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PubMedDate not supplied

Preparation of endometrium for egg donation.

Nowadays oocyte donation is a well established method of assisted reproduction and offers the unique opportunity to treat patients with various clinical indications, with or without ovarian function, in a novel way. In women with ovarian failure, artificial menstrual cycles are required before proceeding to oocyte donation. Oestrogen may be delivered in the form of oral tablets, transdermal patches in order to bypass the gastrointestinal tract thus avoiding first pass metabolism and by vaginal application. Our regimen is oestradiol valerate given in various concentrations, in order to mimic the regular cyclic fluctuations throughout the cycle. Progesterone may be administered in the form of oral tablets, intravaginal suppositories or rings and i.m. injections. Our results, as of most other groups, strongly support the vaginal route of progesterone administration. In women with retained ovarian function, synchronization of donor-recipient cycle presents a special problem, as there is strong evidence that a temporal window of maximal endometrial receptivity exists. Cryopreservation of donated embryos may be used to overcome the problem, but this approach has the important drawback of embryonic loss occurring after freezing and thawing. The method of choice is the administration of gonadotrophin-releasing hormone agonists (GnRHa) to render the patients functionally agonadal in order to circumvent cycle asynchrony between the donor and recipient.

Cryopreservation↗
PubMedDate not supplied

Prevention of postmenopausal osteoporosis with oestrogen replacement therapy and associated compounds: update on clinical trials since 1995.

Hormonal replacement therapy (HRT) is generally regarded as first choice for pharmacological prevention of osteoporosis in women. We reviewed recent studies of HRT regimens and selective oestrogen receptor modulators (SERMs), including controlled trials of at least one-year duration published since 1995 until February 2000 providing data on bone mineral density (BMD) or fractures. Natural and synthetic oestrogens exert a continuum of positive effects on BMD in a dose-dependent, though non-proportional, fashion independent of age and mode of administration. Bone loss may be largely prevented by 25 microg transdermal patch oestradiol, 0.3 mg conjugated equine or 0.3 mg esterified oestrogens. Progestogens neither attenuate nor augment the effect of oestrogens; sole use of tibolone prevents bone loss. Both the SERMs, tamoxifen and raloxifene, slightly increase BMD. There are no adequately powered fracture trials for any HRT regimen. Raloxifene 60 mg daily decreases the relative risk of vertebral fractures by at least 30%, as demonstrated by one 3-year fracture study of osteoporotic women. In conclusion, the recommendation to use oestrogen for postmenopausal osteoporosis, given both the lack of fracture trials and the rare trials on long-term use of HRT in (late) postmenopausal women, is not well supported. Fracture trials could overcome shortcomings of the current level of evidence.

Aged↗
PubMed2004

Testosterone replacement therapy: current trends and future directions.

Male hypogonadism is characterized by abnormally low serum testosterone levels associated with typical symptoms, including mood disturbance, sexual dysfunction, decreased muscle mass and strength, and decreased bone mineral density. By restoring serum testosterone levels to the normal range using testosterone replacement therapy, many of these symptoms can be relieved. For many years, injectable testosterone esters or surgically implanted testosterone pellets have been the preferred treatment for male hypogonadism. Recently, newer treatment modalities have been introduced, including transdermal patches and gels. The development of a mucoadhesive sustained-release buccal tablet is the latest innovation, which will provide patients with an additional option. The availability of new treatment modalities has helped to renew interest in the management of male hypogonadism, highlighting the need to address a number of important but previously neglected questions in testosterone replacement therapy. These include the risks and benefits of treatment in different patient populations (e.g. the elderly) and the need for evidence-based diagnosis and treatment monitoring guidelines. While some recommendations have been developed in individual countries, up-to-date, internationally accepted evidence-based guidelines that take into account national differences in clinical practice and healthcare delivery would optimize patient care universally.

Androgens↗
PubMed1993

Protein S levels during the normal menstrual cycle and during estrogen therapy for premature ovarian failure.

Protein S levels have been reported to be decreased in pregnancy and with oral contraceptive use. This study monitored the effects of estrogen shifts on protein S levels. Four patients with premature ovarian failure were treated with either oral or transdermal patch estrogen replacement. Blood drawn on days 1, 14, and 28 of therapy was analyzed for estradiol, estrone, free and total protein S, and C4b-binding protein (C4b-BP) levels. Similar studies were performed on six normally cycling control patients and seven postmenopausal women. In healthy females, total levels of protein S fell from 22.1 +/- 0.73 micrograms/mL on day 1 to 19.2 +/- 1.29 micrograms/mL on day 14 (p < 0.023). Free protein S levels declined from 6.45 +/- 0.70 micrograms/mL to 5.59 +/- 0.69 micrograms/mL (p < 0.016). C4b-BP levels did not change during the normal menstrual cycle. Baseline total protein S (44.1 +/- 7.0 micrograms/mL) and C4b-BP (193 +/- 18%) levels were elevated in patients with premature ovarian failure. On oral therapy, there was a strong, negative correlation (r = -0.979, p < 0.021) between C4b-BP and estradiol levels. C4b-BP levels did not change in patients with the patch. Both estrogen therapies produced similar declines (44 to 26 micrograms/mL) in total protein S levels. In all cases, total protein S levels changed as a reciprocal function of estradiol. C4b-BP (128 +/- 6.5%) and total protein S (32.2 +/- 3.0 micrograms/mL) levels were higher in postmenopausal women than in nonmenopausal females. Free protein S levels in postmenopausal women (9.6 +/- 0.6 micrograms/mL) were normal.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1998

A novel effect of nicotine on mood and sleep in major depression.

The role of repeated nicotine administration on sleep and major depression was studied. Six non-smoking normal volunteers (NV) and six non-smoking major depressed patients (MD) with a Hamilton Rating Scale for Depression > 18 served as subjects. All subjects underwent the following sleep procedures: acclimatization, control night, four nicotine nights (17.5 mg, transdermal patches) and one withdrawal night (WN). Nicotine increased REM sleep time in both groups and also on the WN. Hamilton scores showed an average reduction of 43.9% in the depressed patients. These findings suggest that nicotine receptor activation may be important in major depression and shows for the first time that nicotine patches may be useful in the treatment of depression.

Administration, Cutaneous↗
PubMed1998

Use of nitroglycerin for uterine relaxation.

Data from human and experimental animal research indicate that nitric oxide (NO), a novel messenger, formed during the nitric oxide synthase-catalyzed oxidation of L-arginine to L-citrulline, is involved in maintaining normal uterine tone during gestation. There are demonstrated and potential benefits of manipulating the L-arginine-NO system during pregnancy. Several recent case reports and case series have described the effective use of nitroglycerin (GTN), a NO donor compound, antenatally, intrapartum, and postpartum for acute uterine relaxation. Therapeutic indications for GTN range from facilitating external cephalic version, difficult vaginal or cesarean section delivery, and manual exploration of the uterus, to its use as a tocolytic. The intravenous regimen of GTN required to obtain the desired degree of uterine relaxation is extremely variable; intravenous bolus doses of 50 micrograms to 500 micrograms GTN with up to three repeated injections of 50 micrograms to 250 micrograms have been reported. Other methods of GTN administration include transdermal patches and sublingual spray. GTN, when used in low doses, may provide safe and effective uterine relaxation with no clinically apparent fetal or maternal adverse effects. However, clinical trials with use of objective methods of evaluating uterine tone and comparing GTN to other tocolytic agents are required before widespread use in advocated.

Animals↗
PubMed1992

Estradiol gel in the treatment of menopausal symptoms: a placebo-controlled double-blind case study of efficacy and safety.

Thirty-nine postmenopausal women were randomized to treatment with either percutaneous estradiol or a placebo. Those taking the estradiol had an increase in serum estradiol to follicular phase levels and a concomitant fall in serum follicle-stimulating hormone (FSH) levels. Atrophic vaginal epithelium became well estrogenized, and the frequency and severity of hot flushes decreased significantly. No significant benefits accrued to those using the placebo. Side effects were mild and similar in both groups. Percutaneous estradiol delivered in an alcohol-water gel is effective in treating climacteric symptoms and is an attractive alternative to both oral and transdermal patch administration of estrogen.

Administration, Topical↗
PubMed2003

New contraceptive methods: update 2003.

The decline in adolescent pregnancy rates noted in the 1990s has been attributed to more teenagers choosing abstinence, the availability of long-acting contraceptive options, and the increased use of condoms. Many adolescents remain at risk of unplanned pregnancy, however, because of method failure, inconsistent or incorrect use, or discontinuation of a method without choosing another method. Practitioners who care for adolescents and young women have access to several new methods in 2003. Recent additions include a contraceptive transdermal patch, a hormone-releasing intravaginal ring, new formulations of pills, and a new intrauterine device. Additionally, the World Health Organization has updated its guidelines to provide the practitioner with evidence-based recommendations to assist in selecting the most appropriate contraceptive method for each patient.

Adolescent↗
PubMedDate not supplied

Determinants of hormone replacement therapy duration among postmenopausal women with intact uteri.

OBJECTIVE: To investigate factors associated with hormone replacement therapy (HRT) duration among postmenopausal women with intact uteri. DESIGN: A Cox proportional hazard model on time to HRT discontinuation is estimated for 2,632 postmenopausal HRT users with intact uteri who began a new episode of treatment between January 1990 and December 1994 in Saskatchewan, Canada. RESULTS: Major contraindicating medical events were highly associated with HRT discontinuation among postmenopausal women. Women who were diagnosed with uterine cancer while taking HRT were almost four times as likely to discontinue HRT, and women who were diagnosed with breast cancer while taking HRT were nearly five times as likely to discontinue HRT. Other statistically significant factors associated with the duration of HRT episodes include administration mode and the ability to try different types and strengths of HRT. Women initiating HRT with a transdermal patch were 50% more likely to discontinue it. Women who were willing and able to experiment with different HRT reduced their likelihood of discontinuing by one-half to three-fourths. CONCLUSIONS: Although some of the factors associated with the hazard of HRT discontinuation among postmenopausal women who are taking the treatment for preventive benefits are immutable, clinicians may influence HRT continuation rates through initial drug choice or modifications in drug type or regimen over the course of therapy.

Estrogen Replacement Therapy↗
PubMed1999

Testosterone and other anabolic steroids as cardiovascular drugs.

There has been much interest in the effect of sex hormones on cardiovascular risk factors and as a therapeutic modality in both men and women. In this article, testosterone is considered as a possible therapy for cardiovascular disease. It has been shown that the level of serum testosterone decreases in men as they age. Healthy men with low testosterone levels have increased cardiovascular risk factors, including high fasting and 2-hour plasma glucose, serum triglycerides, total cholesterol and low-density lipoprotein (LDL) cholesterol, and apo A-I lipoprotein. Injections of testosterone to raise the levels to midnormal range have been shown to decrease total cholesterol and LDL cholesterol, while increasing high-density lipoprotein (HDL) cholesterol. Testosterone affects the clotting system by increasing thromboxane A (2) receptor activity and platelet aggregability. Testosterone has also been shown to augment the fibrinolytic system and antithrombin III activity. In men, testosterone has been shown to have antianginal effects, and endogenous levels have an inverse relationship to systolic blood pressure. Testosterone can be given in oral, injectable, pellet, and transdermal patch forms. There may be a role in administering testosterone to return men to normal physiologic range who have low serum levels. This treatment increases the risk of prostatic cancer, benign prostatism, erythrocytosis, and edema. No long-term studies of the effects of long-term testosterone replacement have been undertaken, so it is difficult to recommend this treatment as yet, but it is being considered as a therapy for augmenting skeletal muscle strength in patients with congestive heart failure.

Anabolic Agents↗
PubMed2005

The role of testosterone therapy in postmenopausal women: position statement of The North American Menopause Society.

OBJECTIVE: To create an evidence-based position statement regarding the role of exogenous testosterone in postmenopausal women. DESIGN: The North American Menopause Society (NAMS) enlisted a panel of clinicians and researchers acknowledged to be experts in the field of testosterone therapy to review the evidence obtained from the medical literature, compile supporting statements and conclusions, and reach consensus on recommendations. The document was reviewed and approved by the NAMS Board of Trustees. RESULTS: Endogenous testosterone levels have not been clearly linked to sexual function in postmenopausal women. Published evidence from randomized controlled trials, although limited, indicates that exogenous testosterone, both oral and nonoral formulations, has a positive effect on sexual function, primarily desire, arousal, and orgasmic response, in women after spontaneous or surgically induced menopause. Data are inadequate to support recommending testosterone use for any other indication, including preserving or increasing bone mineral density, reducing hot flashes, increasing lean body mass, or improving well-being. Hirsutism and acne have been associated with testosterone therapy, but the actual risks are not well defined. It is not known whether testosterone therapy increases the risk of breast cancer, cardiovascular disease, or thromboembolic events. There are few data regarding the safety and efficacy of testosterone therapy in women not using concomitant estrogen therapy or for the use of testosterone therapy for longer than 6 months. Clinically available laboratory assays do not accurately detect testosterone concentrations at the values typically found in women, and no testosterone level has been clearly linked to a clinical syndrome of hypoandrogenism or testosterone insufficiency. CONCLUSIONS: Postmenopausal women with decreased sexual desire associated with personal distress and with no other identifiable cause may be candidates for testosterone therapy. Testosterone treatment without concomitant estrogen therapy cannot be recommended because of a lack of evidence. When evaluating a woman for testosterone therapy, recommendations are to rule out causes not related to testosterone levels (eg, physical and psychosocial factors, medications) and to ensure that there is a physiologic cause for reduced testosterone levels (eg, bilateral oophorectomy). Laboratory testing of testosterone levels should be used only to monitor for supraphysiologic levels before and during therapy, not to diagnose testosterone insufficiency. Monitoring should also include subjective assessments of sexual response, desire, and satisfaction as well as evaluation for potential adverse effects. Transdermal patches and topical gels or creams are preferred over oral products because of first-pass hepatic effects documented with oral formulations. Custom-compounded products should be used with caution because the dosing may be more inconsistent than it is with government-approved products. Testosterone products formulated specifically for men have a risk of excessive dosing, although some clinicians use lower doses of these products in women. Testosterone therapy is contraindicated in women with breast or uterine cancer or in those with cardiovascular or liver disease. It should be administered at the lowest dose for the shortest time that meets treatment goals. Counseling regarding the potential risks and benefits should be provided before initiating therapy.

Androgens↗
PubMedDate not supplied

Estrogen therapy selectively enhances prefrontal cognitive processes: a randomized, double-blind, placebo-controlled study with functional magnetic resonance imaging in perimenopausal and recently postmenopausal women.

OBJECTIVE: Estrogen therapy (ET) seems to differentially effect cognitive processes in younger versus older postmenopausal women, suggesting a window of opportunity when ET is most beneficial. Cognitive improvement in younger postmenopausal women has been attributed to ET's influence on hot flushes and sleep, but empiric examination of the mediating role of menopause symptoms versus direct effects of ET on the brain is limited. DESIGN: In a double-blind trial, 52 women were randomly assigned to estradiol 0.05 mg/day (n = 26) or placebo transdermal patches (n = 26) for 12 weeks. Women completed tests of memory, learning, and executive functioning, and hot flush and sleep assessments at baseline and study end. A subset of women (five ET treated, six placebo treated) also underwent blood oxygenation level-dependent (BOLD) functional magnetic resonance imaging (fMRI) studies. RESULTS: Nondepressed perimenopausal and postmenopausal women were studied. The majority had hot flushes and sleep impairment. Compared with placebo, ET selectively reduced errors of perseveration during verbal recall (P = 0.03), a frontal system-mediated function, but did not influence other cognitive processes. Women with baseline hot flushes had greater cognitive benefit with ET (P < 0.05). Cognitive benefit was not associated with sleep problems or its improvement. Measures of fMRI BOLD activation during tests of verbal and spatial working memory showed significant increases in frontal system activity with ET (P < 0.001). CONCLUSIONS: Estrogen therapy selectively improves executive functioning as demonstrated by reduced perseverative errors and prefrontal cortex activation during verbal recall tasks. Cognitive improvement with ET is associated with hot flushes, but not with sleep, suggesting that ET has a direct central nervous system effect, rather than an indirect effect mediated through improvement of sleep.

Administration, Cutaneous↗
PubMed2005

Topical glyceryl trinitrate for chronic Achilles tendinopathy.

OBJECTIVE: To determine whether continuous application of topical glyceryl trinitrate decreases pain and symptoms in chronic noninsertional Achilles tendinopathy. DESIGN: Randomized double-blind placebo-controlled study of 6-months' duration. SETTING: Community and referral study at an Australian University Hospital. PARTICIPANTS: Recruitment was through newspaper advertisements and private consulting rooms. Eligibility criteria were age >18 years, a history of insidious onset of Achilles tendon pain, a tender nodule localized to the region of the calcaneal insertion, and an ultrasound examination that excluded a tendon tear. Exclusion criteria were Achilles tendinopathy of <3 months' duration, a previous operation on, or dislocation of, the affected ankle or leg, distal neurologic signs, a local corticosteroid injection in the previous 3 months, and current pregnancy. The 65 participants (84 affected tendons; 62% men) had a median age of 49 years (range, 24-79 years), with a median duration of symptoms of 16 months (range, 4-147 months). INTERVENTION: Participants were assigned an active transdermal patch (1/4 of a Nitro-Dur 5 [Schering-Plough] glyceryl trinitrate patch), which delivered 1.25 mg of glyceryl trinitrate over 24 hours, or a placebo patch. Patients were required to cut the patches into quarters and apply 1/d to the site of maximal tenderness for the 24-week duration of the study. All patients were also given 500-mg paracetamol tablets for use with headaches, and instructed in a rehabilitation program that comprised rest from aggravating activities, the use of heel-raise wedges, prolonged daily stretching of the gastrocnemius and soleus musculature, and an eccentric calf muscle-strengthening program. MAIN OUTCOME MEASURES: At the baseline, 2, 6, 12, and 24-week examinations the patient completed a symptom assessment sheet to rate the severity of Achilles pain with activity, at rest, and at night (0 = no pain, 4 = very severe pain). The single assessor used the same scale to measure local tenderness; an 11-point scale for the patient to report pain after the single-leg 10-hop test; and also measured the ankle plantar flexor mean peak force and ankle plantar flexor work. Follow-up was 89% complete. MAIN RESULTS: The groups did not differ in pain with activity, night pain, or local tenderness until the 12-week assessment when participants in the glyceryl trinitrate group reported less pain on each measure (mean scores, 0.9 vs. 1.6 [P = 0.02]; 0.2 vs. 0.7 [P = 0.04]; and 0.9 vs. 1.6 [P = 0.02], respectively). The difference was maintained at 24 weeks for pain with activity (mean scores, 0.4 vs. 1.0 [P = 0.03]). At 24 weeks the glyceryl trinitrate group reported less pain on the 10-hop test than the placebo group (mean scores, 0.5 vs. 1.6 [P = 0.005]). Although the intervention group showed a greater increase in plantar flexor mean total work at 24 weeks than the placebo group, the baseline scores were significantly different. The groups did not differ in pain at rest or in ankle plantar flexor peak force. Combining all the measures showed an estimated 14% (95% CI, 9%-19%) excess of asymptomatic tendons in the intervention group at 6 months. Reported main side effects were headaches (glyceryl trinitrate group, 53%; placebo group, 45%) and rashes (glyceryl trinitrate group, 16%%; placebo group, 12%). CONCLUSION: A topical glyceryl trinitrate patch was more effective than placebo for reducing pain from chronic noninsertional Achilles tendonitis in the first 12 and 24 weeks of use.

Comment↗
PubMed2005

Formulation of medicines for children.

The development of age-adapted dosage forms and taste-masking of bitter-tasting drugs administered orally for children, are formidable challenges for formulation scientists. Childhood is a period of maturation requiring knowledge of developmental pharmacology to establish dose but the ability of the child to manage different dosage forms and devices also changes. Paediatric formulations must allow accurate administration of the dose to children of widely varying age and weight. Whilst the oral route will be preferred for long term use and the intravenous route for the acutely ill, many of the dosage forms designed for adults, such as oro-dispersible tablets, buccal gels and transdermal patches, would also benefit children if they contained an appropriate paediatric dose. The age at which children can swallow conventional tablets is of great importance for their safety. Liquid medicines are usually recommended for infants and younger children so the ability to mask unpleasant taste with sweeteners and flavours is crucial. More sophisticated formulations such as granules and oro-dispersible tablets may be required but there will be limitations on choice and concentration of excipients. There are many gaps in our knowledge about paediatric formulations and many challenges for the industry if suitable preparations are to be available for all ranges. A CHMP points to consider document is soon to be released. More research and clinical feedback are important because a formulation with poor acceptability may affect compliance, prescribing practice and ultimately commercial viability.

Adolescent↗
PubMed2005

Placebo response in a patient with chronic migraine and ergotic overuse.

Facilitation of nociceptive systems has been implicated in Chronic-Migraine pathogenesis. Daily consumption of medication may be a contributing factor. The patient was male, aged 76 years, with history of migraine without aura. Six years ago, he presented with a mild-moderate daily pulsating headache. He was overusing analgesics and ergotamine. After withdrawing, the patient started a nonpulsating headache, diffuse and constant. During follow up, he was refractive to several symptomatic and prophylactic treatments. When we treated him with placebo capsules, the headache responded very well. At first, pain-relief occurred for 6 h and progressively, extended. Two years later, when our patient started to use transdermal patches of fentanyl for treatment of a complex regional pain syndrome type 1, his headache did not improve. Patient has maintained prolonged response to placebo. Actually, he is pain-free for 2-3 days with 1 placebo capsule. We discuss mechanisms of chronic-migraine, drug-overuse, drug-induced headache and placebo addiction. Powerful psychological mechanisms could determine response to placebo in this patient.

Aged↗
PubMed1986

Tolerance development during transdermal administration of nitroglycerin in angina pectoris.

Nitroglycerin delivered by transdermal patch technology has been used in angina pectoris patients as well as in heart failure. In angina pectoris patients the plasma concentrations are low over the 24 hours. Effects can be found especially during the first 12 hours after application of the drug even during steady state conditions. The effect of the drug wanes after 24 hours and some studies suggest reduced effect when the patches have been applied for seven to 14 days. The attenuated effects have been claimed to be due to tolerance. Tolerance is, however, never absolute and in other studies this phenomenon is not shown. Furthermore, rebound phenomena may develop when nitroglycerin therapy is withdrawn. The optimal doses and schemes for nitroglycerin administration thus remain to be clarified.

Administration, Cutaneous↗
PubMed2004

Nondaily hormonal contraception: considerations in contraceptive choice and patient counseling.

PURPOSE: To review currently available choices for non-daily hormonal contraception, considering efficacy, safety, patient counseling issues, and appropriate patient selection. DATA SOURCES: Worldwide medical literature and the individual products' prescribing information. CONCLUSIONS: Patients and clinicians have many nondaily hormonal contraceptive options available--from Depo-Provera quarterly injection, which has been available in the United States for over 10 years, to several new entries (Mirena 5-year intrauterine system, Lunelle monthly injection, NuvaRing monthly intravaginal ring, and Ortho Evra weekly transdermal patch). All these options offer high efficacy and enhanced convenience for many patients over daily oral contraceptives (OCs). Barriers to use of these agents may include patients' lack of information as well as fear or misconceptions regarding the hormones and methods. All of these can be addressed with adequate patient counseling and open dialogue. The clinician and patient need to be well-informed regarding these options so that they can work together and identify the best contraceptive fit for the patient---with the ultimate goal being to increase patient satisfaction and adherence and, thus, avoid unintended pregnancy. IMPLICATIONS FOR PRACTICE: Despite the efficacy of OCs, missed pills are quite common and contribute to unintended pregnancy. Many women in all population categories would benefit from the convenience and reliability of nondaily hormonal contraceptives. The highest efficacy rates with typical use are associated with agents that require minimal user participation (i.e., Depo-Provera, Mirena). Compared to daily regimens, all nondaily options offer increased convenience and may contribute to improved patient adherence. However, barriers to use may exist. Patient fears regarding use of hormones can be minimized by discussing the long-term safety of hormonal contraceptives. (The data are predominantly derived from Depo-Provera and OCs because these agents have been available in the United States and in the rest of the world for much longer than the newer nondaily options.) Patient counseling and appropriate expectations regarding changes in menstrual pattern have been demonstrated to further enhance patient adherence to therapy. Finally, patient lifestyle preferences must be considered. The finding that many women are comfortable with or even prefer amenorrhea, which is associated with options such as Depo-Provera, highlights how important it is for clinicians to avoid making assumptions about a patient's contraceptive preferences. Rather, clinicians and patients should exchange information through an open dialogue. For the majority of patients, nondaily hormonal contraceptives should be considered and offered as first-line options.

Choice Behavior↗
PubMed1994

How effective is nicotine replacement therapy in helping people to stop smoking?

OBJECTIVE: To assess the efficacy of nicotine replacement therapy in helping people to stop smoking. DESIGN: Analysis of the results of 28 randomised trials of nicotine 2 mg chewing gum, six trials of nicotine 4 mg chewing gum, and six trials of nicotine transdermal patch. SUBJECTS AND SETTING: Subjects were self referred (responding to advertisements or attending anti-smoking clinics) in 20 trials and invited (general practice or hospital patients) in 20. Therapists in self referred trials were generally experienced in helping people stop smoking but not in invited trials. MAIN OUTCOME MEASURE: Efficacy was defined as difference in percentages of treated and control subjects who had stopped smoking at one year. RESULTS: Efficacy was highly significant (P < 0.001) for both gum and patch. Nicotine 2 mg chewing gum had an overall efficacy of 6% (95% confidence interval 4% to 8%), greater in self referred subjects than in invited subjects (11% v 3%). Efficacy depended on the extent of dependence on nicotine as assessed by a simple questionnaire; it was 16% (7% to 25%) in "high dependence" smokers, but in "low dependence" smokers there was no significant effect. The 4 mg gum was effective in about one third of "high dependence" smokers. The efficacy of the nicotine patch (9% (6% to 13%) overall) was less strongly related to nicotine dependence, perhaps because the patch cannot deliver a bolus of nicotine to satisfy craving. CONCLUSIONS: Both gum and patch are effective aids to help nicotine dependent smokers who seek help in stopping. Among the most highly nicotine dependent smokers (those craving a cigarette on waking) the 4 mg gum is the most effective form of replacement therapy; it could enable one third to stop. In less highly dependent smokers the different preparations are comparable in their efficacy but the patch offers greater convenience and minimal need for instruction in its use. Overall, nicotine replacement therapy could enable about 15% of smokers who seek help in stopping smoking to give up the habit.

Administration, Cutaneous↗