Tobacco Use Disorder
Conditions
Keywords
Fresh lime, nicotine gum, smoking cessation, craving
Brief summary
The purpose of this study is to determine whether fresh lime alone is effective for smoking cessation.
Detailed description
Smoking is the major preventable cause of chronic medical diseases and death worldwide. Significant efforts led by World Health Organization (WHO) and several countries have been made to help current smokers to quit, particularly in the developing countries, where their smoking rates continued to rise. Clinical practice guidelines were therefore developed to guide all healthcare personnel in those countries to provide treatment for smokers. However, despite that, only a small number of smokers were able to quit successfully. A large number of smokers who are poor and heavily addicted to nicotine remain and have no access to any effective smoking cessation aids. Although there are several effective medications available for smoking cessation nowadays, the high price of them completely keeps poor smokers away from using them. Alternative and cheaper smoking cessation aids are therefore necessary. During the past decade, certain herbal remedies have been introduced in smoking cessation in Thailand. One of them that have been used widely without any supporting evidence is the fresh lime (Citrus aurantifolia), the well-known native citrus to Southeast Asia. It is anecdotally claimed to be effective and safe in smoking cessation. The present study was designed to determine the efficacy and safety of fresh lime as a smoking cessation aid compared with those of nicotine gum.
Interventions
OTHERFresh lime
fresh lime were used every time the participants began to crave cigarettes and as often as they needed. To correctly use it, fresh lime needed to be washed and cut into several small pieces by 1st cutting each lime into quarters and then each quarter further into 4 pieces. When needed, subjects were told to suck each piece of lime and thereafter chew the lime skin. To maintain freshness, the remaining slices were to be covered with plastic wrap and stored in the refrigerator as soon as possible.
Sponsors
Thai Health Professional Alliance Against Tobacco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age over 18 * Smoked regularly at least one year prior to study entry * Had the desire to quit smoking * Signed informed consent
Exclusion criteria
* Having current dental problems * Active peptic ulcer disease * Psychiatric disorders * Citrus allergy * Pregnancy * Use of illicit drugs * Participation in another clinical trial and/or using any first-line smoking cessation aids within the past 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| continuous abstinence rate (CAR) of lime group and gum group | week 12 | CAR from week 9 through week 12 of treatment was defined as proportion of participants who self-reported having refrained from smoking any tobacco products and confirmed by exhaled CO concentration of 10 ppm or less at all previous measurement points between week 9 and week 12 of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events on each group | week 12 | All adverse events related to the use of nicotine gum and fresh lime during the 12-week treatment were measured as number and percent of participants in each group. |
| 7-day point prevalence abstinence (PAR) of lime and gum groups | week 4 | Point prevalence abstinence rate (PAR), which was defined as percentage of participants who were able to abstain from smoking any tobacco products during the preceding week, was evaluated at week 4, 8, 12 and 24. |
| continuous abstinence rates of the lime and gum groups | week 24 | CAR from week 9 through week 24 of the study was defined as proportion of participants who self-reported having refrained from smoking any tobacco products and confirmed by exhaled CO concentration of 10 ppm or less at all previous measurement points between week 9 and week 24. |
| intensity of craving using 100-mm VAS score | week 2 | Intensity of cravings after morning awakening among smokers in both groups were recorded on the day of clinic visits at week 2, 4, 8, 12, and 24 of the study using 100-mm visual analogue scale (VAS). Mean scores of those in the lime and gum groups was calculated and compared. |
Countries
Thailand
Outcome results
None listed