mastodynia is a common medical problem in patients receiving antiandrogen (bicalutamide or flutamide) treatment for prostate cancer; up to 70% of these patients result to be affected; furthermore, this can jeopardise patients' quality of life.
AIMS
To systematically review the quality of evidence of the current literature regarding treatment options for bicalutamide-induced gynecomastia, including efficacy, safety and patients' quality of life.
METHODS
The PubMed, Medline, Scopus, The Cochrane Library and SveMed+ databases were systematically searched between January 1, 2000 and December 31, 2014. All searches were undertaken between January and February 2015. The search phrase used was:"gynecomastia AND treatment AND prostate cancer". Two reviewers assessed 762 titles and abstracts identified. The search and review process was done in accordance with the PRISMA statement. The PICOS (patients, intervention, comparator, outcomes and study design) process was used to specify inclusion criteria. Quality of evidence was rated according to GRADE.
MAIN OUTCOME MEASURES
Primary outcomes were: treatment effects, number of complications and side effects. Secondary outcome was: Quality of Life.
RESULTS
Eleven studies met the inclusion criteria and are analysed in this review. Five studies reported pharmacological intervention with tamoxifen and/or anastrozole, either as prophylactic or therapeutic treatment. Four studies reported radiotherapy as prophylactic and/or therapeutic treatment. Two studies compared pharmacological treatment to radiotherapy. Most of the studies were randomized with varying risk of bias. According to GRADE, quality of evidence was moderate to high.
CONCLUSIONS
Bicalutamide-induced gynecomastia and/or mastodynia can effectively be managed by oral tamoxifen (10-20 mg daily) or radiotherapy without relevant side effects. Prophylaxis or therapeutic treatment with tamoxifen results to be more effective than radiotherapy.
Topics: Androgen Antagonists; Gynecomastia; Humans; Male; Meta-Analysis as Topic; Prostatic Neoplasms; Quality of Life
PubMed: 26308532
DOI: 10.1371/journal.pone.0136094 -
European Journal of Obstetrics,... Dec 2017A systematic review on pain reduction, side effects, and quality of life for various treatments. (Review)
Review
CYCLIC AND NON-CYCLIC BREAST-PAIN
A systematic review on pain reduction, side effects, and quality of life for various treatments.
BACKGROUND
No clear systematic-review on all the various treatment regimen for (Non-) cyclical-breast-pain currently exists.
OBJECTIVES
The aim of this study was to assess the various forms of therapy for treatment of breast-pain and the evidence for their effectiveness.
SEARCH STRATEGY
Search-terms included 'mastalgia' and 'therapy' or 'hormones' or 'nsaid' or 'psychotherapy' or 'analgesia' or 'surgery', and synonyms.
SELECTION CRITERIA
The review was conducted according to the Preferred Reporting Items for Systematic-reviews and Meta-Analysis guidelines. RCT's and pro-/retrospective studies reporting on treatment of breast-pain were considered eligible. Minimal follow-up and sample-size criteria were 6 months and 10 patients respectively.
DATA COLLECTION AND ANALYSIS
Data was extracted using standardized tables and encompassed number of subjects, type of breast-pain and treatment, efficacy of treatment and clinical complications/side-effects. No pooling of data could be achieved due to heterogeneity amongst studies.
MAIN RESULTS
Twenty-three studies were included, that reported on 2100 patients in total. Topical-Diclofenac was found to reduce pain by 58.7 and 63.3 on a Visual-Analogue-Scale (VAS) in cyclical and non-cyclical-breast-pain respectively. Persistent cyclical-breast-pain can be treated with short courses (2-6 months) of either Bromocryptine (VAS↓=25.4) or Danazol (VAS↓=33.6) as long as benefits outweigh the side-effects. Last-resort options for unresponsive and severe debilitating breast-pain include surgery in the form of bilateral mastectomy with reconstruction.
CONCLUSIONS
Pain reduction in patients with breast-pain can be achieved with analgesics, hormonal-regimen and possibly surgery as a last resort. Additional studies are needed with well-described patient-characteristics, robust study set-up, and longer follow-up times.
Topics: Hormone Antagonists; Humans; Mastodynia
PubMed: 29059585
DOI: 10.1016/j.ejogrb.2017.10.018 -
Journal of Complementary & Integrative... Dec 2022Cyclic mastalgia is one of the most prevalent problems in women of reproductive age and sometimes it is so severe that it influences their activities and requires... (Review)
Review
Cyclic mastalgia is one of the most prevalent problems in women of reproductive age and sometimes it is so severe that it influences their activities and requires treatment. The available drug treatments for mastalgia are not satisfactory and most patients have inclined towards complementary and alternative medicine including herbal medicines. Therefore, in order to evaluate the effectiveness and side effects of herbal medicines conducting systematic review studies and meta-analysis seems essential, thus this systematic review was conducted with the aim of determining the effect of herbal medicines on cyclic mastalgia and its probable side effects. The databases of Pubmed, Medline, Embase, ProQuest, Scopus, Web of science, Complementary Medicine Database, SID (Scientific information database), Magiran and Iranmedex were searched from 1997 to 2020 and limited only for English and Persian languages. The studies were appraised according to the Cochrane Collaboration's tool. Meta-analysis was conducted using RevMan software. Standardized mean difference (SMD) was calculated to assess an overall estimate of effectiveness for the continuous data. Odds ratio (OR) was calculated for dichotomous data. Thirty papers were included in the study. Meta-analysis of data demonstrated that herbal medicine was an effective method in reducing the severity of mastalgia compared to the placebo (SMD: -3.26, 95% CI: -5.05 to -1.46, p=0.00004). Subanalysis of data showed no difference between the effectiveness of herbal medicine on the severity of mastalgia compared to the pharmacologic treatment. This research demonstrated efficacy of herbal medicines in alleviating cyclic mastalgia. Therefore, these herbal medicines can be regarded as an alternative treatment for women suffering from cyclic mastalgia. However, due to the limited number of studies in relation to each specific herbal treatment, conducting further studies in this area is recommended.
PubMed: 34107571
DOI: 10.1515/jcim-2020-0531 -
Electronic Physician Jan 2017Vitex agnus-castus, also called vitex is aboriginal to the Mediterranean region, with long leaves, tender stem, flowers and ripening seeds. The aim of this study was to... (Review)
Review
INTRODUCTION
Vitex agnus-castus, also called vitex is aboriginal to the Mediterranean region, with long leaves, tender stem, flowers and ripening seeds. The aim of this study was to overview premenstrual, postmenstrual and infertility disorder of Vitex agnus-castus.
METHODS
This review article was carried out by searching studies in PubMed, Medline, Web of Science, and IranMedex databases. The initial search strategy identified about 87 references. In this study, 43 studies were accepted for further screening, and met all our inclusion criteria (in English, full text, therapeutic effects of Vitex agnus-castus and dated mainly from the year 2009 to 2016). The search terms were Vitex agnus-castus, premenstrual, postmenstrual, infertility disorder properties and pharmacological effects.
RESULT
Vitex agnus-castus was shown to contribute to the treatment of premenstrual syndrome (PMS). Moreover, the result of the present study showed that this valuable plant is helpful in alleviation of pain resulting from postmenstrual disease. Furthermore, it was found that Vitex agnus-castus is beneficial in infertility disorder.
CONCLUSION
Vitex agnus-castus (AC) is a phytopharmaceutical compound and is shown to be widely used to treat PMS and PMDD. In addition, it was shown to be beneficial in post-menstrual cases and it can also contribute to treatment of infertility cases in both men and women. Dopaminergic compounds available in this plant help to treat premenstrual mastodynia as well as other symptoms of the premenstrual syndrome.
PubMed: 28243425
DOI: 10.19082/3685 -
International Journal of Environmental... Jun 2021Mastalgia, or breast pain, is common among women which can lead to significant impairment in daily living. Hence, finding an effective treatment that can alleviate the... (Meta-Analysis)
Meta-Analysis Review
Mastalgia, or breast pain, is common among women which can lead to significant impairment in daily living. Hence, finding an effective treatment that can alleviate the symptom is very important. Thus, we carry out this study to determine the efficacy of evening primrose oil (EPO) for mastalgia treatment in women. The review included published randomised clinical trials that evaluated EPO used for treating mastalgia against a placebo or other treatments, irrespective of the blinding procedure, publication status, or sample size. Two independent authors screened the titles and abstracts of the identified trials; full texts of relevant trials were evaluated for eligibility. Two reviewers independently extracted data on the methods, interventions, outcomes, and risk of bias. The random-effects model was used for estimating the risk ratios and mean differences with 95% confidence intervals. Thirteen trials with 1752 randomised patients were included. The results showed that EPO has no difference to reduce breast pain compared to topical NSAIDS, danazol, or vitamin E. The number of patients who achieved pain relief was no different compared to the placebo or other treatments. The EPO does not increase adverse events, such as nausea, abdominal bloating, headache or giddiness, increase weight gain, and altered taste compared to a placebo or other treatments. EPO is a safe medication with similar efficacy for pain control in women with mastalgia compared to a placebo, topical NSAIDS, danazol, or vitamin E.
Topics: Female; Humans; Linoleic Acids; Mastodynia; Oenothera biennis; Plant Oils; Randomized Controlled Trials as Topic; gamma-Linolenic Acid
PubMed: 34200727
DOI: 10.3390/ijerph18126295 -
Journal of Ethnopharmacology Apr 2018Pueraria candollei var. mirifica (Airy Shaw & Suvat.) Niyomdham (commonly termed P. mirifica, PM) growing in upland Thailand has a long history as a postmenopausal... (Review)
Review
ETHNOPHARMACOLOGICAL RELEVANCE
Pueraria candollei var. mirifica (Airy Shaw & Suvat.) Niyomdham (commonly termed P. mirifica, PM) growing in upland Thailand has a long history as a postmenopausal rejuvenant therapy for indigenants. Its amelioration of menopause symptoms in clinical trials was assessed.
MATERIALS AND METHODS
International and Thai databases were searched from inception to February 2017. Clinical trials investigating effects of PM menopausal or postmenopausal women were included. Outcomes were self-reported menopausal symptoms, serum reproductive hormones, urino-genital tract function, and bone surrogates. Methodological quality was assessed by Cochrane risk-of-bias v2.0, and a 22-parameter quality score based on the CONSORT checklist for herbal medicines.
RESULTS
Eight studies (9 articles) used data from 309 menopausal patients. Five-studies demonstrated that PM was associated with climacteric scores reduced by ~50% compared to baseline. Other PM studies using limited numbers of placebo participants suggested improved vaginal and other urogenital tract symptoms. Bone alkaline phosphatase halved (suggesting lowered bone turnover). Variable serum reproductive hormone levels suggested menopausal status differed between studies. PM active ingredients and sources were not defined. Adverse event rates (mastodynia, vaginal spotting, dizziness) were similar in all groups (PM, conjugated equine estrogen, and placebos) but serum C-reactive protein doubled. These studies had design and reporting deficiencies, high risks of biases, and low quality scores.
CONCLUSIONS
The efficacy of PM on menopausal symptoms remains inconclusive because of methodological short-comings especially placebo effects inherent in self-assessment/recall questionnaires and no PM standardization. PM efficacy and safety need a fundamental re-appraisal by: (i) cohort (retro- and prospective) studies on current users to define its traditional use for rejuvenation; (ii) tightly coupling long-term efficacy to safety of well-defined PM and multiple end-points; (iii) using study design related to current understanding of menopause progression and estrogen pharmacology (iv) robust pharmacovigilance.
Topics: Adult; Biomarkers; Clinical Trials as Topic; Evidence-Based Medicine; Female; Humans; Menopause; Middle Aged; Phytotherapy; Plant Extracts; Plants, Medicinal; Pueraria; Risk Assessment; Treatment Outcome
PubMed: 29409850
DOI: 10.1016/j.jep.2018.01.028 -
Current Opinion in Obstetrics &... Dec 2017Investigation of noncyclic mastalgia in women without signs or risk factors for cancer is controversial. An initial imaging strategy can diagnose breast cancer early,... (Review)
Review
PURPOSE OF REVIEW
Investigation of noncyclic mastalgia in women without signs or risk factors for cancer is controversial. An initial imaging strategy can diagnose breast cancer early, potentially leading to better treatment and survival. However, cancer diagnosis is very uncommon in these cases, and this approach can be harmful, as false positives or suspicion results will lead to unneeded interventions and follow-up. The purpose of this review is to analyse the trade-offs between desirable and undesirable consequences of initial imaging tests against clinical follow-up.
RECENT FINDINGS
We found seven relevant studies, all observational, with some methodological limitations and very low-quality evidence. They showed low breast cancer prevalence (around 1-2%, increasing with age), high sensitivity to rule out disease but moderate specificity to rule it in using mammography and echography, and lacked evidence on follow-up and final outcomes.
SUMMARY
There is a low prevalence of breast cancer in patients with painful breast with negative physical examination, and very little research to inform about the effect of performing or avoiding initial imaging test on outcomes of interest. With such limited evidence, only a weak recommendation to reinforce shared decision making about what should be done in the primary care setting can be made, with the backup of a specialized breast unit.
Topics: Breast Neoplasms; Decision Making; False Positive Reactions; Female; Humans; Mammography; Mastodynia; Observational Studies as Topic; Physical Examination; Prospective Studies; Retrospective Studies; Sensitivity and Specificity; Ultrasonography
PubMed: 28961632
DOI: 10.1097/GCO.0000000000000407 -
Complementary Therapies in Medicine Jun 2019A systematic review was conducted to assess the effect of vitamin E on the severity and duration of Cyclic Mastalgia compared to vitamin B6, fish oil, herbal medicines... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
A systematic review was conducted to assess the effect of vitamin E on the severity and duration of Cyclic Mastalgia compared to vitamin B6, fish oil, herbal medicines and placebo.
DESIGN
A systematic review and meta-analysis of clinical trials.
METHODS
A search was carried out in PubMed, Cochrane Library, Embase, Scopus and Google Scholar and Persian databases for articles published from 1980 to 2018. The data obtained were analyzed in RevMan and reported in forest plots. The Odds Ratio (OR) was used to find the effect for the dichotomous data and the Standardized Mean Difference (SMD) for the continuous data. The heterogeneity of the studies was assessed using I and the Random Effects Model was used instead of the Fixed Effects Model if I>25%.
RESULTS
A total of 1051 titles and abstracts were extracted. Fourteen articles ultimately remained, and 11 of them were entered into the meta-analysis. The meta-analysis showed significant differences between vitamin E and placebo in the severity (SMD=-0.51; 95% CI=-0.21 to -0.82) and duration (MD=-1.47; 95% CI=-0.91 to -2.57) of cyclic mastalgia, although herbal medicines had a greater effect on the severity of mastalgia than vitamin E (SMD = 0.51, 95% CI = 0.06 to 0.96).
CONCLUSION
Although herbal medicines are more effective than vitamin E, vitamin E reduces both the severity and duration of the disorder compared to placebos, which only reduce its severity, and can therefore be considered a treatment with minimum side-effects. Due to the high heterogeneity of the studies, the researchers recommend further research on the subject using a standard tool based on the CONSORT statement.
Topics: Animals; Herbal Medicine; Humans; Mastodynia; Severity of Illness Index; Vitamin E
PubMed: 31126540
DOI: 10.1016/j.ctim.2019.03.014