\r\n\tThis book aims to introduce general concepts about clock synchronization describing clock generation techniques and the properties of oscillators, phase-locked loops and in general of frequency synthesizers. Also welcome are topics that describe clock synchronization for digital ICs and the pertaining low-latency clock domain crossing techniques based on clock phase adjustment and standards for clock synchronization, such as the IEEE1588 and the Precision Time Protocol. Moreover, the book aims to describe the issues of sub-nanosecond synchronization in distributed systems on scales from a few tens of meters to a few tens of kilometers.
",isbn:null,printIsbn:"979-953-307-X-X",pdfIsbn:null,doi:null,price:0,priceEur:0,priceUsd:0,slug:null,numberOfPages:0,isOpenForSubmission:!1,hash:"543befd169b67a8eef0040e3a88b7e25",bookSignature:"Prof. Raffaele Giordano",publishedDate:null,coverURL:"https://cdn.intechopen.com/books/images_new/8461.jpg",keywords:"General Properties, Clock Signals, Clock Distribution Systems, Clock Generation, Frequency Stability, Phase Locked Loops, Frequency Synthesizers, Low Latency, Predictable Latency, Clock Synchronization, Global Position System, IEEE 1588",numberOfDownloads:null,numberOfWosCitations:0,numberOfCrossrefCitations:0,numberOfDimensionsCitations:0,numberOfTotalCitations:0,isAvailableForWebshopOrdering:!0,dateEndFirstStepPublish:"June 5th 2019",dateEndSecondStepPublish:"December 25th 2019",dateEndThirdStepPublish:"February 23rd 2020",dateEndFourthStepPublish:"May 13th 2020",dateEndFifthStepPublish:"July 12th 2020",remainingDaysToSecondStep:"a year",secondStepPassed:!0,currentStepOfPublishingProcess:5,editedByType:null,kuFlag:!1,biosketch:null,coeditorOneBiosketch:null,coeditorTwoBiosketch:null,coeditorThreeBiosketch:null,coeditorFourBiosketch:null,coeditorFiveBiosketch:null,editors:[{id:"193125",title:"Prof.",name:"Raffaele",middleName:null,surname:"Giordano",slug:"raffaele-giordano",fullName:"Raffaele Giordano",profilePictureURL:"https://mts.intechopen.com/storage/users/193125/images/system/193125.jfif",biography:'Raffaele Giordano is a Senior Assistant Professor at the Univerisity of Naples "Federico II", Italy. He has spent most of his scientific career in the field of research and development of electronics for data acquisition and processing in Nuclear and Subnuclear Physics experiments, including ATLAS, RD51, Belle2 and SuperB. He is the author of 371 papers on well-recognized scientific international peer-reviewed journals, including IEEE TNS, NIM-A, and JINST. His H-index is higher than 63 and the total number of citations is around 20k. He gave numerous contributions to international conferences (including 15 oral, 2 invited oral). He is the inventor of granted patents in the field of digitally controlled oscillators and methods for radiation hardening of SRAM-based FPGAs.',institutionString:"University of Naples Federico II",position:null,outsideEditionCount:0,totalCites:0,totalAuthoredChapters:"1",totalChapterViews:"0",totalEditedBooks:"0",institution:{name:"University of Naples Federico II",institutionURL:null,country:{name:"Italy"}}}],coeditorOne:null,coeditorTwo:null,coeditorThree:null,coeditorFour:null,coeditorFive:null,topics:[{id:"9",title:"Computer and Information Science",slug:"computer-and-information-science"}],chapters:null,productType:{id:"1",title:"Edited Volume",chapterContentType:"chapter",authoredCaption:"Edited by"},personalPublishingAssistant:{id:"297737",firstName:"Mateo",lastName:"Pulko",middleName:null,title:"Mr.",imageUrl:"https://mts.intechopen.com/storage/users/297737/images/8492_n.png",email:"mateo.p@intechopen.com",biography:"As an Author Service Manager my responsibilities include monitoring and facilitating all publishing activities for authors and editors. From chapter submission and review, to approval and revision, copyediting and design, until final publication, I work closely with authors and editors to ensure a simple and easy publishing process. I maintain constant and effective communication with authors, editors and reviewers, which allows for a level of personal support that enables contributors to fully commit and concentrate on the chapters they are writing, editing, or reviewing. I assist authors in the preparation of their full chapter submissions and track important deadlines and ensure they are met. I help to coordinate internal processes such as linguistic review, and monitor the technical aspects of the process. As an ASM I am also involved in the acquisition of editors. 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Venkateswarlu",coverURL:"https://cdn.intechopen.com/books/images_new/371.jpg",editedByType:"Edited by",editors:[{id:"58592",title:"Dr.",name:"Arun",surname:"Shanker",slug:"arun-shanker",fullName:"Arun Shanker"}],productType:{id:"1",chapterContentType:"chapter",authoredCaption:"Edited by"}},{type:"book",id:"72",title:"Ionic Liquids",subtitle:"Theory, Properties, New Approaches",isOpenForSubmission:!1,hash:"d94ffa3cfa10505e3b1d676d46fcd3f5",slug:"ionic-liquids-theory-properties-new-approaches",bookSignature:"Alexander Kokorin",coverURL:"https://cdn.intechopen.com/books/images_new/72.jpg",editedByType:"Edited by",editors:[{id:"19816",title:"Prof.",name:"Alexander",surname:"Kokorin",slug:"alexander-kokorin",fullName:"Alexander Kokorin"}],productType:{id:"1",chapterContentType:"chapter",authoredCaption:"Edited by"}},{type:"book",id:"314",title:"Regenerative Medicine and Tissue Engineering",subtitle:"Cells and Biomaterials",isOpenForSubmission:!1,hash:"bb67e80e480c86bb8315458012d65686",slug:"regenerative-medicine-and-tissue-engineering-cells-and-biomaterials",bookSignature:"Daniel Eberli",coverURL:"https://cdn.intechopen.com/books/images_new/314.jpg",editedByType:"Edited by",editors:[{id:"6495",title:"Dr.",name:"Daniel",surname:"Eberli",slug:"daniel-eberli",fullName:"Daniel Eberli"}],productType:{id:"1",chapterContentType:"chapter",authoredCaption:"Edited by"}},{type:"book",id:"57",title:"Physics and Applications of Graphene",subtitle:"Experiments",isOpenForSubmission:!1,hash:"0e6622a71cf4f02f45bfdd5691e1189a",slug:"physics-and-applications-of-graphene-experiments",bookSignature:"Sergey Mikhailov",coverURL:"https://cdn.intechopen.com/books/images_new/57.jpg",editedByType:"Edited by",editors:[{id:"16042",title:"Dr.",name:"Sergey",surname:"Mikhailov",slug:"sergey-mikhailov",fullName:"Sergey Mikhailov"}],productType:{id:"1",chapterContentType:"chapter",authoredCaption:"Edited by"}},{type:"book",id:"1373",title:"Ionic Liquids",subtitle:"Applications and Perspectives",isOpenForSubmission:!1,hash:"5e9ae5ae9167cde4b344e499a792c41c",slug:"ionic-liquids-applications-and-perspectives",bookSignature:"Alexander Kokorin",coverURL:"https://cdn.intechopen.com/books/images_new/1373.jpg",editedByType:"Edited by",editors:[{id:"19816",title:"Prof.",name:"Alexander",surname:"Kokorin",slug:"alexander-kokorin",fullName:"Alexander Kokorin"}],productType:{id:"1",chapterContentType:"chapter",authoredCaption:"Edited by"}},{type:"book",id:"2270",title:"Fourier Transform",subtitle:"Materials Analysis",isOpenForSubmission:!1,hash:"5e094b066da527193e878e160b4772af",slug:"fourier-transform-materials-analysis",bookSignature:"Salih Mohammed Salih",coverURL:"https://cdn.intechopen.com/books/images_new/2270.jpg",editedByType:"Edited by",editors:[{id:"111691",title:"Dr.Ing.",name:"Salih",surname:"Salih",slug:"salih-salih",fullName:"Salih Salih"}],productType:{id:"1",chapterContentType:"chapter",authoredCaption:"Edited by"}},{type:"book",id:"872",title:"Organic Pollutants Ten Years After the Stockholm Convention",subtitle:"Environmental and Analytical Update",isOpenForSubmission:!1,hash:"f01dc7077e1d23f3d8f5454985cafa0a",slug:"organic-pollutants-ten-years-after-the-stockholm-convention-environmental-and-analytical-update",bookSignature:"Tomasz Puzyn and Aleksandra Mostrag-Szlichtyng",coverURL:"https://cdn.intechopen.com/books/images_new/872.jpg",editedByType:"Edited by",editors:[{id:"84887",title:"Dr.",name:"Tomasz",surname:"Puzyn",slug:"tomasz-puzyn",fullName:"Tomasz Puzyn"}],productType:{id:"1",chapterContentType:"chapter",authoredCaption:"Edited by"}}]},chapter:{item:{type:"chapter",id:"68822",title:"Heavy Metal Removal Techniques Using Response Surface Methodology: Water/Wastewater Treatment",doi:"10.5772/intechopen.88915",slug:"heavy-metal-removal-techniques-using-response-surface-methodology-water-wastewater-treatment",body:'Due to the vital role of water for humanity, it is necessary to improve and maintain its quality. Environmental and global changes especially industrial wastes and domestic and agricultural activities are the main water pollution source. Worldwide, several water resources even underground water resources are contaminated, and they are not a suitable quality for drinking. Because of the rising living standards, growing world population, unconscious water consumption, and urbanization lead to increasing water supply costs. In most cases, as it contains different and large number of pollutants, wastewater lead to ecosystem hazards for being released around without being processed. So a few decades later, the world could face a major problem with freshwater supply [1]. In the past, very little financial resources have been allocated for wastewater because water supply received more priority than wastewater treatment (WWT). But, because of the increasing rapid population growth and trends in urbanization, WWT plays an important role in human life. Recently, because of the impact of sewage contamination of groundwater, rivers, and lakes, the growing awareness of wastewater treatment is now receiving greater attention from researchers and environmentalists. Research study results revealed that WWT, which is managed appropriately, has a large share in the growing economy when water resources treatment and supply are done in an appropriate manner [2, 3]. Safe, reliable, and sustainable treated WWT strategies have a vital role because of several challenges including adoption of low-cost WWT technologies. To prevent the spread of diseases, WWT systems are crucial, and they should have high levels of hygienic standards for reuse in agricultural and other areas. Lack of WWT can lead to environmental pollution, and it may cause a hazardous effect for the health of humans. To improve global health and to prevent spread of disease, reliable collection and treatment of wastewater are very important. Wastewater treatment and their reuse need innovative and appropriate technologies. Recently, WWT technologies including electrochemical technologies have regained their importance worldwide. In some cases, the electrochemical mechanism for metal recovery is very simple. These technologies have reached comparably with other technologies in terms of cost and efficiency [4]. Economic issues besides environmental and social aspects must be considered when choosing the most appropriate WWT method [5, 6]. All scientists and environmentalists desire widespread recognition of the need to implement more sustainable WWT techniques. Wastewater treatment technologies follow two main approaches: first is the development of a single indicator integrating different criteria and second is the development of a set of multidisciplinary indicators [7, 8]. When large volumes of treated wastewater contain low concentrations of chemical constituent discharge-receiving water body, it may still lead to water quality problem. Discharges from industrial activities have been identified as one of the major sources of aquatic pollution in industrialized countries. After 1990, to remove toxic pollutants in wastewater, scientists focused on persistent organic pollutants including PCBs, PAHs, and especially heavy metals due to destructive effects [9, 10]. People’s anxieties also increase because of pollutions caused by heavy metals. Pollutions caused by heavy metals spread into the aqueous systems from many industries such as metal plating and smelters, eluents from plastics, mining, and textile industries [11]. Toxic heavy metals including mercury and chromium are discharged to the environment, and unfortunately they cannot biodegrade in nature [12, 13]. Heavy metals can be traveled through the food chain via bioaccumulation, the increase of heavy metals in human body causes some major diseases like brain, pancreas, and heart diseases, and they can lead to wide spread capillary damage and gastrointestinal irritation besides possibly necrotic changes in some tissue [14]. Even at low concentrations, heavy metals can cause serious toxic and harmful effects on the organism and the environment. The World Health Organization (WHO) limited heavy metal concentrations. Such as in drinking water, maximum acceptable limit of copper concentration is offered as 1.5 mg L−1, when the limit concentrations of metals containing hazardous waste are different [15, 16]. Ion exchange, extraction, membrane filtration, and chemical precipitation especially adsorption techniques have been applied to remove heavy metals; on the other hand, generally adsorption technique is one of the most chosen method because of its simplicity, nontoxicity, cost-effectiveness, and local availability to remove toxic heavy metals from aqueous medium [12, 17, 18, 19]. In addition, heavy metal removal from different samples by natural adsorbents using adsorption is in the most appropriate technique, and the use of natural adsorbents has been the preferred choice for many researchers [20, 21]. In large number of studies, activated carbon, carbon nanotubes, clays, nanosized metal oxides, zeolites, and various biosorbents were used. However, statistical and optimization research using RSM with CCD or Box-Behnken design about heavy metal removal under various physicochemical parameters is restricted and very rare. Although numerous studies are in literature about heavy metal removal sorption using different materials, there are very little studies with the application of WWT using methodological approach. Classical and conventional methods cannot depict all factor combinations, which affect the experiment. At the same time, these methods take a lot of time to experiment for the determination of the optimum levels. Limitations can be eliminated using a statistical experimental design, which is optimizing all the effecting parameters collectively. In order for modeling of process parameters, RSM that contains a small number of experiments is widely used in various processes especially in adsorption [22]. Experimental design technique is a suitable tool for developing, improving, and optimizing process and multifactor experiments. It researches the common relationship between various factors for the most favorable conditions of the process, which helps to determine the interactions among optimized parameters [22, 23]. The primary target of RSM is to detect the optimum operational conditions for the system or to detect a region that compensates the operating specifications. The aim of this study was to present heavy metal removal from wastewater using RSM as a statistical technique. After discussion of wastewater treatment techniques as detail, several heavy metal removal methods from industrial wastewater will be presented.
There are two aims of wastewater treatment: firstly to purify wastewater without harming the public health and/or causing other nuisance and secondly to gain energy, nutrients, water, and other valuable resources from wastewater during purification steps.
Contaminated waters contain (Figure 1) various pollutants such as nutrients, various chemical compounds, and numerous pathogenic microorganisms besides toxic compounds. Inorganic solids, organic solids, and pathogenic microorganisms along with metals constitute a significant part of wastewater. While inorganic solids include salt, sediment, soil, and especially metals, organic solids contain food wastes, paper, and another household waste material. During WWT step, the removal of primarily organic particles especially suspended solids is vital prior to discharge to the environment. The proteins, lipids and carbohydrates are biodegradable components of wastewater. Biodegradable components contain carbon, and they can be converted to carbon dioxide. If these biodegradable organics are not removed from the wastewater, oxygen demand will exert in the receiving watercourse. Biochemical oxygen demand (BOD) or chemical oxygen demand (COD) is typical measures of organic matter. BOD is the most widely used parameter to quantify organic pollution of water. BOD is the measurement of the dissolved oxygen that is used by microbes in the chemical oxidation of organic matter.
Typical wastewater composition.
It is important to understand the nature of water pollutants because wastewaters contain a large number of pollutants; however, toxicity is observed when the acceptable limits are exceeded. Wastewater contents depend on industrial, agricultural, and municipal wastewater. There are various water pollutants in nature, and they can be categorized as microbiological, radioactive, particulate, organic, and inorganic chemical contaminants. Harmful microbes such as viruses, fungi, bacteria, algae, plankton, and other microorganisms are basic components of bio-pollution in the water. These microorganisms may be responsible for various diseases. Organic toxic pollutants include many insecticides such as dichlorodiphenyltrichloroethane, herbicides, and other pollutants were manufactured for use in various industries. However, heavy metals are the most common inorganic water pollutants. Microbiological, radioactive, particulate, organic, and inorganic chemical water contaminants remain either in suspended, colloidal, or in solvated form.
Because of the increasing population and rapid pollution of water resources, WWT and reuse are an important issue. The efficient use of existing water resources and treatment of polluted water resources with affordable and cheap technologies have been the focus of scientists. WWTs are needed for three reasons; these are water source reduction, WWT, and recycling. Recently, during purification step, while primary treatment includes preliminary physical and chemical purification processes, secondary treatment depends on biochemical decomposition of organic solids to inorganic or stable organic solids. Finally, after the third step called tertiary treatment processes, wastewater is converted into good-quality water, and it can be used for drinking or medicinal supplies. At the end of this step, almost all of the pollutants (up to 99%) can be removed from water. To producing good-quality and safe water, all these three processes should be combined together. Otherwise, it will not be possible to obtain safe water from the wastewater. Many advanced methods and techniques have been used for the recycle of safe water from wastewater, but economic and effective water treatment is still a serious problem. Treatment of wastewater and recycling technologies have been classified (Figure 2), and it is carried out in three stages. They are:
Primary treatment methods
Secondary treatment methods
Tertiary treatment methods
Wastewater treatment and recycling methods.
These methods are briefly described below.
In order to remove organic matter and suspended solids from wastewater by means of physical operations, for example, sedimentation and gravity separation, they are done in primary treatment stage. Preliminary treatment, which is described as preparation for secondary treatment, is in fact intended to produce a liquid waste suitable for biological treatment.
Screening separation method is used to remove solid wastes from wastewater. It is the process where suspended and floating materials including wood, paper, kitchen refuse, pieces of cloth, cork, hair, fibers, and fecal solids are removed from wastewater. In a WWT, screening is generally used as the first operation step. For this purpose, various size screens are used, and their size is selected as per the requirement. Finer particles such as sand and small pebbles can be eliminated by using screening separation method.
About 0.1–0.5 mm pore size is used in filtration separation method, water is passed through a medium having fine pores, and the filtration process is completed. Various membranes and filters, for example, cartridges, can frequently be used to remove suspended solids, greases, oils, and bacteria from the wastewater. The main purpose of filtration separation method is to separate the small solids and remove oil (they can be reduced up to 99%). Filtered water is used for many purposes such as ion exchange, adsorption, or membrane separation processes. In pharmaceutical and biotechnological industries, to the production of pure water, filtration separation method has become the main focus as promising separation tool for WWT. The used membrane has a key role due to selectivity, low fouling, and performance stability for long-term operation in the filtration separation method. Because of these advantages, this method and its performance are becoming more and more important. In addition, it is one of the important enrichment techniques for trace heavy metal ions along with simplicity and rapidity of the procedure. For all these reasons, many scientists have focused on this subject to develop and use alternative and effective membranes [24, 25].
This method is provided for separating components of a fluid or solid particles, but it is used especially for suspend solid from wastewater. Various types of centrifugal machines have been used to remove suspended noncolloidal solids in the centrifugal separation method. To separate solids from wastewater, centrifugal devices with various sizes are used. Density of suspended solids is the most important parameter when separating solid materials by centrifugation. In addition, oils and greases can be reduced and separated during application of centrifugal separation method.
Sedimentation and gravity separation method are based on the removal of suspended solids, grits, and silts from aqueous media. Suspended solid materials settle down to the bottom of the tank under the influence of gravity; this event may vary depending on solid size and density. Some chemicals can sometimes be added to accelerate sedimentation process. Although this method can reduce suspended solids only up to 60%, purification of wastes is a very useful separation application. Water treatment in this technique can be used in many areas such as water for membrane filtration processes and ion exchange method. It is generally applied out prior to conventional treatment.
Coagulation processes are a particularly effective cleaning method for containing oil-in-water emulsions such as sea, lakes, and rivers besides most industrial wastes contain especially oil or petroleum. After sedimentation and gravity separation method, if there are non-settleable solids in wastewater, this is called processing coagulation with the addition of certain chemicals to precipitate these non-settleable solids and non-precipitating deposits. There are some natural coagulants such as aluminum salts, iron materials, alum, starch, and activated silica and also some polymers that can be used as coagulants. In this process, the most important controlling factors are contact time, temperature, and pH. In addition, during biological treatment processes, to remove microbes and any organics in the water, some certain coagulants can be added. Coagulation processes play an important role in recycling and removing pollutants from wastewater.
In order to remove suspended solid including oils, greases, biological solids, and other solids from wastewater, flotation separation method is used. In these processes, suspended solids are removed by adhering them with either air or gas. Various chemicals like alum and activated silica are used to successfully apply the flotation process to wastewater because they help flotation separation method. For paper and refinery industries, flotation separation method is an effective method for WWT because suspended solids that oil and grease is can easily be removed (up to 75–99%) by these processes. Recently, to separate mixed plastic is too difficult using gravity separation; therefore, for WWT and recycling purposes, plastic flotation method has been used as effectively [26].
Secondary treatment techniques have been used to remove soluble and insoluble pollutants from wastewater as biological. The main objective of this process is to convert the organic and inorganic solids into fluorinated residues that are finely divided and dissolved in the wastewater and to remove of soluble and colloidal organics and suspended solids besides reducing BOD and COD through biological process. When water has a high microbe concentration like bacterial and fungal strains, secondary treatment techniques should be selected for treatment because organic matter is converted into other products via these microbes; besides, they detoxify toxic inorganic matter. After this process is applied to wastewater, toxic organic and inorganic substances can be removed [27].
In biological treatment processes, organic matter can be biodegradable by aerobic and facultative bacteria. Aerobic processes depend on temperature, the oxygen amount and availability of oxygen, and the biological activities of the bacteria. If bacterial growth is accelerated by adding some chemicals to the medium, the organic pollutant oxidation rate as biological will also be increased. Aerobic treatment techniques are the most effective method for removing suspended, volatile, and dissolved organics, nitrates, and phosphates besides BOD and COD. Because of the production of a huge amount of biosolids, aerobic treatment techniques have a big disadvantage; however, the biodegradable organic amount can be reduced substantially (up to 90%) using this method.
Anaerobic decomposition, called putrefaction, occurs when free dissolved oxygen is not present in wastewater, and this process is called as anaerobic treatment technique. In this treatment technique, organic matters convert into other organics including sulfur and carbon by anaerobic and facultative bacteria. There are two metabolic phases named acidogenic phase and methanogenic phase in the anaerobic separation technique. Some gases such as methane, hydrogen sulfide, ammonia, and nitrogen can be released. To reduce the biological load of wastewater, this method is very vital [1].
For the production of safe water that people can consume, tertiary water treatment techniques are very important, and they should be applied to wastewater. In this last step, wastewater is subjected to final treatment using some vital techniques, and they are briefly summarized below.
The distillation method is based on the principle that the water is evaporated to the boiling point and the steam is distilled by cooling. After this process, purified water can be obtained free from impurities up to 99% in addition to wastewater is also freed from the volatile pollution. The obtained water by the distillation method is usable in levels of laboratory applications and medicinal preparations. In addition, to prepare potable water from the sea, distillation separation method is an effective tool.
The crystallization method, which is based on the increasing principle of the concentrations of pollutants up to the crystallization point, is an effective method for obtaining quality water. Crystallization technique is useful to remove high concentrations of total dissolved solids including soluble organics and inorganics from wastewater, and it can be created either by mixing some solvents or by evaporation. This process is generally used for wastewater released to the environment from paper and dying industries. In addition, crystallization can be used for pH control because of other constituents including sulfite bicarbonate [1].
When compared to other techniques, evaporation separation method is a natural process and suitable method but only for small wastewater volumes due to its high-energy consumption. However, this technique has some problems such as pollution, calcification, and foaming that have occurred in the presence of suspended solids and carbonates in the wastewater. Thus, to increase the evaporation rate and to reduce energy consumption, vacuum evaporation step can be used. Under natural conditions, water surface molecules escape from the surface, and they generally collected pure water. Recently, to recycle water process, mechanical evaporators and sometimes vacuum evaporation have also been used. Using evaporation separation technique is effective for the removal of pollutants including organic and inorganic compounds, but some volatile organic compounds may recirculate into the water during the evaporation phase. Evaporation treatment technique is applicated to various industry wastewaters like pharmaceutical, petroleum, and fertilizer industries. The obtained water from evaporation treatment technique has been used for different purposes including cooling in towers and boilers [28].
Solvent extraction separation method is an important tool to dissolve pollutants from wastewater using various organic solvents like phosphoric acid. Acetone, methanol, hexane, ethanol, and acetonitrile are the most commonly used organic solvents. In this technique, some organic solvents are added to the wastewater to facilitate contaminant removal. The technique is very effective to remove oils, greases, and various organics. However, the process is often used for extraction and separation of heavy metals like lead, cobalt, and chromium using extraction and separation techniques from various industrial wastewater and effluents [29].
To remove various toxic and hazardous chemicals especially endocrine-disrupting chemicals from wastewater, chemical oxidation techniques are preferred, and it is a promising technology for the treatment of wastewaters containing pharmaceuticals products. Organic compounds that are oxidized by oxidation of readily degradable species such as alcohols and carboxylic acids are the main components of this process [30]. Ozone, hydrogen peroxide, and Fenton’s reagent are commonly used as chemical oxidation reagent. The chemical oxidation rate depends on some variables such as the presence of catalyst, temperature, and pH. Also, pollutants and nature of oxidants identify the rate of chemical oxidation. Various organic pollutants including hydrocarbons, dyes, and phenols can be removed from wastewater using chemical oxidation treatment technique. Recently, there has been a continuously increasing worldwide concern for the development of alternative wastewater reuse and recycling methods. Single oxidation separation method can sometimes be inadequate for the total decomposition of organic contaminants in wastewater. This requires advanced oxidation processes, which involve the use of more than one oxidation process at the same time [31]. Summarize, advanced oxidation process has big advantage because in this process all organic contaminants can be commonly oxidized to carbon dioxide form.
The precipitation method based on the principle that the solubility of the contaminants is reduced and the precipitates which are converted into the solid form are easily separated from the water surface is an effective method for removing metal ions and various organic contaminants from wastewater. Chemical precipitation is a physicochemical process and a very flexible approach to various pollutant removals and can be applied at several stages during wastewater treatment. In industrial applications, precipitation has been the most common technology for metals [32]. In this process, to reduce solubility of the dissolved pollutants, it can be carried out either by lowering the temperature of the water or by adding some chemicals like sodium bicarbonates and ferric chloride, but chemical addition is not preferred because it increases the cost. Common applications of precipitation separation method are wastewater treatment from chromium and nickel plating industries and water recycling besides water softening and removal phosphate from water.
Ion exchange technique provides advantages due to it being technologically simple and enables efficient removal of even traces of impurities from solutions, high treatment capacity, high-removal efficiency, and fast kinetics when compared other usual methods. It can be applicable to various industrial wastewaters to remove hazardous materials. Ion exchange treatment technique depends on toxic or undesirable ions, which are replaced with others ions. There are two types of ion exchangers, which can be classified as cation and anion exchangers. Ion exchangers are natural or synthetic resins with active sites on their surface. Synthetic resins are widely preferred because of their effectiveness in removing heavy metals from wastewater [33]. In order to remove hazardous ions from wastewater, some resins including zeolites, sodium silicates, and acrylic and metha-acrylic resins are used as the most common. Reversible process and low-energy requirements are the most important advantages of this method. Using this method, organic and inorganic pollutants can be reduced about by 95%, but pretreatment may be needed if the wastewater contains oil or grease.
Recently, from the industrial sources, a large amount of oily wastewaters has been generated. The most serious pollutants are oil-in-water emulsions because of treatment cost and ineffective of using treatment methods [34]. Using micro-filtration, a suspended solid pollutant that is a particle size from 0.04 to 1 mm can be removed. Microfiltration separation technique has been widely used to remove macromolecules, emulsion droplets, suspended particles, and microorganisms from various industrial fields including food, pharmaceutical, biotechnological, and petrochemical. In the last decade, membrane separations have been developed using various organic/inorganic membranes like ceramic membranes. It is becoming a promising technology for industrial processes and is utilized currently for oil field-produced WWT. When compared to traditional treatment methods, they have some advantages including high oil removal efficiency, low-energy cost, and compact design. Perhaps the most important advantage is that it does not require any chemicals. Some materials such as cellulose, fiberglass, and cotton can be used as filters in filtration method. Recently, several researchers focused on the new inorganic membrane development, for example, natural mineral-based ceramic membranes, carbon membrane, and zeolite membrane [35].
As membrane technology has been developed, membrane filtration mechanism became a feasible option for wastewaters. Reverse osmosis treatment technique that is called as hyperfiltration is the wastewater purification system that relies on the membranes’ development technology. Using membrane filtration mechanism has shown results of very high efficiency in the filtration of wastewater. According to various studies from literature, when it is used, removal percentage has been achieved as at least 99.9% for COD, total organic carbon, suspended solids, coliforms, and pathogens. To achieve the required filtration, various membranes including cellulose, polyether, and polyamide are used in this process. In this process, the most important parameter is free energy, and other considerable parameters can be identified as pressure, pH, and operation time. To remove the soluble pollutants which contain macro- and microlevel nonpolar, ionic and toxic materials from the wastewater reverse osmosis is a very suitable separation technique. Reverse osmosis treatment technique is the most economic process because the water obtained from this process is of ultrapure water. It can be used in pharmacy and medicines because it can remove various microbes, bacteria, and viruses at high percentages (up to 99.99%) when compared other techniques [36].
Electrolysis method based on the redox reaction principle can be expressed as the separation and deposition of the dissolving materials on an electrode surface. During electrolysis separation method, metal ions are deposited on the electrode and separated from the wastewater. In the last decade, electrochemical oxidation methods have been an increasing interest because they can be applicable to WWT. In this process, various electrodes and anodes such as iron electrode, boron-doped diamond electrode, PbO2 electrode, and graphite electrode [37, 38] have been used to remove different pollutants from wastewater.
To remove various ions and other pollutants which have serious impact on the environment from wastewater, several methods have been used. Electrodialysis technique may be one of the most effective methods among these techniques because of recent progress in membrane technology. Electrodialysis, which is a membrane separation technology, depends on an electric potential difference, which is used to drive ion migration toward oppositely charged electrodes. In this process, under the influence of electric current, water-soluble ions pass through the membranes that are made of ion exchange material [39]. Certain factors, for example, nature of pollutants, applied current amount, temperature, and pH, must be kept in mind to remove dissolved solids. This method has been used to produce potable water from brackish water and for water source reduction [40].
Adsorption separation method is an attractive process because it can be easily applied to WWT, which includes efficiency and flexibility. When it is compared with other treatment methods, it appears superior than others. Some factors that affect adsorption efficiency including the type of adsorbents, pollutant concentration, adsorbent particle size, pH, contact time, and temperature are very important for this process. A pretreatment may be needed to successfully apply the adsorption technique to wastewater because of the presence of suspended particles and oils. To remove pollutants especially heavy metals from wastewater, various adsorbents such as activated carbons from different materials [41, 42], Astragalus [19], carbon nanotubes [43], and a large number of biosorbents [44] have been used by different studies in the literature. However, novel and effective adsorbents with local availability besides economic suitability are still needed. Adsorption technique has two main problems: the first is the regeneration of columns and column life used as an adsorbent and the second is the management of the exhausted adsorbent.
Nowadays, because of rapid technological development especially in developing countries, environmental pollution is a serious problem for the ecosystem because wastewaters contaminated with toxic heavy metals are discharged directly or indirectly into the environment. Unlike most organic contaminants, heavy metals including As, Hg, and Cr are hazardous due to its nonbiodegradable nature [33, 45]. Thus, to protect the people and the environment, these hazardous ions should be removed from wastewater [46]. For example, while industrial wastewaters which contain Cr ions range from 0.5 to 270 mg L−1, inland surface water tolerance limits 0.1 mg L−1, and potable water Cr level should not exceed 0.05 mg L−1 according to various health organization such as the WHO and EPA [47, 48]. To remove heavy metal ions from wastewater, many conventional techniques such as membrane filtration, reverse osmosis, ion exchange, chemical precipitation, electrodialysis, electrochemical treatment, and adsorption have been employed. While most of these methods suffer from operational costs for the treatment process and high capital, the adsorption method is better than the other methods due to its flexibility in design, simplicity of operation, and facile handling, and it is considered more efficient and economical [45, 49]. Since the dynamic characteristics of the adsorption process are complex, it is essential to have optimum working conditions in order to achieve optimum pollution removal efficiency. Process optimization is crucial to determine design parameters value, which is achieving the optimal obtained response level. The RSM is one of the most used methods because of its developing, improving, and optimizing of the processes especially in the presence of complex interactions. It is also used to determine the ideal points of independent variables that are effective under optimum conditions and to evaluate the interactions of these variables [50]. Its greatest advantage is the decreased experimental trial number required to interpret multiple parameters. Therefore, RSM optimization process contains three main steps: (a) appropriate experimental design selection, (b) model coefficient estimation using analysis of variance (ANOVA), and (c) model validation based on prediction and experimental runs of the process response validation of the final model [51]. This experimental design method for an adsorption process is more practical than other approaches because it allows for the opportunity to monitor and interpret interactions between variables and to describe the overall effect of the parameters on the process. The RSM has been successfully used; in addition, its greatest applications have been in industrial research [52].
There are numerous studies, and different results were obtained using various adsorbents reported such as by Anupama et al. [53]. They used a CCD with RSM for removing Cr(VI) from aqueous medium [53]. They investigated the effect of some parameters including pH and temperature on adsorption, and the optimum pH, time, and adsorbent dose were found to be 2.32, 25.76 min, and 1.79 g L−1. Also various adsorption kinetic models and isotherms were compared to find fit model. Jain et al. [54] studied Cr(VI) removal from aqueous solution using Box-Behnken model with combined RSM approach by chemically treated
The choice of method to be used in the treatment of water/wastewater depends on the wastewater type and its composition besides the economic aspect. For example, high-grade contaminated water containing solid waste and poor color must be subjected to tertiary water treatment after primary and secondary water treatment processes. If the water does not contain any solids and is contaminated by other contaminants including inorganic, organic, and biological pollutants, the application of the tertiary treatment technique is sufficient. While surface waters are often polluted by organic, inorganic, and biologic pollutants, secondary and tertiary methods of treatment are needed in the treatment of these waters, and only tertiary methods of treatment should be used since groundwater is exposed to hazardous metal ions and anion pollution. The present study summarized removing heavy metal ions in various industrial wastewaters exposed to heavy metal pollution and was focused on optimizing the removal method and determining optimum experimental conditions.
The authors declare that they have no conflicts of interest in the research.
Ménière’s disease (MD), also called idiopathic endolymphatic hydrops, is one of the most common causes of dizziness originating in the inner ear. The typical clinical manifestations are frequent spontaneous vertigo, fluctuating sensorineural hearing loss, tinnitus, and/or aural fullness. Vertigo is typically the most debilitating symptom, and control of vertiginous episodes is the primary goal of therapeutic interventions for most patients.
There are numerous available therapeutic options for MD including conservative treatments with dietary modifications, oral medication, procedural treatments with intratympanic therapies, and surgical treatments. A failure of conservative therapy often introduces the need for a more aggressive therapy on the treatment algorithm.
Surgical intervention or intratympanic aminoglycosides can be used in patients with intractable vertigo, which, ideally, should control the vertigo while preserving the hearing level and balance. The side effects of aminoglycosides are well-know. The risks of vestibular and cochlear toxicity are mainly related to types of aminoglycosides, route of administration, duration of the therapy, total or cumulative dose, individual susceptibility, renal function, patient’s age, etc.
In 1948, Fowler [1] first used systemic streptomycin to treat vertigo attacks in patients with intractable MD. The results showed that vertigo attacks could be well controlled, but treatment carried the risks of bilateral vestibulopathy, nephrotoxicity, and unpredictable results. In 1957, Schuknekt [2] may have been the first to use intratympanic streptomycin to alleviate vertigo attacks in patients with unilateral intractable MD, and it was firstly named “chemical labyrinthectomy”. Intratympanic gentamicin (ITG) for the treatment of severe vertigo was reported by Lange [3]. The initial approach was complete vestibular ablation to control the vertigo. However, with this approach, the hearing was at a greater risk. Over the past decades, the pharmacological mechanisms of aminoglycosides have been progressively studied in depth and clinical trials have been extensively developed.
At present, intratympanic injection of gentamicin is probably the most effective non-surgical treatment to eradicate vertigo in MD and is gradually gaining popularity in the worldwide. Compared with the treatment regimen decades ago, several modifications for ITG treatment have emerged regarding the concentration of the gentamicin solution, the frequency of injections, and the method of delivery. In this chapter, the history, background, and progression of ITG treatment for MD are discussed, as well as the basic science, therapeutic method, treatment efficacy, indications, contraindications, and complications.
Aminoglycosides are highly potent, broad-spectrum antibiotics and are widely used by various routes of injection to treat serious infections caused by Gram-negative bacteria (e.g.,
Streptomycin, which was discovered in 1944, is the first aminoglycoside antibiotic in human history and was thereafter marked by the successive introduction of a series of milestone compounds (kanamycin discovered in 1957, gentamicin in 1963, and neomycin in 1970s) which definitively established the usefulness of this class of antibiotics for the treatment of Gram-negative bacillary infections. From the 1960s to 1970s, aminoglycosides were widely used, but due to their serious ototoxicity and nephrotoxicity, their systemic application was limited, and they were gradually fading out of the ranks of first-line drugs. At the beginning, the most common side effect of streptomycin used by intravenous injection was temporary imbalance without vertigo or nystagmus. Higher systemic doses increased the chance of permanent imbalance and, occasionally, deafness. These early observations led to animal and cadaver studies which confirmed the vestibulotoxic and cochleotoxic effects of high-dose streptomycin.
Based on its vestibulotoxicity, streptomycin foremost unveiled its potential in the treatment of vestibular diseases. In 1948, about 4 years after streptomycin was discovered, Fowler [1] first used systemic streptomycin to treat vertigo attacks in patients with intractable MD which was refractory to traditional medical treatment. He and others used between 2 and 4 g of intramuscular streptomycin per day in patients with unilateral or bilateral MD, typically until onset of severe imbalance, and reported that vertigo attacks could be well controlled without loss of hearing. Often, and especially with higher dosing, vertigo control was accompanied with the troubling symptoms of permanent, severe imbalance, and oscillopsia.
In 1957, Schuknecht [2] may have been the first to use intratympanic streptomycin to alleviate vertigo attacks in patients with unilateral MD that was uncontrolled by traditional medical management. He conceived of this idea after noting that intratympanic formalin will readily pass into the inner ear and prevented post-mortem degeneration of the inner ear membranous structures in patients. He correctly theorized that streptomycin could also pass into the inner ear and devised a cat animal model that demonstrated clinical and pathologic vestibulotoxicity with intratympanic streptomycin. Based on these results, he devised a clinical trial of intratympanic streptomycin administration to patients with uncontrolled unilateral MD. He administered variable amounts of streptomycin (between 0.125 and 0.5 g), either hourly or over 4 hours, over a variable amount of days. The first group of three patients who received 1 or 2 days of treatment achieved only brief control of their vertigo, but did not lose any hearing. Subsequently, an additional group of five patients received streptomycin for 3 days or longer. These patients had permanent resolution of their vertigo episodes, but at the cost of deafening the ear. Schuknekt coined the term “chemical labyrinthectomy” to describe this phenomenon. He concluded that intratympanic streptomycin at the therapeutic dosage failed to preserve hearing, and should only be considered for patients who are not good surgical candidates, but would otherwise be proper candidates for inner ear ablation [2].
With the administration of intratympanic aminoglycosides, chemical ablation of the inner ear via systemic administration of aminoglycosides fell into disfavor due to the side effects of bilateral vestibulopathy, nephrotoxicity, and unpredictable results. However, choosing which kind of aminoglycoside for intratympanic injection has gradually changed. In 1977, Lange [3] appears to be the first to have used IT administration of gentamicin. He reported about 55 patients suffering from severe unilateral MD, seen over a period of 3–10 years. Patients were treated with intratympanic administration of streptomycin or better, gentamicin. The medication was given using a plastic tube inserted behind the annulus within the transmeatal approach, and 0.1 ml gentamicin (earlier streptomycin) was instilled every 5 hours until the first signs of inner ear reaction (nystagmus or vertigo) appeared. In 90% of the cases, vertiginous attacks ceased after therapy, and hearing was preserved in 76%.
Entering the 1990s, intratympanic gentamicin had gained widespread popularity in the treatment of MD. Compared with streptomycin, ITG for treatment of MD provided equivalently excellent vertigo control while showing a lower incidence of hearing loss in early clinical data. Gentamicin gained popularity over streptomycin and gradually came to be the drug of choice for chemical ablation of inner ear.
In 1993, Nedzelski et al. [5] studied 50 patients with unilateral MD by treatment of microcatheter administration of streptomycin over a 5 h treatment, 4 treatments within 48 hours, and the rate of vertigo control was up to 96%; only 24% of his patients experienced various degrees of hearing loss. Although streptomycin was being used in the study, he advocated for using gentamicin instead for its theoretical reduction of cochleotoxicity.
Beck and Schmidt [6] reported on their 10 years of experience with intratympanally applied streptomycin and gentamicin in the therapy of MD. They theorized that the dosage might be a critical factor for hearing preservation with vertigo control. Aminoglycosides could be titrated to impede the secretory epithelium of the vestibular apparatus without destroying the sensory cells, thus achieving vertigo control while maintaining caloric response, that is, vestibulo-ocular reflex. More importantly, risk of deafness could potentially be eliminated. By reducing the dosage delivered and titrating, they were able to achieve excellent rates of vertigo control (92%) while also achieving respectable hearing preservation rates (15% hearing loss with no cases of deafness).
During the same era, around the early 1990s, two schools of thought emerged in an effort to standardize ITG treatment, dubbed the “shotgun” approach, and the “low-dose” approach. The shotgun approach, championed by Nedzelski and others [5], was characterized by daily IT injections to a fixed endpoint or to a clinical threshold that heralded damage to the inner ear. Proponents of this approach attempted to achieve adequate vestibular ablation for long-term vertigo control. The low-dose approach, championed by Magnusson and others [7], was characterized by weekly IT injections, also to a fixed endpoint or to clinical effect. Proponents of this approach tried to achieve vertigo control while minimizing damage to hearing and potentially preserving the caloric response as well.
Today, intratympanic injection of gentamicin is probably the most effective non-surgical treatment to eradicate vertigo in MD. Yet, it is an ablative method that carries a non-negligible risk of hearing loss. Currently, gentamicin is usually instilled via IT injection or through a tympanostomy tube to the round window niche. These injections are repeated over a variable amount of time, typically between daily to weekly injections, until a clinical endpoint is achieved or until there is a decline in hearing. No consensus has been reached so far on the overall dosage, dosing methods, timing of delivery, treatment duration, clinical endpoint of therapy, or concentration of gentamicin. Both clinical evidence and basic science models should be further studied to scientifically elicit the most effective and safe regimen.
Aminoglycoside antibiotics have a well-documented history of cochleotoxic and vestibulotoxic effects. Administration of intratympanic aminoglycoside antibiotics to patients with MD is based on the notion that the patient’s vestibular symptoms are due to the damaged and distorted vestibular signals emanating from their ear and that they are better off with no signal than with a damaged and distorted signal. The objective of ITG is to weaken vestibular signals in the Ménière’s ear to the point at which they are no longer strong enough to generate a vertigo attack. Ideally, aminoglycosides would act to reduce vestibular function, and thus alleviate the patient’s symptoms of vertigo, while preserving hearing. The degree to which a drug is cochleotoxic or vestibulotoxic differs among aminoglycosides. Gentamicin and streptomycin, for instance, are reported to be more vestibulotoxic. Other aminoglycosides, such as amikacin, are considered to be relatively more cochleotoxic and thus are not used transtympanically. The best evidence for this is the simple clinical observation that patients undergoing systemic gentamicin or streptomycin therapy experience vestibulopathy much more commonly than hearing loss. This feature has been used by otologists to control the vestibular symptoms of MD, initially provided through systemic delivery by Fowler [1] and subsequently through IT injections by Schuknecht [2, 8]. Use of streptomycin has been largely replaced by gentamicin which is thought to be more selectively vestibulotoxic and better able to preserve residual hearing in patients with unilateral MD refractory to medical management [9, 10].
Within the bony labyrinth, several studies have investigated the trafficking and distribution of aminoglycosides, finding different patterns of distribution dependent upon the dose, duration, and route of administration. IT-injected aminoglycosides appear to gain access to the inner ear via the oval window and the round window [11, 12], and uptake either by passive diffusion or by endocytosis [13, 14]. Salt et al. recently quantified diffusion of gentamicin through the oval (35%) versus the round window (57%) [12, 15]. Access to these membranous structures is however uncertain, partly due to their variable permeability in individuals, resulting in unpredictable drug exposure of the inner ear [16, 17, 18]. Similar mechanisms of cellular trafficking (active diffusion and endocytosis) have been proposed in the transport of aminoglycosides into cells of the inner ear [19].
Once the drug crosses the oval window and the round window, the situation becomes more complex and the precise mechanism by which aminoglycosides exert their toxic effects on hair cells is unknown, to date. Previous animal studies showed that in the cochlea, sensory hair cells, the spiral ligament including the stria vascularis, and spiral ganglion cells had a very early uptake of gentamicin. Similarly, hair cells, dark cells, and vestibular ganglion cells are the primary targets in the vestibular system. This may demonstrate that gentamicin most likely diffuses across the inner ear membranes, readily achieving concentrations within the scala vestibuli, cochlear duct, and vestibule and then exerts its cellular toxicity.
Multiple mechanisms, including disruption of calcium-dependent cytokine production resulting in the damage to hair cell membrane integrity, increased superoxide production, hair cell transduction blockage, glutamate decarboxylase inhibition, ornithine decarboxylase inhibition, and free radical damage, all have been developed to explain aminoglycosides’ direct toxicity to hair cells [10, 20, 21]. While most cells of the inner ear demonstrate aminoglycoside penetration, several studies have identified preferential loss of the hair cells at the basal turn of the cochlea over the apical hair cells and vestibular type I hair cells over their type II counterparts [22, 23, 24, 25, 26]. Direct damage to the spiral ganglion has also been observed [27] and histologic studies in rhesus monkeys suggest relative sparing of the maculae [28].
In parallel to previous findings, several studies have demonstrated that direct application of gentamicin into the vestibular labyrinth also causes greater loss of type I versus type II vestibular hair cells [29, 30]. Recently, Lyford-Pike et al. [26] used the animal model, chinchilla, to provide the evidence that the selective loss of type I hair cells assuredly occurred because these cells preferentially accumulate gentamicin acutely after intratympanic administration. Type II hair cells and supporting cells concentrate substantially less gentamicin. These results might theoretically ameliorate the more profound symptom of vertigo (driven by type I hair cells) while preserving cochlear function.
Aminoglycosides may also act to inhibit production of endolymph, restoring the balance between endolymphatic and perilymphatic pressure. This would also act to alleviate all symptoms of endolymphatic hydrops. Additionally, aminoglycosides are theorized to cause selective damage to the cells of the cochlear stria vascularis and planum semilunatum in the cristae ampullae of the semicircular canals, which are involved in ionic regulation and endolymph production [31]. It is also known that gentamicin utilizes the cellular machinery of endolymph production to traffic into the inner ear after systemic administration [32]. The theory that vestibular dark cells and, thus, endolymphatic flow, are the targets by which aminoglycosides alleviate vertigo is of significant clinical interest because it suggests that it is not necessarily important to ablate the vestibule to achieve vertigo control in MD. This idea can explain why patients with intact caloric responses can still achieve significant vertigo control after intratympanic aminoglycoside administration.
In conclusion, direct toxicity to vestibular hair cells and direct toxicity to the endolymph producing apparatus might be the two major mechanisms of action by ITG. Most importantly, gentamicin has been proved to be more vestibulotoxic than cochleotoxic in humans. The inner ear toxicity of gentamicin might follow an order. Secretory dark cells of the vestibule might be the first to be damaged, followed by the vestibular neuroepithelium and the afferent vestibular fibers, and finally, the hair cells of the organ of Corti are destroyed [33, 34].
Ménière’s disease is manifested by episodic vertigo, tinnitus, aural fullness, and fluctuating hearing loss. The treatment of patients with MD is usually directed at the most disabling symptom, which is the debilitating vertigo. MD treatment protocols typically measure vertigo control according to AAO-HNS Committee on Hearing and Equilibrium guidelines for grading vertigo severity [35]. Often, clinical trials also attempt to assess other disease sequelae such as hearing loss, tinnitus, and aural fullness.
As a well-known relapsing-remitting disease, it is rather difficult to accurately evaluate the efficacy of ITG in treatment of MD. Firstly, the natural history of remission and exacerbation of symptoms make evaluation of the effectiveness of treatment remarkably difficult. Commonly, vertigo attacks can improve without treatment of any kind as periods of remission are not uncommon. Thus, a clinical trial without controls will not account for this finding. Another difficulty is that clinical researchers attempt to show hearing preservation with IT gentamicin protocol, but hearing tends to worsen over time in MD regardless of treatment. Finally, the variable nature of MD with fluctuation in levels of hearing and even frequency and severity of vertigo can make clinical trials difficult.
To date, there have only been a few interventional randomized controlled trials investigating the true efficacy of ITG in the treatment of MD. In 2004, the first prospective, double-blind, randomized clinical trial of intratympanic gentamicin versus intratympanic buffer solution (placebo) in patients with active MD was reported by Stokroos et al. [36]. They performed ITG injections with buffered gentamicin (30 mg/ml) every 6 weeks until the vertigo complaints disappeared (12 patients received gentamicin versus 10 for placebo), outcome measures included the number of vertiginous spells, degree of sensorineural hearing loss, labyrinthine function, and labyrinthine asymmetry. Compared to the placebo group, topical gentamicin provided a significant improvement in the number of vertiginous attacks per year at follow up which varied between 6 and 28 months. There was no statistically significant change in hearing or other outcomes in two groups. However, hearing had a tendency to deteriorate in the placebo-treated patients, due to the natural course of the disease, which suggests that early treatment with topical gentamicin may preserve residual sensorineural hearing in active MD.
In 2008, Postema et al. [37] reported another prospective, double-blind, randomized, placebo-controlled trial associated with ITG therapy for control of vertigo in unilateral MD. They used weekly injections of 0.4 ml of gentamicin (30 mg/ml). A total of 4 injections were given through a ventilation tube (16 patients received gentamicin and 12 received a placebo). The results showed that gentamicin treatment resulted in a significant reduction of the score for vertigo complaints (including vertigo severity) and the score for perceived aural fullness. They also noted that a small increase in hearing loss (average of losses at 0.5, 1, 2, and 4 kHz: 8 dB HL) was measured in the gentamicin group.
In 2016, Patel et al. [38] performed a randomized, double-blind, comparative effectiveness trial of intratympanic methylprednisolone (n = 30) versus gentamicin (n = 30) in patients with refractory unilateral MD. Patients were randomly assigned (1:1) to two intratympanic methylprednisolone (62.5 mg/ml) or gentamicin (40 mg/ml) injections given 2 weeks apart, and were followed up for 2 years. In the methylprednisolone group, complete vertigo control (Class A) was achieved in 21/30 patients (70%) compared to 25/30 (83.3%) in the gentamicin group. After methylprednisolone, 22 patients (78.5%) experienced an improved functional level score and 8 patients (28.7%) better pure-tone hearing and speech discrimination. There were also reductions for tinnitus, dizziness, and aural fullness. Fifteen patients (50%) required further courses of methylprednisolone. Two patients were deemed treatment failures and were assigned ITG treatment. The study showed no significant difference between the methylprednisolone and gentamicin for the control of vertigo, total number of injections, number of patients with relapsing vertigo, or the amount of pain from injection but better speech discrimination after methylprednisolone.
Based on the above prospective, double-blind, randomized controlled clinical trials, intratympanic gentamicin, as a medically ablative method, seems to be the most effective non-surgical treatment to eradicate vertigo in intractable MD, but with a potential risk of hearing loss. However, there is no consensus on the treatment protocol of ITG, especially for the concentration of gentamicin, dosage in each application, number of injection, and the time interval between two doses.
In the over 40 years of clinical trials in the treatment of MD by ITG, the majority are case series without controls, mainly because of the significant difficulties in conducting the randomized controlled clinical trials or case/control trials [33]. In earlier studies, the highest rate of vertigo control was reported with daily injections or multiple titrations. On the other hand, considerable hearing loss was experienced in several studies. Moller et al. [39] treated 15 patients with disabling MD with daily injections for periods ranging from 3 to 11 days. They achieved 93.4% of vertigo control, but also 33.4% of hearing loss. They reported that none of the patients were responsive to caloric stimulation. Laitakari [40] reported 90% of vertigo control and 45% of hearing loss in 20 patients who had daily ITG for a minimum of 3 consecutive days. Parnes and Riddell [41] reported 41.7% worsening of the hearing in their group of patients who received three daily injections within 4 days. Murofushi et al. [42], using several daily injections, reported hearing loss in 30% of cases. Corsten et al. [43] reported 81% vertigo control but 57% hearing loss in patients (n = 21) who had gentamicin instillation 3 times a day for 4 consecutive days. Kaplan et al. [44] reviewed the 10-year long-term results of 114 patients treated with gentamicin instillation 3 times a day for 4 consecutive days. They achieved 93.4% of vertigo control and 25.6% of hearing loss.
In the early 2000s, regarding patients with hearing deterioration and even those becoming deaf, there was a discussion about reducing the gentamicin dose or performing the application at longer intervals. Daily titration methods were abandoned. Transtympanic gentamicin therapy was modified to weekly or monthly intervals as “needed” or “on demand” to reduce the symptoms of MD, aiming to maintain cochlear as well as vestibular function. Harner et al. [45] reported a very high rate of vertigo control with preservation of hearing in 43 patients. There were no patients with changes in cochlear function and ablation of the labyrinth. All patients received one injection, and half of them received a repeat injection 1 month after therapy. Minor [46] used gentamicin on weekly intervals until the development of spontaneous nystagmus, head-shaking nystagmus, or head thrust sign. Vertigo was controlled in 91% of the patients, and profound hearing loss only occurred in 1 patient. Atlas and Parnes [47] reviewed the outcomes of 83 patients who received weekly injections. They reported hearing loss in 17% of the patients, with vertigo control in 84%. Martin and Perez [48] reported vertigo control in 83.1% of the patients and hearing loss in 15.5% of them after gentamicin at weekly intervals. De Beer et al. [49] reported 15.8% with hearing loss and 80.7% with vertigo control after, between 1 and 10, intratympanic injections at a minimum interval of 27 days. Casani et al. [50] reported 12% hearing loss after a maximum of 2 injections of gentamicin and 81% vertigo control.
Most recently, Vlastarakos et al. [51] published a systematic review looking at sustained-release delivery of IT gentamicin (dynamic-release versus sustained-release vehicles). Dynamic release (microcatheter at the round window) was found to provide satisfactory vertigo control in 89.3% (70.9% reporting complete control). Sustained-release preparations (gentamicin-soaked wick/pledget) provided 82.2% satisfactory control in the pool of patients (75% with complete control). In patients receiving sustained-release preparations, complete hearing loss was reported in 31.1% patients with another 23.3% of patients experiencing partial hearing loss. This adverse change in hearing was unacceptably high, reinforcing the suggestion of using a sustained-release vehicle only in patients who had failed IT gentamicin injections previously or those without serviceable hearing.
Commonly, intratympanic injection under otoscope or microscope is a simple and recommendable technique. The desired amount of gentamicin is injected over the round window through the posterosuperior quadrant of the tympanic membrane. There are two common doses of gentamicin for injection. The standard intravenous preparation of gentamicin is 40 mg/ml, which can be buffered with 8.4% sodium bicarbonate so that discomfort on injection is reduced. A total of 1.5 ml of gentamicin mixed with 0.5 ml of sodium bicarbonate at these concentrations will produce a final concentration of 26.6 mg/ml gentamicin. Approximately 0.3–0.5 ml of solution is usually adequate to bathe the round window in solution. Typically, patients will remain lying flat with the injected ear up for 10 min to 1 h. This procedure is generally well tolerated by patients, who should be told to expect brief pain on injection, followed by possible vertigo or disequilibrium. Warming the medication can help in this regard (preventing a cold caloric response).
Based on the combination of current clinical practice, basic science models, and results from clinical trials, low drug dose and long interval between injections, mainly in order to reduce the risk of deafness, are reasonably encouraged. The low dose method involves using 1–2 injections of gentamicin and waiting a month or 2 weeks between injections. The rate of vertigo control may be up to 80–90%, with no significant side effects. The second injection is given only if there has been a vertigo spell 2 weeks prior. In other words, instead of titrating to the onset of damage to the vestibular system, the criterion is a positive effect on the disease. Occasionally, a third dose is given.
In short, whatever technique is used, the goal is to apply gentamicin to the round window in sufficient concentration and over a sufficient amount of time that it achieves a therapeutic effect while avoiding both local and systemic side effects, especially hearing loss.
Not all patients with MD can be treated with ITG. Based on the international consensus on treatment of MD obtained from the IFOS meeting 2017 [52], MD should be treated with a step-by-step therapy. The first line of treatment includes the medical conservative treatment, such as dietary modification and oral medicine. After this line of treatment, 80% of patients with MD are cured or in remission. When the vertigo of MD fails to be controlled by the first-line treatment for more than 6 months, it will be regarded as intractable MD. Then the second line is the IT injections, mainly IT steroids as a conservative treatment and ITG in the case of IT steroid failure, and preferentially in patients with hearing impairment. After the second line treatment, 90–95% of the total patients are cured or in remission. The third line is the surgical, either conservative or destructive, treatment. For unilateral intractable MD with serviceable hearing (i.e., speech reception threshold better than 50 dB HL and speech discrimination score of more than 50%) in the treated ear, treatment protocol with an injection repetition not shorter than 1 week between adjacent injections or one with injections on a monthly basis as “needed” is preferred. These methods provide the same level of vertigo control yet offer better preservation of hearing functions [33].
The best indication for ITG treatment appears to be the control of vertigo in profound hearing loss or non-serviceable ears, in which speech reception threshold is worse than 50 dB HL and speech discrimination score less than 50% [53, 54]. Under these scenarios, there is no need to consider the risk of deafness, and titration methods or multiple injections on a daily basis are preferred, since these methods have significantly elevated incidence of hearing loss [33]. Transmastoid labyrinthectomy has traditionally been offered for non-serviceable ears in patients with MD. This method has been the gold standard, and it is very effective in eradication of vertigo in more than 94% of patients. In comparison, ITG therapy provides a minimally invasive ambulatory substitute with low morbidity and fewer side-effects, which is also very cost effective to manage vertigo in these MD patients with non-serviceable ears [53].
Another important indicator is the control of vertigo in patients who have failed endolymphatic sac surgery. Marzo and Leonetti [55] have shown the effectiveness of ITG therapy for patients who have failed endolymphatic sac surgery, thus reducing the need for vestibular neurectomy in those with intractable disease.
To be allergic and hypersensitive to aminoglycosides are two absolute contraindications for ITG. It is worth noting that patients who carried the mitochondrial mutation of the gene MT-RNR1 (mitochondrially encoded 12S ribosomal RNA) are hypersensitive to aminoglycosides. A single injection of aminoglycosides results in complete and definitive deafness in subjects with this mutation [56]. A systematic genetic screening of MD patients is highly recommended to prevent the occurrence of bilateral deafness. The treatment is intended for the abolition of vestibular function; thus, administration of gentamicin must be done carefully in the elderly, who have difficulty attaining vestibular compensation, in patients with complications, or in those with bilateral MD. Taking also into consideration the fact that individual’s drug sensitivity depends on their genetic background, investigation of appropriate drug levels according to evidence-based medicine remains a future task.
The complications of ITG treatment are primarily bi-fold: one is the risk caused by drug toxicity of gentamicin, the other is the risk caused by intratympanic injection. Undoubtedly, the main risk of ITG treatment for vertigo is the sensorineural hearing loss and associated prolonged disequilibrium and ataxia, which are common complaints after this treatment. Less common side effects include local hemorrhage, allergic response and tympanic membrane perforation (especially in an irradiated or otherwise damaged tympanic membrane), local discomfort, inflammation, otitis media or externa, and transient vertigo caused by a caloric reflex effect from the instilled fluid [38, 57]. It is also critical to educate all patients who are given intratympanic aminoglycosides that bilateral permanent hearing loss is possible, even from one single unilateral injection.
Intratympanic injection of gentamicin is probably the most effective non-surgical treatment to eradicate vertigo in MD. But it is also an ablative method that carries a non-negligible risk of hearing loss. Gentamicin has been proved to be more vestibulotoxic than cochleotoxic; direct toxicity to vestibular hair cells and direct toxicity to the endolymph producing apparatus might be the two major mechanisms of action. To date, no consensus has been reached on the dosage, dosing methods, timing of delivery, treatment duration, clinical endpoint of therapy, and concentration of gentamicin. However, based on the combination of current clinical practice, basic science models, and results from clinical trials, low drug dose and long intervals between injections are reasonably recommended. The application of gentamicin-induced vestibular ablation has minimized the number of more invasive procedures such as unilateral labyrinthectomy and vestibular neurectomy. In comparison with surgery, the vertigo control is comparable, the overall cost is reduced, and complications are limited. ITG in treating intractable MD has gradually become a prevalent therapy during the past decades. However, to administer ITG treatment, multiple factors should be comprehensively considered including patient selection, pharmacological mechanism, drug dose, the interval of administration, complications, indications, and contraindications.
The authors thank Alisa Hetrick for her comments on an earlier version of the article.
The authors declare no competing financial interest.
As an Open Access publisher, IntechOpen is dedicated to maintaining the highest ethical standards and principles in publishing. In addition, IntechOpen promotes the highest standards of integrity and ethical behavior in scientific research and peer-review. To maintain these principles IntechOpen has developed basic guidelines to facilitate the avoidance of Conflicts of Interest.
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\n\nAvoidance Measures for Academic Editors of Conflicts of Interest:
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\n\nAll Reviewers are required to declare possible Conflicts of Interest at the beginning of the evaluation process. If a Reviewer feels he or she might have any material, financial or any other conflict of interest with regards to the manuscript being reviewed, he or she is required to declare such concern and, if necessary, request exclusion from any further involvement in the evaluation process. A Reviewer's potential Conflicts of Interest are declared in the review report and presented to the Academic Editor, who then assesses whether or not the declared potential or actual Conflicts of Interest had, or could be perceived to have had, any significant impact on the review itself.
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\n\nNON-FINANCIAL
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\n\nAcademic Editors should declare if the Author of a submitted manuscript is affiliated with the same department, faculty, institute, or company as they are.
\n\nPolicy last updated: 2016-06-09
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