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For women, the average total body weight loss was 7.4% in the phentermine group and 8.7% in the phentermine-fenfluramine (Phen-Fen) group, but the difference was not statistically significant. Among men, the mean weight loss was 7.8% in the phentermine group and 8.2% in the Phen-Fen group, with no significant difference observed. Additionally, there were no notable differences in BMI reduction, severe adverse events, or dropout rates between the two groups for either gender.
Conclusions
This outpatient study did not identify a significant difference in weight loss outcomes between phentermine alone and the Phen-Fen combination therapy when used alongside a very-low-calorie diet (VLCD) for 12 weeks. Phentermine proved to be an effective option for achieving significant weight loss in combination with a VLCD. The drug’s tolerability and the positive physical response suggest that phentermine remains a valuable medication for obesity management in outpatient settings.
Obesity and Its Impact
Obesity is a widespread issue in the United States, affecting 1 in 2 Americans who are overweight and 1 in 3 who are classified as obese (BMI ≥ 30 kg/m²). It is well established that obesity increases the risk of developing hypertension, dyslipidemia, type 2 diabetes, cardiovascular disease, stroke, osteoarthritis, sleep apnea, and several cancers, including breast, prostate, and colon cancer. Obesity is a complex condition influenced by genetics, metabolism, nutrition, culture, and psychological factors. For many obese patients, effective weight loss can be achieved through a combination of pharmacotherapy, dietary changes, exercise, and behavioral interventions.
History of Phentermine and Phen-Fen
In 1992, researcher Weintraub compared the weight-loss effects of phentermine, fenfluramine, and their combination (Phen-Fen). The study suggested that Phen-Fen had a slightly greater effect than phentermine alone, leading to its widespread adoption. Many clinicians viewed Phen-Fen as a synergistic weight-loss treatment, targeting both noradrenergic and serotonergic pathways in the hypothalamus. This approach revolutionized obesity pharmacotherapy in the early 1990s.
During this period, the University of California, Los Angeles (UCLA) Obesity Center introduced a clinical appetite-suppressant program. Many patients chose to use phentermine alone with a VLCD rather than Phen-Fen or dexfenfluramine, primarily due to concerns about adverse effects. Dexfenfluramine was associated with serious side effects, including pulmonary hypertension, prompting its withdrawal from the market in September 1997 along with fenfluramine. However, adipex remained available because it was not linked to valvular disease or pulmonary hypertension.
Study Objective
The goal of this study was to evaluate the effectiveness of phentermine alone compared to Phen-Fen, when used alongside a VLCD for weight loss in an outpatient obesity treatment center.
Patients and Methods
The clinical program was conducted following a protocol approved by the UCLA Institutional Review Board. Data collection took place at the UCLA Outpatient University Obesity Center between 1993 and 1999. The center offers a multidisciplinary weight-loss program that includes weekly visits, a very-low-calorie diet (VLCD), and group classes focused on behavioral modification, nutrition, and exercise.
To be included in the study, patients had to meet the following criteria:
First-time participants in the program.
Minimum attendance of four clinic visits.
Use of either phentermine alone or the phentermine-fenfluramine (Phen-Fen) combination, with no other appetite suppressants.
Complete baseline medical records available.
Baseline BMI of ≥30 kg/m².
Participation in the program for at least 12 weeks.
Age of 18 years or older.
Exclusion criteria included any major medical or psychiatric conditions, and pregnant or lactating women were not eligible. Women of childbearing age were required to use an effective contraception method during the study. All participants provided written informed consent, and their identities remained confidential throughout the program.
A commercially prepared meal-replacement powder was used in an individually adjusted VLCD plan, providing 500 to 800 kcal/day. Each packet contained 100 kcal and 15 grams of high-quality protein and was mixed with water before consumption. Patients followed either a 500 kcal/day regimen (5 packets) or an 800 kcal/day plan (5 packets plus a defined 300 kcal meal).
Clinical Monitoring and Pharmacotherapy
Patients attended weekly clinic visits, where their vital signs and weight were recorded at baseline and each follow-up session. Additionally, blood tests (complete blood count, serum electrolytes, liver function tests) and electrocardiograms (ECG) were conducted at baseline and every two weeks thereafter.
Patients were prescribed either phentermine alone or Phen-Fen during weekly physician consultations. Dosage for the phentermine group included 8 mg, 10 mg, or 15 mg, taken once or twice daily. The Phen-Fen group received fenfluramine 20 mg once daily in combination with one of the phentermine dosages mentioned above. All patients began with the lowest adipex dosage, which was adjusted based on individual responses to appetite suppression, as reported through physician assessments or self-reports.
The choice between phentermine alone or Phen-Fen was determined by discussions between patients and their physicians. Patients with obesity-related conditions such as type 2 diabetes, hypertension, or dyslipidemia continued their prescribed medications, with adjustments made only under their primary care physician’s supervision. Physicians assessed diet adherence, treatment effectiveness, and potential adverse effects (AEs) at each visit.
Weight Loss and BMI Changes
Weight loss results for both treatment groups, separated by sex, are summarized in Table III. Figures 1 and 2 illustrate weight changes over 12 weeks for women and men, respectively.
In women, statistically significant weight loss in the phentermine group was observed by week 4 (P = 0.042 vs. Phen-Fen). However, there was no significant difference in weight loss between phentermine alone and Phen-Fen over the full 12 weeks.
At week 12, weight loss was 7.4% in the phentermine group and 8.7% in the Phen-Fen group, but this difference was not statistically significant.
Among men, weight loss at week 12 was 7.8% in the phentermine group and 8.2% in the Phen-Fen group, with no significant difference between the two.
BMI changes over 12 weeks were not significantly different between the phentermine and Phen-Fen groups for either men or women (Figures 3 and 4).
Statistical analysis confirmed that both groups and both sexes experienced significant weight loss over 12 weeks (P < 0.001 for all groups). However, the rate of weight loss was not significantly different between phentermine alone and Phen-Fen in either men or women.
Patient Dropout Rates
Table IV displays the dropout rates over the study period. No significant differences were observed between the phentermine and Phen-Fen groups for either gender:
Women: 10 patients (7.8%) in the adipex group and 14 patients (7.7%) in the Phen-Fen group dropped out by week 12.
Men: 5 patients (8.3%) in the phentermine group and 6 patients (7.8%) in the Phen-Fen group dropped out by week 12.
These findings indicate that phentermine alone and Phen-Fen had similar retention rates, suggesting comparable tolerability and adherence among participants.
Discussion
The prevalence of obesity has risen dramatically in recent decades, making it a significant public health issue in the United States. Obesity is a complex condition influenced by both genetic and environmental factors; therefore, no single treatment is universally effective. Although diet, exercise, and behavioral modification programs are widely recommended, they often fail to achieve ideal body weight. Even intensive weight-loss programs that incorporate pharmacotherapy face challenges such as high dropout rates and weight regain. However, research has shown that even a modest weight loss of around 10% of initial body weight can lead to substantial health benefits, including improvements in hypertension and type 2 diabetes.
Pharmacotherapy remains an area of interest in obesity treatment, though its effectiveness varies. The research conducted by Weintraub et al. significantly influenced medical practices in the 1990s, particularly regarding the phentermine-fenfluramine (Phen-Fen) combination. In a double-blind clinical trial, patients receiving Phen-Fen (15/60 mg per day) experienced an average weight loss of 14.6 kg (16%) over 24 weeks, compared to 10.0 kg with phentermine alone (15 mg/day) and 7.5 kg with fenfluramine alone (60 mg/day). Many experts believed that this combination was synergistic, affecting both noradrenergic and serotonergic pathways in the hypothalamus.
Phentermine has been available since the 1960s. One of the earliest long-term, double-blind, placebo-controlled studies was conducted by Duncan and Munro in 1968. In their study, 108 obese women were assigned to three groups: placebo, continuous adipex (30 mg daily), or intermittent phentermine (4 weeks on, 4 weeks off) for 36 weeks. Results showed significantly greater weight loss in patients using continuous (12.2 kg) or intermittent phentermine (13.0 kg) compared to placebo (4.8 kg). Reported adverse effects (AEs) were mild, with 8% of phentermine users and 3% of placebo users discontinuing due to stimulant-related side effects, such as agitation or insomnia. Other shorter-term, double-blind studies have also supported phentermine’s efficacy. In a four-month study by Truant et al., the mean weight loss in phentermine-treated patients was 8.8 kg, similar to the 10.4 kg loss observed in the Duncan and Munro study. Additionally, a 14-week study by Williams and Foulsham examined phentermine (30 mg daily) in 59 patients with osteoarthritis, revealing an 8.7% weight loss compared to 2.0% in the placebo group. Collectively, the available evidence suggests that phentermine is both effective and well tolerated.
In our study, phentermine was generally well tolerated, with only mild side effects such as insomnia and anxiety being reported. Additionally, few patients required dosage adjustments due to side effects, making our findings consistent with prior research.
However, certain limitations must be acknowledged. Our study was a nonrandomized, retrospective analysis, meaning treatment selection was not standardized by a specific algorithm or clinical criteria. This introduces the possibility of treatment bias. Another potential limitation is the use of very-low-calorie diets (VLCDs) alongside adipex or Phen-Fen, which prevents the isolation of drug effects from dietary interventions. VLCDs are known to be highly effective in producing short-term weight loss, which may have obscured potential differences between the phentermine-only and Phen-Fen groups.
Adherence to dietary interventions, particularly VLCDs, remains a significant challenge, as obesity studies typically report higher dropout rates than other clinical trials. In studies where adherence is a critical factor, noncompliant patients can be identified through screening strategies, but such trials do not always represent real-world clinical settings.
Our University Obesity Program operates as an outpatient research facility where patients pay for treatment, which differs from conventional research studies where participants are typically compensated. Although our population was self-selected, it reflects patients enrolled in commercial weight-loss programs that integrate VLCD and pharmacotherapy. Unlike many clinical trials, we did not use specific retention strategies, aside from offering a comprehensive, multidisciplinary obesity treatment. Therefore, our findings may be more representative of typical obesity specialty clinics.
Given the proven effectiveness of VLCDs in weight loss, our study found no significant difference between the effects of adipex alone and Phen-Fen when combined with VLCD over 12 weeks. This is a clinically relevant finding. Although fenfluramine is no longer available, both VLCD and phentermine remain viable treatment options. While our study supports the efficacy of these interventions, longer-term research is necessary to confirm the long-term safety and effectiveness of phentermine-based treatment regimens.