All 117 patients who received a complete course of CLT for their disease in one arm, one lower limb, or both lower limbs were analyzed separately. Among the 56 patients with lymphedema of one upper extremity, lymphedema decreased by an average of 62.6% following CLT. Lymphedema continued to decline during follow-up, and the reduction reached a maximum of 97.3% at 18 months following treatment. At 36 months, the reduction averaged 63.8%, which was more than the initial reduction with CLT (Figure 1).
Among the 39 patients with unilateral lower extremity lymphedema, CLT reduced lymphedema by an average of 68.6%. Over the 36-month follow-up period, the average reduction decreased to 62.7%, which did not represent a significant change from the initial reduction (Figure 2).
In the 22 patients with bilateral lower limb lymphedema, the average reduction in leg volume was 3,681 cm³ in the right leg and 3,432 cm³ in the left leg. As mentioned above, in order to calculate each individual's maintenance of reduction over the follow-up period, the initial reduction value was set at 100%. During follow-up, the reductions reached a high of 134% in the right leg and 154% in the left leg at 18 months. At the end of 36 months, the reduction was maintained at 100% in the right leg and increased to 120% in the left leg. These calculations included all patients regardless of compliance (Figure 3).
Compliance was analyzed in patients with one affected leg and those with one affected arm. As mentioned, the group with one affected arm had an average lymphedema reduction of 63% following CLT. Individuals who were noncompliant maintained a 43% subsequent reduction, those with 25% compliance had a 53% reduction, those with 50% compliance had a 60% reduction, and those with 75% compliance had a 58% reduction. However, in patients who were 100% compliant, lymphedema reduction increased to 79% during follow-up (Figure 4A). The difference between the 100% compliant group and the other groups was statistically significant (P less than .001).
In the individuals who had one lymphedematous leg, the average decrease in lymphedema after CLT was 69%. In patients who were 0%, 25%, 50%, 75%, and 100% compliant, lymphedema reductions during follow-up were 28%, 32%, 36%, 42%, and 79%, respectively (Figure 4B). The difference between the 100% compliant group and the other groups was statistically significant (P less than .001).
To demonstrate the benefits of CLT, three patients' courses will be illustrated.
Patient #1: A Woman With Secondary Upper Extremity Elephantiasis
This 84-year old woman developed severe grade 3 elephantiac lymphedema of the right upper extremity and hand in 1969 secondary to mastectomy plus axillary node dissection and radiation therapy. The patient had a history of multiple episodes of cellulitis. Prior to treatment, the patient's right upper extremity and hand were completely nonfunctional, and she required assistance with all activities of daily living.
The patient received four weeks of CLT and achieved a 77% reduction in the edema of her right upper extremity. On her most recent follow-up visit, the lymphedema had improved to a 92% reduction. Her right hand is now functional, and she is much more independent in dressing and other activities of daily living. Figure 5 and Figure 6 show this patient's hand and arm, respectively, before and after CLT and during follow-up.
Patient #2: A Man With Primary Lower Extremity Lymphedema
This 20-year-old male has had primary lymphedema of the left lower extremity since age 7. At age 12, he developed scrotal and penile edema that rapidly progressed with chylous reflux and leakage from the scrotum, buttocks, and left thigh. The patient had elephantiac skin, several open areas on the left thigh and buttocks, and numerous papillomas. Over the ensuing 8 years, he required hospitalization monthly in the ICU for cellulitis-septic shock. The patient has had several debulking surgeries on the lower extremity, scrotum, and penis, and sclerosing treatment of the abdominal lymphatics to reduce chylous reflux.
In November 1993, when the patient developed septic shock again, he received 14 CLT treatments. After a 2-week hospitalization, he received 13 additional days of CLT. After the 27 treatments, all open areas healed and papillomas, skin flaps, and bulges were greatly reduced in size and depth.
The patient was infection-free for 1 year, at which time he had an episode of cellulitis. The patient was treated in the hospital for 8 days with skin debridement, trunk massage, and compressive bandaging. With CLT, he lost 82 of the 89.1 cm³ of leg volume that developed during the episode of acute cellulitis. After this course of therapy, he bandaged himself at night and wore a Custom Jobst one-legged panty (60-mm Hg pressure) during the day.
The patient was well for 18 months until April 1996, when he was hospitalized for 7 days for cellulitis of the left hip. He was able to wear his compression garments after a few days in the hospital, and as a result, the left lower extremity remained stable. No residual increase in lymphedema occurred after the hospitalization.
The patient continues with his lymphedema exercises twice daily, and is once again doing very well, attending college and working. The two episodes of cellulitis in the 3 years since his CLT treatments were infrequent compared to his monthly hospitalizations for cellulitis prior to this form of therapy. Figure 7 shows the patient's leg before and after CLT and during follow-up.
Patient #3: A Woman With Secondary Upper Extremity Lymphedema
A 70-year-old female had a right mastectomy with axillary node dissection followed by radiation therapy in 1984. Minimal edema occurred immediately after the surgery. In 1987, a moderate increase in the lymphedema caused arm discomfort.
The patient was treated for several months with a sequential compression pump. The edema progressed during therapy, and the patient had her first attack of cellulitis in the right arm. Subsequently, episodes of cellulitis recurred approximately every 2 months.
The patient received 4 weeks of CLT in May 1993 and achieved an 82% reduction in the lymphedema of her right upper extremity. Initially, she was fitted with a compression sleeve and glove, and she progressed to an 85% reduction. The patient no longer requires the use of the compression glove and is wearing the compression sleeve from the wrist to axilla only. She has had no further episodes of cellulitis since CLT. Figure 8 shows the patient's arm before and after CLT and during follow-up.
Complex lymphedema therapy has been utilized throughout the world. The basic principle of this therapy is to increase lymphatic drainage by opening collateral circulation from the obstructed lymphotomes into normally functioning lymphotomes.
The Foldis have used CLT to treat over 2,500 patients a year in Germany, and average a 55% reduction in lymphedema in their initial phase of treatment. Their treatment program also has a second phase, which consists of periodic combined physiotherapy for the patient, compressive bandaging, garments, and physical therapy exercises.
It has been difficult for the Foldis to obtain long-term follow-up data on their patients due to the dispersal of many of the patients, as well as German medical regulations prohibiting visits for long-term follow-up. In a 3-year follow-up program, 50% of their patients maintained the initial reduction in lymphedema.
The Casley-Smiths have reported on 618 lymphedematous limbs treated with CPT by multiple therapists throughout Australia. Their results are similar to those obtained by the Foldis and those achieved in our study. The Casley-Smiths found that maintenance of lymphedema reductions, reported for 219 limbs, was directly related to compliance.
Our previous study showed reductions of 73% in arm lymphedema and 88% in leg lymphedema. The reductions of 63% in arm lymphedema and 69% in leg lymphedema seen in the current study, although slightly lower from these earlier results, are not significantly different.
Although double-blind studies are one of the mainstays of scientific investigation, Rothman and Michels have asserted that unless there is persuasive ethical justification, any study proposing the use of placebo in place of effective treatment should be disapproved and ignored. Both the Casley-Smiths and Foldis have stated that a meaningful blinded study on massage, exercises, and compression not only is difficult to perform with a control group but also is unethical since it is well recognized that CPT is highly effective and devoid of side effects.[5,8] Therefore, in this study, we report on all the consecutive patients who received CLT at our facility. The significant reductions in all types and grades of lymphedema achieved with CLT were well maintained.
Phase 2 is considered an essential part of lymphedema therapy. This phase involves the utilization of compressive bandages or garments, special physical therapy exercises, and/or maintenance retreatment. Following CLT, the maintenance program for our patients has consisted of the use of compressive garments and performance of special physical therapy exercises, without subsequent courses of CLT.
Impact of Compliance
Our analysis of compliance showed that the more compliant patients had a significantly increased rate of maintenance of and further decreases in lymphedema reduction. This was particularly evident in the patients with one affected lower limb; in this group, patients who were totally noncompliant had a lymphedema reduction of only 28% after 3 years. In those who were fully compliant, lymphedema reduction increased from an average of 68% to 79% after 3 years.
Evaluation of patients with 25%, 50%, and 75% compliance showed increased reductions with increasing compliance. When compliance was analyzed in patients with one affected arm, similar benefits of greater compliance were seen in all categories.
Drawbacks of CLT
There are several drawbacks of CLT. First, the treatment is labor intensive. Also, CLT requires specially trained physicians and therapists. As Foldi has stated, "It would be easier and cheaper to prescribe drugs than to use this labor intensive manual lymph treatment and bandaging. Unfortunately, no substitute has been found for combined physiotherapy."
There are few well-trained lymphedema physical therapists in the US. Unfortunately, without any certification for properly trained physical therapists in lymphedema, many poorly trained therapists perform treatments with poor results.
Complex lymphedema therapy produces an initial rapid decrease in all stages of lymphedema. The lymphedema reductions achieved with this safe, noninvasive treatment can be maintained and may even improve over time.
Patient compliance with the use of compressive garments and performance special exercises has a direct bearing on the maintenance of and increase in initial reductions. Not only does the long-term reduction in lymphedema improve patients' medical, physical, and economic quality of life, but also the increased comfort, appearance, and function are potent psychological stabilizers.