A secondary analysis should be regarded as an observational trial and should be identified explicitly as such. Another limitation was the postregistration of the trial because of our mistaken idea that we did not want to disclose this study idea. See this image and copyright information in PMC. Ease of Use. They recorded in a diary chart. Gastrointestinal side effects were observed in a few women and there were no differences between the magnesium and placebo groups. The sample size calculation was based upon the 50% reduction in frequency of leg cramps in both groups obtained from Dahle et al (reference number 12) and Supakatisant C & Phupong V (reference number 13) trials. Power analyses are incomplete. An unmarked version of your revised paper without tracked changes. Is the manuscript technically sound, and do the data support the conclusions? Some systematic reviews showed that is unclear whether oral magnesium provides an effective treatment for leg cramps and large well-conducted randomised controlled trials are needed to answer the question of leg cramps treatment [2, 10, 11, 12]. 1) Abstract. When all required modifications have been addressed, you will receive a formal acceptance letter and your manuscript will proceed to our production department and be scheduled for publication. Can J Kidney Health Dis. Table 1 was also checked and corrected. 3. pg. Please enable it to take advantage of the complete set of features! Independent ttest was used to compare mean percentage change of number of leg cramps and mean tablets of returned drug between groups. Among pregnant women who remained with leg cramps the mean of leg cramps episodes per week showed no significance difference between the Mg++ and placebo groups; t-student test: p = 0.408. Imbalances of Calcium, Magnesium and potassium play a part in causing cramps. Answer: We agree with you but a sub-sample size was calculated based on previous trials with interventions to reduce the frequency of leg cramps. [2]. 2) I don't understand how the sizes of the groups differ so much following an 1 to 1 allocation process. 3. The CONSORT checklist does not longer correspond to the presented study. The sample size was calculated based on 50% reduction of leg cramps. Although magnesium deficiency has been implicated with an increased risk for gestational and adverse perinatal outcomes, there is not enough high-quality evidence to show that dietary magnesium supplementation during pregnancy is beneficial. Consenting pregnant women received a 4 weeks magnesium citrate capsule (300 mg elemental magnesium citrate per capsule) or a daily placebo capsule identical in colour and shape. Results: 8600 Rockville Pike This study aims to evaluate the efficacy of Mg++ supplementation in leg cramps treatment in pregnancy. Without allocation concealment, randomization would be unsuccessful. You can probably blame your nerves. Apart from that, the new calculation is based on 50% reduction of leg cramps and not on the variable defined as the primary endpoint (presence of leg cramps) so that the methodological basis of the study in itself is also questionable. Unable to load your collection due to an error, Unable to load your delegates due to an error. The rationale for the trial requires more explanation in the introduction to highlight any gaps in knowledge. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the Comments to the Author section, enter your conflict of interest statement in the Confidential to Editor section, and submit your "Accept" recommendation. (2005), Dahle L.O., Berg G., Hammar M., Hurtig M. & Larsson L. (1995), The effect of oral magnesium substitution on pregnancyinduced leg cramps, American Journal of Obstetrics and Gynecology, Hertz G., Fast A., Feinsilver S.H., Albertario C.L., Schulman H. & Fein A.M. (1992), Dietary Reference Intakes: Calcium, Phosphorus, Magnesium, Vitamin D and Fluoride, Sleep in late pregnancy predicts length of labor and type of delivery, Nygaard I.H., Valbo A., Pethick S.V. E.g. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. Answer: The primary endpoint was changed to the frequency of leg cramps. Nygaard IH, Valb A, Pethick SV, Bhmer T. Eur J Obstet Gynecol Reprod Biol. Thus, we needed 39 women in each group to detect statistical difference (=0.05, =0.1). 1 to 1 matching yes 50 vs 63 in the placebo group. For example, in tbale 1, 36 in Mg group and 30 in placebo group were currently employed; while in total, 68 were currently employed. 1. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. leg cramps, pregnancy, magnesium bisglycinate chelate, oral, trial, Cunningham F.G., Leveno K.J., Bloom S.L., Hauth J.C., Gilstrap L.C.I. Lower extremity changes experienced during pregnancy. According to the American RDA, the RDA of magnesium during pregnancy is 350360mg per day (Suphiphat etal. 's study (Dahle etal. Medical issues. The first serum level was deleted. If you encounter any issues or have any questions when using PACE, please email us at gro.solp@serugif. Reviewer #5: The authors aimed to evaluate to evaluate the effect of magnesium supplementation for the prevention of leg cramps in pregnant women. In your revised cover letter, please address the following prompts: a) If there are ethical or legal restrictions on sharing a de-identified data set, please explain them in detail (e.g., data contain potentially identifying or sensitive patient information) and who has imposed them (e.g., an ethics committee). These results demonstrated that oral magnesium supplement can improve the frequency and intensity of pregnancyinduced leg cramps. A 50% reduction was cited by Supakatisant C, Phupong V, reference number 16 (Oral magnesium for relief in pregnancy-induced leg cramps: a randomised controlled trial. National Library of Medicine Eighty women completed the study. Our results were similar with Nygaard et al [14]. The pregnant women in this study had a magnesium serum level in the minimum limit of normality (1.8 mg/dl) and around half of participants had hypomagnesemia. 1995; Nygaard etal. Before MannWhitney Utest was used to compare median absolute change in the number of leg cramps and median absolute change of pain score between groups. official website and that any information you provide is encrypted This observational clinical trial studied 132 pregnant women with leg cramps in the first trimester of pregnancy. Methods This observational clinical trial studied 132 pregnant women with leg cramps in the first trimester of pregnancy. official website and that any information you provide is encrypted The overall manuscript would benefit from copyediting before resubmission. Faculty of Medicine, For more information please contact gro.solp@sserpeno. All the database was reviewed with a biostatistician and it was observed that eleven 18-year-old pregnant women had not been included in the analysis. Nutrition in pregnancy: basic principles and recomendations, Micronutrients in pregnancy in low- and middle-income countries. I am sorry to say, but from my point of view there are unsurmountable methodological deficits. 2020 Jan 10;15(1):e0227497.doi: 10.1371/journal.pone.0227497. Currently, there is no standard treatment for pregnancyinduced leg cramps. Answer: Thank you very much for reviewing our manuscript. Epub 2020 Dec 14. Epub 2012 Aug 22. PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Oral magnesium for leg cramps treatment in pregnancy is a controversial issue according to recent Cochrane systematic review. [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. However, the 50% reduction in the frequency of leg cramps was set as a primary outcome. Pregnant women who attended the antenatal care clinic at the Department of Obstetrics, IMIP, were invited to join this study. Dahle etal. All relevant data are within the mansucript and its Supporting Information files. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). -, Hall H, Lauche R, Adams J, Steel A, Broom A, Sibbritt D. Healthcare utilisation of pregnant women who experience sciatica, leg cramps and/or varicose veins: A cross-sectional survey of 1835 pregnant women. The https:// ensures that you are connecting to the The PLOS ONE style templates can be found at, http://www.journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and http://www.journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf. The effects were now quantified in ORs. If eligible, we will contact you to opt in or out. Arajo CAL, Lorena SB, Cavalcanti GCS, Leo GLS, Tenrio GP, Alves JGB. The site is secure. Hawke F, Sadler SG, Katzberg HD, Pourkazemi F, Chuter V, Burns J. Cochrane Database Syst Rev. Both frequency and intensity of leg cramps can be reduced without any significant side effects. The authors declare that they have no conflicts of interest. Would you like email updates of new search results? Additionally, the 50% reduction in frequency of leg cramp in treatment group might be too positive. Many other inconsistences in your manuscript. 1995). The average daily magnesium consumption in a Thai female (nonpregnant) is only 42.29% of the recommended dietary allowance (RDA). 5. When a woman met the study inclusion criteria, the nurses picked a sequentially numbered opaque plastic container. (2012) systematic reviewed showed no evidence that oral Mg is helpful for leg cramps during pregnancy, with low heterogeneity among trials. Oral magnesium supplementation during pregnancy did not reduce the ocurrence and frequency of episodes of leg cramps. Department of Pediatrics, Faculdade Pernambucana de Sade (FPS), Recife, Pernambuco, Brazil. About 3050% of pregnant women experience leg cramps at least twice a week during the third trimester [2,3]. However this evaluation includes a high degreee of subjectivity; 2) Magnesium serum level was not assessed after intervention; 3) Pregnancy women were studied in the first trimester of pregnancy but leg cramps is a more common problem in the third trimester; 4) Because this study was observational, it could be prone to biases. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Cochrane Database Syst Rev. 1995). 2021 May 17;5(5):CD008496. Would you like email updates of new search results? The limitation of this study was that magnesium levels were not assessed. government site. Oral magnesium supplementation for leg cramps in pregnancy-An observational controlled trial PLoS One. Epub 2008 Sep 3. A total of 394 pregnant women were screened and 132 enrolled according to the inclusion criteria. participant privacy or use of data from a third partythose must be specified. But a more recent study of people with many types of cramps, . Zarean & Tarjan verified that pregnant women with low magnesium level supllemented with magnesium (200 mg) had less leg cramps during pregnancy [17]. 2021 Feb 21;13(2):692. doi: 10.3390/nu13020692. The main reason for the screening failure was absence of leg cramps. They found that oral magnesium could decrease leg cramps distress. Before 2. The current sample size might not be sufficient for detecting the differences in the primary outcome, since they calculated it according to the frequency of leg cramp. Transdermal magnesium has fast absorption without causing any unpleasant digestive side effects like cramps and loose stool. Oral magnesium bisglycinate chelate can improve the frequency and intensity of pregnancyinduced leg cramps and may be a treatment option for women suffering from this condition. Unable to load your collection due to an error, Unable to load your delegates due to an error. High doses of magnesium from supplements or medications can cause nausea, abdominal cramping and diarrhea. 4.) The .gov means its official. Reduces leg cramps: Magnesium may help reduce leg cramps common during pregnancy. Bethesda, MD 20894, Web Policies While actually, the overall number of placebo is 66. Three women quit the study because of personal reasons and other three women were lost to followup. Background Oral magnesium for leg cramps treatment in pregnancy is a controversial issue according to recent Cochrane systematic review. it is unlikely that magnesium supplementation during pregnancy provides clinically meaningful cramp prophylaxis to leg-cramps. It was assumed a 5% bilateral alpha error, a 80% power and an expected 35% percentage of cramps in the intervention group. HHS Vulnerability Disclosure, Help What is the baseline level for cramps? 4. Even if perfectly balanced why did they not analyse in the context of a logistic regression, where the effects could be quantified in ORs? National Library of Medicine Federal government websites often end in .gov or .mil. Magnesium supplements are marketed for the prophylaxis of cramps but the efficacy of magnesium for this purpose remains unclear. Please do not edit.]. Thank you for submitting your work to PLOS ONE. found no significant effect of magnesium lactate/magnesium citrate on both frequency and intensity of leg cramps in pregnant women (Nygaard etal. This randomised placebocontrolled trial demonstrates that supplement of oral magnesium bisglycinate chelate significantly reduced both frequency and intensity of pregnancyinduced leg cramps than the placebo. demonstrated the therapeutic effect of magnesium lactate/magnesium citrate against leg cramps in pregnancy when compared with placebo (Dahle etal. You are completely rigth. This is supposed to offer robustness to our results. Both health care providers and women were masked to treatment assignment. Clinical trial registration: isrctn.org, http://isrctn.org, ISRCTN03989660 (This was registered after trial completion). An official website of the United States government. Data present as meanstandard deviation or n (%) (95% CI). The sample size calculation was based upon the 50% reduction in frequency of leg cramps in both groups obtained from Dahle etal. If your institution or institutions have a press office, please notify them about your upcoming paper to enable them to help maximize its impact. Secondary outcomes were the ocurrence of leg cramps and oral magnesium side effects. The primary outcome was the frequency of leg cramps which was defined as painful, involuntary contraction of muscles occurring at rest, mostly at night, and causing a palpable knot in the muscle, recorded at least twice a week. Additional statistical rationale for the sample size calculation is needed. An average of frequency of leg cramps reduced from every 1.5 days to every 3 days after the 3week period of magnesium supplement. The https:// ensures that you are connecting to the For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. They were randomized 1:1 to 300 mg/day of oral Mg++ citrate (n = 66) or placebo (n = 66). Before Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Careers, Unable to load your collection due to an error. 2008). Effectiveness. CI, confidence interval. Registration is free. FOIA Matern Child Nutr. In the present study, the therapeutic effect of magnesium bisglycinate chelate on leg cramps was better because of the form of magnesium and the longer duration of treatment (4 weeks). Methods: Who was blinded to the information? Other limitations are as follows: 1) The intensity of leg cramps pain was not evaluated. There were no studies of people who cramp while exercising. Please note that Supporting Information files do not need this step. This study was part of the Brazil MAGnesium trial [13] and registered at ClinicalTrials.gov (Identifier {"type":"clinical-trial","attrs":{"text":"NCT02032186","term_id":"NCT02032186"}}NCT02032186). PACE helps ensure that figures meet PLOS requirements. Magnesium is the second most abundant intracellular cation and a cofactor for more than 300 metabolic reactions in the body (Elin 1987). Bookshelf Function for sample size was determined by the software Clinical.com Statistics Sample Size Calculator View Power Calculations: N1={z1/2pq(1+1k)+z1p1q1+(p2q2k)}2/2q1=1p1q2=1p2p=p1+kp21+Kq=1pN1={1.960.570.43(1+11)+0.840.70.3+(0.450.551)}2/0.252N1=60N2=KN1=60N1={z1/2pq(1+1k)+z1p1q1+(p2q2k)}2/2q1=1p1q2=1p2p=p1+kp21+Kq=1pN1={1.960.570.43(1+11)+0.840.70.3+(0.450.551)}2/0.252N1=60N2=KN1=60, p1, p2 = proportion (incidence) of groups #1 and #2, = |p2-p1| = absolute difference between two proportions, = probability of type I error (usually 0.05), = probability of type II error (usually 0.2), K = ratio of sample size for group #2 to group #1. I am pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Accessibility Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. This may be another reason why the magnesium supplement had a higher therapeutic effect in this study. The intervention lasted 4 weeks and was completed between November 2015 and January 2018. 1 Magnesium for skeletal musclecramps (Review). Magnesium deficiency enhances neuromuscular transmission. All the database was reviewed with a biostatistician and it was observed that eleven 18-year-old pregnant women had not been included in the analysis. government site. Objective: Our purpose was to determine whether women with pregnancy-related leg cramps would benefit from oral magnesium supplementation. Background characteristics were also recorded; for example: age, gravida, parity, gestational age, income, education, standing or walking hours per day, prepregnancy body mass index (BMI), antenatal supplement drugs, calcium supplement, blood pressure, leg oedema and varicose vein. Answer: Thank you for this correction. Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent. For information on unacceptable data access restrictions, please see http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. What will this RCT add? Analysis of the trial was conducted in the intenttotreat (ITT) analysis. The recommended daily amount of magnesium for U.S. adults are as follows (note these amounts are higher for those pregnant or lactating): Males ages 19 to 30: 400 . 3.) This seems to indicate that the pregnant women studied were at nutritional risk. The 50% reduction of cramp intensity was also significantly higher in the treatment group than in the placebo group (69.8% vs. 48.8%, P=0.048). Why was a 50% reduction in leg cramps expected? Pregnancy also causes frequent leg cramps, possibly due to weight gain and disrupted circulation. Background: 2020 Oct 22;7:2054358120964078. doi: 10.1177/2054358120964078. 3) abstract says the 2 groups were comparable. 1995). IMIP registers about 6,000 deliveries per year. Do you want your identity to be public for this peer review? Leg cramps are common in pregnant women. Chisquared test and Fisher's exact test for categorical variables, independent ttest for continuous variables and MannWhitney Utest for nonparametric variables) were used when appropriate. Please enable it to take advantage of the complete set of features! The study is merely an observational trial. The ratio for randomization was 1:1, while the number of women in Mg supplementation group was 57 and 64 in the placebo group. These numbers were generated in a computer by Random Allocation Software2.0 program. PLOS authors have the option to publish the peer review history of their article (what does this mean?). Please have a check. CS wrote the draft article and VP critically revised the draft. Garrison SR, Allan GM, Sekhon RK, Musini VM, Khan KM. Both capsules were manufactured by IMIPs Department of Pharmacology. If they will be preparing press materials for this manuscript, please inform our press team within the next 48 hours. 2. We would appreciate receiving your revised manuscript by Sep 07 2019 11:59PM. Careers. The .gov means its official. For the followup CRF, leg cramps characteristics and side effects such as nausea, vomiting and diarrhoea were recorded. 2) information on the blinding is needed in title and/or abstract. Please see below the point-by-point responses to the reviewers specific comments. Profile of patient followup following randomisation to either treatment or placebo group. Answer: Effects and their CIs were provided. Federal government websites often end in .gov or .mil. DOI: 10.1111/j.1740-8709.2012.00440.x Abstract Leg cramps are common in pregnant women. the analysis plan is pretty poor. Before After the study was approved by the Ethics Committee of the Faculty of Medicine, Chulalongkorn University, eligible women who signed the informed consent were randomised into two groups: treatment or placebo group. Have the authors made all data underlying the findings in their manuscript fully available? Muscle cramps arise from spontaneous discharges of the motor nerves rather than from within the muscle itself (Miller & Layzer 2005). Pregnant women with different gestational ages were studied, interventions for variable periods of time (2 to 4 weeks) were used, different oral magnesium doses and oral formulations were administered. Our product contains 240 easy to swallow magnesium capsules that is TWICE the amount of products on the market. doi: 10.1002/14651858.CD010655.pub3. Magnesium was given orally in 10 of 11 studies, and by . 's study (Dahle etal. In the introduction, it would be more relevant to cite magnesium effects on muscle/ mechanistic effects rather than cite general information on the etiology of cramps. Our sample size was calculated based on the frequency of leg cramps which is the parameter most used in trials assessing leg cramps interventions. As a result, this study was able to show the higher effectiveness of magnesium in treating leg cramps. that's not 1 to 1? We carefully considered all comments offered by the reviewers. Too little potassium, calcium or magnesium in the diet can cause leg cramps. Has the statistical analysis been performed appropriately and rigorously? this value is a typo? Dalton LM, N Fhloinn DM, Gaydadzhieva GT, Mazurkiewicz OM, Leeson H, Wright CP. The screening failure rate is very high. 2015 Aug 11;(8):CD010655. All this informations were taken from the research diaries previously given to participants. Non-drug therapies for the secondary prevention of lower limb muscle cramps. In conclusion, oral magnesium supplementation during pregnancy did not reduce the ocurrence and frequency of episodes of leg cramps. We tried to develop a randomized double-blind controlled trial. Does oral magnesium substitution relieve pregnancyinduced leg cramps? Nygaard etal. On the contrary, Nygaard etal. Maternal & Child Nutrition 2015; 11(2):139145), methods section, The sample size calculation was based upon the 50% reduction in frequency of leg cramps in both groups obtained from Dahle etal. Magnesium was compared to placebo in nine of 11 studies, and compared to calcium, vitamin E, vitamins B and B, and no treatment, in two studies of pregnant women. Magnesium bisglycinate chelate (Chelated Magnesium, elemental Mg 100mg per tablet; Qualimed Co. Ltd., Bangkok, Thailand) was assigned to the treatment group and corresponding placebo to the placebo group. Supplementing with magnesium shows many benefits during pregnancy including a reduced risk of preeclampsia, stillbirth, low birth weight, and fetal growth restriction. 1995 Jul;173(1):175-80. doi: 10.1016/0002-9378(95)90186-8. The conclusions must be drawn appropriately based on the data presented. The criteria for discontinuation of the study were: symptoms reported by the patient or clinical signals due to the intake of the magnesium capsules or the cancellation of prenatal care at IMIP. A 2015 review of studies of 390 pregnant women found that taking magnesium or calcium supplements made little to no difference when it came to experiencing leg cramps. However other studies showed different results. If you have any billing related questions, please contact our Author Billing department directly at gro.solp@gnillibrohtua. The English summary of the protocol is an abbreviated version of the manuscript and provides no additional detail. Indiana University Richard M Fairbanks School of Public Health, UNITED STATES. Thank you very much for the opportunity to address the comments from the Reviewers. Started oral Mg citrate, and later Mg chloride, along with Epsom salts (Mg sulfate) baths. The BRAzil MAGnesium (BRAMAG) trial: a randomized clinical trial of oral magnesium supplementation in pregnancy for the prevention of preterm birth and perinatal and maternal morbidity. Thus, the compliance could be evaluated. Eighty women completed the study. At baseline, 74 (56.3%) had two . sharing sensitive information, make sure youre on a federal and transmitted securely. The number of subjects without leg cramp was significantly higher in the treatment group than the placebo group (48.8% vs. 27.9%, P=0.04) (Table2). Magnesium supplementation also aids in sleep, supports bone health, helps with muscle cramps, and has mood-boosting properties. leg cramps; magnesium bisglycinate chelate; oral; pregnancy; trial. Leg cramps are involuntary painful skeletal muscle contractions lasting from seconds to minutes, often nocturnal, and frequently involve the gastrocnemius [1,2]. The sample size calculation was based on the estimation of 50% reduction in frequency of leg cramp in Mg treatment group. 2. This limitation was added in the discussion: 4) Because this study was observational, it could be prone to biases. Accessibility For missing value: In your flwo chart, all 66*2 were included into your analysis, however, in your table 2 only 64 in treatment and 64 in control group were included into analyses. The importance of magnesium in clinical healthcare. This doubleblinded, randomised, placebocontrolled trial included 86 healthy pregnant women, 14-34 weeks of gestation who had leg cramps at least twice per week. Shortly after the formal acceptance letter is sent, an invoice for payment will follow. Congratulations! 2015 Apr;11(2):139-45. doi: 10.1111/j.1740-8709.2012.00440.x. Young G. Leg Cramps. However, the same can't be said for supplements. Systematic reviews have used frequency of leg cramps as a primary outcomes. This study is the first of its kind to use this form of magnesium. Answer: Thank you for this observation. The study period was 4 weeks. Please use the space provided to explain your answers to the questions above. 1992; Valbo & Bohmer 1999). Answer: We apologize for this mistake. The record will include editor decision letters (with reviews) and your responses to reviewer comments. 2015;. Satisfaction. Fortyone women were assigned to magnesium bisglycinate chelate (300mg per day) and 39 women to placebo. This site needs JavaScript to work properly. Answer: The CONSORT check list was changed to STROBE checklist. We acknowledge the assistance of medical and nursing staff of the antenatal care unit, Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University for their help in recruiting patients and ensuring the smooth conduct of the trial. Even more because magnesium requirements increase during pregnancy [7]. MeSH When you are ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. 2020 Dec 4;12(12):CD010655. Answer: Compliance/adherence, adverse events, and clinical intercurrences were monitored by the research team at each routine prenatal visit until the completion of the treatment. The site is secure. The primary outcome was the frequency of leg cramps episodes per week reported by pregnant women. Currently, there is no standard treatment for pregnancy-induced leg cramps. Oral magnesium for leg cramps treatment in pregnancy is a controversial issue according to recent Cochrane systematic review. Our study has strengths and limitation. 1994; Institute of Medicine 1999). 5: Exclusion of those with Mg at baseline >9.5mmol/dL is not physiologically plausible given the Mg reference range.. this value is a typo? Shwalfenberg GK, Genuis SJ. Answer: Baseline level for cramps was included. The pretreatment CRF was completed before beginning the treatment. Overall rating 5.0. After 4 weeks of intervention it was observed a 28.4% (39/132) (CI 95%: 20.937.0) reduction of leg cramps in all participants and no difference between the two groups was found; reduction of 27.2% (18/66) (CI 95%: 17.039.6) in Mg++ group and a reduction of 32.8% (21/66) (CI 95%: 21.645.7) in the placebo group. This is an interesting topic, but some details are missing from this manuscript. Internal research grant: Grant for Development of New Faculty Staff, Chulalongkorn University. Leg cramps after treatment, side effects and returned drug. 3) the methods section is very poor. -, Ponnapula P, Boberg JS. 5. The study medication packages were supplied with sequential numbers. Nutrition Allergies to Magnesium Fitness Magnesium and Heart Rate Women between the ages of 14 and 18: 400 milligrams of magnesium Women between the ages of 19 and 30: 350 milligrams of magnesium Women between the ages of 31 and 50: 360 milligrams of magnesium The round ligament is a muscle that supports the uterus, and when it stretches . Please check your manuscript thoroughly. Yldrm, E., & Apaydn, H. (2021). The registration refers to the Brazil MAGnesium trial, but neither the current study is referred to nor are the aims of the study defined as secondary outcomes. Oral magnesium supplementation for leg cramps in pregnancy a randomized controlled trial. Caution . Study design: Seventy-three women with pregnancy-related leg cramps were interviewed about their symptoms in a prospective, double-blind, randomized trial. & Wenstrom K.D. Magnesium supplementation in pregnancy (Review), Effect of magnesium therapy on nocturnal leg cramps: a systematic review of randomized controlled trials with meta-analysis using simulations. The site is secure. Details of leg cramps were recorded before beginning the treatment and the fourth week of study. Thank you for submitting your manuscript to PLOS ONE. Nygaard IH, Valbo A, Pethick SV, Bohmer T. Does oral magnesium substitution relieve pregnancy-induced leg cramps? In contrast, for those experiencing pregnancy-associated rest cramps the literature is conflicting and further research in this patient population is needed. We studied pregnancy-associated cramps and our conclusion is the same of Garrison et al, i.e. This file should be uploaded as separate file and labeled 'Manuscript'. Is the manuscript technically sound, and do the data support the conclusions? Answer: Participants, their doctors and all investigators. Presence of leg cramps was now considered as a secondary outcome. 2. Bookshelf Magnesium deficiency or insufficiency during pregnancy may pose a health risk for both the mother and the newborn, with implications that may extend into adulthood of the offspring. A P<0.05 was considered statistically significant. Because magnesium bisglycinate chelate's absorption rate is 2.2 times better than magnesium lactate or magnesium citrate, it was chosen for this trial. All the manuscript was completely reviewed. b) If there are no restrictions, please upload the minimal anonymized data set necessary to replicate your study findings as either Supporting Information files or to a stable, public repository and provide us with the relevant URLs, DOIs, or accession numbers. The primary outcome was the presence of the leg cramps. Randomised, cross-over, placebo controlled trial of magnesium citrate in the treatment of chronic persistent leg cramps. They found no significant effect of oral magnesium on frequency or intensity of leg cramps in pregnant women. Four pregnant women showed gastrointestinal side effects; 2 in each group had nauseas and diarrhoea. It measured cramp frequency on a fivepoint ordinal . sharing sensitive information, make sure youre on a federal -, Zhou K, West HM, Zhang J, Xu L, Li W. Interventions for leg cramps in pregnancy (Review). These 11 pregnant women (2 in the intervention group and 9 in the control group) were now included in the analysis and the ratio 1:1 restored. But the causes of leg cramps are wide-ranging. From this result, we recommend oral magnesium bisglycinate chelate for the treatment of pregnancyinduced leg cramps. Methods Maternal blood levels of magnesium may fall during pregnancy while the body is working to maintain adequate levels for the baby. some elaboration is needed, 4) no information on analyses methods in the abstract. Each pack was individually prescribed for each participant. PLOS authors have the option to publish the peer review history of their article (what does this mean?). The secondary outcomes were the 50% reduction of cramp intensity and side effects. 3.For missing value: In your flwo chart, all 66*2 were included into your analysis, however, in your table 2 only 64 in treatment and 64 in control group were included into analyses. Answer: The criteria for discontinuation of the study were: clinical signs or symptoms reported by the patient due to the intake of the capsules or the cancellation of prenatal care at hospital. Answer: Thank you very much for your analysis. HHS Vulnerability Disclosure, Help This systematic review implications for research were: To resolve the uncertainty surrounding the role of magnesium in pregnant women, parallelgroup blinded placebocontrolled RCTs of magnesium in that population are needed. A randomisation scheme was generated by random number table using a blockoffour technique. Supakatisant & Phupong in a RCT studied 80 pregnant women for 4 weeks [16] and observed a fifty per cent reduction of cramp frequency and intensity in the oral magnesium bisglycinate chelate group (300mg/day). (eg. Background characteristics of the study population. This letter should be uploaded as separate file and labeled 'Response to Reviewers'. official website and that any information you provide is encrypted This study aims to evaluate the efficacy of oral magnesium supplementation in the treatment of cramps during pregnancy in a low-income region. After careful consideration, we feel that it has merit but does not fully meet PLOS ONEs publication criteria as it currently stands. The groups showed no significant diferences with respect to age, years of study, employment, income, parity, body mass index, gestational age, number of leg cramps episodes per week and serum magnesium level (Table 1). Bethesda, MD 20894, Web Policies FOIA I will list several important design flaws: 1. The eligible pregnant women were those with 1434 weeks of gestation, having pregnancyinduced leg cramps at least twice a week, no other medical disease, no concurrent obstetrics complication, no other prescriptions for leg cramps and no history of magnesium allergy. MeSH Though rare, large dosesmore than 5,000 . National Library of Medicine Three serum levels are listed: should one be deleted? The reference Currently the 20% dropout rate is a little bit large. the contents by NLM or the National Institutes of Health. In table 2, 27,2 should be 27.2. 1). The odds ratio was calculated by logistic regression. The STROBE checklist would be more appropriate and will guide the authors to important aspects, which should be included in the description of the study. Cochrane Database Syst Rev. Hindawi 2017; Article ID 4179326:14. In addition, the definition of leg cramps was not well stablished in some studies. For example, in tbale 1, 36 in Mg group and 30 in placebo group were currently employed; while in total, 68 were currently employed. eCollection 2020. -. This observational controlled trial showed no efficacy of oral magnesium supplementation in the treatment of leg cramps during pregnancy. Randomization was performed in a 1:1 ratio using a table of random numbers, prepared by a researcher who did not participate in the data collection. Depending on your age, you need anywhere from 350 to 400 milligrams of magnesium every day while you're pregnant. Leg cramps are common for pregnant women often resulting in sleep disruption and related complications. The authors have declared that no competing interests exist. HHS Vulnerability Disclosure, Help The current sample size might not be sufficient for detecting the differences in the primary outcome, since they calculated it according to the frequency of leg cramp. FOIA If they will be preparing press materials for this manuscript, you must inform our press team as soon as possible and no later than 48 hours after receiving the formal acceptance. Does oral magnesium substitution relieve pregnancy-induced leg cramps? 2008 Nov;141(1):23-6. doi: 10.1016/j.ejogrb.2008.07.005. The etiology of cramps during pregnancy is unclear, but is believed to be due to overload of the ankle plantar flexors, excessive exercise, metabolic disorders, circulatory problems, underlying medical conditions, nutritional deficiencies (vitamins E and D) or electrolyte imbalances (eg. {"type":"clinical-trial","attrs":{"text":"NCT02032186","term_id":"NCT02032186"}}, {"type":"clinical-trial","attrs":{"text":"NCT 02032186","term_id":"NCT02032186"}}, Interventions for leg cramps in pregnancy (Review), Lower extremity changes experienced during pregnancy. The primary outcome was the frequency of leg cramps episodes per week reported by pregnant women. BMC Pregnancy Childbirth. And the author did not provide the detailed allocation concealment for randomization. Table 1: income values are approximately $50,000 annually? It was corrected. Currently, there is no standard treatment for pregnancy-induced leg cramps. pg. This study began after ethical approval. These 11 pregnant women (2 in the intervention group and 9 in the control group) were now included in the analysis and the ratio 1:1 restored. . 1.) This is very important in a RCT study. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. Many other inconsistences in your manuscript. Therefore, the sample size and corresponding power is not adequate for the current outcome (presence of leg cramps) and puts the validity of the analysis and subsequent conclusion into question. Code break envelopes were supplied to the lead pharmacist but not available for the investigation team. The number of participants in two groups were imbalanced. Leg cramp frequency and intensity were not influenced by oral magnesium supplementation. Thank you for submitting your manuscript to PLOS ONE. Among pregnant women who remained with leg cramps the mean of leg cramps episodes per week showed no significance difference between the Mg++ and placebo groups; t-student test: p = 0.408. Oral magnesium supplementation for leg cramps in pregnancy-An observational controlled trial. 9.) Adherence was defined as the ingestion of at least 80% of the prescribed dose. Muscle cramping can be a . Based on this we changed our primary outcome from the presence of leg cramps to frequency of leg cramps. Accessibility This number in the table 2 was corrected (Placebo 64 to Placebo 66). At baseline, 74 (56.3%) had two leg cramps episodes per week, 28 (21.1%) three episodes, 13 (9.8%) four episodes and 9 (6.8%) five or more episodes. Details of leg cramps were recorded before beginning the treatment and the fourth week of study. Eighty women completed the study. During the second trimester, a common cause of cramping is round ligament pain. eCollection 2020. The .gov means its official. What is the odds ratio? 4. The study period was 4 weeks. The objective of this study was to evaluate the therapeutic efficacy of oral magnesium in pregnant women with leg cramps. This present study shows the therapeutic effect of oral magnesium bisglycinate chelate in treating pregnancyinduced leg cramps. . Thus, the objective of this study was to evaluate the therapeutic effectiveness of oral magnesium bisglycinate chelate as a treatment for pregnancyinduced leg cramps. Dahle LO, Berg G, Hammar M, Hurtig M, Larsson L. Am J Obstet Gynecol. Four pregnant women showed gastrointestinal side effects; 2 in each group had nauseas and diarrhoea. Analytical statistics (i.e. 2020 Apr 9;20(1):208. doi: 10.1186/s12884-020-02877-0. Conclusion: Keywords: Cochrane Database Syst Rev. 3,4. 2. For any other questions or concerns, please email gro.solp@enosolp. This double-blinded, randomised, placebo-controlled trial included 86 healthy pregnant women, 14-34 weeks of gestation who had leg cramps at least twice per week. 2.) Please re-check your numbers. Please see http://www.bmj.com/content/340/bmj.c181.long for guidelines on how to de-identify and prepare clinical data for publication. One further aspect is, that randomization corresponds to the estimated sample size (2000 assigned to magnesium, 1000 assigned to placebo (with 2:1 allocation ratio) according to protocol on ClinicalTrials.gov) and not to the subsample of 132 patients (with an apparent 1:1 allocation ratio). pg. If you choose no, your identity will remain anonymous but your review may still be made public. *Chisquared test, Fisher's exact test, Independent ttest and MannWhitney Utest were used. 8.) Dahle LO, Berg G, Hammar M, Hurtig M, Larsson L. The effect of oral magnesium substitution on pregnancy-induced leg cramps, Oral magnesium for relief in pregnancy-induced leg cramps: a randomised controlled trial, Effect of Magnesium Supplement on Pregnancy Outcomes: A Randomized Control Trial, http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols, http://www.journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf, http://www.journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf, http://journals.plos.org/plosone/s/supporting-information, http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions, http://www.bmj.com/content/340/bmj.c181.long, http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. The OR of leg cramps was 1.3 (CI 95%: 0.6-2.9), p = 0.527, taking the placebo group as reference. There were no significant differences between the two groups in terms of side effects such as nausea and diarrhoea. Clipboard, Search History, and several other advanced features are temporarily unavailable. Reviewer #2: This is a randomized controlled trial to evaluate the effect of oral magnesium supplementation on leg cramps in pregnant women. Answer: The introduction was complemented. Interventions for leg cramps in pregnancy. doi: 10.1002/14651858.CD009402.pub2. Objectives Many therapies for leg cramps have been tried as gabapentin, pycnogenol, electrolytes and vitamins (magnesium, calcium, sodium, and vitamin E and vitamin D), massage, muscle stretching, relaxation, heat therapy and dorsiflexion of the foot [2]. The sample size of the initial study is based on the primary outcome (perinatal composite outcome). After 4 weeks of intervention it was observed a 28.4% (39/132) (CI 95%: 20.937.0) reduction of leg cramps in all participants and no difference between the two groups was found; reduction of 27.2% (18/66) (CI 95%: 17.039.6) in Mg++ group and 32.8% (21/66) (CI 95%: 21.645.7) in the placebo group. Interventions for leg cramps in pregnancy. They were randomized 1:1 to 300 mg/day of oral Mg++ citrate (n = 66) or placebo (n = 66). Answer: We apologize for this mistake. These trials have different measurements. Currently, there is no standard treatment for pregnancyinduced leg cramps; however, several studies have been conducted so far. Hall H, Lauche R, Adams J, Steel A, Broom A, Sibbritt D. Healthcare utilisation of pregnant women who experience sciatica, leg cramps and/or varicose veins: A cross-sectional survey of 1835 pregnant women, The importance of magnesium in clinical healthcare, Magnesium: The Forgotten Electrolyte-A Review on Hypomagnesemia. Nutrients. 2. An official website of the United States government. Stata version 12.1 was used for statistical analysis. This information was now provided in the method section. Leg cramps are involuntary, localised and usually painful skeletal muscle contractions, which commonly affect calf muscles (Young 2009). Fortyone women were assigned to the magnesium bisglycinate chelate group (300mg per day) and 39 women were assigned to the placebo group. Provide information on whether any stopping rules were instituted (CONSORT missing item). This primary outcome was determined a priori, and the research proposal was sent to the Institute Reviewer Board. These results demonstrated that oral magnesium supplement can improve the frequency and intensity of pregnancy-induced leg cramps. Disclaimer. The elemental form of magnesium is chelated to maximize absorption. Garrison SR, Allan GM, Sekhon RK, Musini VM, Khan KM. This trial tests the hypothesis that oral magnesium supplementaton during pregnancy may reduce the frequency od leg cramps episodes. Women started recording followup CRF at the beginning of the fourth week and completed it at the end of the fourth week. magnesium, calcium and sodium) [1,2,4]. For background characteristics, there were no significant differences between the groups with respect to age, gravida, parity, gestational age, income, education, hours of standing or walking per day, prepregnancy BMI, antenatal supplement drug, calcium supplement, blood pressure, leg oedema and varicose vein (Table1). Varghese A, Lacson E Jr, Sontrop JM, Acedillo RR, Al-Jaishi AA, Anderson S, Bagga A, Bain KL, Bennett LL, Bohm C, Brown PA, Chan CT, Cote B, Dev V, Field B, Harris C, Kalatharan S, Kiaii M, Molnar AO, Oliver MJ, Parmar MS, Schorr M, Shah N, Silver SA, Smith DM, Sood MM, St Louis I, Tennankore KK, Thompson S, Tonelli M, Vorster H, Waldvogel B, Zacharias J, Garg AX; Dialysate Magnesium (Dial-Mag) Investigators. Chi-squared test for categorical variables and independent t-test for continuous variables were used when appropriate. Answer: During the second trimester 70.0 % (91/130) of 130 participants that had leg cramps in the first trimester continued presenting leg cramps. The study was approved by the IMIPs Committee on Research (document number 4033), and was registered in the ClinicaTrials.gov ({"type":"clinical-trial","attrs":{"text":"NCT 02032186","term_id":"NCT02032186"}}NCT 02032186). For pregnant people 18 or older, the requirements are increased to 350-360 mg per day ( 2 ). Please re-check your numbers. Chulalongkorn University, Leg cramps are common for pregnant women; 3045% of pregnant women suffer from leg cramps (Hertz etal. Participants were asked to return followup CRF and the plastic container at the end of the fourth week. Bethesda, MD 20894, Web Policies These authors also contributed equally to this work. Furthermore, there has been a report that Thai people consumed less dietary magnesium per day compared with the western population. The results of this study provided new information regarding the use of magnesium bisglycinate chelate in women with pregnancyinduced leg cramps. Fifteen millimol per day of magnesium lactate/magnesium citrate or placebo was prescribed for 3 weeks. the contents by NLM or the National Institutes of Health. A new paragraph and four news references were added. 2008 Nov;141(1):23-6. doi: 10.1016/j.ejogrb.2008.07.005. we need some measure of the absolute, not only relative, reduction. 13.) Definition of leg cramps was sudden tonic or clonic involuntary contraction of the gastrocnemius muscle associated with severe pain. When you are ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. This doubleblinded, randomised, placebocontrolled trial included 86 healthy pregnant women, 14-34 weeks of gestation who had leg cramps at least twice per week. 7. The mean magnesium serum level was 1.84 mg/dL (CI 95%: 1.801.87) in the Mg++ group and 1.84 mg/dL (CI 95%: CI 1.801.87) in placebo group (t-Student test: p = 0.872). Answer: Thank you for this observation. The primary outcome is the presence of leg cramps, while the outcome used for calculating sample size is the secondary outcome. Randomisation scheme was generated by Random allocation Software2.0 program from a third partythose must be clear, correct and! 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