Original Article
Withdrawal Syndrome after the Double-Blind Cessation of Caffeine Consumption
N Engl J Med 1992; 327:1109-1114October 15, 1992DOI: 10.1056/NEJM199210153271601
- Abstract
- Abstract
Background.
People who stop consuming caffeine may have symptoms, but the incidence and severity of caffeine withdrawal are not known. This study was performed to determine the effects in the general population of ending one's dietary intake of caffeine.
Methods.
We studied 62 normal adults whose intake of caffeine was low to moderate (mean amount, 235 mg —the equivalent of 2.5 cups of coffee — per day). They completed questionnaires about symptoms and tests of their mood and performance when consuming their normal diets (base-line period) and at the end of each of two two-day periods during which they consumed caffeine-free diets and under double-blind conditions received capsules containing placebo (placebo period) or caffeine (caffeine period) in amounts equal to their daily caffeine consumption.
Results.
More subjects had abnormally high Beck Depression Inventory scores (11 percent), high scores on the trait scale of the State—Trait Anxiety Inventory (8 percent), low vigor scores (11 percent) and high fatigue scores (8 percent) on the Profile of Mood States, and moderate or severe headache (52 percent) during the placebo period than during either the base-line period (2, 0, 0, 0, and 2 percent, respectively; P<0.05) or the caffeine period (3, 2, 2, 0, and 6 percent; P<0.05). More subjects reported unauthorized use of medications during the placebo period (13 percent) than during the caffeine period (2 percent, P = 0.017). Performance of a tapping task was slower during the placebo period than during the base-line and caffeine periods (P<0.01).
Conclusions.
Persons who consume low or moderate amounts of caffeine may have a withdrawal syndrome after their daily consumption of caffeine ceases. (N Engl J Med 1992;327:1109–14.)
Article Activity
- Article
HEADACHE, lethargy, and other symptoms are known to follow the discontinuation of caffeine administration (caffeine withdrawal),1 but the relevance of these observations to the general population is unclear. The incidence and severity of caffeine withdrawal are not fully known, and caffeine withdrawal has often been considered irrelevant to clinical practice. The American Psychiatric Association states that caffeine withdrawal is usually not severe enough to warrant clinical attention and has omitted caffeine withdrawal from its list of organic mental syndromes associated with psychoactive substances.2 Evidence suggests that medical professionals rarely consider caffeine use in interpreting symptoms that overlap with the caffeine withdrawal syndrome.3
Symptoms including headache, lethargy, fatigue, muscle pain or stiffness, and dysphoric mood changes have been reported to occur after the cessation of doses of caffeine as low as 100 mg per day,4 , 5 the equivalent of about one cup of coffee, two cups of tea, or three cans of caffeinated soft drinks.6 In these studies the caffeine was administered in capsules, in amounts and according to schedules determined by the investigators and in some cases to atypical subjects (i.e., the investigators themselves)5; the generality of the results is therefore uncertain.
Because neither the severity of symptoms after caffeine withdrawal in the general population nor the extent to which caffeine withdrawal can interfere with daily functioning is fully known, we undertook this study to determine whether the abrupt cessation of daily caffeine consumption results in a withdrawal syndrome in the general population. We therefore determined the effects of abruptly ending dietary caffeine consumption in adults with a mean daily caffeine intake (235 mg per day) similar to that in the general U.S. population.7 , 8 Withdrawal was evaluated with tests designed to assess psychiatric and somatic symptoms and performance.
Methods
Subjects
We studied 62 normal adults recruited through newspaper advertisements and notices on bulletin boards in the community. The subjects were screened for eligibility by telephone and then in person. The screening included a medical, psychiatric, dietary, and drug-use history; the NEO Personality Inventory (a questionnaire completed by the subjects and designed to measure major dimensions of normal adult personality traits)9; the measurement of blood pressure and heart rate; and an electrocardiogram. Subjects were included in the study if they were 18 to 50 years old; had at least a high-school diploma or equivalent; had no history of psychiatric disorder; had a normal blood pressure, heart rate, and electrocardiogram; had no physical condition contraindicating the consumption of caffeine; had not used illicit drugs in the past six months; were not currently taking medication; and consumed caffeine every day, but an average of no more than 600 mg per day, based on a seven-day food diary. A total of 138 subjects were screened; 44 of them did not meet the inclusion criteria, 32 were eligible but chose not to participate, and 62 participated. The subjects were told that the purpose of the study was to evaluate the effects on mood and behavior of compounds found in foods and beverages and that they would receive a placebo or one of several compounds (chlorogenic acids, diterpenes, caffeine, tannin, sugar, or theophylline) commonly found in foods and beverages. The research protocol was approved by the institutional review board, and each subject gave informed consent to the study.
The mean (±SD) age of the subjects was 30±8 years, their weight was 65±9 kg, and their daily intake of caffeine was 235±126 mg. Other demographic characteristics and the distribution of caffeine intake are shown in Table 1Table 1
Demographic Characteristics and Daily Caffeine Consumption of the 62 Study Subjects.. All the subjects had normal scores on the neuroticism domain of the NEO Personality Inventory,9 as would be expected of a group of normal subjects.Study Design
The subjects completed a series of tests while consuming their normal diet (base-line period) and then again at the end of each of two two-day study periods, during which they consumed a caffeine-free diet and received capsules containing in random order either caffeine in an amount equal to their individual average daily caffeine consumption or placebo. The base-line, placebo, and caffeine periods generally occurred at weekly intervals, the latter two on the same weekdays. Before each study period, the subjects consumed their usual diet for at least five days. Among the women, the study periods began 5 to 19 days after the last menstrual period.
The placebo (powdered lactose) and caffeine (anhydrous) were administered in opaque, hard, size 0 gelatin capsules under double-blind and closely supervised conditions. On each day of the placebo and caffeine periods, two capsules were administered, one between 6 and 9 a.m. and the other three to five hours later. During the caffeine period, each subject's daily dose was divided equally between the two capsules. The subjects came to the laboratory immediately before the administration of each capsule and remained there only as long as necessary to ingest the capsule.
Assessment of Withdrawal Symptoms, Psychological Distress, and Impairment of Performance
A series of tests was administered once during the base-line period (between 8 a.m. and 5 p.m.) and once at the end of the second day of the placebo and caffeine periods, three to six hours after the administration of the second capsule. All tests were administered before 6 p.m. The tests were administered at the end of the second day of the caffeine and placebo periods because withdrawal symptoms are generally greatest 20 to 48 hours after the most recent consumption of caffeine.1 The tests were the Beck Depression Inventory, a 21-item questionnaire designed to assess the severity of depression11; the State—Trait Anxiety Inventory, a 40-item questionnaire designed to measure anxiety12; the revised Symptom Checklist-90 (SCL-90-R), a 90-item questionnaire designed to assess patterns of psychological symptoms13; the Profile of Mood States, a 65-item questionnaire designed to assess mood states14; and a 33-item caffeine-withdrawal questionnaire, a portion of which was previously reported to be sensitive in identifying caffeine withdrawal.4 , 5 During the base-line period the subjects completed all the tests according to standard instructions (except for the Profile of Mood States, which was based on how they felt at the time of the assessment). During the placebo and caffeine periods, the subjects were asked to answer on the basis of how they had felt during the previous two days (except for the State—Trait Anxiety Inventory, which was based on how they felt at the time of the assessment).
After completing the questionnaires, the subjects completed a series of psychomotor-speed and cognitive-performance tests, including a digit—symbol substitution task,15 a reaction-time task,16 a number-recall task,17 a numerical—Stroop task,18 and a tapping task.
Dietary Restrictions
The dietary restrictions imposed during the placebo and caffeine periods were written without reference to caffeine. The only beverages allowed were milk, fruit juices, and water; chocolate products were prohibited. To divert attention from caffeine, food items without caffeine were also restricted, including shellfish and all foods containing saccharin or aspartame (NutraSweet). Finally, the subjects were asked not to take any medications. Because we expected that subjects having withdrawal symptoms might be tempted to take analgesic drugs, the subjects were told that the use of medications would not be penalized. They were asked at the end of the caffeine and placebo periods to report any over-the-counter or prescription medications used during the period.
Analyses of Salivary Caffeine
Five-milliliter samples of saliva were collected at each laboratory visit during the placebo and caffeine periods to assess compliance with the dietary restrictions. Salivary caffeine concentrations were measured as previously described,19 , 20 in samples collected when the assessment was administered. The results indicated that the subjects had not consumed caffeine during the placebo period; the mean values were 0.10 and 2.05 μg per milliliter during the placebo and caffeine periods, respectively. The sensitivity of the assay was 0.005 μg per milliliter.
Statistical Analysis
The results during the three study periods were compared with repeated-measures analysis of variance and Newman—Keuls post hoc tests.21 These analyses included the ratings of items and the total scores on the Beck Depression Inventory; the primary-symptom scores and global scores on the SCL-90-R; the state and trait scores on the State—Trait Anxiety Inventory; the scores on all factors of the Profile of Mood States; the item ratings on the caffeine-withdrawal questionnaire; the taps per minute on the tapping task (for each trial and for the entire task); and the dependent measures previously reported for the digit—symbol substitution task.15 the reaction-time task,16 the number-recall task.17 and the numerical—Stroop task.18
The results of several tests were also analyzed as the percentage of subjects having abnormal scores (as defined below). In those instances, the above analyses were conducted with dichotomous variables (e.g., scores were categorized as 0 if below a particular cutoff point and as 1 if above that point). For the Beck Depression Inventory, a cutoff point of 15 was used.11 For the SCL-90-R, the cutoff point was based on the criteria for reaching a positive diagnosis.13 For the State—Trait Anxiety Inventory and the Profile of Mood States, the cutoff points were set at 2 SD from the mean scores of normal adults11 and college students,14 respectively. Abnormal scores for headache on the caffeine-withdrawal questionnaire were ratings of moderate and severe (2 or 3 on a scale of 0 to 3).
A chi-square test with continuity correction was conducted to compare the percentage of subjects who violated the dietary restrictions by taking medications during the placebo and caffeine periods. Such a violation was defined as any use of an over-the-counter or prescription medication during a study period.
Pearson correlation coefficients were calculated between each subject's average daily intake of caffeine and the difference in score (placebo minus caffeine) for each measure listed above.
P values of 0.05 or less were considered to indicate statistical significance. For the results of repeated-measures analysis of variance, Huynh-Feldt corrected P values are reported.22 Statistical tests were two-tailed.
Results
Ceasing to consume caffeine affected measures from every questionnaire completed by the subjects themselves, as well as one of the performance tasks. Table 2Table 2
Effects of Cessation of Caffeine Consumption in Normal Subjects.* lists the most prominent effects after the cessation of caffeine consumption. For all the measures in Table 2 the results in the placebo period were significantly different from those in the base-line and caffeine periods.The severity of the effects that followed the cessation of caffeine consumption was assessed by comparing the percentage of subjects with abnormal responses on several measures during the base-line, placebo, and caffeine periods. The percentage of subjects who reported moderate or severe headache during the placebo period (52 percent) was significantly higher than the percentages during the base-line (2 percent) and caffeine (6 percent) periods (Fig. 1Figure 1
Percentage of Subjects Reporting Moderate or Severe Headache during the Base-Line, Placebo, and Caffeine Periods.Results for the placebo period were significantly different from those for the other two periods according to the Newman—Keuls post hoc test (P<0.05).
). On the Beck Depression Inventory, the State—Trait Anxiety Inventory, and the Profile of Mood States, the percentage of subjects with abnormal scores during the placebo period was significantly higher than the percentages during the base-line and caffeine periods (Fig. 2Figure 2
Percentage of Subjects with Abnormal Scores on the Beck Depression Inventory, Abnormal Trait Scores on the State—Trait Anxiety Inventory, and Abnormal Vigor and Fatigue Scores on the Profile of Mood States during the Base-Line, Placebo, and Caffeine Periods.Abnormal scores were defined as a score of more than 15 for the Beck Depression Inventory, more than 2 SD above the mean values in normal subjects for the trait anxiety and fatigue scores, and more than 2 SD below the mean values in normal subjects for the vigor scores. In all cases, results for the placebo period were significantly different from those for the other two periods according to the Newman—Keuls post hoc test (P<0.05).
).The percentage of subjects who violated the dietary restrictions by taking medications was significantly higher during the placebo period than during the caffeine period (13 percent vs. 2 percent, P = 0.038). All the medications taken were analgesic drugs (aspirin, ibuprofen, acetaminophen, or acetaminophen and codeine).
Figure 3Figure 3
Mean (±SE) Response Rates on the Tapping Task during the Base-Line, Caffeine, and Placebo Periods.The tapping task required subjects to tap 200 times on a key as fast as they could in three consecutive trials separated from one another by approximately 10 seconds. The triangles (base line), open circles (placebo), and closed circles (caffeine) represent the mean values for the three trials during each study period. For each trial, Newman—Keuls post hoc tests indicated that the tapping rate during the placebo period was significantly lower than the rates during the base-line and caffeine periods; in no trial did the rates during the base-line and caffeine periods differ significantly from each other. The closed circles have been displaced horizontally for clarity.
and Table 2 show that the rate of tapping during the placebo period was significantly slower than the rates during the base-line and caffeine periods in all three trials.The dose of caffeine was significantly correlated with the difference in scores during the placebo and caffeine periods for only six measures: the ratings of drowsy/sleepy (r = 0.27, P = 0.033), yawning (r = 0.34, P = 0.006), and headache (r = 0.27, P = 0.033) on the withdrawal questionnaire; the SCL-90-R Positive Symptom Distress Index (r = 0.25, P = 0.049); the insomnia item on the Beck Depression Inventory (r = 0.26, P = 0.042); and the average latency on the reaction-time test (r = 0.31, P = 0.014).
One year after the end of the study, some subjects who had abnormal responses during the placebo period were interviewed. Since the subjects and interviewer were not aware of the order of the study periods, the subjects identified the periods as the first or second time dietary restrictions were imposed and capsules administered. The following comments from various subjects indicate prominent symptoms reported for the placebo period: "I felt like I had the flu, a severe headache, extreme fatigue." "[I felt] sad, uncertain about the future, a general feeling of glum." "I couldn't concentrate even when I had to do those tests. I'm basically not a low person; [I was] mildly sad and depressed." "I had a severe headache [that] progressed into vomiting, flu-like symptoms. I can only compare that sickness to the radiation and treatment [radiation and chemotherapy treatment for cervical cancer] of the past year. It was as bad as that; the only difference was that it didn't last as long." None of these subjects reported similar symptoms during the caffeine period.
Discussion
This study suggests that in normal adults, abruptly ceasing the daily consumption of caffeine results in a clinically relevant withdrawal syndrome. Fifty-two percent of the subjects had moderate or severe headache (Fig. 1), 8 to 11 percent had symptoms associated with depression and anxiety (Fig. 2), and 13 percent used over-the-counter and prescription analgesic drugs during the placebo period. Motor performance was also disrupted. Finally, the subjects who had abnormal responses during the placebo period provided anecdotal comments further characterizing the caffeine withdrawal syndrome as severe and disruptive of their normal activities.
The subjects consumed low-to-moderate amounts of caffeine and appeared to be representative of persons who consume caffeine in the general population. Half the subjects consumed less than 226 mg per day, and all but four consumed less than 400 mg per day. This distribution is consistent with amounts ingested by adults in the United States who consume caffeine regularly (82 percent of adults); the mean intake for caffeine-consuming adults has been estimated at 227 mg per day, with 99 percent consuming less than 563 mg per day.7
Recognizing caffeine withdrawal is important to physicians whose patients report symptoms that overlap with the caffeine withdrawal syndrome or in whom the discontinuation of caffeine consumption is medically indicated. Caffeine withdrawal symptoms such as headache, fatigue, and mood disturbances overlap with symptoms commonly reported to psychiatrists, family practitioners, and internists. Patients are often asked to stop consuming caffeine before operations23 , 24 or procedures such as endoscopies, colonoscopies, and cardiac catheterizations. Whether patients scheduled to undergo these procedures could be allowed caffeine supplements to avoid symptoms of withdrawal is a question worthy of consideration. Long-term abstinence from caffeine may be advised by physicians for the treatment of anxiety, arrhythmia, esophagitis or hiatal hernia, fibrocystic disease of the breast, insomnia, palpitations, and tachycardia.25 By analogy with other drugs that produce a withdrawal syndrome (e.g., opioids and benzodiazepines), a gradual reduction in caffeine intake may be preferable to abrupt cessation.
These results support recent arguments26 that caffeine withdrawal be included in the Diagnostic and Statistical Manual of Mental Disorders and the International Classification of Diseases by suggesting that caffeine withdrawal can be more severe and can occur in a substantially larger proportion of the general population than was previously recognized. Physicians should be aware of this syndrome when they encounter patients who have symptoms after ceasing to consume caffeine or when they advise patients to stop consuming caffeine.
Supported in part by a U.S. Public Health Service Research Grant (R01 DA03890) from the National Institute on Drug Abuse.
Presented in part to the Committee on Problems of Drug Dependence, Palm Springs, Fla., June 18, 1991.
We are indebted to Ms. Jeanne J. Harrison and Ms. Jennifer Unger for their technical assistance in conducting this study and to Ms. Linda Felch for consultation and assistance with the statistical analyses.
Source Information
From the Departments of Psychiatry and Behavioral Sciences (K.S., S.M.E., E.C.S., R.R.G.) and Neuroscience (R.R.G.), Johns Hopkins University School of Medicine, and the Addiction Research Center, National Institute on Drug Abuse (K.S., S.M.E.), both in Baltimore. Address reprint requests to Dr. Griffiths at the Department of Psychiatry and Behavioral Sciences, Behavioral Biology Research Center, Johns Hopkins University School of Medicine, 5510 Nathan Shock Dr., Suite 3000, Baltimore, MD 21224.
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