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The Multiple Lifestyle Modification for Patients With Open Access Protocol BMJ Open: first published as 10.1136/bmjopen-2014-004920 on 14 August 2014. Downloaded from The multiple lifestyle modification for patients with prehypertension and hypertension patients: a systematic review protocol Juan Li,1 Hui Zheng,1 Huai-bin Du,2 Xiao-ping Tian,2 Yi-jing Jiang,3 Shao-lan Zhang,4 Yu Kang,5 Xiang Li,2 Jie Chen,1 Chao Lu,1 Zhen-hong Lai,1 Fan-rong Liang1 To cite: Li J, Zheng H, ABSTRACT et al Strengths and limitations of this study Du H-bin, . The multiple Introduction: The objective of this systematic review lifestyle modification for is to investigate the effectiveness, efficacy and safety ▪ patients with prehypertension To the best of our knowledge, this is the first of multiple concomitant lifestyle modification and hypertension patients: a systematic review to investigate the effectiveness, systematic review protocol. therapies for patients with hypertension or efficacy and safety of multiple lifestyle changes BMJ Open 2014;4:e004920. prehypertension. for patients with hypertension. doi:10.1136/bmjopen-2014- Methods and analysis: Electronic searches will be ▪ The results of this systematic review can provide 004920 performed in the Cochrane Library, OVID, EMBASE, clinicians with useful clinical information to etc, along with manual searches in the reference lists guide their patient care and increase the under- ▸ Prepublication history for of relevant papers found during electronic search. We standing of lifestyle modifications, as well as this paper is available online. will identify eligible randomised controlled trials motivate patients with hypertension to adopt and To view these files please utilising multiple lifestyle modifications to lower blood maintain multiple lifestyle changes. visit the journal online pressure. The control could be drug therapy, single ▪ The limitation of this systematic review is that it (http://dx.doi.org/10.1136/ lifestyle change or no intervention. Changes in may be difficult to retrieve all the multiple life- bmjopen-2014-004920). systolic blood pressure and diastolic blood pressure style modifications for patients with hyperten- constitute primary end points, and secondary end sion. We will cooperate with the experienced http://bmjopen.bmj.com/ points include the number of patients meeting the medical librarian to design an appropriate search JL and HZ contributed office target blood pressure, the number of patients strategy, in order to ensure a broad search. equally. reporting microvascular or macrovascular complications, etc. We will extract descriptive, Received 1 February 2014 methodological and efficacy data from identified Revised 23 July 2014 randomised controlled trials (RCTs). We will calculate BACKGROUND Accepted 30 July 2014 the relative risk for proportion of patients with a Essential hypertension continues to be an normal blood pressure in the experimental group. important public health challenge world- 1 Dichotomous data will be analysed using risk wide. Hypertension (7%) is the leading on September 25, 2021 by guest. Protected copyright. difference and continuous data using weighted mean cause of death followed by stroke (16.6%) 2 differences, both with 95% CI. We will use the χ and heart failure (7.3%).2 It is an independ- 2 test and the I statistic to assess heterogeneity. We ent risk factor affecting the development of will use the fixed effects model to compute the cardiovascular disease (myocardial infarction, efficacy unless there is evidence of heterogeneity. If heart failure and stroke), chronic kidney heterogeneity of effect size persists with respect to disease and peripheral vascular disease.2 blood pressure change, further metaregression will be Hypertension affects 29.3% of the adult performed within groups. We will examine the 3 potential for publication bias by using a funnel plot. population in the USA. It affects almost Dissemination: We will synthesise results from 18.8% of the Chinese population according RCTs which provide more precise and accurate to the fourth National Nutrition and Health 4 information on the effect of multiple lifestyle changes Survey in 2002. The Joint National on blood pressure. The results of this review will Committee ( JNC)-7 created a new category increase the understanding of multiple lifestyle of hypertension, ‘prehypertension’,5 which is For numbered affiliations see modifications for patients with hypertension or fi end of article. de ned as systolic blood pressure (SBP) of prehypertension. 120–139 mm Hg or diastolic blood pressure Trail registration number: Our protocol is (DBP) of 80–89 mm Hg. Patients in this cat- Correspondence to registered on PROSPERO (CRD42013006476), http:// egory are at increased risk for progression to Fan-rong Liang; www.crd.your.ac.uk/PROSPERO. [email protected] hypertension. Numerous studies emerged Li J, et al. BMJ Open 2014;4:e004920. doi:10.1136/bmjopen-2014-004920 1 Open Access BMJ Open: first published as 10.1136/bmjopen-2014-004920 on 14 August 2014. Downloaded from later to investigate the risk of prehypertension for Participant characteristics various types of adverse outcomes, including stroke, cor- Participants to be included are adult participants onary heart disease and cardiovascular disease (CVD), (≥18 years of age) presenting with prehypertension – and all-cause mortality.6 9 From 2005 to 2006, approxi- (SBP: 120–139 mm Hg; DBP 80–89 mm Hg) or essential mately three of eight adults in the USA had blood pres- hypertension (SBP ≥140 mm Hg; DBP ≥90 mm Hg), sure in the prehypertensive range of 120–139/ according to the JNC guideline.5 Restrictions will not be 80–89 mm Hg and roughly one in eight adults had placed on the gender or ethnic background of blood pressure in the range of 130–139/85–89 mm participants. Hg.10 Furthermore, the number of patients with hyper- tension and prehypertension patients is still increasing. Although hypertension and prehypertension affects a Intervention characteristics fi large portion of the population, recognition and Studies utilising multiple lifestyle modi cations (a com- 11 bination of at least two of the following methods: weight adequate treatment are less than ideal. Despite the – loss,21 DASH diet,22 25 dietary sodium reduction,26 phys- availability of multiple effective antihypertensive drugs, 27 hypertension control rates remain poor. Hypertension ical activity, moderation of alcohol consumption) will fi expenditures represent a significant amount of health- be reviewed. We include multiple lifestyle modi cations care resource use.12 The total annual medical expendi- consisting of at least dietary pattern changes (including tures attributed to hypertension including comorbidities sodium reduction) and physical activity. We also allow are estimated to range from US$108 to US$110 billion.13 cointerventions if they are applied in all arms (including As we all known, some antihypertensive drugs may cause antihypertensive drugs, self-monitoring). The lifestyle fi side effects such as dizziness, headache, fatigue, chest modi cation should last for at least 4 weeks, and the discomfort, cough and sexual dysfunction, prompting follow-up phase should be at least 4 weeks. And how did some patients to discontinue therapy. the patients implement the lifestyle changing must be fi Therefore, there is an urgent need to develop and speci ed in the original article. However, studies using implement non-pharmacological methods (such as salt nurse, physician or pharmacologist counselling reduction, weight loss and exercise) to improve preven- (face-to-face, group counselling, etc), and computer or tion and treatment of this major cause of death. As a telephone monitoring will be excluded. modifiable risk factor, treatment of prehypertension and hypertension through lifestyle changes is a vital Control arm characteristics 14 approach. Lifestyle interventions have a profound Studies utilising any type of non-pharmacological treat- impact on the national economic impact of hyperten- 12 15 16 ment, single lifestyle change, waiting list, no intervention sion. The JNC-8 and 2013 ESH/ESC guidelines or any type of antihypertensive drugs as a control arm http://bmjopen.bmj.com/ 17–20 fi and the results of trials on lifestyle modi cation for will be included. fi hypertension recommended that lifestyle modi cation is We will include the following controls: capable of lowering the blood pressure. However, little is 1. Multiple lifestyle modifications+antihypertensive fi known about the ef cacy of programmes that intervene drugs versus antihypertensive drugs; on multiple lifestyle factors to maximise the blood pres- 2. Multiple lifestyle modifications versus waiting list sure lowering effect. Evidence regarding the magnitude control or no intervention; fi of multiple lifestyle modi cation-related reductions in 3. Multiple lifestyle modifications versus sham control fi on September 25, 2021 by guest. Protected copyright. blood pressure is inconsistent. Also, the bene ts of mul- (irrelevant lifestyle modification for hypertension); tiple lifestyle changes have not been carefully examined. 4. Multiple lifestyle modifications versus single lifestyle We raised the following questions: (1) Is a multiple con- modification. comitant lifestyle modification therapy effective for patients with hypertension or prehypertension? (2) If so, what is the magnitude of multiple lifestyle modification- Outcome measures related reductions on blood pressure? We will pool The primary outcomes of this systematic review are the results from randomised control trials
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