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AUTHOR' S NOTE AND ACKNOWLEDGMENTS When I was 14 years old, my parents would leave me in charge of my younger sister. After she went to bed, I would listen to the radia When the Hit Parade came on, the announcer would extol the pleasures of cigarettes-"so smooth ... so refresh- ing ...... I then would search the house and clean out the ashtrays of my father's cigarette butts. The butts were foul smelling but once lit, they weren't too bad. I felt grown up and could enjoy the "smoothness" and "refreshment" of tobacco. I also remember watching my father light up when Johnny the bellhop sang out "CALL FOR PHILIP MORRIS" at the start of The-Edgar Bergen and Charlie McCarthy Show. When I was 16, my favorite cousin gave me a pipe and tobacco for my birthday. I remember taking a big puff and coughing, but I got used to it. I collected a half-dozen pipes that summer; my favorite was a corncob pipe. I couldn't wait for the first school foot- ball game to show everyone I smoked a pipe. At the game, I paraded in front of the stands smoking my pipe and puffing away for all to see. During World War II, I entered the Army at age 18. I had tried cigarettes but preferred my pipes. At Scott Field, IL, where I was inducted, I was given my free rations: three Hershey bars, a bar of soap, a package of razor blades, two packages of gum,_one roll of Life Savers, six packs of cigarettes, and two cigars. I asked if I could have more candy bars and less cigarettes but was told that the rations were the same for everyone. I sat on my bed with my trea- sures and looked around the barracks. Everyone else was smoking, so I opened a pack and began smok- ing. Later that night I tried one of the cigars. The cigar tasted better than the cigarettes. We generally had a "smoke break" every hour during basic training. The number of free candy bars and cigarette packs varied, but I always had more cigarettes than I could smoke. The major en- tertainment at night after movies was "playing craps." I often won a dozen packs of cigarettes. A year later, I was at Camp Carson, CO, training in a "night attack" outfit. This meant climbing up hills with a full pack. I grew up at the seashore and had never experienced high altitudes. I was gasp- ing for breath and decided to stop smoking cigarettes. When I was overseas, I traded my cigarettes for cigars and candy or gave my cigarettes to foreign civilians. After the war ended, cigarettes brought a good price on the black market. I relate my experience with smoking to indicate how pervasive cigarette smoking was when I was growing up. You were expected to smoke, and the free cigarettes, "smoke breaks," and advertising en- couraged it. As a public health researcher with an interest in health promotion, I became involved in quit- smoking methods in 1962. A result of these efforts was the funding in 1964 of the Smoking Control Research Project, which tried three cessation methods: group counseling, individual counseling, and pills (tranquilizers). During the project, I evaluated available quit smoking methods. A report of the evaluation of smoking control methods was supported by the Na- tional Clearinghouse for Smoking and Health and published in 1969. An update that evaluated ces- sation methods used from 1969 to 1977 was sup- ported by the Center for Disease Control and published in 1978. This review of smoking cessa- tion methods used from 1978 to 1985 serves as a current update. I would like to thank Dr. Joseph W. Cullen, Deputy Director, Division of Cancer Prevention and Control, National Cancer Institute (NCI), for sup- porting this review and evaluation. It was through Dr. Cullen's generous support that this review is more comprehensive than the former reviews. In ad- dition, chapters on maintenance and worksite smok ing control were added at Dr. Cullen's request. It has been a pleasure to work with Dr. Cullen. Marilyn M. Massey, M.P.H., of Prospect Associ- ates, the support services contractor for NCI's Smoking, Tobacco, and Cancer Program, handled the technical details of the subcontract arrange- ments for this effort. I thank her for her support and assistance that helped to ensure that the project proceeded smoothly. Dr. Margaret E. Mattson, Division of Cancer Prevention and Control, reviewed the manuscript for NCI. I thank her for her comments. Four outside experts were engaged by NCI to review and comment on the manuscript. Drs. Harry TIMN 293331

A. Lando (Ames, IA), Edward Lichtenstein (Eugene, OR), and C. Tracy Orleans (Lawrenceville, NJ) reviewed the manuscript, except the worksite chap- ter, while Russell E. Glasgow (Eugene, OR) reviewed the worksite chapter. Each of the reviewers submit- ted lengthy comments that improved the manuscript. In several cases, I included their com- ments directly into the text. I thank them for their efforts. I am grateful to Eileen O'Farrell (Davis, CA) for her careful editing of the manuscript and to Karen Jacob (Prospect Associates) for managing the production of the camera-ready document. Lastly, I wish to express appreciation to my wife, Joann, for her support and love throughout this project. Jerome L. Schwartz, Dr. P.H. Health Care Research Specialist Davis, California xiv TIMN 293332

1. INTRODUCTION In the April 1929 issue of The Dragnet Magazine, a popular pulp monthly featuring "detective and crook stories," there appeared five advertisements, the highest number advertising any single product, for mail-order remedies to banish the tobacco habit 1 One read in part: 'Ibbacco Redeemer will positively remove all craving for tobacco in any form in a few days. This we absolutely guarantee in every case or money refunded. Write today for our free booklet showing the deadly effect of tobacco upon the human system and positive proof that'Ibbacco Redeemer will quickly free you of the habit. Another said: Superba 'Ibbacco Remedy destroys all crav- ing for Cigarettes, Cigars, Pipes, Chewing or Snuff. Original and only remedy of its kind. Used by over 500,000 men and women. Perfectly harmless. Full treatment sent on trial. Costs $1.50 if it cures. Costs nothing if it fails. Write today for complete treatment. Cigarette consumption has declined very slow- ly despite widespread dissemination of the "facts" about smoking, the initiation of educational and media programs, the introduction of warning labels on cigarette packages (July 1966), the ban- ning of cigarette advertisements from television (January 1971), and the development of a variety of methods aimed at helping cigarette smokers break their habit. Per capita cigarette consump- tion in the United States declined in early 1964 but rose to nearly its former level by the end of that year; it declined again in late 1965, only to rise once more in 1966 and 1967.2 Starting in late 1967, however, when the annual consumption of cigarettes was 549.5 billion, a slow decline began that continued during 1968 and 1969. Consump- tion decreased by 3.5 billion cigarettes in 1968 and by an additional 16.7 billion in 1969, lowering per capita consumption to 1958 levels.3 Per capita consumption of cigarettes increased slightly during the early 1970's4 and peaked in 1973 at 4,112 cigarettes annually.g In 1979, per capita consumption of cigarettes approximated that in 1952.4 Per capita consumption fell to 3,731 cigarettes in 1982 and to 3,447 in 1983.5 The Federal ZYade Commission (FTC) reported In June 1985 that cigarette sales were falling for the first time since 1969 despite an increasing population and record advertising expenditures by tobacco companies.5 Cigarette sales fell from 636.5 billion cigarettes in 1981 to 632.5 billion in 1982 and 584.4 billion in 1983. Spending on cigarette advertising climbed, however, to nearly $2.7 billion in 1983, the highest ever, which was up from $1.9 billion in 1982. SMOKING AS A HEALTH PROBLEM6 The 1979 Surgeon General's report on smoking and health revealed that cigarette smoking is far more dangerous than supposed in 1964 when the first Surgeon General's report was published.7 The Surgeon General reported that the health damage resulting from cigarette smoking costs this Nation an estimated 325,000 premature deaths each year and $27 billion in medical care, absenteeism, decreased work productivity, and accidents. Cigarette smoking is the most important prevent- able environmental factor contributing to illness, disability, and death in the United States. Overall Mortality Life expectancy at any age is significantly short- ened by cigarette smoking. A two-pack-a-day smoker between the ages of 30 and 35 years has a life expectancy 8 to 9 years shorter than that of a nonsmoker of the same age. Prospective studies indicate that cigarette smokers have approximate- ly a 70-percent greater chance of dying from disease than do nonsmokers.8 Mortality ratios are proportional to the amount smoked and to the years of cigarette smoking and are higher for those who initiated smoking at younger ages and for those who inhale. Former cigarette smokers experience declining mortality ratios as their years of nonsmoking 1 TIMN 293333

increase. It takes about 15 years for mortality ratios of former smokers to approach those of nonsmokers.9 Provided that the person has not quit because of illness, cessation diminishes an in- dividual's risk. Coronary heart disease is the chief contributor to the excess mortality among cigarette smokers, followed by lung ca.ncerr and chronic obstructive lung disease. Morbidity Data from the National Health Interview Survey show that current smokers have more acute and chronic conditions than do persons who have never smoked 1O Current smokers report more chronic bronchitis, emphysema, chronic sinusitis, peptic ulcer disease, and arteriosclerotic heart disease than do persons who have never smoked. Gastric ulcer is also linked to smoking. The age- adjusted incidence of acute conditions for men who had ever smoked was 14 percent higher and for women was 21 percent higher than for those who never smoked. The 1974 survey data revealed that there are more than 81 million excess work days lost and more than 145 million excess days of bed disability per year because of smoking in the U.S. population. Current and former smokers report more hospitalizations than do nonsmokers. Lung Cancer The causal relationship between smoking and lung cancer is well established. Lung cancer ac- counts for 25 percent of all cancer deaths in the United States; it is estimated that 85 percent of lung cancer cases are due to cigarette smoking 11 Overall, smokers are 10 times more likely to die from lung cancer than are nonsmokers, and heavy smokers are 15 to 25 times more at risk. Lung cancer mortality in women is increasing more rapidly than in men, and it is expected that lung cancer will be the leading cause of cancer deaths among women in the next decade.12 Certain occu- pational exposures (e.g., asbestos) can act synergistically with smoking to increase the in- cidence of lung cancer. Ex-smokers experience decreasing lung cancer mortality that approaches the rates of nonsmokers after 10 to 15 years of not smoking. Other Cancers 'Ibbacco use has been linked to cancers of the larynx, oral cavity, esophagus, bladder, kidney, and pancreas lg-l4 An estimated 50 to 70 percent of oral, laryngeal, and esophageal cancer deaths are associated with smoking. The use of alcohol in conjunction with smoking acts synergistically 2 to increase greatly the risk of these cancers. There is a strong association between cigarette smoking and cancers of the bladder and pancreas, and smokers are twice as likely as nonsmokers to die of these diseases. The risk of pancreatic cancer in- c--eases with the number of cigarettes smoked; a two-pack-a-day smoker has five times the risk of a nonsmoker. Quitting smoking reduces one's cancer risk substantially. The more years that one does not smoke cigarettes, the greater the reduc- tion in excess cancer risk. Cardiovascular Disease Smoking is an important risk factor for coronary heart disease and acts synergistically with other risk factors such as hypertension and hypercholes- terolemia 15•16 Smoking increases the probability of the recurrence of myocardial infarction, and smoking cessation reduces the risk of mortality from coronary heart disease. Smoking is a major risk factor for arteriosclerotic peripheral vascular disease. In persons with angina pectoris or inter- mittent claudication of peripheral vascular disease, smoking reduces the established thresh- old for precipitation. Smoking is a key factor in circulatory problems of the arms and legs, which frequently lead to gangrene. This danger is partic- ularly strong for diabetics who smoke. Women who smoke and use oral contraceptives are at a higher risk than are others of experienc- ing myocardial infarction and thromboembolism. Cigarettes and oral contraceptives have a synergis- tic effect; the risk of their combined use is much greater than the sum of the dangers posed by either alone. The risk of nonfatal myocardial in- farction among women during the childbearing age is increased twofold by the use of estrogen- containing oral contraceptives and tenfold if users also smoke?''ls It is unlikely that a "safe cigarette" can be developed that will reduce cardiovascular risk.20 Data indicate that smokers of low-yield cigarettes do not have a lower risk of myocardial infarction, coronary disease, or decline in lung function than do consumers of higher yield cigarettes.2l Numerous studies have shown that those who quit smoking cigarettes experience a substantial decrease in coronary heart disease mortality and an improvement in life expectancy.22 For those who continue to smoke, there is no "safe" level of cigarette consumption.23z4 Nonneoplastic Bronchopulmonary Disease Smokers have more respiratory symptoms and greater pulmonary function abnormalities than do TIMN 293334

nonsmokers.25 Respiratory infections are more common in smokers, who take longer to recover. Respiratory symptoms decrease and pulmonary function improves when a person quits smoking. Cigarette smoking acts independently of and synergistically with the other risk factors that contribute to bronchitis. Peptic Ulcer There is a positive dose-response relationship between smoking and the incidence of peptic ulcer disease. The risk of dying from peptic ulcer is, on the average, twice as high for smokers as nonsmokers.26 Although not proved, cigarette smoking probably retards the healing rates for both stomach and intestinal ulcers. A smoker who develops an ulcer should therefore stop smoking. Effects of Smoking on Pregnancy Cigarette smoking during pregnancy has a significant and adverse effect on the well-being of the fetus, the health of the newborn baby, and the future development of the child.27 Mothers who smoke increase substantially their risk of spontaneous abortion, premature birth, and death of the infant during the first days of life. There is evidence that children of mothers who smoke may be deficient in physical growth and intellectual and emotional development.27 Smoking and Occupational Exposure Smoking and physical and chemical agents interact to produce adverse health effects on certain occupational groups. Both cigarette smoking and exposure to certain occupational hazards increase the risk for chronic lung disease.28 These risks can occur independently or may combine to produce a greater degree of lung injury than would have occurred from either exposure separately. Thus smoking can act synergistically with toxic agents to increase disease, and inhaling can serve as a vehicle for toxic agents in the workplace. Chemicals can contaminate tobacco products and thus enter the body through inhalation, ingestion, or skin absorption. Workers can run a higher than usual risk of exposure when the same toxic chemicals in cigarette smoke occur at their jobs. Smoking also has been found to contribute to industrial accidents. Summary of the Consequences of Smoking Cigarette smoking is linked to many of the leading precursors of disease and disability such as coronary heart disease, lung cancer, bronchitis, emphysema, and peptic ulcers. 'Ibbacco use increases the hazards associated with certain types of occupational exposure and the use of oral contraceptives and has an adverse effect on the fetus. Cigarettes also may interact with certain drugs and alter the results of some diagnostic tests.29 Smokers who give up cigarettes can improve their health, while those who continue to smoke live shorter lives and are at a higher risk of developing diseases. This is why it is important to discourage young people from starting to smoke and to encourage those who smoke to stop. Most smokers want to quit, but there are those who believe that they cannot quit on their own. The availability of treatment programs may encourage quit attempts in individuals who would not otherwise attempt cessation. It is for this reason that smoking cessation methods have been developed. The material that follows will review and evaluate cessation methods that were used from 1978 to 1985. SMOKING HABITS IN THE UNITED STATES AND CANADA Smoking Levels in the United States In 1983, a total of 34.8 percent of U.S, males 20 years of age and older smoked *3O This represents a decrease of 17.3 percent since 1965, when the percent of adult male smokers was 52.1. In the same period, smoking among U.S. females 20 years of age and older declined from 34.2 to 29.5 percent. Between 1980 and 1983, the percentage •Cited here are statistics on cigarette smoking as reported by Federal Government sources. A Gallup Poll in June 1986 reported that cigarette smoking had declined to its lowest level in the poll's 42-year findings.31 Interviews with 1,004 scientifically selected adults. 18 years and older, revealed that 31 percent reported having smoked during the week before the interview. Similar polls in 1983 and 1985 found that 38 and 35 percent, respectively, reported that they smoked. More men (35 percent) than women (28 percent) were smokers in 1986, and more blacks (34 percent) than whites (31 percent) were smokers. Education is closely related to whether people smoke. In the current audit, only 23 percent of college graduates were cigarette smokers. The proportion rose to 35 percent among high school graduates and to 45 percent for those without a high school diploma. The following regional differences were reported for percent smokers: East-31. Midwest-29, South-35, and West-29. Smokers under 30 years tended to be lighter smokers. In this age group, 58 percent claimed to smoke less than one pack of cigarettes per day, compared with 39 percent of smokers over 30 years. The majority of smokers in all population groups would like to quit, including 75 percent nationally. 3 TIMN 293335

of males who smoked declined at all ages except for those 65 years and over; among females, the percentage of smokers increased in the age group 20 to 34 years but declined for senior citizens.3O About 35 million Americans have quit smoking, but the picture of teenage smoking is particularly discouraging. Although the percentage of children under 19 years who are regular smokers declined between 1974 and 1979, smoking prevalence among females 17 to 19 years increased during that period and now exceeds that of males.32 Whereas smoking among boys 17 to 19 years declined from 31.0 percent in 1974 to 19.3 percent in 1979, smoking among girls of that age increased from 25.9 to 26.2 percent during the same period. Among girls 15 to 16 years, there was a decrease between 1974 and 1979 in the percent of regular smokers from 20.2 to 11.8; for boys, the decrease was from 18.1 to 13.5 percent. Smoking among white males declined from 51.3 percent in 1965 to 37.1 percent in 1980 and among white females from 34.5 to 30.0 percent.33 A similar pattern was seen among black adults- a decline for males from 59.6 to 44.9 percent and for females from 32.7 to 30.6 percent. The proportion of the white adult male popula- tion who have stopped smoking increased between 1965 and 1980 from 21.2 to 31.9 percent, and for white females the increase was from 8.5 to 16.3 percent.33 A similar trend was observed among blacks: the percentage of former smokers among adult males increased from 12.6 to 20.6 percent, and for adult females the increase was from 5.9 to 11.8 percent. Most national data on the smoking behavior of adults indicate that blacks, as com- pared to whites, are more apt to smoke yet smoke fewer cigarettes per day, smoke cigarettes of higher tar and nicotine content, and are less apt to quit smoking.34 Although the numbers of people who smoke have declined, those who continue to smoke have increased their daily consumption from 20.0 cigarettes in 1970 to 21.7 cigarettes in 1980.35 Daily consumption was heaviest among those aged 35 to 64 years. Only 11.4 percent of the smokers in 1970 reported consuming 40 or more cigarettes per day, but by 1980 the percentage had risen to 16.8 38 Those smoking fewer than 20 cigarettes per day declined from 39.8 percent in 1970 to 33.8 percent in 1980. The kind of cigarettes that Americans smoke has changed dramatically. In 1984, 94 percent of the cigarettes smoked were filter tipped, up from 1 percent in 1950.37 Low-tar, low-nicotine ciga- rettes were heavily promoted by manufacturers, resulting in a 60-percent share of the market in 1980. Grise reports a movement back to full- flavored cigarettes with the market share of low- tar, low-nicotine cigarettes dropping to 53 percent in 1984.37 4 Adults with the lowest and highest educational levels have a lower prevalence of smoking. There is less smoking among adult males with higher family incomes, while the prevalence of adult female smoking increases with family income. Separated or divorced persons have the highest smoking rates; married persons have higher rates than single or widowed persons. Smoking among professionals is relatively low; managers, ad- ministrative personnel, and blue-collar workers have higher rates of smoking.38 Data in 1978 from the National Center for Health Statistics showed that 59 percent of the smokers had tried to quit.39 In the previous year, 30 percent of the smokers attempted to quit, and 20 percent of those who tried reported that they succeeded. A higher proportion of black smokers than white smokers attempted to quit (39 to 30 percent), but a lower proportion of blacks than whites succeeded (10 to 21 percent). Smoking Levels in Canada In December 1983, 5.8 million Canadians 15 years of age and older, an estimated 31 percent of the adult population, were regular smokers.40 Oc- casional smokers represented 3.3 percent of the population, and pure pipe or cigar smokers 1.6 per- cent. The proportion of nonsmokers in the popula- tion appears to be rising. Nonsmokers represented 64.0 percent of the adult Canadian population in 1983 of which 18.6 percent were former smokers and 45.4 had never smoked. The results of a 1983 survey showed that regular smoking among the adult male Canadian popula- tion declined from 48.9 percent in 1970 to 34.0 percent in 1983 and among women declined from 32.4 to 28.3 percent.4O The percent decline in smoking prevalence between 1979 and 1983 was consistent in all age groups for both sexes, although males accounted for the largest share of the decline. The percentage of teenage Canadian females who smoked regularly increased from 24.9 percent in 1970 to 26.7 percent in 1977 and then declined to 20.3 percent in 1983. Between 1970 and 1983, the percentage of teenage males regularly smok- ing declined from 35.7 percent to 20.3 percent. The data indicated that 40 percent of all Canadian smokers made an attempt to quit smoking in the year preceding the survey. SUMMARY OF 1969 REVIEW This monograph reviews U.S. and Canadian smoking cessation programs reported in the litera- ture between 1978 and 1985. It is intended as an TIMN 293336

update of Schwartz's 1969 review41 and Schwartz and Rider's 1977 report.4z The 1969 review evaluated smoking cessation programs conducted in the United States, Canada, Australia, England, Scandinavia, and other parts of Europe during the years 1957 through 1968. The report covered 97 methods in 62 trials and evaluated their results in terms of following up on how many persons remained nonsmokers. Cessa- tion methods were classified in six general headings and a miscellaneous category. The six headings were Lobeline, Other Medication and Clinics, Five-Day Plan, Desensitization-Aversion Therapy, Physician Counseling, and Group Discus- sion and Therapy. Of the 62 studies reviewed in 1969, 34 had a followup after 6 months, 15 had a followup after less than 6 months, and 13 did not have a followup. Only 12 reports based the followup on all persons in the study; 8 others based their followup on at least three-fourths of the participants. Most in- vestigators calculated outcome rates only for per- sons who completed treatment. 'liventy programs used untreated controls or placebos. Of the 13 medication trials, 2 showed better results, 8 showed the same, and 3 showed worse results for the drug than for a placebo. In 18 experiments in which treated subjects were matched with controls, the method of treatment was better in 8, similar in 3, and worse in 7. The "better" results were not always statistically significant. A method often showed better initial results than did the control but also had high rates of recidivism, so that placebos achieved equal or better long-term success. Results at the end of treatment varied among the studies in the listing, with reported highs of 89 and 85 percent for two withdrawal clinics and 84 per- cent for a method using the threat of monetary loss among college students. No success was recorded in one aversive trial, only 10-percent suc- cess using electric shock, and 4-percent success for tranquilizers. Evaluations were done of 38 American, 14 English, 5 Scandinavian, and 2 Canadian pro- grams and 1 each from 3 other countries. Of the U.S. studies, 9 were in Pennsylvania, 6 each were in New York and California, 4 were in Oregon, and 13 were in 12 other states. The uses of medication, group therapy, the Five-Day Plan, and aversion therapy, in that order, were the popular methods prior to 1969. The earlier review contained only two reports of hypnosis, indicating perhaps that hypnotherapists were not reporting their results. Students of Lichtenstein began their work with aversive methods in the mid-1960's, and three of their trials were reported in the review.43 A number of studies reviewed in 1969 achieved between 20- and 38-percent success at followup. Some of the most significant U.S. studies prior to 1969 were those of Lawton, who began group pro- grams in Philadelphia around 1960 and reported a 4-year followup success of 16 percent.44 An im- portant study by Ross reported from 6- to 27-percent success at followup with an overall rate of 17 percent using medication and educational methods at a large-scale clinic at Roswell Park Memorial Institute in Buffalo, NY.45 The Smoking Control Research Project, conducted in northern California, used seven combinations of tran- quilizers, placebos, groups, and individual counseling with 1-year success rates of from 8 to 31 percent and 20 percent overall.46 The 1969 review stated that the combined ac- tivities of smoking cessation methods had con- tributed to the antismoking campaign, which would influence nonparticipating smokers and youths who had not taken up the habit. The review concluded the following: In summary, many investigators have tried "methods" to help smokers give up ciga- rettes but few have shown high success rates.... Part of the reason why success has not been better might be partially ex- plained by results of a survey in which it was found that the most commonly offered meth- ods of stopping are the ones least acceptable to smokers who wish to quit.47 Thus, the high dropout rates experienced by many methods may be due to low acceptance of the method. Smoking is a difficult habit to break. The results of the Smoking Control Research Proj- ect indicate that many smokers must try several times before they can quit. For them, the smoking clinic is one step closer to total success .... The studies reviewed indicate that they have served their purpose by show- ing that people can be helped to stop smok- ing by a variety of techniques. They have also demonstrated that drugs,... such as lobeline and tranquilizers are not effective in assisting smokers to give up the habit. Conditioning methods are both ineffective and impractical as they reach only limited numbers of per- sons.. . . The problem now is to explain the process of cessation and recidivism and to explore the possibility of applying mass media ap- proaches to reach large numbers of smokers. The potential of new and original smoking cessation techniques, presented on in- dividual, group, or mass media bases, has not been fully explored. However, too much should not be expected from any one ap- proach, no matter how ingenious, since no TIMN 293337 5

single method can be counted on to produce high rates of long term success. Most methods achieve their maximal success at the end of the treatment program but recidivism occurs sharply during the next few months. Thus, even if highly successful m°thods were de- vised, these techniques themselves cannot be expected to maintain the burden of keeping people off cigarettes once abstinence is achieved. This task must necessarily be re- served for societal and environmental in- fluences.. . . The action of voluntary and governmental agencies, increased efforts by physicians to counsel patients in their offices, and the applica- tion of research findings about the psychosocial factors involved in smoking cessation, are help- ing to create the environmental conditions which will aid smokers to quit permanently.`'8 SUMMARY OF 1969-1977 REVIEW Methods summarized in the 1977 review were those employed in the U.S. and Canadian pro- grams over a 9-year period.42 (Some English studies were included in the evaluation.) About 400 reports were reviewed. The monograph also contained a list of 66 doctoral dissertations com- pleted during the years 1970-1976 that related to smoking control methods. Smoking cessation was examined from several viewpoints: the intervention techniques of self- care, medication, and hypnosis; the service packages delivered by nonprofit institutions, health professionals, and commercial enterprises; the counseling and research trials offered by medical sponsors; the behavior modification techniques; and the mass media and community programs. Evaluations during this period revealed that many methods lacked proper design and followup. A recurrent problem was that of validating whether the subject had really quit smoking. Validation of abstinence by physical measure- ments was starting to be used primarily by pro- grams associated with a laboratory. Some pro- grams claimed success based on reduction of the number of cigarettes smoked rather than on com- plete cessation. Many programs failed to conduct followups at least 6 months after the termination of the program. It was during this period that a consensus of scientists recognized cigarette smoking as being addictive. Nicotine was identified as the chemical basis of the addiction, so a number of studies ex- amined the strength and effects of nicotine. Development of nicotine chewing gum by Swedish investigators progressed to the stage of clinical trials. Organized clinics examined their clientele and surmised that they tended to attract the ad- dicted smokers. 6 Many methods during the period had excellent end-of-treatment success rates with up to 80 per- cent of the subjects quitting smoking for at least a short time. In the long run, however, even these methods showed only fair results. Of 67 trials con- ducted in the United States and Canada between 1969 and 1977 with at least 6 months followup, two-fifths had quit rates of at least 35 percent of the participants, one-fifth had quit rates between ' 22 and 34 percent, and two-fifths had rates below 22 percent. Twenty-seven percent of the programs scored at least 40-percent success at 6 months, and 18 percent achieved 50-percent success. A few investigators claimed 67- to 88-percent quit rates at followup. The best results were for programs employing group counseling, hypnosis, and the rapid- smoking aversion technique. Rapid smoking showed mixed results, but the rates were improved when this procedure was combined with social support and good maintenance practices. Many of the developments in aversive methods, including rapid smoking, came from Lichtenstein's clinic in Eugene, OR. Other investigators involved in a good deal of behavioral testing were Lando in the United States, Best and Pederson in Canada, and Russell in England. Group support methods were more popular than individual counseling primarily because treating a group of people is more economical. During the review period, hypnosis gained in popularity as a cure for smoking. Spiegel introduced the self-hyp- nosis technique for smoking cessation. Success rates were contradictory for hypnosis with some hypnotists claiming high quit rates and others reporting poor success. In the 1970's, the American Cancer Society took a prominent role in smoking cessation with their extensive withdrawal clinics, development of a quit kit, initiation of the Great American Smokeout na- tionally, and sponsorship of the International Con- ference on Smoking Cessation.49 In Canada, the Ministry of National Health and Welfare began a national effort to reduce cigarette smoking that included support for cessation pro- grams. The Canadian Council on Smoking and Health was organized in 1974 to coordinate smok- ing activities among voluntary organizations. The American Health Foundation (AHF) in- itiated a large-scale smoking cessation program in 1972. The AHF treated over 5,000 smokers dur- ing a 5-year period. Methods varied from minimal self-care to combined therapies. Other noteworthy developments were the in- troduction of mass media and community cam- paigns through the Stanford and San Diego pro- grams. The Multiple Risk Factor Intervention Zi-ial (MRFIT) was initiated in 1972; its 2-year followup results showed 47-percent success. TIMN 293338

'Paking medication for smoking cessation did not produce an average of even 20-percent abstinence in the short run, much less over time. The Five- Day Plan was widely available, but its long-term success rates were low. On the other hand, the Five-Day live-in program sponsored by the St. Helena Health Center achieved 35-percent abstinence at a 1-year followup. The monthly pro- gram at St. Helena treated over 2,000 smokers dur- ing an 8-year period. The yellow pages of the telephone books of over 200 cities in 1977 identified 116 different types of smoking cessation programs as follows: Type Number Proprietary and commercial firms ... 32 Medically sponsored .............. 12 Voluntary groups ................. 9 Used hypnosis ...................35 Used psychological or behavioral techniques ..................... 20 Used acupuncture ................ 8 Of the 27 cities in the United States with popula- tions greater than half a million, all but New Orleans had smoking cessation programs listed in the yellow pages. Some of the concluding comments from the 1977 review follow: ... Many smokers simply are not suscepti- ble to intervention; this is largely because no single method is available that can work uniformly well with large numbers of in- dividuals. And this is so because people dif- fer in personality, emotions, and personal satisfactions. Also people differ in their smok- ing habits, particularly how and why they use cigarettes, whether or how strongly they are addicted to cigarettes, and whether they have motivation and determination to quit smok- ing.... It is for these reasons that many dif- ferent smoking methods are needed in- cluding multicomponent methods. Several ingredients are necessary for suc- cessful treatment: an acceptable method, dedicated leaders, and well-planned maintenance procedures. Longer treatments usually reinforce commitment to cessation, especially when extended by maintenance efforts.. . . Proprietary methods have become widely available, and their fees provide added incen- tive to remain abstinent. It has been very dif- ficult, however, to obtain valid survey data on the quit rates of commercial clinics. Many claim excellent success rates that are based only on persons who go through the entire program and stop smoking.... Commercial clinics do attract smokers who wish to quit to their programs, and this contributes to the public awareness of quit clinics and provides a resource where smokers can be referred.... The most efficient, widest-reaching penetration is apt to occur through mass media promotion of cessation methods and a continued acceleration of positive govern- ment action against smoking. An example of a large scale attempt to increase awareness of health and to effect behavior change is the Canadian Operation Lifestyle program which reached nearly two-thirds of the population. The use of radio and television as cessation approaches has a great potential. Most physi- cian counseling treatments suffer from poor maintenance. Physicians lack the time and commitment to provide long-term support. In studies where physicians do discuss the pa- tients' smoking habits and encourage quit- ting, however, results show that the influence is important.. . . A review of smoking control programs con- ducted during the last few years leads the authors to conclude that certain conditions improve success: (1) the use of multiple cessa- tion methods which can deal with different types of people or different uses of cigarettes; (2) payment, as in the commercial programs which intensifies commitment; (3) the presence of illness or risk factors which enhance motivation to quit; and, (4) good maintenance procedures which continue to support the ex-smoker. Once the smoker abstains, a myriad of forces act upon the individual influencing him to return to smoking. These forces in- clude environmental, sociai, and internal fac- tors, such as mass media, smoking of peers, and stress.. . . When the smoker breaks his habit he still has to contend with the effects of his former addiction. This is why maintenance is impor- tant. This review found that those programs with well planned long-term maintenance reduce recidivism and increase their eventual success rates. Programs that tailor their followup efforts to the individual's situation or to special problems will improve their effectiveness. ... gO METHODOLOGICAL WEAKNESS OF CESSATION EVALUATIONS Although there have been improvements, cessa- tion evaluations continue to be deficient in design and methodology. These deficiencies were de- cribed by Bernsteing' and Schwartz41 in 1969 and later by others, notably Lichtenstein and TIMN 293339 7

Danaher52 and McFall.53 There are seven problem areas, although some progress has been made in three of these areas over the last several years. The problems are discussed below. (1) Validity of self-reports of smoking behavior remains the leading problem in the evaluation of cessation results. By the use of physiological measurements, numerous investigators have shown that up to one-fourth of the people claim- ing abstinence were not telling the truth g4-g' For- tunately, this is the area in which the most prog- ress has been made with the availability of physiological tests to validate abstinence. More and more programs are making the effort to use these tests to check self-reports, but it is still in- convenient and costly for community programs and individual investigators to use them. Some in- vestigators have used informants or observers to corroborate self-reports, but their value has been questioned.56 All investigators, as well as practi- tioners, should consider the use of physiological measures to validate self-reports. (2) Some investigators continue to evaluate their results in terms of reduced numbers of cigarettes smoked rather than cessation of smoking. Because most smokers who merely reduce their consump- tion return to higher levels of smoking and because stopping smoking is the primary goal of cessation programs, abstinence is the criterion that should be used to measure success. There also has been much progress in this area. Psychologists and students doing doctoral research remain primarily the ones using reduc- tion in smoking as a way to evaluate their results. This is because it is not difficult to demonstrate significant differences between treatments based on reduction using a small number of subjects. These significant differences, however, have little meaning when abstinence is considered. All pro- grams, except those concerned with controlled smoking, topography, or nicotine dependence, should use abstinence for evaluation purposes. Those investigators who insist on using reduction in smoking should also report abstinence data so that their results can be evaluated and compared to other programs. (3) There are three problems with followups: they are sometimes based only on those who (a) complete treatment or (b) reply to followups; (c) often the followup period is too short. Some pro- grams even base their success rates entirely on people who quit by the end of treatment. A 1-year followup is best, but 6 months is acceptable. Less than 6 months has questionable value. Progress has been made over the last several years in the length of the followup with most programs now do- ing a 1-year followup. There is no progress on the other two aspects, as many programs continue to 8 do partial followups. It is desirable to present results on all subjects, not just on those com- pleting treatment or reached at followup. Some programs (particularly many hypnosis and acupuncture trials) do not describe how they did their followup, which makes it difficult to deter- mine if their claimed cure rate is valid. (4) Methods, procedures, subjects, followups, and other aspects of the program are often poorly described. The overriding objective of clinical evaluation is replicability, which is only possible when the method is adequately described (e.g., recruitment, type of subjects, procedures, materials, type of leader, length of treatment, number of sessions, and contact with program) and when it does not contain nonreproducible ex- traneous aspects.58 Space limitations for journal articles sometimes pose restrictions on authors, but there is available space to describe briefly treatment methods. Perhaps authors can indicate that further methodological details are available on request. (5) The need for control or comparison groups and tighter designs has been detailed by Bern- stein.51 Controls are especially needed by research programs and experimental trials. Community clinics do not need control groups, but if they use several procedures, they should systematically test them to find out each procedure's contribution to success. (6) It is often difficult to determine what "method" was actually used as some programs in- clude three or four methods as part of treatment. This makes it impossible to determine what worked or did not work and diminishes the chance to compare methods. For example, Orleans and Rotberg provided a consultation service for pa- tients referred by physicians.59 Some patients received physician advice to quit smoking, motiva- tional counseling, and written guidelines for set- ting an abrupt quitting date. In addition, they were given the American Lung Association self-help manual, signed a compliance contract, and were monitored in a 4-week nicotine fading program. (7) The last problem deals with the difficulty of making comparisons between methods. Sometimes a single method is subject to vast dif- ferences of execution. For example, physician counseling can consist of a warning to quit, various amounts of advice on how to quit, or a careful followup program. Group counseling can be vastly different depending on whether the leader is a lay person, a psychologist, or a physi- cian. Such differences, unless explained, can make comparisons tenuous. Other factors that make comparisons difficult are the differences in subjects (men vs. women, volunteers vs. chronically ill patients vs. randomly TIMN 293340